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Generics

  • Big-money meds lose patent protection in 2016

    Total spending on products whose patents expired between 2012 and 2015 declined by $14.2 billion last year, according to IMS Health’s Institute for Health Care informatics. And 2016 could bring about further cost reductions.

  • Study: Biosimilars comparable to branded counterparts
    BALTIMORE, Md. — A new study from Johns Hopkins Bloomberg School of Public Health is highlighting the similarities between biosimilar drugs and the biologic drugs they seek to imitate. The study looked at scientific literature around biosimilars to conclude that “biosimilar drugs have very similar safety and effectiveness as their counterparts.”
     

  • Mylan launches generic Dexedrine capsules
    PITTSBURGH — Mylan on Monday announced the launch of its generic of Dexedrine (dextroamphetamine sulfate) extended-release capsules. The drug is indicated to treat narcolepsy and attention deficit disorder with hyperactivity as part of a treatment plan including other measure in patients 6 to 16 years of age. 
     
    Mylan’s generic will be available in 5-, 10- and 15-mg dosage strengths. The product had U.S. sales of about $101.3 million for the 12 months ended May 31, according to IMS Health data. 
     

  • Companies fight to launch biosimilars amid expiries

    In April, the Food and Drug Administration granted approval to Pfizer’s Inflectra (infliximab) — a biosimilar of Janssen’s Remicade and possibly the second biosimilar to be launched in the United States. But like the first biosimilar, Zarxio (filgrastim-sndz), Inflectra is subject to a 180-day waiting period before launch, and is currently facing opposition from Janssen, which claims Remicade’s patent doesn’t expire until 2018.

  • FDA approves Lysteda generic from Amerigen
    SILVER SPRING, Md. — The Food and Drug Administration has approved Amerigen Pharmaceuticals’ generic of Lysteda (tranexamic acid) instant release tablets, the company announced Tuesday. The drug is indicated to treat cyclic heavy menstrual bleeding. 
     
    Amerigen’s generic will be available in 650-mg dosage strength. Due to an agreement with Ferring Pharmaceuticals, which markets Lysteda, Amerigen may launch its generic under license at an undisclosed future date. 
     

  • Aurobindo breaks ground on N.J. facility
    EAST WINDSOR TOWNSHIP, N.J. — Aurobindo Pharma has broken ground on its new facility 567,000-sq. ft. manufacturing facility here, the township announced Monday. Aurbindo CEO Robert Cunard and chairman P.V. Ramprasad Reddy attended the groundbreaking alongside East Windsor Township mayor Janice Mironov, deputy mayor Peter Yeager and council members Denise Daniels and John Zoller. 
     

  • Teva gets FTC approval for Allergan generics acquisition
    JERUSALEM — The Federal Trade Commission has approved Teva’s proposed consent order for its planned acquisition of Allergan’s generics business, Actavis Generics, the company announced Tuesday. With the final regulatory hurdle behind it, the company said it expects the $40.5 billion transaction to complete next week.  
     

  • Report: Teva, Mylan may buy Pfizer's overseas generic business

    Teva Pharmaceutical and Mylan have shown preliminary interest in a Brazilian generic drug-making joint-venture in which Pfizer has a 40% stake, according to Fortune. (Fortune)

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