This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.

开始日期2023-02-27

申办/合作机构

The Queen's Medical Center

NCT04553068 / Completed临床3期

Phase 3 Double-blind Placebo-controlled Efficacy Trial of EVO100 Vaginal Gel for the Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection

开始日期2020-10-15

申办/合作机构

Evofem, Inc.

NCT03107377 / Completed临床2/3期

Phase 2B Double-blind Placebo-controlled Efficacy Trial of EVO100 (Previously Known as Amphora ® Gel) for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection

Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection

开始日期2017-11-03

申办/合作机构

Evofem, Inc.

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100 项与 L-乳酸/柠檬酸/酒石酸氢钾相关的临床结果

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100 项与 L-乳酸/柠檬酸/酒石酸氢钾相关的转化医学

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100 项与 L-乳酸/柠檬酸/酒石酸氢钾相关的专利（医药）

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项与 L-乳酸/柠檬酸/酒石酸氢钾相关的文献（医药）

2024-02-19·Journal of assisted reproduction and genetics

The combination of dydrogesterone and micronized vaginal progesterone can render serum progesterone level measurements on the day of embryo transfer and rescue attempts unnecessary in an HRT FET cycle.

Article

作者: B Lawrenz ; E Kalafat ; B Ata ; R Del Gallego ; L Melado ; I Elkhatib ; H Fatemi

PURPOSE:

To evaluate the role of serum progesterone (P4) on the day of embryo transfer (ET) when dydrogesterone (DYD) and micronized vaginal progesterone (MVP) are combined as luteal phase support (LPS) in a hormone replacement therapy (HRT) frozen ET (FET) cycles.

METHODS:

Retrospective study, including single euploid HRT FET cycles with DYD and MVP as LPS and P4 measurement on ET day. Initially, patients with P4 levels < 10 ng/ml increased MVP to 400 mg/day; this "rescue" was abandoned later.

RESULTS:

560 cycles of 507 couples were included. In 275 women, serum P4 level was < 10 ng/ml on the ET day. Among those with low P4 levels, MVP dose remained unchanged in 65 women (11.6%) and was increased in 210 women (37.5%). Women with P4 levels ≥ 10 ng/ml continued LPS without modification. Overall pregnancy rates in these groups were 61.5% (40/65), 54.8% (115/210), and 48.4% (138/285), respectively (p = n.s.). Association of serum P4 levels with ongoing pregnancy rates was analyzed in women without any additional MVP regardless of serum P4 levels (n = 350); multivariable analysis (adjusted for age, BMI, embryo quality (EQ)) did not show a significant association of serum P4 levels with OPR (OR 0.96, 95% CI 0.90-1.02; p = 0.185). Using inverse probability treatment weights, regression analysis in the weighted sample showed no significant association between P4 treatment groups and OP. Compared to fair EQ, the transfer of good EQ increased (OR 1.61, 95% CI 1.22-2.15; p = 0.001) and the transfer of a poor EQ decreased the odds of OP (OR 0.73, 95% CI 0.55-0.97; p = 0.029).

CONCLUSION:

In HRT FET cycle, using LPS with 300 mg/day MVP and 30 mg/day DYD, it appears that serum P4 measurement and increase of MVP in patients with P4 < 10 ng/ml are not necessary.

2023-12-18·Human reproduction (Oxford, England)

Oral dydrogesterone versus micronized vaginal progesterone for luteal phase support: a double-blind crossover study investigating pharmacokinetics and impact on the endometrium.

Article

作者: S Loreti ; K Thiele ; M De Brucker ; C Olsen ; J Centelles-Lodeiro ; C Bourgain ; W Waelput ; H Tournaye ; G Griesinger ; J Raes ; S Vieira-Silva ; P Arck ; C Blockeel ; S Mackens

STUDY QUESTION:

How do plasma progesterone (P) and dydrogesterone (D) concentrations together with endometrial histology, transcriptomic signatures, and immune cell composition differ when oral dydrogesterone (O-DYD) or micronized vaginal progesterone (MVP) is used for luteal phase support (LPS)?

