Cipla receives final approval for generic version of Biogen IDEC Inc.'s Tecfidera® (Dimethyl Fumarate DR Capsules 120mg, 240mg and 120mg/240mg Starter Pack)
Cipla Limited (BSE: 500087; NSE: CIPLA EQ) announced on September 28, 2020, that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for Dimethyl Fumarate DR Capsules in 120mg and 240mg doses. This product is a generic version of Biogen IDEC's Tecfidera®, which saw US sales of approximately $3.8 billion in the 12 months ending July 2020. The generic drug is indicated for treating relapsing forms of multiple sclerosis and is available for shipping immediately, supported by Co-Pay Assistance.
- Final FDA approval for Dimethyl Fumarate DR Capsules enhances Cipla's product portfolio.
- The expected market for Cipla's generic Tecfidera® could potentially yield significant revenue given the original drug's $3.8 billion sales.
- None.
MUMBAI, India, Sept. 28, 2020 /PRNewswire/ -- Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Dimethyl Fumarate DR Capsules 120mg, 240mg and 120mg/240mg Starter Pak from the United States Food and Drug Administration (US FDA).
Cipla's Dimethyl Fumarate DR Caps 120mg, 240mg and 120mg/240mg Starter Pak is AB-rated generic therapeutic equivalent version of Biogen IDEC Inc.'s Tecfidera®. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
According to IQVIA (IMS Health), Tecfidera® had US sales of approximately
The product is available for shipping immediately. Cipla will providing Co-Pay Assistance.
About Cipla:
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT July'20), 3rd largest in the pharma private market in South Africa (IQVIA MAT July'20), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.
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