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Generics

  • 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.


  • Dr. Reddy's gets OK to market generic 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.

  • 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.


  • Generics move McKesson profits up

    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).

  • 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.

  • 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.


  • Caraco reports quarterly earnings

    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.

  • Mylan looks to market generic Lidoderm

    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.

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