| P/E TTM | 16.51Sector PE 45.87 |
|---|---|
| Market Cap | ₹91,298.55 CrPharmaceuticals |
| Revenue TTM | ₹29,966.58 CrOperating Revenue |
| RSI | 51.38Neutral Zone |
Key highlights
- Approval granted for Amifampridine Tablets 10 mg, bioequivalent to Firdapse by Catalyst Pharmaceuticals
- Lupin is eligible for 180-day shared generic exclusivity as a first-to-file applicant
- Company reported quarterly revenue of ₹8,276.89 crore, up 32.04% year-on-year
- Net profit for the June 2026 quarter stood at ₹1,415 crore with a 29.6% operating margin
- Approval strengthens a pipeline that includes 50 first-to-file opportunities
Shared Generic Exclusivity in the US Market
The United States Food and Drug Administration has granted approval for Lupin's Abbreviated New Drug Application for Amifampridine Tablets, 10 mg. This product is a generic version of Firdapse Tablets, marketed by Catalyst Pharmaceuticals, Inc., and is indicated for the conditions specified in its approved labeling. By being among the first to file a substantially complete ANDA, Lupin has secured eligibility for 180 days of shared generic exclusivity.
This regulatory advantage typically allows for a period of limited competition, enabling the company to establish its market presence for the drug within the United States specialty pharmaceutical segment.
Strategic Expansion of the Generic Portfolio
- Lupin currently manages a global portfolio distributed across more than 100 markets
- The company holds 50 first-to-file opportunities, including 21 exclusive FTFs as of August 2026
- Recent approvals in 2026 include Phytonadione Injectable Emulsion and Modafinil Tablets
- The generic pipeline is supported by 45 injectable projects and 20 inhalation projects
- Management has guided for high single-digit revenue growth for the 2027 fiscal year
- Lupin operates 15 manufacturing facilities and 6 research centers globally
Financial Performance and Pipeline Momentum
This approval follows a period of robust financial growth for the pharmaceutical major. For the quarter ended June 30, 2026, Lupin reported operating revenue of ₹8,276.89 crore, marking a 10.73% sequential increase from the previous quarter. The company maintains a healthy balance sheet with cash from operating activities totaling ₹7,334.5 crore annually.
The approval of Amifampridine adds to a string of recent regulatory successes, including the tentative approval of Apixaban Oral Suspension in September 2026. The company continues to target a significant expansion in its biosimilar division, aiming for $500 million in revenue from the segment within five years.
| Date | Announcement | Amount |
|---|---|---|
| 08 Oct 2026 | U.S. FDA approval for Phytonadione Injectable Emulsion USP (1 mg/0.5 mL Prefilled Syringe)Source: BSE filing | – |
| 28 Sep 2026 | U.S. FDA tentative approval for Apixaban Oral Suspension (1.25 mg/mL) via 505(b)(2) pathwaySource: lupin.com | – |
| 04 Sep 2026 | U.S. FDA approval for Modafinil Tablets USP (100 mg and 200 mg)Source: lupin.com | – |
| 17 Aug 2026 | U.S. FDA final approval for Pitolisant Tablets (4.45 mg and 17.8 mg)Source: lupin.com | – |
| 24 Jul 2025 | U.S. FDA approval for Liraglutide and Glucagon Injectable ProductsSource: lupin.com | – |
| 24 Apr 2025 | U.S. FDA approval for generic Tolvaptan Tablets (15 mg, 30 mg, 45 mg, 60 mg, and 90 mg) with 180-day exclusivitySource: lupin.com | – |
What to watch next
- Board meeting to consider Q2 and H1 FY27 financial results on November 03, 2026
- Filing of 15+ additional ANDAs planned throughout the remainder of FY27
- Launch of 5+ biosimilar products targeted by FY31
| Share price | ₹1996.5 |
|---|---|
| Market capitalisation | ₹91,298.55 Cr |
| Revenue (annual) | ₹27,958.03 Cr |
| Net profit (annual) | ₹5,332.84 Cr |
| Revenue (latest quarter) | ₹8,276.89 Cr+10.73% vs previous quarter |
| Net profit (latest quarter) | ₹1,415.00 Cr-3.10% vs previous quarter |
| P/E (TTM) | 16.51×Sector 45.87× |
| Promoter holding | 46.84%-0.01% QoQ |
| FII holding | 23.28%Current quarter |
Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.
Exchange filing by Lupin Limited announcing US FDA approval for Amifampridine Tablets with 180-day exclusivity. Market figures from a third-party data provider.
