NewsBytes — Generics, 9/24/12

NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


The drug makers announced the launch of oxaliplatin injection, which Sanofi markets under the brand name Eloxatin. Eloxatin had sales of $1.7 billion during the 12-month period ended in June, according to IMS Health. Hospira and Sagent launched their versions of the drug on Aug. 9, while Teva Health Systems, an Irvine, Calif.-based division of the Israeli drug maker, launched the drug on Aug. 15.


Hospira originally launched generic oxaliplatin in August 2009 after a court ruled in its favor in a patent-infringement suit filed by Sanofi. Sanofi and Hospira later settled the suit in 2010, requiring Hospira to suspend sales of the drug in June 2010, but allowing it to relaunch ahead of the expiration of Sanofi’s patent. The patents on Eloxatin expire between January 2013 and February 2016, according to Food and Drug Administration records. 



ALLEGAN, Mich. — The FDA has approved an oral painkiller made by Perrigo, the drug maker said.


Perrigo announced the approval of morphine sulfate oral solution in the 100-mL/5% strength. The drug is a schedule II controlled substance and is used to treat moderate to severe acute and chronic pain. Sales of the drug are about $26 million per year, according to Wolters Kluwer Health. Perrigo said it would ship the drug immediately.



PRINCETON, N.J. — Sandoz has launched a generic version of a topical medication used to treat psoriasis, the company said. 


Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of calcipotriene cream in the 0.005% strength, calling it the first generic version of Leo Pharma’s Dovonex. Dovonex had sales of about $118.8 million during the 12-month period ended in May, according to IMS Health.



BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the privately owned drug maker said. Amneal said it would spend the money over a two-year period lasting through 2014 to “significantly” grow operations at research-and-development, manufacturing and distribution plants in New York, New Jersey and Kentucky. The company, which employs more than 1,100 people in the United States, said the expansion would create 500 more jobs.


“We clearly understand the value of, and are fully committed to, investing and growing within the market we serve, significantly expanding our number of ‘Made in the USA’ products,” Amneal president Chirag Patel said. “Generic pharmaceuticals ensure the lowest cost of medications to help make health care more affordable to all consumers.”


PARSIPPANY, N.J. — Teva Pharmaceutical Industries, Mylan and Ranbaxy Labs launched generic versions of a Type 2 diabetes drug made by Takeda Pharmaceutical last month, as Watson Pharmaceuticals sued the FDA after the agency prevented it from launching its own version.


Watson said it was entitled to share market exclusivity for a generic version of Takeda’s Type 2 diabetes drug Actos (pioglitazone). Under the Hatch-Waxman Act of 1984, the first company to file a complete regulatory approval application with the FDA for a generic version of a drug is entitled to 180 days in which to compete exclusively with the branded version upon approval. In some cases, multiple companies share exclusivity, and a 2010 settlement with Takeda would allow Watson, Teva Pharmaceutical Industries, Mylan and Ranbaxy Labs to launch generic versions of Actos.


Watson said the FDA denied its claim of shared exclusivity based on the timing of its reinstatement of several of its original paragraph IV certifications, a type of challenge to a branded drug maker’s patent commonly issued by generic drug companies. Watson said it had converted its paragraph IV certification to a different type of challenge at the FDA’s direction, later reinstating the paragraph IV certification after it settled a patent-infringement suit with Takeda. The FDA’s denial of Watson’s claim would delay its launch of the drug by six months, the company said.


“When we learned of [the] FDA’s position regarding our application, we made efforts to work cooperatively with [the] FDA to resolve the situation,” Watson president and CEO Paul Bisaro said. “[The] FDA has refused to grant shared exclusivity and seeks to unnecessarily delay the launch of Watson’s generic Actos product, with potential harm to consumers who may face constraints on supply as a result of this action.”


Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health. The lawsuit remained unresolved at press time.



PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said. The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and is used to treat narcolepsy, obstructive sleep apnea and shift work disorder.


There has been some contention surrounding the drug since the FDA determined in April that Teva was the first company to file for regulatory approval of the generic, thus entitling it to 180 days in which to compete with the branded version, as provided for under the Hatch-Waxman Act of 1984. 


But under an agreement with the Federal Trade Commission related to Teva’s acquisition of Cephalon in October 2011, Par Pharmaceutical launched the generic version on April 6, while Teva launched an authorized generic, a term used to refer to the branded drug marketed under its generic name at a reduced price. Mylan responded by suing the FDA, asserting that Teva was disqualified from submitting a regulatory filing challenging Provigil’s patent protection because a company could not infringe its own patent, and that Mylan should be considered the first-to-file company.


Mylan CEO Heather Bresch said she was “pleased” that Mylan would be launching the drug prior to the expiration of the 180-day exclusivity period. Branded and generic versions of the drug had sales of about $1.3 billion during the 12-month period ended in June, according to IMS Health.


Mylan also announced the launch of lithium carbonate extended-release tablets, a drug used to treat manic episodes of bipolar disorder. Various versions of the drug had sales of about $15.2 million during the 12-month period ended in June, according to IMS Health.



JERUSALEM — Teva Select Brands has launched a new drug used to treat schizophrenia. The company, a subsidiary of Israeli drug maker Teva Pharmaceutical Industries, announced late last month the launch of clozapine orally disintegrating tablets in the 12.5-mg, 25-mg and 100-mg strengths.


The drug is a generic version of Jazz Pharmaceuticals’ FazaClo.