Content about Drug Price Competition and Patent Term Restoration Act

March 19, 2012

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

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

Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott's Niaspan.

January 20, 2012

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


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.

HAYWARD, Calif. — 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.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

November 15, 2011

The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.

WASHINGTON — The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.

October 25, 2011

The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.

WASHINGTON — The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.

The FTC, which under the leadership of chairman Jon Leibowitz, repeatedly has attacked what it calls "pay-for-delay" deals between branded and generic drug manufacturers and has been lobbying the Congressional Joint Select Committee on Deficit Reduction, also known as the super committee, to ban the deals.

October 11, 2011

The Food and Drug Administration has accepted the first regulatory approval application for a generic version of a cancer drug made by Eisai.

HIGH POINT, N.C. — The Food and Drug Administration has accepted the first regulatory approval application for a generic version of a cancer drug made by Eisai.

Banner Pharmacaps announced Tuesday that it had filed for regulatory approval of generic bexarotene gelatin capsules in the 75-mg strength, a generic version of Eisai's Targretin, used to treat cutaneous T-cell lymphoma, or CTCL skin cancer. Under the Hatch-Waxman Act of 1984, once the drug is approved, Banner will be the exclusive supplier of a generic version of Targretin for 180 days.

September 12, 2011

The issue of patent settlements, their effect on drug prices and availability, and by extension their legality has been around for a long time and will likely remain an issue for years to come. But according to a report released in May by the Federal Trade Commission, the settlements have been on the rise, increasing from 16 in 2009 to 31 in 2010.


The issue of patent settlements, their effect on drug prices and availability, and by extension their legality has been around for a long time and will likely remain an issue for years to come. But according to a report released in May by the Federal Trade Commission, the settlements have been on the rise, increasing from 16 in 2009 to 31 in 2010.


September 12, 2011

While settlements constitute the most prominent patent-related issue for generic drugs, two others have cropped up this year as well.


NEW YORK — While settlements constitute the most prominent patent-related issue for generic drugs, two others have cropped up this year as well.


September 12, 2011

At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.


At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.


September 1, 2011

Branded drugs sold under their generic names at a reduced price can reduce retail and wholesale drug prices, according to a new report by the Federal Trade Commission.

WASHINGTON — Branded drugs sold under their generic names at a reduced price can reduce retail and wholesale drug prices, according to a new report by the Federal Trade Commission.

The FTC report found that when an authorized generic is introduced onto the market, it can lower the expected profits of the generic drug's manufacturer and, over the longer term, affect generic manufacturers' decisions to challenge patents covering branded drugs with low sales, though patent challenges by generic drug makers "remain robust."

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

May 20, 2011

Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

February 25, 2011

Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

January 31, 2011

Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

CHADDS FORD, Pa. — Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

Endo said Monday that Teikoku Seiyaku and U.S. subsidiary Teikoku Pharma USA had received a Paragraph IV certification from Mylan stating the latter’s intention to market a generic lidocaine topical patch. The drug is a generic version of Endo’s and Teikoku’s Lidoderm.

January 28, 2011

The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.

January 26, 2011

Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.

January 4, 2011

Par Pharmaceutical has started shipping a generic version of a hypertension drug, the company said Monday.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping a generic version of a hypertension drug, the company said Monday.

Par announced the shipment of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/320-mg and 10-mg/320-mg strengths. The drug is a generic version of Novartis’ Lotrel, which has annual sales of $361 million in the two strengths, according to IMS Health.

January 4, 2011

Generic drug maker Par Pharmaceutical has begun shipping its version of a treatment for heart rhythm problems, the company said Monday.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has begun shipping its version of a treatment for heart rhythm problems, the company said Monday.

Par announced the shipment of propafenone SR capsules, a treatment for atrial fibrillation in patients without structural heart disease.

The drug is a generic version of GlaxoSmithKline’s Rhythmol SR, which has annual sales of around $121 million, according to IMS Health.

December 15, 2010

Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

MORRISTOWN, N.J. — Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.

Watson announced Tuesday that it had filed an application with the Food and Drug Administration seeking approval for hydromorphone hydrochloride extended-release tablets in the 8-mg, 12-mg and 16-mg strengths. The drug is a generic version of Mallinckrodt’s Exalgo.

November 29, 2010

Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

November 15, 2010

Generic drug maker Actavis has filed for approval of a generic version of an antidepressant...

LAVAL, Quebec — Generic drug maker Actavis has filed for approval of a generic version of an antidepressant made by Canada’s Labopharm, Labopharm said.

 

The drug maker said it received a notification stating that Actavis had applied to the Food and Drug Administration for approval of a generic version of Oletpro (trazodone hydrochloride) extended-release tablets in the 150-mg and 300-mg strengths.

 

 

October 4, 2010

Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug...

NEW YORK Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug made by Eisai, according to published reports.

Bloomberg reported Tuesday that the Indian drug maker had won 180 days’ exclusivity in which to market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets, pending final Food and Drug Administration approval, beating out Israel-based Teva Pharmaceutical Industries.

October 4, 2010

Generic drug maker Watson Pharmaceuticals is seeking approval for a generic treatment for Parkinson’s disease,...

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals is seeking approval for a generic treatment for Parkinson’s disease, prompting a lawsuit from the drug’s manufacturer.

 

Watson said Tuesday that Watson Labs, a subsidiary of the company, had filed for approval for rasagiline mesylate tablets, a treatment for Parkinson’s used either alone or with the drug levodopa. The drug is a generic version of Teva Neuroscience’s Azilect.