Content about Generic drug

March 7, 2012

Drug price inflation outpaces general inflation, AARP study finds

Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

WASHINGTON — Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

The study, conducted by AARP's Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.

March 2, 2012

Teva launches generic version of Prometrium

A generic drug maker has launched its version of an Abbott Labs drug.

JERUSALEM — A generic drug maker has launched its version of an Abbott Labs drug.

Teva Pharmaceutical Industries said it launched progesterone capsules in the 100-mg and 200-mg strengths, a generic version of Prometrium.

Prometrium is indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogen tablets. The drug also is indicated for use in secondary amenorrhea.

For the 12 months ended Jan. 31, Prometrium had sales of approximately $198 million, according to IMS Health data.

March 2, 2012

Watson launches authorized generic menopause drug

Watson has launched an authorized generic drug for treating postmenopausal women, the company said Friday.

PARSIPPANY, N.J. — Watson has launched an authorized generic drug for treating postmenopausal women, the company said Friday.

Watson announced the launch of progesterone capsules in the 100-mg and 200-mg strengths, an authorized generic version of Abbott Labs' Prometrium, under an agreement with Abbott. Abbott will manufacture the drug and supply it to Watson, which will market and distribute it and share profits. Other terms were not disclosed, the companies said.

February 29, 2012

Mylan launches generic version of Forest Labs' Lexapro

Mylan has launched a generic drug for treating depression and anxiety, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic drug for treating depression and anxiety, the company said Wednesday.

Mylan announced the launch of escitalopram tablets in the 5-mg, 10-mg and 20-mg strengths, the first generic version of Forest Labs' Lexapro. The drug is used for treating major depressive disorder and generalized anxiety disorder.

February 28, 2012

Glenmark recalls seven lots of contraceptive drug

The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

NEW YORK — The U.S. unit of Indian generic drug maker Glenmark is recalling a generic contraceptive drug, the company said.

Glenmark Generics USA announced the recall of seven lots, imported from India, of norgestimate and ethinyl estradiol tablets in the 0.18-mg/0.035-mg, 0.215-mg/0.035-mg and 0.25-mg/0.035-mg strengths. The company said a packaging error resulted in blister packs being rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiration date visible only on the outer pouch.

February 24, 2012

Hospira joins GPhA

Generic drug maker Hospira has joined the country's largest lobby for the generic drug industry, the company said.

LAKE FOREST, Ill. — Generic drug maker Hospira has joined the country's largest lobby for the generic drug industry, the company said.

Hospira, which specializes in generic injectables and infusion technology, announced that it had joined the Generic Pharmaceutical Association. In addition to generic pharmaceuticals, the company also makes biosimilars for the European market.

February 24, 2012

Par completes acquisition of Edict

Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

Par announced that it had completed its $20.5 million acquisition of Chennai, India-based Edict Pharmaceuticals.

Edict specializes in oral solid drugs and currently has 11 regulatory approval applications under review at the Food and Drug Administration.

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February 23, 2012

Mylan's Tony Mauro elected as GPhA chairman

The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.

WASHINGTON — The president of one of the world's largest generic drug manufacturers will serve as chairman of the Generic Pharmaceutical Association, the organization said Thursday.

February 21, 2012

Pfizer inks generics deal with Chinese drug maker

Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

NEW YORK — Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.

Pfizer announced the joint venture with Zhejiang Hisun Pharmaceutical to develop, manufacture and commercialize generic drugs. Hisun will invest $295 million into the venture — called Hisun Pfizer Pharmaceutical Co. — and own a 51% stake, while Pfizer will invest $250 million and own 49%.

February 14, 2012

Mylan to challenge court decision over generic asthma, COPD drug

Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

February 9, 2012

GPhA testifies before House subcommittee on generic user fees

The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

WASHINGTON — The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

February 8, 2012

Drug costs decline but remain high for many families, study finds

While the financial burden that families face due to prescription drugs has declined, costs nevertheless remain a challenge for many of them, according to a new study by nonprofit research organization Rand Corp.

