We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Mylan and Sandoz have filed a legal brief with the U.S. Supreme Court challenging Teva’s appeal to salvage the patent protection on its blockbuster multiple sclerosis drug Copaxone. Read More
Generic versions of Depomed’s shingles drug Gralise are unlikely in the near future after a federal judge sided with the brand manufacturer’s patent infringement suit against a 2012 ANDA filed by Actavis. Read More
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized last week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
Indian generics maker Dr. Reddy’s Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. Read More
The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More
Indian generics makers have hired a U.S.-based lobbyist to head off the threat of a trade downgrade and polish an image that has been tarnished by FDA import bans and warning letters for manufacturing practice violations. Read More
Alabama’s Supreme Court Aug. 15 reaffirmed its ruling that a brand drugmaker can be held liable for damages caused by a generic version of its product if the generic carries warning labels that are drafted by the brand company. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts about the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
AstraZeneca is suing India-based generics firm Zydus Cadila to block its bid for a version of the brand manufacturer’s acid-reflux drug Nexium. Read More
New Jersey-based Mutual Pharmaceutical and two other generics firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale. Read More
Boehringer Ingelheim is suing Amneal Pharmaceuticals over its bid to make a generic version of the brand manufacturer’s anti-stroke drug Aggrenox. Read More
A group of brand and generic drugmakers has asked a federal judge to toss out a multidistrict class action lawsuit accusing them of colluding to delay generic versions of the painkiller Lidoderm, arguing that a patent infringement settlement between the parties was anything but anticompetitive. Read More