Generic Line
Boehringer Ingelheim, Teva Sued Over Aggrenox Pay-for-Delay Agreement
A California prosecutor is suing Boehringer Ingelheim and a Teva subsidiary, saying their $120 million agreement to push back the release of a generic Aggrenox blood thinner illegally delayed market competition for over seven years. Source: Generic Line
Read MoreDrugmakers Back Regeneron, Sanofi in Amgen Repatha Patent Case
Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from selling their cholesterol drug Praluent. Source: Generic Line
Read MoreCelltrion Files Challenges to Four of Genentech’s Herceptin Patents
South Korean biosimilars firm Celltrion is challenging the validity of four Genentech patents for combination therapies to treat metastatic breast cancer. Source: Generic Line
Read MoreInternational Regulators Release Template for Assessing Biowaivers
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Source: Generic Line
Read MoreFTC: Shire ViroPharma Filed Baseless Claims to Block Generics
A complaint from the Federal Trade Commission alleges Shire ViroPharma unlawfully stifled generic competition. Source: Generic Line
Read MoreGAO Downgrades Rating of FDA’s Action Plans for Postmarket Monitoring
In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate details and performance measures. Source: Generic Line
Read MoreAppeals Court Reverses Infringement Ruling on Shire’s Lialda Patent
In a loss for Shire, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit ruled Actavis did not infringe a patent covering the ulcerative colitis drug Lialda, reversing a lower court decision. Source: Generic Line
Read MoreGenerics Regulators Release Template for Biowaiver Assessment
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Source: Generic Line
Read More20 States Join Suit Accusing 6 Generics Makers of Price Fixing
Twenty states have joined an antitrust lawsuit accusing six generics makers of colluding to fix the price of generic versions of antibiotic doxycycline hyclate and the diabetes drug glyburide. Source: Generic Line
Read MoreLilly Prevails Against Teva’s Patent Case, Maintains Alimta Exclusivity Until 2022
Eli Lilly & Co. had their patent sustained by a federal appeals court, barring generics manufacturer Teva Pharmaceuticals from marketing its own version of the billion-dollar cancer drug Alimta. Source: Generic Line
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