Content about Generics

January 23, 2012

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

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.

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

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.


January 20, 2012

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.


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

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.


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

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

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

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

January 19, 2012

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

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

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.

January 17, 2012

Jeff George, the global head of Sandoz, was ranked No. 9 on Fortune magazine's annual top “40 under 40” list, a selection of the top 40 young business leaders from a variety of industries.

HOLZKIRCHEN, Germany — Jeff George, the global head of Sandoz, was ranked No. 9 on Fortune magazine's annual top “40 under 40” list, a selection of the top 40 young business leaders from a variety of industries.

George, who has served as head of Sandoz since 2008, has led the drug maker to achieve double-digit revenue growth and make significant strides with respect to its differentiated products strategy, particularly in the field of biosimilars, Sandoz said.

January 17, 2012

The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

WASHINGTON — The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

The Pharmaceutical Care Management Association announced Tuesday the launch of its new "That's What PBMs Do" ad campaign, which includes print and video ads that focus on what the PCMA called PBMs' role in reducing pharmacy costs, Medicare Part D and mail-order pharmacy.

January 17, 2012

A committee formed by Taro Pharmaceutical Industries in December is continuing to evaluate an acquisition offer by India-based Sun Pharmaceutical Industries, Taro said.

HAIFA BAY, Israel — A committee formed by Taro Pharmaceutical Industries in December is continuing to evaluate an acquisition offer by India-based Sun Pharmaceutical Industries, Taro said.

Sun is hoping to acquire Israel-based Taro for $24.50 per share.

The committee, comprising members of the company's board of directors, has brought on Citigroup Global Markets as its financial adviser and is receiving legal advice from Israeli legal firm Goldfarb Seligman & Co. and U.S. firm Willkie Farr & Gallagher.

January 16, 2012

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

SILVER SPRING, Md. — The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

But the agency said it knew of two undisclosed hospitals that it said had reused the cartridge components of insulin pens in administering insulin to more than 2,000 patients, though the hospitals reportedly changed the pens themselves.

January 16, 2012

The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

WASHINGTON — The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

GDUFA calls for the generic industry to pay $299 million per year for five years, in addition to what Congress gives the FDA. The money would come in the form of user fees for companies that submit regulatory approval applications to the agency for review.

January 12, 2012

Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.

CINCINNATI — Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.

Prasco announced that it had partnered with Shire to distribute carbamazepine extended-release capsules in the 100-mg, 200-mg and 300-mg strengths. The drug is an authorized generic version of Carbatrol, used to treat certain types of seizures and pain.

Authorized generics are branded drugs sold under their generic names at a reduced price.

January 10, 2012

Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

LAKE FOREST, Ill. — Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

The company said the phase-3 trial of biosimilar EPO (erythropoietin) would compare its product with Amgen's Epogen in patients with kidney dysfunction who have anemia. The trial, which will enroll about 1,000 patients who already have taken Epogen, follows a phase-1 trial that ended last year, and results of the late-stage trial are expected next year.

January 9, 2012

Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

PITTSBURGH — Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

Mylan said that it was sued by Takeda Pharmaceutical, Watson Pharmaceuticals and Andrx Labs in the U.S. District Court for the Southern District of New York in response to Mylan's filing a regulatory approval application with the Food and Drug Administration for a generic version of Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride) extended-release tablets in the 15-mg/1,000-mg and 30-mg/1,000-mg strengths.

January 9, 2012

Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

ALLEGAN, Mich. — Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

Perrigo announced the $36 million acquisition of Alpharetta, Ga.-based CanAm Care, whose assets include Dex4 hypoglycemia products, insulin delivery syringes and pen needles, lancing, wound care and compression stockings.

January 6, 2012

Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said.

PRINCETON, N.J. — Sandoz has launched a shampoo used to treat severe scalp psoriasis, the generic drug maker said.

Sandoz announced the introduction of clobetasol propionate shampoo in the 0.05% strength, an authorized generic version of Galderma Labs' Clobex. An authorized generic drug is a branded drug sold under its generic name, usually by a third-party company at a reduced price.

Various versions of the shampoo had sales of about $54.9 million during the 12-month period ended in October 2011, according to IMS Health.

 

January 4, 2012

The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

January 4, 2012

Perrigo last week announced that it has received final Food and Drug Administration approval for its generic prescription allergy remedy desloratadine 5 mg, the generic equivalent to Schering-Plough's Clarinex.

ALLEGAN, Mich. — Perrigo last week announced that it has received final Food and Drug Administration approval for its generic prescription allergy remedy desloratadine 5 mg, the generic equivalent to Schering-Plough's Clarinex.

Under the terms of a patent-infringement suit settlement, Perrigo can commercially launch its generic desloratadine product July 1. The new product launch may be a prescription or over-the-counter product, depending on its status at the time of launch, Perrigo stated.

January 3, 2012

Actavis has begun shipping clobetasol propionate shampoo and clobetasol propionate lotion, which were granted 180-day marketing exclusivity by the Food and Drug Administration.

MORRISTOWN, N.J. — Actavis has begun shipping clobetasol propionate shampoo and clobetasol propionate lotion, which were granted 180-day marketing exclusivity by the Food and Drug Administration.

The shampoo and topical lotion are generic equivalents of Galderma's Clobex shampoo and Clobex topical lotion, which have garnered sales of $89.9 million for the 12 months ended in September 2011.

January 3, 2012

The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

PITTSBURGH — The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

The FDA approved Mylan's levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.

Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.