LUPIN LIMITED | MedPath

Lupin Receives FDA Approval for Generic Rivaroxaban Tablets for Thrombosis Prevention

7 days ago

• Lupin has received U.S. FDA approval for its generic version of Rivaroxaban Tablets, expanding its cardiovascular portfolio with a key anticoagulant medication. • Rivaroxaban is primarily indicated for the prevention and treatment of deep vein thrombosis, pulmonary embolism, and stroke prevention in patients with atrial fibrillation. • The approval represents a significant milestone for Lupin in the competitive generic pharmaceutical market, potentially offering a more affordable alternative to Janssen's branded Xarelto.

Shionogi to Acquire Japan Tobacco's Pharmaceutical Subsidiaries for $1.1 Billion

14 days ago

• Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities. • The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake. • This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities to Level Global Oversight

16 days ago

• The FDA has announced plans to significantly expand unannounced inspections at foreign manufacturing facilities producing food, medicines, and medical products for U.S. consumers. • Despite receiving advance notice of inspections, foreign facilities were found to have serious deficiencies more than twice as often as domestic sites, highlighting the need for stricter oversight. • FDA Commissioner Dr. Martin Makary emphasized ending the "double standard" where foreign manufacturers received advance notice while U.S. companies faced rigorous unannounced inspections.

Pretomanid Price Drops 25%, Boosting Access to Life-Saving TB Treatment Across Africa

24 days ago

• The price of pretomanid, a critical component of drug-resistant tuberculosis treatment, has fallen to $169 per course, down from $364 in 2019, making it available for less than $1 per day. • TB Alliance's multi-manufacturer strategy has successfully created market competition, with Mumbai-based Lupin becoming the third licensed manufacturer to produce the high-quality drug. • The full BPaL/M regimen now costs $310, a 47% reduction since 2022, potentially allowing treatment for an additional 120,000 people with drug-resistant TB annually.

Lupin Limited Sets New Benchmark with India's Largest Diabetes Real-World Evidence Study

a month ago

• Lupin Limited has successfully onboarded 67,802 diabetes patients across 1,336 clinics in India's largest real-world evidence study for vildagliptin and its combinations, confirmed on March 15, 2025. • The groundbreaking study, conducted under the "Adding Colours to Diabetes Blues" campaign by Lupin's Verifica therapy, collected comprehensive data on demographics, disease duration, laboratory investigations, and treatment outcomes. • According to principal investigator Dr. Sanjay Kalra, the study provides critical insights that bridge the gap between clinical trials and actual patient experiences in India's diverse population.

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

a month ago

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

Indian Pharma Companies to Launch Generic Empagliflozin at 90% Lower Cost

2 months ago

• Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility. • Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet. • The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.

Lupin Launches Generic Rivaroxaban in US Market Following FDA Approval

3 months ago

• Lupin has launched Rivaroxaban Tablets USP, 2.5 mg in the US market after receiving final approval from the FDA for its Abbreviated New Drug Application. • The generic equivalent of Janssen's Xarelto® targets patients with coronary artery disease and peripheral artery disease, with estimated annual US sales of $446 million. • This strategic launch strengthens Lupin's position in the high-value anticoagulant market, following the company's strong Q3 performance with a 38.8% increase in profit.

Lupin's Somerset Facility Receives FDA Establishment Inspection Report, Confirming Compliance

3 months ago

• Lupin Limited has received the Establishment Inspection Report (EIR) from the US FDA for its Somerset, New Jersey manufacturing facility following an inspection conducted in January 2025. • The EIR issuance confirms the facility's compliance with US regulatory standards, strengthening Lupin's position in the US pharmaceutical market and validating its quality control systems. • Managing Director Nilesh Gupta highlighted that this milestone demonstrates Lupin's commitment to maintaining the highest standards of quality and compliance in pharmaceutical manufacturing.

Lupin Gains FDA Approvals for HIV, Cystic Fibrosis, and Heart Failure Generics

6 months ago

• Lupin receives FDA approval for generic Sacubitril/Valsartan tablets, a heart failure therapy, targeting a $6.06 billion market. • Tentative FDA approval granted to Lupin for generic Abacavir/Dolutegravir/Lamivudine tablets, an HIV treatment for pediatric patients. • Lupin's Ivacaftor oral granules, a generic for cystic fibrosis, also receive tentative FDA approval with potential for 180-day exclusivity.