October 31, 2013

Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

October 29, 2013

Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.

July 22, 2013

Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

May 30, 2013

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 30, 2013

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

April 21, 2013

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

March 25, 2013

The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

March 21, 2013

Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

February 28, 2013

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

January 3, 2013

A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

December 28, 2012

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

November 29, 2012

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.

November 29, 2012

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”

November 15, 2012

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.

November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

September 18, 2012

2012 is turning out to be a pretty important year for generic drugs, important enough that some of the things happening over the past several months have begged comparison to 1984, probably the biggest milestone year for the industry.

August 15, 2012

Watson Pharmaceuticals is suing the Food and Drug Administration, alleging that an agency decision would improperly delay its release of a generic drug for diabetes, the company said Wednesday.

July 16, 2012

Is the reauthorization of the Prescription Drug User Fee Act “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act?”

July 10, 2012

President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

April 19, 2012

Generic drug maker Watson is challenging the patent protection on a drug used to treat Type 2 diabetes.

March 19, 2012

Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

January 20, 2012

It has become a perennial issue, and one that is likely to crop up at least once this year: patent settlements.

November 21, 2011

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.