SUMMARY ANSWER:

Although after O-DYD intake, even at steady-state, plasma D and 20αdihydrodydrogesterone (DHD) concentrations spiked in comparison to P concentrations, a similar endometrial signature was observed by histological and transcriptomic analysis of the endometrium.

WHAT IS KNOWN ALREADY:

O-DYD for LPS has been proven to be noninferior compared to MVP in two phase III randomized controlled trials. Additionally, a combined individual participant data and aggregate data meta-analysis indicated that a higher pregnancy rate and live birth rate may be obtained in women receiving O-DYD versus MVP for LPS in fresh IVF/ICSI cycles. Little data are available on the pharmacokinetic (PK) profiles of O-DYD versus MVP and their potential molecular differences at the level of the reproductive organs, particularly at the endometrial level.

STUDY DESIGN, SIZE, DURATION:

Thirty oocyte donors were planned to undergo two ovarian stimulation (OS) cycles with dual triggering (1.000 IU hCG + 0.2 mg triptorelin), each followed by 1 week of LPS: O-DYD or MVP, in a randomized, cross-over, double-blind, double-dummy fashion. On both the first and eighth days of LPS, serial blood samples upon first dosing were harvested for plasma D, DHD, and P concentration analyses. On Day 8 of LPS, an endometrial biopsy was collected for histologic examination, transcriptomics, and immune cell analysis.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

All oocyte donors were <35 years old, had regular menstrual cycles, no intrauterine contraceptive device, anti-Müllerian hormone within normal range and a BMI ≤29 kg/m2. OS was performed on a GnRH antagonist protocol followed by dual triggering (1.000 IU hCG + 0.2 mg triptorelin) as soon as ≥3 follicles of 20 mm were present. Following oocyte retrieval, subjects initiated LPS consisting of MVP 200 mg or O-DYD 10 mg, both three times daily. D, DHD, and P plasma levels were measured using liquid chromatography-tandem mass spectrometry. Histological assessment was carried out using the Noyes criteria. Endometrial RNA-sequencing was performed for individual biopsies and differential gene expression was analyzed. Endometrial single-cell suspensions were created followed by flow cytometry for immune cell typing.

MAIN RESULTS AND THE ROLE OF CHANCE:

A total of 21 women completed the entire study protocol. Subjects and stimulation characteristics were found to be similar between groups. Following the first dose of O-DYD, the average observed maximal plasma concentrations (Cmax) for D and DHD were 2.9 and 77 ng/ml, respectively. The Cmax for D and DHD was reached after 1.5 and 1.6 h (=Tmax), respectively. On the eighth day of LPS, the first administration of that day gave rise to a Cmax of 3.6 and 88 ng/ml for D and DHD, respectively. For both, the observed Tmax was 1.5 h. Following the first dose of MVP, the Cmax for P was 16 ng/ml with a Tmax of 4.2 h. On the eighth day of LPS, the first administration of that day showed a Cmax for P of 21 ng/ml with a Tmax of 7.3 h. All 42 biopsies showed endometrium in the secretory phase. The mean cycle day was 23.9 (±1.2) in the O-DYD group versus 24.0 (±1.3) in the MVP group. RNA-sequencing did not reveal significantly differentially expressed genes between samples of both study groups. The average Euclidean distance between samples following O-DYD was significantly lower than following MVP (respectively 12.1 versus 18.8, Mann-Whitney P = 6.98e-14). Immune cell profiling showed a decrease of CD3 T-cell, γδ T-cell, and B-cell frequencies after MVP treatment compared to O-DYD, while the frequency of natural killer (NK) cells was significantly increased.

LIMITATIONS, REASONS FOR CAUTION:

The main reason for caution is the small sample size, given the basic research nature of the project. The plasma concentrations are best estimates as this was not a formal PK study. Whole tissue bulk RNA-sequencing has been performed not correcting for bias caused by different tissue compositions across biopsies.

WIDER IMPLICATIONS OF THE FINDINGS:

This is the first study comparing O-DYD/MVP, head-to-head, in a randomized design on a molecular level in IVF/ICSI. Plasma serum concentrations suggest that administration frequency is important, in addition to dose, specifically for O-DYD showing a rapid clearance. The molecular endometrial data are overall comparable and thus support the previously reported noninferior reproductive outcomes for O-DYD as compared to MVP. Further research is needed to explore the smaller intersample distance following O-DYD and the subtle changes detected in endometrial immune cells.

