Mylan (MYL) and Pfizer (PFE +0.5%) settle their suit regarding MYL's ANDA for a generic version of Celebrex (celecoxib). Under the terms of the agreement, MYL may begin selling its version at the earliest market formation but not later than December 2014. No other terms are disclosed.
MYL has appealed the recent ruling by the U.S. District Court for the Northern District of West Virginia affirming rival Teva's (TEVA +2.7%) 180-day exclusivity as the "first filer."
The FDA approves the first generic versions of Pfizer's Celebrex (celecoxib). Teva Pharma (TEVA -0.4%) receives 180-day marketing exclusivity for the 100 mg, 200 mg and 400 mg strengths because it was the first to file. It will compete with Mylan (MYL +0.2%) in marketing the 50 mg strength.
Teva and Celebrex maker Pfizer (PFE) reached a settlement on April 17 regarding Teva's generic version which it plans to launch in December of this year. According to IMS, the branded product generated $2.2B in U.S. sales in 2013.
Mylan (MYL) launches its generic version of Glaxo's (GSK) Malarone Tablets (atovaquone & proguanil hydrochloride 62.5 mg/25 mg and 250 mg/100 mg) for the prophylaxis and treatment of P. falciparum malaria. According to IMS Health, Malarone generated ~$89M in U.S. sales for the 12-month period ending March 31, 2014.
Teva (TEVA) has lost a case in which it tried to persuade a court to delay the release of generic forms of Copaxone by saying that more testing was needed for these versions of the multiple-sclerosis drug.
A 20-milligram dosage of Copaxone is due to lose its patent protection on May 24, after which Mylan (MYL) and Novartis (NVS) unit Sandoz can start selling cheaper forms of the treatment.
Teva hopes to switch patients to a longer-lasting 40-milligram regimen, which is protected until 2015.
Taking exception to the FDA's decision to award exclusive rights to Teva Pharmaceutical Industries (TEVA) to sell a generic version of Pfizer's (PFE) Celebrex, Actavis (ACT) sues the regulator. The company's action follows Mylan's (MYL) suit filed on Friday.
The company believes the agency acted improperly when it awarded exclusivity to Teva despite a ruling from the U.S. Court of Appeals for the Federal Circuit that resulted in the expiration of that entitlement.
The Celebrex patent will expire in May. Teva plans to launch its generic version in December.
Celebrex generated almost $3B in sales in 2013 according to Pfizer.
A federal district court forces a settlement in the patent case between Mylan (MYL) and Endo Pharmaceuticals (ENDP) over the migraine drug FROVA (Frovatriptan Succinate Tablets). The court vacates its January 28, 2014 decision in favor of Endo paving the way for Mylan to launch its generic version after FDA approval instead of having to wait until November 7, 2015 when the 864 patent expires.
According to IMS Health, Frovatriptan sales in the U.S. last year were ~$66M.