Janssen Generic ARV licensing

To facilitate and ensure sustainable and affordable access to generic versions of Janssen’s HIV medicines within the licensing territory.

Janssen Generic ARV licensing

Janssen R&D Ireland (formerly Tibotec Pharmaceuticals) granted multiple non-exclusive licenses to Hetero Drugs, Emcure Pharmaceuticals, Strides ArcoLab and Matrix Laboratories of India, and Aspen Pharmacare of South Africa to manufacture, market and distribute generic versions of its non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC 278), subject to its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults. The Indian companies have rights to market the product in 112 lower-middle-income countries (LMICs). Aspen has rights to market the product in SSA, including South Africa. These agreements offer licensees the technical information and knowledge (“tech transfer”) to manufacture the active pharmaceutical ingredients (API) and finished product. They also enable the development of appropriate fixed-dose combinations (FDCs) of rilpivirine with other HIV medicines within the licensing territories. The generic manufacturers will be responsible for timely regulatory filing for generic rilpivirine and for seeking pre-qualification from the World Health Organization (WHO) and FDA ANDA generic drug approvals.


  • Janssen

    United States | Staff size: 10,000+

    Janssen Research & Development, LLC, is united and energized by one mission – to discover and develop innovative medicines that ease patients' suffering, and solve the most important...

  • Aspen Pharmacare

    Goods Supplier
    South Africa | Staff size: 5001-10,000

    Aspen Pharmacare Holdings Limited is a multinational South African holding company for pharmaceutical concerns. The Group is committed to sustaining life and promoting healthcare through...

  • Emcure Pharmaceuticals Limited

    Goods Supplier
    India | Staff size: 5001-10,000

    The Company was incorporated as Emcure Pharmaceuticals Private Limited on April 16, 1981 as a private limited company under the Companies Act, 1956.

    They are a growing...

  • Mylan Laboratories Limited

    Goods Supplier
    United States | Staff size: 10,000+

    Mylan is one of the world’s leading global pharmaceutical companies. Their medicines range from difficult-to-manufacture dosage forms, such as injectables and transdermal patches, to...

  • Strides Acrolab Limited

    Goods Supplier
    India | Staff size: Unknown

    Incorporated in 1990, Strides Arcolab is a first generation, pharmaceutical company headquartered in Bangalore, India. With business interests in differentiated pharma generics, branded...

  • Hetero Drugs Ltd.

    Goods Supplier
    Pakistan | Staff size: 10,000+

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished...

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Key Information

  • Start Date 2008