According to PatSnap reports, Intra-Cellular Therapies (ITCI) filed patent infringement claims against Dr. Reddy's in November 2024 over three CAPLYTA (lumateperone) patents. The case was closed after 70 days via consolidation into lead action 3:24-cv-04264, which encompasses parallel ANDA litigation against multiple generic challengers. ITCI asserted US12128043B2, US12122792B2, and US12090155B2 covering formulations or related aspects of lumateperone, the active ingredient in CAPLYTA capsules approved for schizophrenia and bipolar depression. The consolidation under Rule 42(a) means the New Jersey District Court merged this action with lead case 3:24-cv-04264 because all defendants challenge the same CAPLYTA patent estate. The consolidated proceeding includes Aurobindo, Alkem, Hetero, MSN, Sandoz, and Zydus as co-defendants alongside Dr. Reddy's Laboratories.
According to reports from CNBC TV18, Business Standard, and Moneycontrol, Aurobindo Pharma announced that the US Food and Drug Administration (US FDA) has classified its subsidiary Eugia Pharma Specialities' Unit-III facility in Pashamylaram, Sangareddy district, Telangana, as 'Official Action Indicated' (OAI) following an inspection conducted from January 27 to February 6, 2026. The facility, operated by Eugia Pharma Specialities Ltd, a wholly owned subsidiary of Aurobindo Pharma, concluded with 11 observations during the inspection period. As per the company's latest disclosure, the facility is specifically located at Phase-III, TSIIC, EPIP, IDA, Pashamylaram, Patancheru Revenue Mandal, Sangareddy District, Telangana. The company has made this disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Earlier this month, the company received final approval from the USFDA to manufacture and market Tofacitinib Tablets in 5 mg and 10 mg strengths, demonstrating continued regulatory progress despite the OAI classification.
As reported by Business Standard, Aurobindo Pharma reported strong financial performance in Q4 FY26, with consolidated net profit rising 2% to ₹921.26 crore on a 4.4% increase in net sales to ₹8,751.50 crore compared to Q4 FY25. The company, which is engaged in manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services, demonstrated resilient growth despite regulatory challenges. The positive financial results provide a contrasting backdrop to the FDA compliance issues facing the company's pharmaceutical operations.
According to CNBC TV18, Business Standard, and Moneycontrol, shares of Aurobindo Pharma Ltd ended at ₹1,472.25 on the BSE, up by ₹8.15 or 0.56% in the previous trading session, with the stock touching a 52-week high of ₹1,550 on May 21, 2026, and a 52-week low of ₹1,017 on September 2, 2025. At the current market price, the stock is trading 5.02% below its 52-week high and 44.76% above its 52-week low, with the company's market capitalisation standing at ₹85,508.52 crore. The stock has gained more than 34% over the past one year, reflecting investor confidence in the company's operational momentum despite ongoing regulatory challenges.
According to the report, if violations are found on-site, they require further administrative sanctions and mandatory corrective actions. The resolution of 'Official Action Indicated' can usually happen only after a re-inspection. While the facility can continue selling approved drugs, it will not receive approvals for new drugs until the violations are addressed to the satisfaction of the USFDA. This regulatory challenge comes as Aurobindo faces both FDA compliance issues and patent litigation over its CAPLYTA generic formulations, though the company's strong financial performance and recent biologics facility launch suggest continued operational momentum.
As reported by CNBC TV18, this month Aurobindo Pharma inaugurated TheraNym, a dedicated biologics contract manufacturing organisation (CMO), marking its entry into the biologics contract manufacturing segment. The facility, located in Borapatla near Hyderabad, was inaugurated by Telangana Minister for IT, Industries & Commerce and Legislative Affairs D. Sridhar Babu and Telangana Minister for Science and Technology Damodar Raja Narasimha. TheraNym has been positioned as one of India's largest dedicated biologics contract manufacturing facilities, with MSD (known as Merck & Co. in the US and Canada) joining as its anchor customer.
