Teva files ANDA for generic version of HIV drug
FOSTER CITY, Calif. Teva is hoping to release its version of an HIV drug before the drug’s patents expire.
Gilead Sciences announced that it had received notice that Teva had applied for regulatory approval with the Food and Drug Administration for a generic version of Viread (tenofovir disoproxil fumarate). The application contained a Paragraph IV certification, which asserts that three of the four patents covering Viread are invalid, unenforceable or won’t be infringed by Teva’s version of the drug.
Under the Hatch-Waxman Act of 1984, Gilead has 45 days from the receipt of the letter to file a patent-infringement lawsuit against Teva. A lawsuit would restrict the FDA from approving Teva’s version of Viread for up to two-and-a-half years or until a court decision. Teva would need to invalidate all four of Viread’s patents before it could launch.
Gilead has a lawsuit pending against Teva in response to Teva’s attempt to gain approval for generic versions of the HIV drugs Truvada (emtricitabine and tenofovir disoproxil fumarate) and Atripla (efavirenz, emtricitabine and tenofovir).
Lupin receives FDA approval for hypertension generic
BALTIMORE The Food and Drug Administration has given approval to a generic version of a drug used to treat high blood pressure made by an Indian drug maker.
Lupin Pharmaceuticals announced Thursday that it had received approval for perindopril erbumine tablets, used to treat essential hypertension and management of coronary artery disease.
The drug is a generic version of Solvay Pharmaceuticals’ Aceon, which had sales of $24 million during the 12-month period ending in September 2009, according to IMS Health.
Loose ends should be tied to make e-prescribing a reality
WHAT IT MEANS AND WHY IT’S IMPORTANT Relative to the national chains, independent pharmacies have limited resources and, given the importance and benefit of e-prescribing, further helping to facilitate the adoption of e-prescribing via grants — not to mention facilitating two-way communication between prescribers and pharmacists — is critical to help push overall adoption closer to the finish line.
THE NEWS: (NCPA: E-prescribing should be more efficient in two-way communication, cost. For the full story, click here)
As stated in the article, the National Community Pharmacists Association, at a recent e-prescribing committee, recommended providing grants to offset implementation and transaction fee costs and making two-way communication between prescribers and pharmacists easier.
In written testimony at a hearing of the Department of Health and Human Services’ Health Information Technology Policy Committee Information Exchange Workgroup, the NCPA acknowledged that community pharmacists have a vested interest in making e-prescribing work but yet cost challenges remain.
E-prescribing has been praised especially in recent years as it has been shown to increase the likelihood that patients will get their prescriptions filled and, in turn, avoid more expensive medical procedures. There’s also less of a chance for errors compared with paper prescriptions.
E-prescribing has achieved impressive milestones in recent years but the journey is far from over. In October 2009, e-prescribing network provider Surescripts announced that 23% of all office-based physicians, nurse practitioners and physician assistants in the United States are now e-prescribing. At that rate, Surescripts projected that its total number of active e-prescribers in 2009 would more than double the 74,000 active e-prescribers at the end of 2008.