Content about Generic drug

August 11, 2011
Avanir sues Par, Actavis over generic versions of neurological drug

Drug maker Avanir Pharmaceuticals has filed suit against two generic drug makers seeking to launch versions of a drug used to treat pseudobulbar affect, which causes sudden, involuntary episodes of laughing and crying, and occurs secondary to numerous other neurological conditions.

ALISO VIEJO, Calif. — Drug maker Avanir Pharmaceuticals has filed suit against two generic drug makers seeking to launch versions of a drug used to treat pseudobulbar affect, which causes sudden, involuntary episodes of laughing and crying, and occurs secondary to numerous other neurological conditions.

Avanir filed the suit in the U.S. District Court for the District of Delaware against Par and Actavis, which had filed for regulatory approval of Nuedexta (dextromethorphan hydrobromide and quinidine sulfate).

August 10, 2011
Innopharma gets FDA nod for epilepsy generic

The Food and Drug Administration has approved a generic drug for epilepsy.

PISCATAWAY, N.J. — The Food and Drug Administration has approved a generic drug for epilepsy.

Innopharma announced the FDA approval of levetiracetam injection. The drug is a generic version of UCB's Keppra.

Innopharma has a licensing agreement with X-GEN Pharmaceuticals for marketing and distribution of the drug.

August 9, 2011
Endo sales, profits climb in Q2

Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

CHADDS FORD, Pa. — Profits for Endo Pharmaceutical Holdings rose to $54.6 million during second quarter 2011, up 6% from $51.5 million in second quarter 2010, the drug maker said.

Sales for the quarter were $607.5 million, compared with $396.5 million in second quarter 2010. Sales of branded drugs were $398.3 million, an 8% increase over last year, which the company attributed to better sales of the pain drug Opana ER and the joint pain drug Voltaren Gel.

August 4, 2011
FDA reorganizes Office of Generic Drugs

The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

SILVER SPRING, Md. — The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

The new organizational scheme will add a new division to the bioequivalence program called Division of Bioequivalence II and a new chemistry division, Division of Chemistry IV.

July 29, 2011
Strides Arcolab's generic diabetes drug enters market

The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.

BANGALORE, India — The Food and Drug Administration has approved a generic drug for diabetes made by Indian generic drug maker Strides Arcolab.

The FDA approved acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a niche drug used to treat Type 2 diabetes, Strides said.

Acarbose tablets have sales of about $21 million, according to IMS Health.

July 28, 2011
Watson launches generic Seasonique

Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched a generic version of a contraceptive made by Duramed Pharmaceuticals, Watson said Thursday.

Watson announced the launch of Amethia (levonorgestrel and ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]) after the U.S. Court of Appeals for the Federal Circuit denied Duramed’s request for a temporary injunction; a patent infringement lawsuit that Duramed filed against Watson remains pending.

July 26, 2011
Lupin seeks to market generic Lo Loestrin Fe

Generic drug maker Lupin is seeking approval for a generic version of a contraceptive made by Warner Chilcott, according to published reports.

NEW YORK — Generic drug maker Lupin is seeking approval for a generic version of a contraceptive made by Warner Chilcott, according to published reports.

Reuters reported that Lupin had applied for approval of a generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets), an oral contraceptive.

July 25, 2011
CVS: Generics essential to reducing health costs

Health care is like precision engineering; tweaking one element ever so slightly can mean the difference between a healthy life and an early death or, in the case of drug spending, between nearly $50,000 and just north of $1,000.


Health care is like precision engineering; tweaking one element ever so slightly can mean the difference between a healthy life and an early death or, in the case of drug spending, between nearly $50,000 and just north of $1,000.


July 25, 2011
ReportersNotebook — Chain Pharmacy, 8/1/11

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said. Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.


July 22, 2011
NACDS outlines role of pharmacy in patient care to Senate committee

The National Association of Chain Drug Stores announced Thursday that it has submitted comments to the U.S. Senate Special Committee on Aging outlining the value of the pharmacist-patient interaction in helping improve health and reduce costs in the Medicare program, and urged the committee to support the Medication Therapy Management Empowerment Act of 2011, which seeks to increase access to pharmacy services for Medicare beneficiaries.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced Thursday that it has submitted comments to the U.S. Senate Special Committee on Aging outlining the value of the pharmacist-patient interaction in helping improve health and reduce costs in the Medicare program, and urged the committee to support the Medication Therapy Management Empowerment Act of 2011, which seeks to increase access to pharmacy services for Medicare beneficiaries.

July 22, 2011
NACDS supports Affordable Medicines Utilization Act of 2011

Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

ALEXANDRIA, Va. — Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

July 19, 2011
Affordable Medicines Utilization Act of 2011 encourages use of generic drugs

New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

WASHINGTON — New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

Senators Scott Brown, R-Mass.; Ron Wyden, D-Ore.; and John McCain, R-Ariz., introduced the Affordable Medicines Utilization Act of 2011, saying that the bill would encourage states to take advantage of cost-saving generic drugs.

