Content about Generics

February 21, 2012

A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

MUMBAI, India — A division of Pfizer is asserting that it incurred nearly $1 billion in damages related to the launch of generic versions of one of its drugs.

In a lawsuit filed in the U.S. District Court for the District of New Jersey against Sun Pharmaceutical Industries and Teva Pharmaceutical Industries, Wyeth Pharmaceuticals said it estimated that it suffered damages of $960 million from Sun's and Teva's launches of generic versions of the gastroesophageal reflux disease drug Protonix (pantoprazole).

February 21, 2012

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 17, 2012

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams.

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.


February 17, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


February 16, 2012

Poor medication adherence is a national problem, but it can be particularly problematic among populations with low health literacy or limited English proficiency.

MORRISVILLE, N.C. — Poor medication adherence is a national problem, but it can be particularly problematic among populations with low health literacy or limited English proficiency.

A deal between two companies aims to provide mobile medication adherence services to both groups. Polyglot Systems and CellepathicRx have partnered to use CPRx's mobile health platform to deliver Polyglot's Meducation content to hard-to-reach patients through mobile Web and email technologies and smart phone applications.

February 15, 2012

Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

PHOENIX — Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

According to a report released Wednesday by Wolters Kluwer Pharma Solutions' inThought research group, while Lipitor (atorvastatin) has 41% of the market share of all dispensed prescriptions of atorvastatin, it has 35% of the payer approval volume.

February 14, 2012

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 13, 2012

A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

PARSIPPANY, N.J. — A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

Watson Labs has filed an abbreviated new drug application with the FDA and is seeing to market drospirenone and ethinyl estradiol and levomefolate calcium tablets in the 3-mg/0.02-mg/0.451-mg strength and levomefolate calcium tablets in the 0.451-mg strength, a generic version of Bayer HealthCare Pharmaceuticals' Beyaz.

February 9, 2012

The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.

February 9, 2012

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

February 9, 2012

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

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.

February 8, 2012

Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

PARSIPPANY, N.J. — Subsidiaries of Watson Pharmaceuticals and Johnson & Johnson have settled a lawsuit filed by the latter when Watson attempted to market a generic version of one of its contraceptive drugs.

February 7, 2012

Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration's suspension order of its Lakeland, Fla., distribution center.

DUBLIN, Ohio — Cardinal Health was granted a temporary restraining order Friday against the Drug Enforcement Administration's suspension order of its Lakeland, Fla., distribution center.

A preliminary injunction hearing is currently scheduled for Feb. 13.

February 7, 2012

New product sales and the acquisition of Paddock Labs prompted second-quarter net sales to jump 17% to $838 million for Perrigo for fiscal year 2012, the drug maker said.

ALLEGAN, Mich. — New product sales and the acquisition of Paddock Labs prompted second-quarter net sales to jump 17% to $838 million for Perrigo for fiscal year 2012, the drug maker said.

For the company's consumer healthcare products segment, net sales rose 10% to $471 million, compared with the year-ago period, thanks to new product sales of $26 million and the diabetes care category, along with an increase in sales of existing products of $20 million.

February 6, 2012

Mylan has completed its acquisition of two skin drugs from Valeant Pharmaceuticals, the generic drug maker said Monday.

PITTSBURGH — Mylan has completed its acquisition of two skin drugs from Valeant Pharmaceuticals, the generic drug maker said Monday.

Mylan announced that it had acquired the regulatory approval applications for generic clindamycin phosphate and benzoyl peroxide gel, a generic version of Valeant's BenzaClin, and a license to manufacture and market fluorouracil cream in the 5% strength, a version of Valeant's Efudex.

February 6, 2012

In the five years since he has led the National Association of Chain Drug Stores, president and CEO Steve Anderson has operated under a sound policy; so simple, it is the advice he gives his own children: “We don’t start any fights — but we sure are going to finish them.” On Monday, Anderson and NACDS chairman Bob Loeffler, who also serves as H-E-B chief administrative officer, told NACDS Regional Chain Conference attendees that now they are going to take that fight to the PBM lobby.

NAPLES, Fla. — In the five years since he has led the National Association of Chain Drug Stores, president and CEO Steve Anderson has operated under a sound policy; so simple, it is the advice he gives his own children: “We don’t start any fights — but we sure are going to finish them.” On Monday, Anderson and NACDS chairman Bob Loeffler, who also serves as H-E-B chief administrative officer, told NACDS Regional Chain Conference attendees here, that now they are going to take that fight to the PBM lobby.

February 3, 2012

Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

NORTH WALES, Pa. — Teva Pharmaceuticals has launched a generic version of a psychiatric drug, the company said Friday.

Teva announced the launch of olanzapine orally disintegrating tablets in the 5-mg, 10-mg, 15-mg and 20-mg strengths in blister packs of 30.

The drug is a generic version of Eli Lilly's Zyprexa Zydis, used to treat schizophrenia and bipolar disorder.


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February 2, 2012

The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

February 1, 2012

A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

NEW YORK — A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

Pfizer announced the voluntary nationwide recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 additional lots of the drug's generic version. Pfizer manufactured and packaged the drugs, while Akrimax Pharmaceuticals commercialized them, and they were sold under the Akrimax brand.

January 31, 2012

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

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 30, 2012

Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.

PHILADELPHIA — Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.

The drug maker said its abbreviated new drug application for hydrochlorothiazide capsules in the 12.5-mg strength was approved. The drug is a generic version of Watson Pharmaceuticals' Microzide capsules.

January 30, 2012

Watson Pharmaceuticals is planning to open a global research and development technology center.

PARSIPPANY, N.J. — Watson Pharmaceuticals is planning to open a global research and development technology center.

The center will be a 32,000-sq.-ft., 50-acre complex consisting of lab, production and office space. The drug maker said it primarily will be used for developing generic pharmaceutical products, in particular for inhalation technology and respiratory products, with the ability to conduct formulation development and analytical testing.

January 27, 2012

Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.