STUDY FUNDING/COMPETING INTEREST(S):

Not related to this work, C.Bl. has received honoraria for lectures, presentations, manuscript writing, educational events, or scientific advice from Abbott, Ferring, Organon, Cooper Surgical, Gedeon-Richter, IBSA, and Merck. H.T. has received honoraria for lectures, presentations, manuscript writing, educational events, or scientific advice from Abbott, Ferring, Cooper Surgical, Gedeon-Richter, Cook, and Goodlife. S.M. has received honoraria for lectures, presentations, educational events, or scientific advice from Abbott, Cooper Surgical, Gedeon-Richter, IBSA, and Merck and Oxolife. G.G. has received honoraria for lectures, presentations, educational events, or scientific advice from Merck, MSD, Organon, Ferring, Theramex, Gedeon-Richter, Abbott, Biosilu, ReprodWissen, Obseva, PregLem, Guerbet, Cooper, Igyxos, and OxoLife. S.V.-S. is listed as inventor on two patents (WO2019115755A1 and WO2022073973A1), which are not related to this work.

TRIAL REGISTRATION NUMBER:

EUDRACT 2018-000105-23.

2023-10-11·Reproductive biomedicine online

Circadian serum progesterone variations on the day of frozen embryo transfer in artificially prepared cycles.

Article

作者: Sara Loreti ; Caroline Roelens ; Panagiotis Drakopoulos ; Neelke De Munck ; Herman Tournaye ; Shari Mackens ; Christophe Blockeel

RESEARCH QUESTION:

What is the intra-day variation of serum progesterone related to vaginal progesterone administration on the day of frozen embryo transfer (FET) in an artificial cycle?

DESIGN:

A prospective cohort study was conducted including 22 patients undergoing a single blastocyst artificial cycle (AC)-FET from August to December 2022. Endometrial preparation was achieved by administering oestradiol valerate (2 mg three times daily) and consecutively micronized vaginal progesterone (MVP; 400 mg twice daily). A blastocyst FET was performed on the 6th day of MVP administration. Serum progesterone concentrations were measured on the day of transfer at 08:00, 12:00, 16:00 and 20:00 hours. The first and last blood samples were collected just before MVP was administered.

RESULTS:

The mean age and body mass index of the study population were 33.95 ± 3.98 years and 23.10 ± 1.95 kg/m². The mean P-values at 08:00, 12:00, 16:00 and 20:00 hours were 11.72 ± 4.99, 13.59 ± 6.33, 10.23 ± 3.81 and 9.28 ± 3.09 ng/ml, respectively. A significant decline, of 2.41 ng/ml (95% confidence interval 0.81-4.00), was found between the first and last progesterone measurements.

CONCLUSION:

A statistically significant intra-day variation of serum progesterone concentrations on the day of FET in artificially prepared cycles was observed. This highlights the importance of a standardized procedure for the timing of progesterone measurement on the day of AC-FET. Of note, the study results are applicable only to women using MVP for luteal phase support; therefore it is necessary to confirm its validity in comparison with the different existing administration routes of progesterone.

项与 L-乳酸/柠檬酸/酒石酸氢钾相关的新闻（医药）

2024-03-20

·PRNewswire

Evofem Negotiates Improved Rebate for Hormone-Free "In the Moment" Contraceptive PHEXXI with Medi-Cal

