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Last Updated: April 11, 2025

Lupin Ltd Company Profile


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Drugs and US Patents for Lupin Ltd

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lupin Ltd ILOPERIDONE iloperidone TABLET;ORAL 206890-003 May 5, 2022 DISCN No No ⤷  Try for Free ⤷  Try for Free
Lupin Ltd KAITLIB FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203448-001 Dec 17, 2015 AB RX No No ⤷  Try for Free ⤷  Try for Free
Lupin Ltd LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 208031-003 Jan 3, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free
Lupin Ltd OLMESARTAN MEDOXOMIL olmesartan medoxomil TABLET;ORAL 206631-002 Apr 27, 2017 DISCN No No ⤷  Try for Free ⤷  Try for Free
Lupin Ltd POTASSIUM CHLORIDE potassium chloride CAPSULE, EXTENDED RELEASE;ORAL 203002-001 Dec 18, 2015 AB RX No No ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries
Paragraph IV (Patent) Challenges for LUPIN LTD drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Injection 250 mcg/0.5 mL, 1 mL PFS ➤ Subscribe 2012-03-30
➤ Subscribe for Oral Suspension 500 mg/5 mL ➤ Subscribe 2014-07-22

Supplementary Protection Certificates for Lupin Ltd Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1020454 10C0022 France ⤷  Try for Free PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1412357 122008000046 Germany ⤷  Try for Free PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1920764 1290027-0 Sweden ⤷  Try for Free PRODUCT NAME: TRAVOPROST
1948158 2016C/026 Belgium ⤷  Try for Free PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0542411 C300397 Netherlands ⤷  Try for Free PRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: LUPIN LTD – Market Position, Strengths & Strategic Insights

In the dynamic and fiercely competitive pharmaceutical industry, Lupin Ltd has emerged as a formidable player, carving out a significant market position through strategic initiatives and innovative approaches. This comprehensive analysis delves into Lupin's current standing, exploring its strengths, market positioning, and the strategic insights that drive its growth in the global pharmaceutical landscape.

Lupin's Market Position

Lupin Ltd, a multinational pharmaceutical company based in Mumbai, India, has established itself as a major force in the global pharmaceutical market. As of 2025, Lupin holds a strong position in various key markets, including India, the United States, and emerging economies.

Global Presence

Lupin's global footprint extends to over 100 countries, with a particularly strong presence in the following regions:

  1. India: Lupin is the 7th largest pharmaceutical company in the Indian market[1].
  2. United States: The company ranks as the 5th largest generics player in the US, with a 5.3% market share by prescriptions[6].
  3. Europe, Middle East, and Africa (EMEA): This region accounts for 11% of Lupin's global sales[1].
  4. Emerging Markets: Lupin has a growing presence in Asia-Pacific and Latin American countries, contributing 8% to its global sales[1].

Product Portfolio

Lupin's diverse product portfolio spans various therapeutic areas, including:

  • Cardiovascular
  • Diabetology
  • Respiratory
  • Anti-infectives
  • Central Nervous System (CNS)
  • Gastrointestinal
  • Oncology

The company's focus on chronic disease segments has been a key driver of its growth, particularly in the Indian market.

"Lupin's India Region Formulations business primarily focuses on the chronic segment, contributing 59.8% of its total revenue, with Lupin holding the fifth position in the industry."[3]

Strengths and Competitive Advantages

Research and Development

Lupin's commitment to innovation is evident in its substantial investment in R&D. In Q3 FY2025, the company allocated 7.7% of its sales (INR 4,344 Mn) to R&D efforts[1]. This focus on innovation has led to several breakthroughs, including:

  1. The world's first Fixed Dose Triple Combination drug, Vilfuro-G, for managing Chronic Obstructive Pulmonary Disease[3].
  2. A robust pipeline of 10 biosimilar products under development[6].

Manufacturing Capabilities

Lupin boasts an impressive manufacturing infrastructure, including:

  • 15 state-of-the-art manufacturing sites globally[1]
  • 7 research centers[1]
  • Specialized facilities for the production of APIs, formulations, and biotechnology products

This extensive manufacturing network enables Lupin to maintain quality control and meet global regulatory standards while ensuring a steady supply of products.

Strong Market Leadership

Lupin has established leadership positions in several key therapeutic areas:

  • Market leader in 28 out of 77 products marketed in the US generics market[6]
  • Among the top 3 by market share in 57 products in the US[6]
  • Leader in the anti-TB segment and ranks second in the Respiratory segment in India[3]

Global Regulatory Compliance

Lupin's commitment to quality and regulatory compliance is evident in its track record:

  • Received approval for 6 ANDAs from the U.S. FDA in Q3 FY2025[1]
  • Cumulative ANDA filings with the U.S. FDA stand at 430, with 334 approvals to date[1]
  • 49 First-to-File (FTF) filings, including 17 exclusive FTF opportunities[1]

Strategic Insights and Growth Drivers

Focus on Chronic Disease Segments

Lupin's strategic focus on chronic disease segments, particularly in the Indian market, has been a key growth driver. The company's top five therapy areas in India - Cardiology, anti-diabetes, Respiratory, Gastrointestinal, and anti-infective - collectively account for 73.6% of Lupin's sales[3].

