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HEPCINAT (Sofosbuvir), a drug that has revolutionised the treatment of Chronic Hepatitis C virus (HCV)

NATCO living up to its purpose of “Making speciality medicines accessible to all” has launched Sofosbuvir under the brand name of HEPCINAT. HEPCINAT (Sofosbuvir), a drug that has revolutionised the treatment of Chronic Hepatitis C virus (HCV) infection is made available at a very affordable price. NATCO is the first company in India to launch this product; this is truly a momentous occasion for the HCV care givers, patients and the company.

HCV infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and for many years has hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Initially, Interferon and Ribavirin therapy was the treatment standard of care, but it offered limited performance across the wide spectrum of HCV disease and was fraught with excessive and often limiting side effects.

Sofosbuvir (SOF) is a potent first-in-class nucleotide inhibitor that acts directly on the viral replication enzyme and brings cure in as high as 90 to 100% of patients, which was never heard of in the treatment of HCV. The introduction of SOF, a safe and efficacious drug with the potential to cure HCV that affects 150-200 million people worldwide is indeed a rare event in the history of medicine. This is truly a momentous occasion for all those involved in the HCV care.

SOF is a well tolerated effective antiviral agent that is heralding a new era of all oral therapy for HCV. SOF is safe and can be used across different viral genotypes, disease stages, and special patient groups, such as those co-infected with human immunodeficiency virus. When used in combination with ribavirin or another direct-acting antiviral agent, SOF has revolutionized the HCV treatment spectrum and set the stage for nearly universal HCV antiviral therapy. More so than any other anti-HCV drug developed to date, SOF offers the widest applicability for all infected patients, and new regimens will be tailored to maximize performance. Sofosbuvir is truly an evolution and revolution in the treatment of HCV.

HEPCINAT (Sofosbuvir) is available throughout India and it is dispensed against the prescription of a Hepatologist/Gastroenterologist/HCV treatment specialist.

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NATCO receives generic Ledipasvir + Sofosbuvir approval for India

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.

Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand HARVONI®. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies.

NATCO will price its generic medicine, Hepcinat LP, at an MRP of INR 25,000/- for a bottle of 28 tablets. NATCO was the first licensed company to launch the generic version of this combination drug earlier in Nepal. NATCO had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI®, in 100 other developing countries in addition to India.

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Celgene has agreed to provide Natco with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic Lenalidomide in the United States

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) and its US partner Allergan announce settlement of its pending litigation with Celgene regarding generic Lenalidomide.

Celgene has agreed to provide Natco with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic Lenalidomide in the United States beginning on January 31, 2026.  In addition, Natco will receive a volume-limited license to sell generic Lenalidomide in the United States commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total Lenalidomide capsules dispensed in the United States during the first full year of entry.  The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total Lenalidomide capsules dispensed in the U.S. in the final year of the volume-limited license under this agreement.

REVLIMID® had recorded sales of nearly $3.4 billion in the US market for the year ending September 2015 (Source: Celgene Website)

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