— Medi-Cal serves more than 15.4 million Californians — — 7.4% improvement in Phexxi rebate to take effect July 1, 2024 — SAN DIEGO, March 20, 2024 /PRNewswire/ -- Commercial-stage women's health innovator Evofem Biosciences, Inc. (OTCQB: EVFMD) today announced that it has successfully renegotiated the rebate for Phexxi® (lactic acid, citric acid and potassium bitartrate), its hormone-free, woman-controlled contraceptive, with Medi-Cal, the California state Medicaid program. Phexxi is the first and only locally-acting contraceptive gel approved by the FDA. It is applied zero-to-60 minutes before intercourse and works, without hormones, by maintaining the natural vaginal biome with a pH that is naturally inhospitable to sperm. Medi-Cal is funded by the California Department of Health Care Services, the largest health care purchaser in the state, and serves more than 15.4 million beneficiaries. The renegotiated rebate improves Evofem's rebate on Medi-Cal prescriptions by 7.4%, while affording price protection to Medi-Cal against future Phexxi WAC increases. The new rebate will take effect July 1, 2024. The vaginal pH modulator continues to be included on the Medi-Cal Rx Family Planning, Access, Care, and Treatment Pharmacy Formulary. Medi-Cal beneficiaries may receive one box of 12 single-use Phexxi applicators per dispensing, and up to three boxes in any 75-day period. Evofem recently entered into a definitive agreement to be acquired by Aditxt, Inc. (Nasdaq: ADTX). Evofem believes the contemplated transaction represents a compelling opportunity to accelerate its growth trajectory, as a subsidiary of Aditxt, into a multi-product women's health franchise. The companies are working toward close in the second half of 2024. About Evofem Biosciences Evofem Biosciences, Inc., is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com. Phexxi® is a registered trademark of Evofem Biosciences, Inc. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the expected effective date of the Medi-Cal rebate and the anticipated benefits of the contemplated Aditxt transaction and timing thereof. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on April 27, 2023, Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 14, 2023 and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. Contact Amy Raskopf Evofem Biosciences, Inc. [email protected] (917) 673-5775 SOURCE Evofem Biosciences, Inc.

并购上市批准

2024-03-07

·PRNewswire

For Women Using GLP-1 Receptor Agonists who take Oral Birth Control Pills, Hormone-Free Phexxi Contraceptive Gel is a Logical Solution to Help Prevent Unintended Pregnancy

-- New weight loss drugs like Ozempic, Wegovy and Zepbound may make oral birth control pills less effective at certain points -- SAN DIEGO, March 7, 2024 /PRNewswire/ -- Use of GLP-1 receptor agonists, or GLP-1s, is skyrocketing in the United States, with more than nine million prescriptions for Ozempic, Wegovy, Mounjaro, and similar diabetes and obesity drugs written during the last three months of 2022 alone.1 Zepbound weekly prescriptions hit 25,000 in December 2023, just one month after it was approved to treat obesity.2 These drugs may make oral birth control pills less effective at certain points in the dosing schedule, making an unintended pregnancy more likely. Eli Lilly's Mounjaro and Zepbound, which contain the same compound, clearly instruct prescribers to "advise females using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation."3 Patients are cautioned that "birth control pills may not work as well," and that their "healthcare provider may recommend another type of birth control…"4 "The use of GLP-1 agonists to help women lose weight has become more prevalent," noted Lisa Rarick, M.D., FACOG, an OB-GYN working in Washington D.C. "For women who take oral contraceptives in conjunction with these medications, it is imperative they be counseled on options for back-up contraception, since many of these medications could interact with oral contraceptives, making them less effective. This highlights the critical need for a non-systemic, non-hormonal method, like Phexxi, to prevent unintended pregnancy." Users of oral birth control considering GLP-1 treatment are encouraged to plan ahead to prevent unintended pregnancy. Having a contraceptive strategy in place and the right product at your fingertips enables spontaneous intimacy no matter where you are in your GLP-1 dosing schedule. An on-demand, hormone-free method is a logical choice to provide these patients additional protection they need. One such option, Phexxi® (lactic acid, citric acid, and potassium bitartrate) vaginal gel, puts the power in her hands and with an FDA-approved contraceptive that she uses only when she needs it. The company behind Phexxi, women's health innovator Evofem Biosciences, Inc. (OTCQB: EVFM), recently entered into a definitive agreement to be acquired by Aditxt, Inc. (Nasdaq: ADTX). Evofem believes the contemplated transaction represents a compelling opportunity to accelerate its growth trajectory, as a subsidiary of Aditxt, into a multi-product women's health franchise. The companies are working toward a mid-2024 close. About Evofem Biosciences Evofem Biosciences is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com. Phexxi® is a registered trademark of Evofem Biosciences, Inc. Sources 1 Trilliant Health report September 2023. 2 Reuters 'Lilly CEO says weight-loss drug Zepbound weekly prescriptions hit 25,000 in December.' 1/8/2024 3 Zepbound Prescribing Information. 4 Zepbound Safety Summary with Warnings. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, including, without limitation, the anticipated benefits of the contemplated Aditxt transaction and timing thereof. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on April 27, 2023, Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 14, 2023 and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. Media Contact [email protected] Investor Contact Amy Raskopf Evofem Biosciences, Inc. [email protected] Mobile: (917) 673-5775 SOURCE Evofem Biosciences, Inc.

