Content about Generic drug

September 18, 2012

It’s a little hard not to say “Oh, how the mighty have fallen” when a retailer announces that it will give away for free what was once the world’s top-selling drug. But for retailers, it also makes good business sense. 

September 18, 2012

Mergers among generics cos. on the rise

Over the last few years of DSN’s coverage of the impending patent cliff and how it would affect the generic drug industry, IMS Health VP industry relations Doug Long predicted that the gradual commoditization of primary care drugs — long the lifeblood of generic drug makers — would lead to consolidation of the industry. 

September 18, 2012

NCPA independent pharmacist survey challenges abusive auditing practices

Abusive auditing and unfair reimbursement practices harm community pharmacists’ ability to provide critically needed patient counseling and care to seniors, according to a new survey released Tuesday by the National Community Pharmacists Association.

ALEXANDRIA, Va. — Abusive auditing and unfair reimbursement practices harm community pharmacists’ ability to provide critically needed patient counseling and care to seniors, according to a new survey released Tuesday by the National Community Pharmacists Association.

NCPA polled more than 350 community pharmacists about their recent experience with audits conducted by pharmacy benefit managers and other Medicare Part D plan intermediaries. The survey also asked about generic drug reimbursement caps known as maximum allowable costs (MACs).

September 18, 2012

NewsBytes — Generics, 9/24/12

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. 

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. 

September 18, 2012

PDUFA, GDUFA make 2012 milestone year

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. 

September 14, 2012

FDA approves Lannett tension headache drug

The Food and Drug Administration has granted regulatory approval for a generic drug to treat tension headaches.

PHILADELPHIA — The Food and Drug Administration has granted regulatory approval for a generic drug to treat tension headaches.

Lannett announced the approval of butalbital, acetaminophen and caffeine tablets in the 50-mg/325-mg/40-mg strength. the drug is a generic version of Watson Pharmaceuticals' Fioricet.

Branded and generic versions of the drug had sales of $30 million during the 12-month period ended in July, including $15 million for branded Fioricet. Lannett plans to start shipping its version next month, the company said.

September 14, 2012

Impax, Teva settle with J&J, Alza over generic ADHD drug

Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder.

HAYWARD, Calif. — Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder.

Impax Labs and Teva Pharmaceuticals USA had settled a patent infringement suit with Janssen Pharmaceuticals and Alza over Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg, 36-mg and 54-mg strengths.

September 13, 2012

Pfizer, Chinese drug maker ink branded generics deal

Pfizer has inked a deal with a Chinese drug maker to make branded-generic drugs for China and global markets, the companies said.

HANGZHOU, China — Pfizer has inked a deal with a Chinese drug maker to make branded-generic drugs for China and global markets, the companies said.

September 11, 2012

Dr. Reddy's launches generic hypertension pill

Generic drug maker Dr. Reddy's Labs has launched a generic drug for treating high blood pressure, the company said.

HYDERABAD, India — Generic drug maker Dr. Reddy's Labs has launched a generic drug for treating high blood pressure, the company said.

Dr. Reddy's announced the launch of metoprolol succinate extended-release tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths. The drug will be available in bottle counts of 100 and 500.

The drug is a generic version of AstraZeneca's Toprol-XL, branded and generic versions of which had sales of about $1.13 billion during the 12-month period that ended in June, according to IMS Health.

September 7, 2012

Mylan settles with Pfizer over generic bladder drug

Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

PITTSBURGH — Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

The Pittsburgh-based company said it settled with Pfizer over its generic version of Detrol LA (tolterodine tartrate) extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat urge urinary incontinence, urgency and frequency.

September 7, 2012

Perrigo seeks approval for generic bronchospasm drug

Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

ALLEGAN, Mich. — Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

September 6, 2012

Mylan launches drug reference for mobile devices

Mylan has launched an application version of the reference guide to its drugs, the generic drug maker said Thursday.

PITTSBURGH — Mylan has launched an application version of the reference guide to its drugs, the generic drug maker said Thursday.

The company announced what it called the first ever app of its Generic Brand Reference Guide, a free reference for healthcare professionals, patients and pharmacy students that enables the fast identification of brand and generic drugs. The 2012 print edition of the GBR was made available in a pocket-sized format earlier this year.

September 4, 2012

Impax settles with Genzyme over kidney dialysis drugs

Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

Impax announced a settlement with Genzyme concerning generic versions of Renvela (sevelamer carbonate) 800 mg tablets and 2.4 g and 0.8 g oral suspension and Renagel (sevelamer hydrochloride) tablets in the 400 mg and 800 mg strengths.

August 30, 2012

Supreme Court of Canada: Shoppers Drug Mart can challenge private-label generic Rx ban in Ontario

Canadian pharmacy retailer Shoppers Drug Mart announced on Thursday that the Supreme Court of Canada has granted its application for leave to appeal to Ontario’s ban on private-label generic drugs.