NEW YORK — While the financial burden that families face due to prescription drugs has declined, costs nevertheless remain a challenge for many of them, according to a new study by nonprofit research organization Rand Corp.

January 31, 2012

FDA approves Hi-Tech Pharmacal's anxiety drug

The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a generic drug for anxiety made by Hi-Tech Pharmacal, the drug maker said Tuesday.

The FDA approved Hi-Tech's lorazepam oral concentrate in the 2-mg-per-mL strength, a generic version of Roxanne Labs' Intensol.

Branded and generic versions of the drug had sales of $10 million in 2011, according to IMS Health.

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January 31, 2012

FDA approves Lannett obesity drug

The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

Lannett announced the approval of phentermine hydrochloride capsules in the 15-mg strength.

Various versions of the drug had sales of $11 million at average wholesale price in 2011, according to Wolters Kluwer.

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January 23, 2012

ReportersNotebook — Chain Pharmacy, 1/30/12

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

January 20, 2012

80% of drug shortages are injectables, 80% are generics

One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs. According to healthcare analytics firm IMS Health, while this represents a small and highly concentrated portion of the overall drug market, it includes a number of critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system disorders and pain.

January 20, 2012

Challenges and opportunities abound as generic wave hits the shore

One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

WHAT IT MEANS AND WHY IT'S IMPORTANT — One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

January 20, 2012

FTC, drug cos. clash over patent settlements

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

January 20, 2012

GDUFA reduces wait time for generics

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications. 

January 20, 2012

Generics cos. turn to biosimilars as patent cliff approaches

With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while. 

January 20, 2012

Generics face new and long-standing issues

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

January 20, 2012

Lipitor’s patent loss signals future for other top drugs

If the patent cliff were a sports team, Pfizer’s cholesterol- lowering drug Lipitor (atorvastatin) would be its mascot.

If the patent cliff were a sports team, Pfizer’s cholesterol- lowering drug Lipitor (atorvastatin) would be its mascot. Because it’s the top-selling drug, well, ever — with 2010 sales well in excess of $7 billion in the United States alone — Lipitor’s loss of patent protection on Nov. 30, 2011, didn’t start or end the patent cliff but in many ways symbolized it. 

January 19, 2012

Watson launches generic version of Bayer's Yaz

Generic drug maker Watson Pharmaceuticals has launched its version of a contraceptive made by Bayer HealthCare Pharmaceuticals, Watson said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has launched its version of a contraceptive made by Bayer HealthCare Pharmaceuticals, Watson said.

The company announced the launch of Vestura (drospirenone and ethinyl estradiol), a generic version of Bayer's Yaz.

Yaz and its generic versions had sales of about $510 million during the 12-month period ended in November, according to IMS.

January 18, 2012

Analysts provide outlook for 2012

A wide range of factors and "moving parts" will likely make 2012 a challenging year for pharmacy retailers as the economy, generic drugs and the dispute between Walgreens and Express Scripts figure prominently, analysts say.

NEW YORK — A wide range of factors and "moving parts" will likely make 2012 a challenging year for pharmacy retailers as the economy, generic drugs and the dispute between Walgreens and Express Scripts figure prominently, analysts say.

Still, they say, various factors may serve to benefit drug stores and other retailers that operate pharmacies.

January 18, 2012

Frost & Sullivan forecasts strong growth in generic drug market through 2017

Patent expirations of key blockbuster drugs and efforts by payers to contain costs are likely to bring strong growth to the global generic drug market in the next few years as market-earned revenues grow by more than $100 billion, according to an analysis by research firm Frost & Sullivan.

LONDON — Patent expirations of key blockbuster drugs and efforts by payers to contain costs are likely to bring strong growth to the global generic drug market in the next few years as market-earned revenues grow by more than $100 billion, according to an analysis by research firm Frost & Sullivan.

The report, titled "Generic Pharmaceuticals Market — A Global Analysis" and focusing on the United States and Europe, also found that healthcare expenditure and sales revenues are poised to shift to India, China, Brazil, Turkey and South Korea.