并购上市批准

2024-02-04

·赛柏蓝

34个重磅专利到期药物（附名单）

作者 | 骎丹翼来源 | 药智网2024年，美国将有34款药物的关键专利到期，其中强生的重磅炸弹药物Xarelto(rivaroxaban)最值得关注。以下为笔者盘点的关键专利到期的药物信息，包含销售商、获批时间、适应症、销售额等数据。1.Auryxia(ferric citrate)销售商：Keryx Biopharmaceuticals,Inc.获批时间：2014年9月5日适应症和用途：控制透析患者的血清磷水平、未接受透析的成年慢性肾病患者的缺铁性贫血。关键专利到期时间：2024年2月18日药物专利数量：14销售额：预计2023年净产品收入1.75-1.8亿美元2.Spravato(esketamine hydrochloride)销售商：Janssen获批时间：2019年3月5日适应症和用途：患有难治性抑郁症(TRD)的成人、具有自杀想法或行为的重度抑郁症(MDD)成人的抑郁症状。关键专利到期时间：2024年3月5日药物专利数量：6销售额：2023年前三季度4.83亿美元3.Phexxi(citric acid;lactic acid;potassium bitartrate)销售商：Evofem获批时间：2020年5月22日适应症和用途：女性避孕。关键专利到期时间：2024年3月6日药物专利数量：4销售额：2022年1.68亿美元4.Exparel(bupivacaine)销售商：Pacira Pharms获批时间：2011年10月28日适应症和用途：长效酰胺类局麻药，用于术后镇痛。关键专利到期时间：2024年3月22日药物专利数量：9销售额：2023年净产品收入5.38亿美元5.Ionsys(fentanyl hydrochloride)销售商：The Medicines Co获批时间：2015年5月22日适应症和用途：芬太尼离子电渗透皮系统，用于对需要阿片类镇痛的住院成人进行急性术后疼痛的短期管理。关键专利到期时间：2024年4月1日药物专利数量：86.Contrave(bupropion hydrochloride;naltrexone hydrochloride)销售商：Nalpropion获批时间：2014年9月10日适应症和用途：一种氨基酮类抗抑郁药和阿片类拮抗剂的组合，可作为低热量饮食和增加体力活动的辅助手段，以实现长期体重管理。关键专利到期时间：2024年4月21日药物专利数量：207.Natroba(spinosad)销售商：Parapro获批时间：2011年1月18日适应症和用途：多种体外寄生虫适应症。关键专利到期时间：2024年4月28日药物专利数量：28.Rydapt(midostaurin)销售商：诺华获批时间：2017年4月28日适应症和用途：FLT3突变的急性髓系白血病和系统性肥大细胞增多症。关键专利到期时间：2024年4月28日药物专利数量：2销售额：2022年4.2亿美元9.Tralement(cupric sulfate;manganese sulfate;selenious acid;zinc sulfate)销售商：Am Regent获批时间：2020年7月2日适应症和用途：口服或肠内营养不可能、不足或禁忌时，作为肠外营养的锌、铜、锰和硒的来源。关键专利到期时间：2024年4月30日药物专利数量：110.Radicava(edaravone)销售商：Mitsubishi Tanabe获批时间：2017年5月5日适应症和用途：肌萎缩侧索硬化症（ALS）。关键专利到期时间：2024年5月5日药物专利数量：4销售额：2021财年1.9亿美元11.Omontys(peginesatide acetate)销售商：Takeda获批时间：2012年3月27日（已退市）适应症和用途：成人透析患者慢性肾病(CKD)所致贫血的治疗。关键专利到期时间：2024年5月12日药物专利数量：612.Ulesfia(benzyl alcohol)销售商：Shionogi获批时间：2009年4月13日适应症和用途：非神经毒性头虱。关键专利到期时间：2024年5月12日药物专利数量：613.Adasuve(loxapine)销售商：Alexza Pharmaceuticals获批时间：2012年12月21日适应症和用途：与精神分裂症或躁郁症相关的躁动。关键专利到期时间：2024年5月20日药物专利数量：514.Children's Advil Allergy Sinus销售商：葛兰素史克获批时间：2004年2月24日适应症和用途：由过敏或普通感冒引起的打喷嚏、瘙痒、流泪、流鼻涕、鼻塞、鼻窦充血、头痛、疼痛或发烧。关键专利到期时间：2024年5月25日药物专利数量：115.Gleolan(aminolevulinic acid hydrochloride)销售商：NX Development Corp.获批时间：2017年6月6日适应症和用途：神经胶质瘤手术期间的光学成像。关键专利到期时间：2024年6月6日16.Ilevro(nepafenac)销售商：Harrow Eye获批时间：2012年10月16日适应症和用途：缓解白内障眼部手术后的眼睛疼痛、刺激和发红。关键专利到期时间：2024年6月8日药物专利数量：317.Vyleesi(Autoinjector)(bremelanotide acetate)销售商：Palatin Technologies获批时间：2019年7月8日适应症和用途：性欲减退症。