Content about Generics

February 23, 2011
Caraco, Sun to merge

Generic drug maker Caraco Pharmaceutical Industries will merge with Sun Pharmaceutical Industries, Caraco said Tuesday.

DETROIT — Generic drug maker Caraco Pharmaceutical Industries will merge with Sun Pharmaceutical Industries, Caraco said Tuesday.

Sun, which already owns 75.8% of Caraco, will pay $5.25 per share for the remaining shares of Caraco that it doesn’t already own and make Caraco a private company.

Sun originally made the going private offer in December, offering $4.75 per share for Caraco.

February 22, 2011
GPhA announces executive committee, board of directors

The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

ORLANDO, Fla. — The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

The GPhA said Watson Pharmaceuticals president and CEO Paul Bisaro had been reelected as chairman for a second, one-year term. Also elected were Mylan Pharmaceuticals president Tony Mauro, as vice chairman; and Momenta Pharmaceuticals president Craig Wheeler, as secretary treasurer.

February 22, 2011
Hi-Tech Pharmacal receives market exclusivity for generic Neurontin

Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

Hi-Tech announced the approval of gabapentin oral solution in the 250 mg/5 mL strength, a generic version of Pfizer’s Neurontin oral solution.

The drug is used to treat postherpetic neuralgia and epilepsy. Neurontin had sales of $15 million in 2010, according to IMS Health.

February 22, 2011
Medco's Q4, fiscal-year sales rise

Sales at Medco Health Solutions increased to $16.9 billion during fourth quarter 2010 and to $66 billion for the fiscal year as a whole, representing respective 11.1% and 10.3% increases over the same periods the year before, the pharmacy benefit manager said Tuesday.

FRANKLIN LAKES, N.J. — Sales at Medco Health Solutions increased to $16.9 billion during fourth quarter 2010 and to $66 billion for the fiscal year as a whole, representing respective 11.1% and 10.3% increases over the same periods the year before, the pharmacy benefit manager said Tuesday.

Profits for the quarter were $378.5 million, a 10.8% increase over fourth quarter 2009, while profits for the year were $1.4 billion, an 11.5% increase over fiscal year 2009.

February 22, 2011
Perrigo files regulatory application for Taclonex generic

Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.

February 22, 2011
Prasco agrees to distribute authorized generic of Pentasa

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

February 18, 2011
Anticipating regulations, biosimilars move through pipeline

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


February 18, 2011
As innovaters prep for patent cliff, generics prosper from patent losses

A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.


February 18, 2011
Impax granted FDA approval for generic Adoxa

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

Impax said its generic division, Global Pharmaceuticals, will launch the product.

February 18, 2011
Industry advocates tout
 increase in generics use

Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.


February 18, 2011
ReportersNotebook — Chain Pharmacy, 2/28/11

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 17, 2011
Report: Exclusivity period for biotech drugs may be reduced to seven years

The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

February 17, 2011
Teva's Jinteli now available

Generic drug maker Teva Pharmaceutical Industries has launched a generic drug for treating symptoms of menopause.

NORTH WALES, Pa. — Generic drug maker Teva Pharmaceutical Industries has launched a generic drug for treating symptoms of menopause.

Teva announced Thursday the availability of Jinteli (norethindrone acetate and ethinyl estradiol) tablets.

The drug is a generic version of Warner Chilcott’s FemHRT and is available in the 1-mg/5-mcg strength.

February 15, 2011
Mylan gets approval for generic version of Vfend

Mylan has launched a generic drug for fungal infections, the company said Tuesday.

PITTSBURGH — Mylan has launched a generic drug for fungal infections, the company said Tuesday.

Mylan announced the launch, through subsidiary Mylan Pharmaceuticals, of voriconazole tablets in the 50-mg and 200-mg strengths. The drug is a triazole antifungal agent.

The tablets are a generic version of Pfizer’s Vfend, which had sales of $186 million in 2010, according to IMS Health. Mylan launched its version of the drug under a settlement with Pfizer.

