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Generics

  • Aurobindo earns FDA approval for multiple sclerosis generic

    EAST WINDSOR, N.J. — The U.S. Food and Drug Administration approved Aurobindo Pharma’s Dalfampridine Extended-Release tablets, 10 mg, intended for treatment of multiple sclerosis.

    The FDA’s Division of Bioequivalence determined the Aurobindo drug to be bioequivalent, and therefore therapeutically equivalent to the referenced listed drug, Amprya from Acorda Therapeutics.

    According to QuintilesIMS, the Aurobindo product has an estimated market size of $347 million for the 12 months ended November 2016.

  • Lupin intros Ortho-Cyclen 28 generic
    MUMBAI and BALTIMORE, Md. — Lupin on Tuesday announced the launch of its generic of Ortho-Cyclen 28 (norgestimate and ethinyl estradiol, 0.25 mg/0.035 mg) tablets. The drug is indicated for women of reproductive potential to prevent pregnancy. 
     
    The drug had U.S. sales of $204 million for the 12 months ended September 2016, according to QuintilesIMS data. 
     

  • FDA approves Perrigo’s Topicort Spray generic
    SILVER SPRING, Md. — The Food and Drug Administration has approved Perrigo’s generic of Topicort Spray (desoximetasone topical spray, 0.25%), the company announced Tuesday. The companies have settled prior patent litigation on confidential terms. 
     
    The drug is indicated to treat plaque psoriasis in patients 18 years of age or older and had sales estimated at $24 million for the 12 months ended November 2016, the company said. 
     

  • FamilyWize introduces Medicine Cabinet
    BETHLEHEM, Pa. — FamilyWize on Monday announced a new feature for patients looking for the best price on their prescription medications. The FamilyWize Medicine Cabinet, which the company says is the next evolution of its Drug Price Lookup Tool. The Medicine Cabinet allows users to create a personal profile and easily find the lowest price for their prescriptions through FamilyWize’s website and mobile app. 
     

  • FDA approves Aurobindo’s Micardis HCT generic
    SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo’s generic of Micardis HCT (telmisartan and hydrochlorothiazide) tablets, the company announced Friday. 
     
    The drug is indicated to treat hypertension and had a market size of $81.9 million for the 12 months ended November 2016, according to QuintilesIMS data.  
     

  • FDA approves Aurobindo’s Geodon generic
    SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo’s generic of Geodon (ziprasidone HCl) capsules, the company announced Wednesday. The drug is indicated to treat schizophrenia. 
     
    Aurobindo’s generic will be available in 20-, 40-, 60- and 80-mg dosage strengths. The drug has an estimated market size of $117 million for the 12 months ended November 2016, according to QuintilesIMS. 

  • Report: Lannett could be first company bankrupted amid drug price scrutiny
    LOS ANGELES — A new report from Citron Research is outlining why it expects Lannett to be the first pharmaceutical company to go bankrupt as a result of recent scrutiny on drug pricing. The analysis notes that Lannett is highly leveraged and dependent on three drugs for a bulk of its sales and that even modest price cuts to its biggest sellers would cause it to violate its debt covenants. 
     

  • New study: Growing share of drug prices go to rebates, supply chain
    WASHINGTON — A new study from the Berkeley Research Group is taking a look at the share of prescription drug spending that’s retained by biopharmaceutical companies, generics makers, pharmacy benefit managers, health plans and other supply chain stakeholders. 
     
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