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    Natco Pharma files ANDA for generic version of Bosentan tablets for oral suspension

    Farhat NasimWritten by Farhat Nasim Published On 2019-06-05T10:00:24+05:30  |  Updated On 16 Aug 2021 11:48 AM IST

    Bosentan 32 mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson and Johnson) under the brand name Tracleer.


    Hyderabad: City-based Natco Pharma Limited has recently submitted an Abbreviated New Drug Application (ANDA) with Para IV certification of with the U.S Food and Drug Administration (USFDA) for the generic version of Bosentan 32 mg tablets for oral suspension.


    Bosentan 32 mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson and Johnson) under the brand name Tracleer.


    Tracleer is indicated for the treatment of pulmonary arterial hypertension. As per Johnson and Johnson' s (JnJ) annual report for the year ending 2018, Tracleer had registered sales of approximately $268 million in the US market and the 32 mg is one strength that is indicated for a paediatric patient.


    Natco believes that its ANDA is possibly the sole first-to-file based on the filing date.


    Also Read: Natco Pharma Q4 PAT plunges to Rs 120 crore


    "We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of the potential launch of the product," said Natco in a release.


    Natco Pharma was established in 1981 as a private limited company. The company develops, manufactures and markets finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs). The company's major product categories include Domestic Formulations, International Formulations, APIs and Blockbusters.


    Also Read: Natco Pharma settles patent litigation with Onyx Therapeutics over anti cancer drug- Kyprolis

    Actelion PharmaANDABosentangenerichypertensionJnJJohnson and JohnsonNatco pharmaPAHPulmonary arterial hypertensionTracleerUSFDA

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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