February 15, 2011
PCMA leader: Generics, mail-order pharmacy help save money

Mark Merritt, the president and CEO of the Pharmaceutical Care Management Association, responded to a provision on the Pentagon's new budget proposal, which encourages Tricare members to use generic medications and mail-service pharmacies to save money.

WASHINGTON — Mark Merritt, the president and CEO of the Pharmaceutical Care Management Association, responded to a provision on the Pentagon's new budget proposal, which encourages Tricare members to use generic medications and mail-service pharmacies to save money.

February 15, 2011
Watson's global generics business sees boost

Watson's global generics business drove the drug maker's net revenue in the fourth quarter, according to a financial earnings release.

MORRISTOWN, N.J. — Watson's global generics business drove the drug maker's net revenue in the fourth quarter, according to a financial earnings release.

February 14, 2011
Report: Generic drug makers may look to diversify portfolios

An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

PHILADELPHIA — An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

According to the report, “Gaining Market Share in the Generic Drug Industry Through Acquisitions and Partnerships,” generic drug makers face competition, as well as government-mandated price cuts in Europe and such policies as lowest-price tendering. As a result, many could seek deals that would cause them to diversify their portfolios.

February 11, 2011
E-prescribing of generics may be limited by pending legislation

Bills introduced in the legislatures of nearly a dozen states have pharmacy benefit managers and the generic drug industry fearing that the bills could lead to limits on doctors’ abilities to prescribe generics through e-prescribing.

NEW YORK — Bills introduced in the legislatures of nearly a dozen states have pharmacy benefit managers and the generic drug industry fearing that the bills could lead to limits on doctors’ abilities to prescribe generics through e-prescribing.

The Pharmaceutical Care Management Association, the main lobby for PBMs, said the bills would prohibit doctors from seeing lower-cost drug options, including generics and preferred brands; would prevent the e-prescribing software from showing safety information; and would disallow lower-cost pharmacy options.

February 11, 2011
FDA approves Quixin generic

The Food and Drug Administration has approved Hi-Tech Pharmacal’s generic version of a drug for eye infections.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved Hi-Tech Pharmacal’s generic version of a drug for eye infections.

Hi-Tech announced the approval of levofloxacin ophthalmic solution in the 0.5% strength, a treatment for bacterial conjunctivitis. The company plans to launch next month.

The drug is a generic version of Vistakon’s Quixin, which had sales of $2 million in 2010, according to IMS Health.

February 11, 2011
Mallinckrodt receives FDA approval for generic Duragesic

The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

February 10, 2011
Actavis OKed to market generic Protonix

Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

MORRISTOWN, N.J. — Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

The generic drug maker said it would market pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is the generic equivalent of Pfizer's Protonix, which had U.S. sales of approximately $1.6 billion for the 12 months ended Dec. 31, 2010, according to IMS Health.

Actavis said it would distribute the drug soon.

February 10, 2011
Court: Watson's generic OTC decongestant does not infringe on branded versions

Over-the-counter generic versions of a line of products used to treat congestion do not infringe on the patents covering the branded versions, a federal court ruled Wednesday.

MORRISTOWN, N.J. — Over-the-counter generic versions of a line of products used to treat congestion do not infringe on the patents covering the branded versions, a federal court ruled Wednesday.

February 9, 2011
Report: Sandoz has as many as 10 follow-on biologics in works

Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

NEW YORK — Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

Reuters, citing an interview with Sandoz head Jeff George in the German newspaper Handelsblatt, said the generics arm of Swiss drug maker Novartis had eight to 10 new biosimilar molecules in development.

February 8, 2011
Teva reports Q4, full-year results

Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker's financial well-being.

JERUSALEM — Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker's financial well-being.

February 7, 2011
FDA approves Hospira's generic Hycamtin

The Food and Drug Administration has approved a generic cancer drug from Hospira.

LAKE FOREST, Ill. — The Food and Drug Administration has approved a generic cancer drug from Hospira.

The drug maker announced the approval of topotecan injection for treating small-cell lung cancer sensitive disease after first-line chemotherapy has failed.

The drug is a generic version of GlaxoSmithKline’s Hycamtin, which had sales of more than $140 million in 2010, according to Hospira.