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Generic firm Mylan said June 2 that it had reached a settlement with Pfizer to market versions of Celebrex (celecoxib), marking the latest twist in the generic conversion of the blockbuster arthritis pain drug. Read More
Generic-maker Mylan has launched a version of Bristol-Myers Squibb’s advanced ovarian carcinoma drug Paraplatin Injection in 50 mg/5 ml multidose vials. Read More
Teva cleared a major hurdle this month in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
A federal judge tossed out claims over a patent in Sandoz’s bid to launch a generic version of United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin, but two more patent challenges remain. Read More
Generic firm Glenmark Pharmaceuticals wants a federal appeals court to rehear its case over rights to the combination hypertension drug Tarka, arguing that an April decision was invalid because it incorrectly attributed exclusive patent rights. Read More
Endo Pharmaceuticals and Impax Laboratories are facing a lawsuit alleging that the two drugmakers conspired to keep a generic version of Endo’s pain medication Opana ER off the market. Read More
A federal judge rejected AstraZeneca’s motion to block generics from making versions of its inhaled corticosteroid Pulmicort Respules, and instead will consider that request and broader patent issues on the drug when the trial resumes this fall. Read More
A federal appeals court needs to rethink its definition of “a patient” or risk upholding a dangerous precedent in future Hatch-Waxman cases, trade groups BIO and PhRMA argued after a recent patent ruling on the colon cleanser Suprep. Read More
The FDA and Customs and Border Protection (CBP) yesterday began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More