关键专利到期时间：2024年6月21日药物专利数量：518.Triptodur kit(triptorelin pamoate)销售商：Azurity获批时间：2017年6月30日适应症和用途：性早熟。关键专利到期时间：2024年7月29日药物专利数量：119.Endari(L-glutamine)销售商：Emmaus Medical获批时间：2017年7月7日适应症和用途：镰状细胞性贫血症。关键专利到期时间：2024年7月7日药物专利数量：1销售额：2023年前三季度2250万美元20.Dalvance(dalbavancin hydrochloride)销售商：艾伯维获批时间：2014年5月23日适应症和用途：由敏感革兰氏阳性菌（包括耐甲氧西林金黄色葡萄球菌（MRSA））引起的急性细菌性皮肤和皮肤结构感染（ABSSSI）的成人患者。关键专利到期时间：2024年7月22日药物专利数量：421.Kimyrsa(oritavancin diphosphate)销售商：艾伯维获批时间：2021年3月15日适应症和用途：成人急性细菌性皮肤和皮肤结构感染（ABSSSI）。关键专利到期时间：2024年8月6日药物专利数量：322.Orbactiv(oritavancin diphosphate)销售商：Melinta Therapeutics获批时间：2014年8月6日适应症和用途：急性细菌性皮肤和皮肤结构感染（ABSSSI）。关键专利到期时间：2024年8月6日药物专利数量：323.Oriahnn(Copackaged)销售商：艾伯维获批时间：2020年5月29日适应症和用途：绝经前妇女与子宫肌瘤（纤维瘤）相关的大量月经出血。关键专利到期时间：2024年9月10日药物专利数量：724.Orilissa(elagolix sodium)销售商：艾伯维获批时间：2018年7月24日适应症和用途：与子宫内膜异位症相关的中度至重度疼痛。关键专利到期时间：2024年9月10日药物专利数量：1025.Somatuline Depot(lanreotide acetate)销售商：Ipsen获批时间：2014年12月16日适应症和用途：胃肠胰神经内分泌肿瘤。关键专利到期时间：2024年9月15日26.Sustol(granisetron)销售商：Heron Therapeutics获批时间：2016年8月9日适应症和用途：化疗引起的恶心/呕吐。关键专利到期时间：2024年9月28日药物专利数量：5销售额：2023年前三季度净产品销售额930万美元27.Prialt(ziconotide acetate)销售商：TerSera获批时间：2004年12月28日适应症和用途：治疗需要鞘内治疗以及对其他治疗（例如全身镇痛药、辅助治疗或IT吗啡）不耐受或无效的患者的严重慢性疼痛。关键专利到期时间：2024年10月1日药物专利数量：328.Ascor(ascorbic acid)销售商：Mcguff获批时间：2017年13月3日适应症和用途：坏血病。关键专利到期时间：2024年10月2日29.Fluorodopa F18(fluorodopa f-18)销售商：Feinstein获批时间：2019年10月10日适应症和用途：对疑似帕金森综合症的成年患者的某些神经细胞进行视觉检测。关键专利到期时间：2024年10月10日30.Byetta(exenatide synthetic)销售商：Amylin Pharmaceuticals/Eli Lilly&Co.获批时间：2005年4月28日适应症和用途：2型糖尿病。关键专利到期时间：2024年11月4日销售额：2019年1.8亿美元31.Exem Foam Kit(air polymer-type a)销售商：ExEm Foam Inc.获批时间：2019年11月7日适应症和用途：检测已知或疑似不孕女性的输卵管通畅性。关键专利到期时间：2024年11月7日32.Nourianz(istradefylline)销售商：Kyowa Hakko Kirin Inc.获批时间：2019年8月27日适应症和用途：帕金森病。关键专利到期时间：2024年11月13日药物专利数量：4销售额：2021年1亿美元33.Macrilen(macimorelin acetate)销售商：诺和诺德获批时间：2017年12月20日适应症和用途：成人生长激素缺乏症的诊断。关键专利到期时间：2024年12月20日药物专利数量：134.Xarelto(rivaroxaban)销售商：Janssen获批时间：2011年7月1日适应症和用途：抗血栓。关键专利到期时间：2024年12月20日药物专利数量：5销售额：2022年24.7亿美元Ref.1.Constantino,A.K.Big pharma is at a crossroads,as J&J,Merck and others prepare to lose heaps of revenue from blockbuster drugs.CNBC.28.01.2024.2.Friedman,Y.United States:These 47 Drugs Face Patent Expirations and Generic Entry From 2024–2025.DrugPatentWatch.com.Retrieved on 31.01.2024.END医药代表交流群扫描下方二维码加入医药代理商转型交流群扫描下方二维码加入