Expansion in Emerging Markets

Lupin's aggressive expansion in emerging markets has contributed significantly to its growth. The company's revenue from international operations reached approximately 50% of total sales in FY2023, driven by a year-on-year growth rate of 11% in these markets[4].

Innovation in Product Development

Lupin's commitment to innovation is evident in its product development strategy. The company launched over 20 new products across various markets in FY2023, particularly in the US and India[4].

Strategic Partnerships

Lupin has formed strategic partnerships to enhance its research capabilities and expand its market reach. In 2023, the company entered into a collaboration with Sun Pharmaceutical to co-develop new oncology drugs, tapping into a market with a projected size of over ₹11,000 crores in India by 2025[4].

Diversification into Diagnostics

In December 2021, Lupin forayed into the diagnostics business, aiming to provide a comprehensive range of diagnostic tests in India. The company plans to enroll over 100 laboratories and 1,000 LupiMitra collection centres across India between 2022 and 2025[6].

Financial Performance and Growth Projections

Lupin's financial performance reflects its strong market position and growth strategies:

  • India formulation sales for Q3 FY2025 were INR 19,305 Mn, up 12% compared to Q3 FY2024[1]
  • EMEA sales for Q3 FY2025 were INR 6,249 Mn, up 21% compared to Q3 FY2024[1]
  • Global API sales for Q3 FY2025 were INR 2,891 Mn, up 4% compared to Q3 FY2024[1]

Looking ahead, analysts project that Lupin's revenue may grow at a compound annual growth rate (CAGR) of around 8%-10% over the next five years[4]. EBITDA margins are expected to improve, with estimates suggesting margins could rise to 24% by FY2025 from the current 22%[4].

Challenges and Risk Factors

Despite its strong market position, Lupin faces several challenges:

  1. Intense Competition: The pharmaceutical market is highly competitive, with major players like Sun Pharmaceutical and Aurobindo Pharma recording similar growth rates[5].

  2. Regulatory Scrutiny: Pharmaceutical companies are subject to stringent regulatory oversight. Lupin spent approximately 300 crore rupees on regulatory compliance in its most recent fiscal year, representing a 15% year-on-year increase[5].

  3. Market Volatility: Fluctuations in currency exchange rates can impact Lupin's international revenues. The Indian Rupee's volatility against the US Dollar in Q2 FY2024 affected the company's export revenues[5].

  4. Pricing Pressures: Increasing competition and regulatory measures to control drug prices can put pressure on Lupin's profit margins.

Future Outlook and Strategic Directions

As Lupin navigates the evolving pharmaceutical landscape, several key areas are likely to shape its future strategy:

  1. Expansion of Biosimilars Portfolio: With 10 biosimilar products under development, Lupin is well-positioned to capitalize on the growing biosimilars market, projected to surpass USD 35 billion by 2025[4].

  2. Focus on Complex Generics: Lupin's strong pipeline in complex generics, particularly in the respiratory segment and complex injectables, is expected to drive future growth[3].

  3. Digital Health Initiatives: Through its subsidiary Lupin Digital Health, the company is likely to increase its focus on digital health solutions to enhance patient care and engagement[1].

  4. Continued Geographical Expansion: Lupin's ongoing expansion in Europe and other markets such as Australia is expected to further diversify its revenue streams[3].

  5. Investment in R&D: Continued investment in research and development will be crucial for Lupin to maintain its competitive edge and bring innovative products to market[4].

Key Takeaways

  1. Lupin Ltd has established a strong global presence, particularly in India, the US, and emerging markets.
  2. The company's focus on chronic disease segments and investment in R&D have been key drivers of its growth.
  3. Lupin's diverse product portfolio and manufacturing capabilities provide a competitive advantage in the global pharmaceutical market.
  4. Strategic partnerships and expansion into new business areas like diagnostics demonstrate Lupin's commitment to diversification and innovation.
  5. While facing challenges such as intense competition and regulatory scrutiny, Lupin's strong financial performance and growth projections indicate a positive outlook for the future.

FAQs

  1. What is Lupin's market position in the US pharmaceutical market? Lupin is the 5th largest generics player in the US, with a 5.3% market share by prescriptions.

  2. How much does Lupin invest in Research and Development? In Q3 FY2025, Lupin invested 7.7% of its sales (INR 4,344 Mn) in R&D efforts.

  3. What are Lupin's key therapeutic areas in India? Lupin's top five therapy areas in India are Cardiology, anti-diabetes, Respiratory, Gastrointestinal, and anti-infective, collectively accounting for 73.6% of its sales.

  4. How is Lupin expanding its presence in emerging markets? Lupin has been aggressively expanding its footprint in emerging markets, especially in Asia, Africa, and Latin America, with international operations reaching approximately 50% of total sales in FY2023.

  5. What is Lupin's strategy for future growth? Lupin's future growth strategy includes expanding its biosimilars portfolio, focusing on complex generics, investing in digital health initiatives, continuing geographical expansion, and maintaining a strong focus on R&D.

Sources cited: [1] https://www.lupin.com/lupin-q3-fy2025-results/ [3] https://www.lupin.com/esg-report/business-review.php [4] https://dcfmodeling.com/blogs/health/lupinns-financial-health [5] https://dcfmodeling.com/ar/blogs/health/lupinns-financial-health [6] https://en.wikipedia.org/wiki/Lupin_Limited

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.