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Eon Labs moved closer to launching a generic version of GlaxoSmithKline’s (GSK’s) profitable antidepressant Wellbutrin SR after a district court denied rival firm Andrx’s motions to block the product, and an appeals court temporarily suspended an injunction sought by GSK.
Provisions in the new Hatch-Waxman Act patent rules could provide a loophole for brand firms to delay generic competition by not listing all patents in the FDA’s Orange Book.
With a pool of cheap yet highly skilled scientists, and a new patent law coming into force next year, India could become one of the top pharmaceutical manufacturing centers in the world, experts say.
In a pair of recent generic-brand court rulings, a federal judge has issued a preliminary injunction against Eon Labs’ Wellbutrin SR generic product and another has upheld Pfizer’s patent on its antidepressant Zoloft.
A federal judge has cleared the way for generic firm Endo Pharmaceuticals to launch a version of Purdue Pharma’s pain treatment OxyContin, ruling that patents on the brand product were unenforceable.
Mylan said it would appeal a recent federal court ruling that rejected the firm’s claims that NaPro BioTherapeutics obtained its formulation patents for a generic paclitaxel product through fraud and inequitable conduct on the U.S. Patent and Trademark Office.
In a ruling that could change the way the FDA grants 180-day exclusivity, a federal judge has reversed the agency’s decision that Apotex must share its six-month exclusivity period for a version of GlaxoSmithKline’s depression drug Paxil with rival generic firms.