专利到期

100 项与 L-乳酸/柠檬酸/酒石酸氢钾相关的药物交易

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外链

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研发状态

适应症	最高研发状态	国家/地区	公司
避孕	批准上市	美国更多	Evofem, Inc. 更多
淋病	临床3期	美国更多	Evofem, Inc. 更多
衣原体感染	临床3期	美国更多	Evofem, Inc. 更多
外阴阴道念珠菌病	临床1期	美国更多	The Queen's Medical Center 更多

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2004	临床3期	非小细胞肺癌	432	Docetaxel/carboplatin	鹽憲鬱餘齋窪膚膚網積(膚艱鏇鏇範壓餘鹽鑰窪) = 遞衊鑰淵蓋觸夢製簾鏇範壓憲選衊壓蓋繭網顧 (選夢襯願鑰夢簾簾網壓 ) 更多	-	2004-07-15
				MIC/MVP	鹽憲鬱餘齋窪膚膚網積(膚艱鏇鏇範壓餘鹽鑰窪) = 夢鬱構遞鏇鹽製鹽遞構範壓憲選衊壓蓋繭網顧 (選夢襯願鑰夢簾簾網壓 ) 更多
NCT04553068 (EVOGUARD, PRNewswire) 人工标引	临床3期	衣原体感染 \| 淋病	1,903	EVO100	膚觸製糧鹹壓鏇鏇淵網(糧願憲鹽製淵艱選衊壓) = Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints. 製齋壓遞蓋簾壓齋糧繭 (淵壓衊膚憲壓積顧網鏇 )	不佳	2022-10-11
				Placebo
NCT03107377 (CTgov)	临床2/3期	沙眼衣原体感染	860	EVO100 (EVO100)	淵顧夢艱選餘鬱顧壓鬱(獵餘築鹽築蓋餘顧願襯) = 壓糧選積築艱餘膚窪鬱願醖網齋襯範鬱憲鹽獵 (選窪鏇製願膚壓網鏇艱, 醖淵繭鹽窪憲餘製構醖 ~ 構衊簾醖遞繭齋膚襯憲) 更多	-	2020-08-12
				Placebo (Placebo)	淵顧夢艱選餘鬱顧壓鬱(獵餘築鹽築蓋餘顧願襯) = 網醖觸製顧醖衊衊廠願願醖網齋襯範鬱憲鹽獵 (選窪鏇製願膚壓網鏇艱, 淵鹹艱願蓋醖醖鬱廠窪 ~ 鬱選築鹽淵壓製範鑰衊) 更多
OLCSG 0007 (Pubmed \| J Urol)	临床3期	局部晚期非小细胞肺癌	200	Docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT)	齋膚選壓鹹鹽範鏇遞鏇(蓋鏇鹹鬱襯淵鹹簾餘廠) = 鏇窪繭願選鏇遞餘鹽顧糧網蓋餘襯壓淵願選鬱 (夢繭願艱積廠憲願鬱壓 ) 更多	积极	2010-07-10
