Content about Generic drug

January 9, 2014

Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

PITTSBURGH — Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

The generic drug maker announced the launch of mycophenolic acid delayed-release tablets in the 180-mg and 360-mg strengths. The drug is a generic version of Novartis' Myfortic. As the first company to file a completed regulatory approval application for the generic, Mylan is entitled to 180 days in which to compete exclusively against Novartis' product before the Food and Drug Administration can approve additional generic versions.

January 7, 2014

Ani Pharmaceuticals has bought 31 generic drugs from Teva Pharmaceuticals for $12.5 million, the company said.

BAUDETTE, Minn. — Ani Pharmaceuticals has bought 31 generic drugs from Teva Pharmaceuticals for $12.5 million, the company said.

January 7, 2014

Growth in health spending has slowed in recent years, including spending by private and public payers, according to data released by the Centers for Medicare and Medicaid Services that also found a small contribution to the lower growth from the healthcare reform law.

WASHINGTON — Growth in health spending has slowed in recent years, including spending by private and public payers, according to data released Monday by the Centers for Medicare and Medicaid Services that also found a small contribution to the lower growth from the healthcare reform law.

December 26, 2013

Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

DUBLIN — Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

Actavis said Warner Chilcott, now one of its subsidiaries, had filed with the FDA for approval of the ethinyl estradiol and etonogestrel vaginal ring in the 0.015-mg-per-day and 0.12-mg-per-day strengths. The device is a generic version of Merck's NuvaRing.

December 18, 2013

The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

December 18, 2013

Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

BALTIMORE — Lupin has launched a generic drug for treating HIV, following its victory in a patent-infringement suit in federal court, the Indian drug maker said Wednesday.

Lupin's U.S. subsidiary launched its generic version of ViiV Healthcare's Trizivir (abacavir sulfate; lamivudine; zidovudine) tablets in the 300-mg/150-mg/300-mg strength. The launch follows a ruling by the U.S. District Court for the District of Delaware that the drug did not infringe on Viiv's patent.

December 18, 2013

The U.S. healthcare system saved $217 billion in 2012 thanks to the use of generic drugs, according to a new report by a generic drug industry trade group.

WASHINGTON — The U.S. healthcare system saved $217 billion in 2012 thanks to the use of generic drugs, according to a new report by a generic drug industry trade group.

December 17, 2013

Forty blockbuster drugs will use patent exclusivity in the United States between this year and 2020, according to a new study.

BURLINGTON, Mass. — Forty blockbuster drugs will use patent exclusivity in the United States between this year and 2020, according to a new study.

December 11, 2013

A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

DUBLIN — A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.

Actavis said its Warner Chilcott subsidiary had settled with Zydus Pharmaceuticals USA and Cadila Healthcare over Zydus' generic version of Asacol HD (mesalamine) delayed-release tablets.

December 10, 2013

Teva Pharmaceutical Industries anticipates that it could lose about $500 million in sales next year if a generic version of its multiple sclerosis drug hits the market, the Israeli drug maker said Tuesday.

JERUSALEM — Teva Pharmaceutical Industries anticipates that it could lose about $500 million in sales next year if a generic version of its multiple sclerosis drug hits the market, the Israeli drug maker said Tuesday.

December 9, 2013

A survey of more than 1,000 independent pharmacists finds that acquisition costs for generic drugs have spiked by as much as 1,000% this year.

ALEXANDRIA, Va. — A survey of more than 1,000 independent pharmacists finds that acquisition costs for generic drugs have spiked by as much as 1,000% this year.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

WASHINGTON — The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

December 6, 2013

Taro Pharmaceutical Industries plans to repurchase up to $200 million of its own shares, the Israeli generic drug maker said.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries plans to repurchase up to $200 million of its own shares, the Israeli generic drug maker said.

Taro announced a tender offer to repurchase the shares for between $84.50 and $97.50 each, with the total amount representing 4.6% to 5.3% of its outstanding shares.

The offer expires on Dec. 23, the company said.

 

December 6, 2013

Teva Pharmaceutical Industries' U.S. subsidiary has launched a generic drug for treating warts and skin lesions, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries' U.S. subsidiary has launched a generic drug for treating warts and skin lesions, the company said.

Teva Pharmaceuticals announced the launch and availability of imiquimod cream, a generic version of Medicis Pharmaceutical Corp.'s Aldara.

The drug is used to treat external genital and rectal warts, certain types of actinic keratosis and basal cell carcinoma. Various versions of the drug had sales of about $244 million in 2011, according to IMS Health.

 

December 4, 2013

The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

BURLINGTON, Mass. — The availability of new generic drugs for treating HIV will erode sales of HIV antiretroviral drugs into the next decade in developed countries, according to a new report.

