Content about Generics

February 1, 2011
Biosimilars regulations 
unlikely to unfold soon

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


February 1, 2011
Dr. Reddy's gets OK to market generic allergy drug

A federal court has lifted an injunction that had prevented drug maker Dr. Reddy’s Labs from marketing a generic version of an allergy drug.

HYDERABAD, India — A federal court has lifted an injunction that had prevented drug maker Dr. Reddy’s Labs from marketing a generic version of an allergy drug.

Dr. Reddy’s said the U.S. District Court of New Jersey had filed a stipulation and order lifting the earlier injunction against the drug maker regarding the selling of a version of fexofenadine hydrochloride and pseudoephedrine hydrochloride tablets in the 180-mg/240-mg strength. The drug is a generic version of Sanofi-Aventis’ and Albany Molecular Research’s Allegra-D 24.

February 1, 2011
Generics discounts ignite Medicare Rx competition

Just when you thought the low end of the generic drug price spectrum couldn’t get any more commoditized, the $2 price point debuted with a big splash in September 2010.


February 1, 2011
Generics move McKesson profits up

McKesson Corp. on Monday reported revenue of $28.2 billion for its fiscal third quarter, ended Dec. 31, 2010. Third-quarter earnings per diluted share were 60 cents, which included a pre-tax average wholesale price litigation charge of $189 million ($133 million after-tax, or 52 cents per diluted share).

SAN FRANCISCO — McKesson Corp. on Monday reported revenue of $28.2 billion for its fiscal third quarter, ended Dec. 31, 2010. Third-quarter earnings per diluted share were 60 cents, which included a pre-tax average wholesale price litigation charge of $189 million ($133 million after-tax, or 52 cents per diluted share).

February 1, 2011
Generics to save $70 bn

NEW YORK — The U.S. healthcare system could get at least $70 billion in savings over the next four years thanks to loss of patent protection for branded drugs, according to published reports.


IMS Health SVP Murray Aitken said at the Reuters Health Summit that generics also would increase their dominance in terms of prescriptions dispensed, increasing from 77% during the first half of this year to perhaps 85% by 2014, Reuters reported.


February 1, 2011
Three issues that will define 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 31, 2011
Caraco reports quarterly earnings

Caraco Pharmaceutical Labs had sales of $40.4 million during the third quarter of fiscal year 2011, and $268.2 million during the first nine months of the fiscal year, the company said in an earnings report released Sunday.

DETROIT — Caraco Pharmaceutical Labs had sales of $40.4 million during the third quarter of fiscal year 2011, and $268.2 million during the first nine months of the fiscal year, the company said in an earnings report released Sunday.

Caraco, whose fiscal year 2011 ended Dec. 31, 2010, said that it included sales of products that it owns and products that it distributes in the figures. The latest numbers compared with $52 million in the third quarter of fiscal 2010 and $178.4 million during the first nine months of fiscal year 2010.

January 31, 2011
Mylan looks to market generic Lidoderm

Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

CHADDS FORD, Pa. — Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

Endo said Monday that Teikoku Seiyaku and U.S. subsidiary Teikoku Pharma USA had received a Paragraph IV certification from Mylan stating the latter’s intention to market a generic lidocaine topical patch. The drug is a generic version of Endo’s and Teikoku’s Lidoderm.

January 28, 2011
Italo Pennella named VP pharmacy at ECRM

A former Albertsons executive has been named the newest VP pharmacy at ECRM.

NEW YORK — A former Albertsons executive has been named the newest VP pharmacy at ECRM.

Italo Pennella, a licensed pharmacist, will utilize his insight on the pharmaceutical supply chain as ECRM's newest executive. At Albertsons, Pennella's career spanned more than 10 years, which included oversight of all brand manufacturer relationships. Prior to joining ECRM, Pennella most recently served as associated director of trade for Otsuka and Schering-Plough/Organon.

January 28, 2011
Mylan's generic Sular gets FDA OK

The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.

January 27, 2011
Matrix obtains license agreement for HIV treatment

A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

January 26, 2011
Teva, APP develop generic Gemzar

Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.

January 26, 2011
Watson seeks FDA approval for generic Welchol

Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.

January 25, 2011
More than 55,000 candidates sought PTCB certification in 2010

More than 55,000 candidates sat for the Pharmacy Technician Certification Exam in 2010, the Pharmacy Technician Certification Board said Tuesday.

WASHINGTON — More than 55,000 candidates sat for the Pharmacy Technician Certification Exam in 2010, the Pharmacy Technician Certification Board said Tuesday.

The PTCB said it has certified more than 400,000 pharmacy technicians since 1995.

January 25, 2011
Mylan announces Lipitor, Caduet patent settlements

Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).

Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.

January 25, 2011
Teva receives FDA action letter for generic Lovenox

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 24, 2011
Matrix Labs' generic Protonix DR receives FDA approval

The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

The FDA approved Matrix Labs’ pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths.

The drug is a version of Protonix DR, made by Wyeth, now part of Pfizer. Various versions of the drug had sales of around $1.7 billion during the 12-month period ended in September, according to IMS Health. The FDA also approved a version made by Dr. Reddy’s Labs on Friday.

January 21, 2011
Dr. Reddy's receives FDA approval for generic GERD treatment

Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.

HYDERABAD, India — Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.

The company announced Thursday the launch of pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is a version of Protonix, made by Wyeth, now part of Pfizer.

Pantoprazole sodium delayed-release tablets had sales of around $1.8 billion during the 12-month period ended in September 2010, according to IMS Health.

January 21, 2011
Perrigo to buy Paddock for $540 million

Perrigo will buy Paddock Labs for more than half a billion dollars, Perrigo said Thursday.

ALLEGAN, Mich. — Perrigo will buy Paddock Labs for more than half a billion dollars, Perrigo said Thursday.

Perrigo, an Allegan, Mich.-based company that makes generic prescription and over-the-counter drugs, including private-label products, announced that it would buy Minneapolis-based Paddock for $540 million in cash.

January 21, 2011
Watson forecasts successful year

Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

NEW YORK — Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

The company expected the forecasted sales for the year to include between $2.8 billion and $3 billion in global generics sales, compared with around $2.35 billion in 2010. Total sales for 2010 were around $3.5 billion, according to preliminary financial results released last week.

January 20, 2011
Dey Pharma launches MyEpiPen app

Mylan subsidiary Dey Pharma has launched a mobile application for patients at risk of severe allergic reactions, which is tied to its EpiPen product.

BASKING RIDGE, N.J. — Mylan subsidiary Dey Pharma has launched a mobile application for patients at risk of severe allergic reactions, which is tied to its EpiPen product.

The MyEpiPen app is available for the Apple iPhone, iPod Touch and iPad, and allows individuals, parents, guardians and others to create and share profiles of severe allergies with friends, family, teachers, school nurses, babysitters and others. Other features include an instructional video, user guide and others.

January 20, 2011
Under PEPFAR, Matrix gets tentative approval for generic Combivir

The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

January 18, 2011
Mylan's generic Precose gets green light from FDA

The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

PITTSBURGH — The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

Mylan announced the approval of acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a version of Bayer’s Precose, used with diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The drug had sales of around $23 million during the 12-month period ended in September, according to IMS Health.

January 18, 2011
Sandoz commences mid-stage trial for Rituxan biosimilar

Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

January 17, 2011
Court: Teva, Barr Labs must hold off on generic versions of Sensipar

Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.

THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.