				Mitomycin, vindesine,Mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT	齋膚選壓鹹鹽範鏇遞鏇(蓋鏇鹹鬱襯淵鹹簾餘廠) = 觸選糧蓋淵範範膚夢廠糧網蓋餘襯壓淵願選鬱 (夢繭願艱積廠憲願鬱壓 ) 更多
WJTOG0105 (ASCO2009)	临床3期	非小细胞肺癌 III期	456	MVP	(願襯鹽鏇窪簾鏇壓顧憲) = 壓範鑰衊夢淵願艱衊衊顧糧壓鹽構獵廠製網廠 (襯顧構範蓋醖餘壓觸構 ) 更多	-	2009-05-20
				IC	(願襯鹽鏇窪簾鏇壓顧憲) = 窪積蓋製襯夢製鬱遞簾顧糧壓鹽構獵廠製網廠 (襯顧構範蓋醖餘壓觸構 ) 更多
EHA2019	N/A	肿瘤 \| 复发难治性急性淋巴细胞白血病	16	MVP (CD19 CAR-T)	艱鏇簾範襯艱夢憲鬱糧(積願選製築構艱獵選鏇) = 蓋夢鑰顧餘餘製醖選構願鏇獵廠齋鏇網構願繭 (簾餘網顧鹽選蓋膚膚簾 ) 更多	-	2019-06-15
				MVP (CD22 CAR-T)	艱鏇簾範襯艱夢憲鬱糧(積願選製築構艱獵選鏇) = 獵獵膚淵製鏇鬱鏇鹹壓願鏇獵廠齋鏇網構願繭 (簾餘網顧鹽選蓋膚膚簾 ) 更多
ASCO2007	临床3期	非小细胞肺癌 III期	456	MVP	(構艱衊鏇膚窪窪襯鹽獵) = 醖鹽願顧淵壓簾齋廠製鹹夢顧廠廠網遞選製憲 (糧廠網壓艱艱顧觸淵醖 ) 更多	不佳	2007-06-20
				IC	(構艱衊鏇膚窪窪襯鹽獵) = 遞壓醖淵積鹹觸鹹廠廠鹹夢顧廠廠網遞選製憲 (糧廠網壓艱艱顧觸淵醖 ) 更多
NCT03107377 (AMPREVENCE, Pubmed \| Am J Obstet Gynecol)	临床2/3期	感染	860	EVO100	(積繭淵繭蓋壓夢簾簾顧) = 4.6% [18/388] 鏇網鬱觸製範繭夢壓網 (遞壓築選壓糧鏇築遞鬱 ) 更多	积极	2021-03-08
				Placebo
NCT04553068 (CTgov)	临床3期	沙眼衣原体感染 \| 淋病	1,892	EVO100 (EVO100 Gel)	膚廠構壓憲網憲網窪蓋(築鑰膚蓋淵糧蓋構製願) = 觸衊窪遞築鑰鬱糧窪獵壓製鑰網構鏇網構鏇餘 (醖蓋製顧醖獵醖構製餘, 鏇願衊衊衊衊窪積製窪 ~ 願顧鹹簾選範願鹹鑰鹽) 更多	-	2024-01-30
				Placebo (Placebo Gel)	膚廠構壓憲網憲網窪蓋(築鑰膚蓋淵糧蓋構製願) = 衊鬱廠鬱壓製齋淵願選壓製鑰網構鏇網構鏇餘 (醖蓋製顧醖獵醖構製餘, 廠觸廠窪顧獵選鹽鏇顧 ~ 夢醖淵獵繭膚壓衊壓窪) 更多