July 19, 2011
Teva settles patent dispute with Amgen

Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

THOUSAND OAKS, Calif. — Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

The U.S. District Court in Pennsylvania has barred Teva from selling its human G-CSF (human granulocyte colony-stimulating factor) product Neutroval in the United States until Nov. 10, 2013. What's more, the court's injunction extends to Teva's other human G-CSF product, Neugranin. Teva will not sell Neugranin until Nov. 10, 2013, unless it first obtains a final court decision that Amgen's patents are not infringed by Neugranin.

July 11, 2011
Amneal launches three generic liquid drugs

Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

July 8, 2011
Watson seeks FDA approval for generic Vyvanse

Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.

July 7, 2011
Generic medication use can help trim costs for chronically ill patients

Preventive health care may be signficiantly less costly than previously thought because of the expanded use of cost-effective generic medications for the treatment and prevention of chronic diseases, according to researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark.

WOONSOCKET, R.I. — Preventive health care may be signficiantly less costly than previously thought because of the expanded use of cost-effective generic medications for the treatment and prevention of chronic diseases, according to researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark.

July 7, 2011
Hi-Tech Pharmacal reports strong sales for Q4, full year

Generic drug maker Hi-Tech Pharmacal reported its fourth-quarter net sales increased 45% to $57.2 million from the year-ago period.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal reported its fourth-quarter net sales increased 45% to $57.2 million from the year-ago period.

Net income for Hi-Tech totaled $12.7 million, or 98 cents per diluted share, compared with $6.5 million, or 50 cents per diluted share in fourth quarter 2010.

July 7, 2011
Lupin to market additional strengths of generic Lotrel

The Food and Drug Administration has approved an additional strength of a generic drug made by Lupin Pharmaceuticals for high blood pressure, Lupin said Wednesday.

BALTIMORE — The Food and Drug Administration has approved an additional strength of a generic drug made by Lupin Pharmaceuticals for high blood pressure, Lupin said Wednesday.

Lupin announced the approval of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths. The company already markets the drug in the 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg and 10-mg/20-mg strengths.

July 5, 2011
Shire files suit against Amneal, Sandoz over generic Vyvanse

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

June 28, 2011
Hi-Tech Pharmacal acquires rights to branded drugs

Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

Hi-Tech, which paid $3.6 million in cash for rights to the products and inventory, said some of Atley's drugs already have been approved by the Food and Drug Administration, while others were pending approval. The company didn't say which products it was acquiring the rights to, but noted that Hi-Tech subsidiary ECR Pharmaceuticals will produce and promote the products.

June 27, 2011
Report: Some branded diabetes drug prices at Walmart, Kmart rise at fast rate

Prices for the top 10 most prescribed branded diabetes drugs have risen faster at Walmart and Kmart than at other retailers, according to a published report.

NEW YORK — Prices for the top 10 most prescribed branded diabetes drugs have risen faster at Walmart and Kmart than at other retailers, according to a published report.

Citing a recent study by researchers at the Mount Sinai Medical Center in New York, Reuters reported that Walmart raised prices for branded diabetes drugs by 32% between 2008 and 2010, compared with 21% for the industry as a whole — including independent and chain retail pharmacies and mail-order companies. Kmart raised prices by 35%.

June 27, 2011
With law ban, marketing system for Rxs is safe... for now

The law targeting data mining in Vermont, along with laws in New Hampshire and Maine, would have forced drug companies to significantly change the way they market drugs to physicians had the Supreme Court allowed them to stand in the case of Sorrell, Attorney General of Vermont, et al. vs. IMS Health Inc., et al.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The law targeting data mining in Vermont, along with laws in New Hampshire and Maine, would have forced drug companies to significantly change the way they market drugs to physicians had the Supreme Court allowed them to stand in the case of Sorrell, Attorney General of Vermont, et al. vs. IMS Health Inc., et al.

(THE NEWS: Supreme Court strikes down Rx data mining law. For the full story, click here.)

June 22, 2011
Dr. Reddy's brings generic Levaquin to market

Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

The company said its levofloxacin tablets in the 250-mg, 500-mg and 750-mg strengths have entered the market, following the Food and Drug Administration's approval of Dr. Reddy's abbreviated new drug application. Dr. Reddy's levofloxacin tablets in the 250-mg and 500-mg strengths are available in 50-count bottles, while the 750-mg strength bottle is available in 30-count bottles.

June 21, 2011
Watson seeks to commercialize generic Avodart

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.

June 20, 2011
Adherence, generics to reduce $403bn in waste

The latest drug trend report from pharmacy benefit manager Express Scripts estimated that if patients using maintenance medications used cheaper therapies when possible, adhered to their medication therapies and used home delivery, it could eliminate $403 billion in pharmacy waste every year.