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October 23, 2012
United Therapeutics awaits FDA decision on oral PAH drug as Sandoz seeks generic approval

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

October 10, 2012
FDA approves generic cardiovascular drug

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

Actavis announced Wednesday the approval of diltiazem hydrochloride extended-release capsules.

The drug is a generic version of Valeant's Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.

September 18, 2012
Generics saved U.S. $1 trillion in 9 years

A trillion of anything is difficult to wrap one’s head around, whether it’s the number of grains of sand on a beach or stars in the sky. It’s so much easier for the human mind to look at such a quantity as the sum of its parts rather than on the basis of its individual components.


A trillion of anything is difficult to wrap one’s head around, whether it’s the number of grains of sand on a beach or stars in the sky. It’s so much easier for the human mind to look at such a quantity as the sum of its parts rather than on the basis of its individual components.


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.


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
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.


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.


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 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.

July 30, 2012
Watson seeks approval for acne, bronchospasm drugs

Generic drug maker Watson Pharmaceuticals is challenging the patent protection on a drug for acne and a drug for bronchospasm, the company said Monday.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection on a drug for acne and a drug for bronchospasm, the company said Monday.

July 5, 2012
FDA gives tentative approval to generic hypertension drug

Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

MORRISTOWN, N.J. — Actavis has received a preliminary approval for a generic drug for treating high blood pressure, the drug maker said Thursday.

May 29, 2012
Watson settles with Endo, Teikoku Seiyaku over generic version of Lidoderm patch

Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

Watson announced Tuesday a settlement through one of its subsidiaries with Endo Pharmaceuticals and Teikoku Seiyaku Co. over its generic version of Lidoderm (lidocaine) topical patch. Lidoderm had sales of $1.2 billion during the 12-month period ended in March 2012, according to IMS Health.

April 23, 2012
Watson launches authorized generic diabetes drug

Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

PARSIPPANY, N.J. — Watson Pharmaceuticals announced the launch of an authorized generic version of a drug used to lower blood glucose in patients with Type 2 diabetes.

April 11, 2012
Prasco to market authorized generic Vancocin

Prasco Labs will market an authorized generic version of a drug used to treat diarrhea caused by a bacterial infection, the company said Wednesday.

CINCINNATI — Prasco Labs will market an authorized generic version of a drug used to treat diarrhea caused by a bacterial infection, the company said Wednesday.

Prasco announced that it had signed a deal with ViroPharma to market an authorized generic version of Vancocin (vancomycin hydrochloride) capsules in the 125-mg and 250-mg strengths. The drug is used to treat diarrhea related to Clostridium difficile infection.

March 19, 2012
Watson challenges Abbott patent on Niaspan

Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott's Niaspan.

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.

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
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.

November 15, 2011
GPhA urges congressional super committee not to ban patent settlements

The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.

WASHINGTON — The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.

October 25, 2011
FTC staff report attacks branded-generic patent settlements

The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.

WASHINGTON — The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.

The FTC, which under the leadership of chairman Jon Leibowitz, repeatedly has attacked what it calls "pay-for-delay" deals between branded and generic drug manufacturers and has been lobbying the Congressional Joint Select Committee on Deficit Reduction, also known as the super committee, to ban the deals.

October 21, 2011
Senators urge congressional super committee to support 'pay-for-delay' ban

Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

WASHINGTON — Two senators are trying to get the Joint Select Committee on Deficit Reduction to take up a bill that would ban so-called "pay-for-delay" patent settlements between brand and generic drug companies, according to published reports.

The Pharma Letter reported that Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, had urged the "super committee" to support a bill that would ban settlements that include any form of payment in exchange for holding off launch of a generic drug.

October 17, 2011
Lannett begins shipping three generic drugs

Lannett announced that it has begun shipping three generic drugs that recently were approved by the Food and Drug Administration.

PHILADELPHIA — Lannett announced that it has begun shipping three generic drugs that recently were approved by the Food and Drug Administration.

The generic drug maker said that it has shipped diethylpropion tablets in the 25-mg strength; phentermine hydrochloride capsules in the 37.5-mg strength and loxapine capsules in 5-mg, 10-mg, 25-mg and 50-mg strengths.

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.


May 16, 2011
Generic, authorized generic of Amrix launched

Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.

April 19, 2011
GPhA applauds new IMS Institute report

The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

WASHINGTON — The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

According to the analysis, contained in the report “The Use of Medicines in the United States: Review of 2010,” the average co-payment for a generic drug was $6.06 per prescripton last year, compared with $23.65 to $34.77 for preferred and nonpreferred brand drugs.

April 19, 2011
IMS Institute: Rx drug spend experiences slower growth

U.S. spending on drugs grew 2.3% to $307.4 billion in 2010, according to a new report by the IMS Institute for Healthcare Informatics, part of industry research firm IMS Health.

PARSIPPANY, N.J. — U.S. spending on drugs grew 2.3% to $307.4 billion in 2010, according to a new report by the IMS Institute for Healthcare Informatics, part of industry research firm IMS Health.

March 31, 2011
Aurobindo receives approval for generic Razadyne, Monopril

Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

HYDERABAD, India — Indian generic drug maker Aurobindo has received two approvals from the Food and Drug Administration.

The company said Wednesday that it received approval for galantamine tablets in the 4-, 8- and 12-mg strengths. The drug is a version of Johnson & Johnson’s Alzheimer’s treatment Razadyne; various versions of the drug had sales of $41 million during the 12 months ended in September 2010, according to IMS Health.