TORONTO — Canadian pharmacy retailer Shoppers Drug Mart announced on Thursday that the Supreme Court of Canada has granted its application for leave to appeal to Ontario’s ban on private-label generic drugs.

“The company respects the decision of the Supreme Court of Canada and is pleased with the outcome,” the retailer stated. A hearing date has not yet been set, and no further details were provided.

According to Reuters, Canada’s Katz Group also has been granted leave to challenge the ban.

August 28, 2012

2012 off to 'soft start' as patent cliff continues

While the growth in healthcare costs remains a threat in the United States, the growth in drug expenditures is moderating, but numerous opportunities exist for retail, according to a speech delivered Tuesday morning at the National Association of Chain Drug Stores' 2012 Pharmacy and Technology Conference in Denver by Doug Long, VP industry relations of healthcare industry research firm IMS Health.

DENVER — While the growth in healthcare costs remains a threat in the United States, the growth in drug expenditures is moderating, but numerous opportunities exist for retail, according to a speech delivered Tuesday morning at the National Association of Chain Drug Stores' 2012 Pharmacy and Technology Conference in Denver by Doug Long, VP industry relations of healthcare industry research firm IMS Health.

August 23, 2012

FDA approves Wockhardt hypertension drug

The Food and Drug Administration has approved a generic drug for high blood pressure made by Wockhardt, the Indian drug maker said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for high blood pressure made by Wockhardt, the Indian drug maker said.

Wockhardt announced the approval of felodipine extended-release tablets in the 2.5 mg, 5 mg and 10 mg strengths. The drug is a generic version of AstraZeneca's Plendil, and Wockhardt said it would launch the drug immediately.

Various versions of the drug have a market presence of more than $66 million, according to IMS Health.

August 23, 2012

FDA gives Wockhardt tentative approval for bipolar, schizophrenia drug

Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

PARSIPPANY, N.J. — Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

Wockhardt announced the tentative approval for ziprasidone hydrochloride in the 20 mg, 40 mg, 60 mg and 80 mg strengths, used to treat bipolar disorder and schizophrenia, and the company plans to launch the drug on Sept. 2, 2012.

August 23, 2012

FDA releases GDUFA draft guidance

The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

A collection of documents posted on the FDA's website includes guidance for the generic drug industry on self-identification of generic drug facilities, sites and organizations, questions and answers about the draft guidance and others.

August 17, 2012

Generics offer affordability for specialty Rx

The U.S. healthcare system presents a paradox: It’s the most expensive system in the world, and yet it produces among the worst results among developed countries.

The U.S. healthcare system presents a paradox: It’s the most expensive system in the world, and yet it produces among the worst results among developed countries. According to the most recent report from the National Health Expenditure Accounts, spending on health care reached $2.6 trillion in 2010, or more than $8,400 per person and around 18% of the country’s gross domestic product. 

August 15, 2012

FDA approves Wockhardt enlarged prostate drug

The Food and Drug Administration has approved a drug for enlarged prostate made by generic drug maker Wockhardt, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for enlarged prostate made by generic drug maker Wockhardt, the company said.

Wockhardt, based in Mumbai, India, announced the approval of alfuzosin hydrochloride extended-release tablets in the 10-mg strength, which is designed to treat enlarged prostate, also known as benign prostatic hyperplasia.

The drug is a generic version of Sanofi's Uroxatral. Various versions of the drug have sales of about $81.5 million, according to IMS Health.

August 15, 2012

Watson sues FDA over generic Actos

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.

PARSIPPANY, N.J. — 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.

August 10, 2012

Mylan launches generic sleep disorder, bipolar disorder drugs

Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

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 used to treat narcolepsy, obstructive sleep apnea and shift work disorder.

August 9, 2012

Hospira relaunches chemotherapy drug

Hospira has relaunched a generic chemotherapy drug for the U.S. market, the generic drug maker said Thursday.

LAKE FOREST, Ill. — Hospira has relaunched a generic chemotherapy drug for the U.S. market, the generic drug maker said Thursday.

The company, which specializes in generic injectables, announced the relaunch of oxaliplatin, a version of Sanofi's Eloxatin.

August 6, 2012

Amneal plans $120 million expansion

Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

BRIDGEWATER, N.J. — Generic drug maker Amneal Pharmaceuticals will spend $120 million to expand three of its plants, the company said Monday.

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.

August 6, 2012

Winn-Dixie adds generic form of Plavix to generics prescription program

Winn-Dixie announced the generic form of Plavix (clopidogrel) now is available for $4 for 30-day and $10 for 90-day prescriptions as part of the company's prescription savings program.

JACKSONVILLE, Fla. — Winn-Dixie announced the generic form of Plavix (clopidogrel) now is available for $4 for 30-day and $10 for 90-day prescriptions as part of the company's prescription savings program.

Winn-Dixie recently launched a prescription savings program in all of its pharmacies that offers deep discounts on more than 400 generic medications and varied discounts on branded and other generic medication.