Content about Generics

April 19, 2011

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

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.

April 18, 2011

The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

HAWTHORNE, N.Y. — The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

Taro announced Monday the approval of imiquimod cream in the 5% strength. The drug is used to treat actinic keratosis and external genital warts, and is a generic version of Graceway Pharmaceuticals’ Aldara.

Imiquimod cream has annual sales of around $340 million in the United States, according to Taro.

April 15, 2011

Drug stores may be best positioned to navigate any headwinds whipped up by rising fuel costs and may even benefit from them, a Credit Suisse analysis published Friday found.

NEW YORK — Drug stores may be best positioned to navigate any headwinds whipped up by rising fuel costs and may even benefit from them, a Credit Suisse analysis published Friday found.

April 14, 2011

Despite a difficult economy and rising health costs, the benefits of an integrated pharmacy service were evident as CVS Caremark helped its pharmacy benefit manager clients — employers, health plans and third-party administrators — manage pharmacy costs, according to the company's annual "Insights Report."

WOONSOCKET, R.I. — Despite a difficult economy and rising health costs, the benefits of an integrated pharmacy service were evident as CVS Caremark helped its pharmacy benefit manager clients — employers, health plans and third-party administrators — manage pharmacy costs, according to the company's annual "Insights Report."

April 14, 2011

The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

HYDERABAD, India — The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

Dr. Reddy's fexofenadine HCl tablets are bioequivalent versions of Sanofi-Aventis’ Allegra, which received Rx-to-OTC switch approval from the FDA in January.

The fexofenadine HCl Rx market had branded and generic sales of approximately $452 million for the 12 months ended last December, according to IMS Health.

April 14, 2011

Drug manufacturers are coming up with new versions of their drugs for erectile dysfunction as those drugs’ loss of patent protection and subsequent generic competition draw near, according to published reports.

NEW YORK — Drug manufacturers are coming up with new versions of their drugs for erectile dysfunction as those drugs’ loss of patent protection and subsequent generic competition draw near, according to published reports.

April 12, 2011

The road to waste reduction is paved with good intentions.

ST. LOUIS — The road to waste reduction is paved with good intentions.

That’s the conclusion of pharmacy benefit manager Express Script’s "2010 Drug Trend Report," which found that 33% of annual pharmacy-related waste can be eliminated by encouraging patients to improve common behaviors linked to their prescription drugs by harnessing their good intentions.

April 11, 2011

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.

Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue's patents.

April 11, 2011

The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.

Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.

April 8, 2011

The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.

April 8, 2011

Impax Labs will collaborate with a specialty pharmaceutical company dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.

HAYWARD, Calif., and HIGH POINT, N.C. — Impax Labs will collaborate with a specialty pharmaceutical company dedicated to the research, development and manufacturing of unique gelatin-based dosage forms.

Impax said it has entered a deal with Banner Pharmacaps in respect to the supply and commercialization of two softgel capsule products.

The products and terms of the agreement were not disclosed.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

April 7, 2011

Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

NORTHVALE, N.J. — Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

The drug maker announced the initial shipment of phentermine hydrochloride tablets in the 37.5-mg strength. The drug is a generic version of Teva’s Adipex-P.

Adipex-P and generic versions had sales of about $40 million in 2010, according to IMS Health.

The shipment was made under a collaborative agreement with precision dose and its subsidiary, TAGI Pharma.

April 6, 2011

Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

RALEIGH, N.C. — Indian drug maker Lupin and U.S. drug maker Salix Pharmaceuticals announced Wednesday a licensing deal for technology related to a drug for traveler’s diarrhea.

Under the deal, Salix will receive exclusive worldwide rights for Xifaxan (rifaximin) drug technology developed by Lupin and jointly by both companies in all countries except India.

Salix is required to pay Lupin $10 million upfront, as well as potential payments related to regulatory milestones.

April 6, 2011

British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

April 5, 2011

Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.

April 5, 2011

Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

April 4, 2011

Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

TORONTO — Canadian drug maker Intellipharmaceutics International is seeking approval for a generic version of a treatment for mental disorders.

Intellipharmaceutics announced Monday that it had filed an application with the Food and Drug Administration for quetiapine fumarate extended-release tablets, a generic version of AstraZeneca’s Seroquel XR.

April 4, 2011

The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

Mylan announced the approval of latanoprost ophthalmic solution in the 0.005% strength. The drug is a generic version of Xalatan, made by Pharmacia and Upjohn, now part of Pfizer.

Various versions of the drug had sales of around $711 million in 2010, according to IMS Health.

April 1, 2011

An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

HAYWARD, Calif. — An investigational drug for Parkinson’s disease was safe and effective, according to results of a late-stage clinical trial scheduled for presentation next week.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it would present data from a phase-3 trial of extended-release IPX066 (carbidopa-levodopa) at the American Academy of Neurology Conference’s annual meeting in Hawaii, which takes place from April 9 through April 16.

The company also said there were no unexpected serious side effects observed in patients.

April 1, 2011

The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for iron deficiency anemia made by Watson Pharmaceuticals, Watson said Thursday.

The drug maker announced the approval of Nulecit (sodium ferric gluconate complex in sucrose), an injectable and generic version of Sanofi-Aventis’ Ferrlecit.

The drug is used to treat iron deficiency anemia in adults and children ages 6 years and older undergoing chronic hemodialysis and receiving supplemental epoetin therapy.

March 31, 2011

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.

March 31, 2011

The American Enterprise Institute for Public Policy Research on Monday published a working paper that identified $329 million in overspending as a result of underutilization of generics.

WASHINGTON — The American Enterprise Institute for Public Policy Research on Monday published a working paper that identified $329 million in overspending as a result of underutilization of generics.

As total spending on 20 medicines with generic equivalents totaled approximately $1.5 billion, AEI concluded Medicaid overspent by 22% ($1.5 billion versus $1.17 billion) on these pharmaceuticals.

March 30, 2011

Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

HYDERABAD, India — Dr. Reddy’s Labs will assume ownership of a penicillin manufacturing site in Bristol, Tenn., from GlaxoSmithKline.

The generic drug maker said it completed the acquisition of the facility and related product portfolio, including Augmentin and Amoxil brands. GSK will retain the existing rights for the aforementioned brands outside the United States.

Further financial terms and conditions of the transaction are not being disclosed.