Healthcare market research firm Decision Resources released the report Wednesday, showing that sales of antiretroviral drugs in the United States, France, Germany, the United Kingdom, Spain, Italy and Japan would be $13.1 billion in 2022, down from 2012's $13.4 billion.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug for treating community-acquired pneumonia, agency records showed.

According to the FDA's website, the agency granted the preliminary authorization for Roxane Labs' linezolid oral suspension in the 100-mg-per-5-mL strength.

December 3, 2013

Impax Labs has settled a patent-infringement suit filed by Purdue Pharma concerning the opioid painkiller OxyContin, Impax said Tuesday.

HAYWARD, Calif. — Impax Labs has settled a patent-infringement suit filed by Purdue Pharma concerning the opioid painkiller OxyContin, Impax said Tuesday.

December 3, 2013

The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a generic drug used to treat prostate disease, agency records showed.

The FDA granted tentative approval to Roxane Labs' dutasteride capsules in the 0.5-mg strength. The drug is a generic version of GSK's Avodart, used to treat benign prostatic hyperplasia.

Tentative approval means that a drug meets the agency's conditions for approval, but can't receive final approval until Avodart loses its patent protection, which will occur in 2015.

 

November 26, 2013

Generic drug maker Hospira will have its investor conference next week, the company said Tuesday.

LAKE FOREST, Ill. — Generic drug maker Hospira will have its investor conference next week, the company said Tuesday.

The drug maker, based in the Chicago area, will have the investor day at its headquarters on Dec. 5. Hospira specializes in manufacturing injectable generic drugs, including biosimilars for the European market.

The event will include slide presentations, and the company will stream it via audio webcast at its investors website, hospirainvestor.com.

 

November 22, 2013

Canadian pharmacy retailer Shoppers Drug Mart has announced that the Supreme Court of Canada has upheld the Dec. 23, 2011, decision of the Court of Appeal of Ontario that restored the prohibition on private-label generic drug products in the Province of Ontario, which was subsequent to a decision of the Ontario Divisional Court dated Feb. 3, 2011, that declared the regulatory restrictions in respect of private-label generic drug products to be invalid.

TORONTO — Canadian pharmacy retailer Shoppers Drug Mart has announced that the Supreme Court of Canada has upheld the Dec. 23, 2011, decision of the Court of Appeal of Ontario that restored the prohibition on private-label generic drug products in the Province of Ontario, which was subsequent to a decision of the Ontario Divisional Court dated Feb. 3, 2011, that declared the regulatory restrictions in respect of private-label generic drug products to be invalid.

November 22, 2013

Teva Pharmaceutical Industries has launched its generic version of a drug for patients with cystic fibrosis, the Israeli drug maker said Thursday.

JERUSALEM — Teva Pharmaceutical Industries has launched its generic version of a drug for patients with cystic fibrosis, the Israeli drug maker said Thursday.

Teva announced the launch of tobramycin inhalation solution, a generic version of Novartis' drug Tobi. The Food and Drug Administration approved Teva's product last month. The drug is used to treat CF in patients whose lungs contain bacteria called Pseudomonas aeroginosa.

Tobi had sales of about $350 million during the 12-month period that ended in June, according to IMS Health.

 

November 20, 2013

Ranbaxy Labs is celebrating the 20th anniversary of its operations in Ukraine, the Indian generic drug maker said Wednesday.

GURGAON, India — Ranbaxy Labs is celebrating the 20th anniversary of its operations in Ukraine, the Indian generic drug maker said Wednesday.

The drug maker established a base in the eastern European country in 1993 and has since become the largest drug company in the market, whose value is estimated at $3.7 billion, according to the company. Ranbaxy's products in Ukraine include branded and generic drugs.

November 18, 2013

Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly's Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.

November 12, 2013

Hospira had sales of $1 billion in third quarter 2013, the generic drug maker said.

LAKE FOREST, Ill. — Hospira had sales of $1 billion in third quarter 2013, the generic drug maker said.

Hospira, which specializes in making generic injectable drugs, as well as biosimilars for the European market, said the sales figures for the quarter were a 1.4% increase over the $994 million in sales reported in third quarter 2012. Profits for the quarter were $84.5 billion, compared with $78.4 billion during the same period last year.

November 8, 2013

Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will launch its version of a contraceptive product at the beginning of January, the drug maker said.

Amneal said it would launch its version of 24 Fe (norethindrone acetate and ethinyl estradiol tablets; ferrous fumarate tablets) in the 1 mg/20 mcg and 75 mg strength. As the first company to successfully file for Food and Drug Administration approval of the drug, Amneal's product will have 180 days in which to compete exclusively against the branded version.