MSN France

Exelixis had filed a pair of lawsuits against Teva centered on patents that expire in the 2030s, but now the companies have settled the cases. With stalwart cancer drug Cabometyx driving its commercial performance, Exelixis has put plenty of effort behind defending the drug's intellectual property. Now, a patent deal with generics giant Teva adds one more layer to its defenses. Sunday, Exelixis said it has resolved the patent litigation it brought against Teva in response to the latter company's generic application with the FDA. Under the settlement, Exelixis will grant Teva a license to market its Cabometyx generic starting on Jan. 1, 2031, Exelixis said in a release. Before launching, Teva's copycat would also have to win FDA approval. The companies didn't disclose the financial terms of the deal.  Last year, Exelixis filed a patent lawsuit (PDF) in response to Teva's advancement of a generic application with the FDA. The lawsuit asserted infringement of Exelixis' patent No. 11,298,349, which expires in February 2032.  Before that, Exelixis filed a lawsuit in 2021 centered on three patents, the latest of which expires in July 2033. The new settlement resolves all existing patent litigation between the companies in Delaware federal court. The deal is subject to review by U.S. authorities. Aside from Teva, Exelixis is pursuing patent claims against India's MSN Labs. In January, Exelixis said the Delaware federal court ruled in its favor, rejecting MSN's challenge to patent No. 7,579,473. After that ruling, Exelixis said it planned to ask the court for an order barring regulatory approval of MSN's generic until August 2026. Since its original approval in April 2016 to treat certain patients with renal cell carcinoma, Cabometyx has been a commercial driver for Exelixis. It's also picked up approvals in hepatocellular carcinoma and thyroid cancer and the franchise generated $1.4 billion last year. But the Teva deal also follows some clinical setbacks for the pair of Cabometyx and Roche's Tecentriq. In March, the company disclosed that the combo failed to stave off cancer progression or death compared with Cabometyx alone in kidney cancer patients who’ve progressed on initial immunotherapy.  That trial fail followed others for the combo in liver cancer and lung cancer.

PISCATAWAY, N.J., April 23, 2021 /PRNewswire/ -- MSN Labs, based in Hyderabad, India, received FDA approval to market their generic versions of Albendazole 200mg tablets (AB rated to Albenza©), Droxidopa 100mg, 200mg, 300mg capsules (AB rated to Northera ©), Deferasirox Granules 180mg, 360mg sachets (AB rated to Jadenu Sprinkles©) and Pregabalin ER 82.5mg, 165mg, 330mg tablets, (AB rated to Lyrica CR©) under the Novadoz label. Novadoz is the U.S sales and marketing affiliate for MSN's portfolio of finished dosage forms. The company has commenced shipping of all the products which received approvals during Q1 2021. Albendazole 200mg is marketed in bottles of 2 tablets. It is indicated for the treatment of neurocysticercosis which is an infection caused by the pork tapeworm in the muscles, brain, and eyes that may cause seizures, brain swelling, and vision problems. The most recent 12 month published sales of the brand and generics total $26.9mil. Droxidopa 100mg, 200mg, & 300mg are available in bottles of 30 capsules. It is indicated for the symptomatic treatment of dizziness, lightheadedness, or fainting/black out sensation due to neurogenic orthostatic hypotension (a sudden fall in blood pressure). Novadoz participated in a Day 1 launch of the product, coinciding with the expiration of the brand exclusivity. Previous 12 month published sales for the brand totaled $366mil. Novadoz has also offered a patient e-voucher assistance plan for those qualified consumers needing aid to cover their out of pocket prescription co-pay costs for Droxidopa. Visit NovadozPharma.com to learn more information on the program. Among their recent FDA approvals include niche products, Deferasirox Granules 180mg, and 360mg that are available in a carton of 30 sachets. The product is used treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions. The other niche offering includes Pregabalin ER 82.5mg, 165mg, and 330mg tablets available in bottles of 30. The product is indicated for the treatment of pain caused by nerve damage due to diabetes or shingles (herpes zoster). Seshu Akula, Novadoz President North America Generics, states, "The first quarter of 2021 was a very active period for the MSN/Novadoz organization with four FDA approvals. We successfully introduced these products to the market, while keeping pace with the high demand for our existing product line created by the pandemic." He adds, "MSN's position as a global leader in APIs has provided Novadoz with the scale and leveraged strength comparable to some of the largest generic pharma companies in the U.S. We are well positioned in the generic industry with a deep pipeline of oral solids, injectable, and specialty products that we expect to launch over the next 10 years." MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates. MSN is a global leader in this category. Additionally, the company also manufactures oral solids, liquids, and specialty injectable products in sixty-five markets throughout the world, doing business in the U.S. as Novadoz Pharmaceuticals. For more information, visit the company's websites at NovadozPharma.com & MSNLabs.com. CONTACT: Tom DeStefano Novadoz Pharmaceuticals Vice President Sales and Marketing (848) 200-1909