Lupin Company Profile

What is the competitive landscape for LUPIN

LUPIN has two hundred and forty-eight approved drugs.

There are eight US patents protecting LUPIN drugs. There are twenty-five tentative approvals on LUPIN drugs.

There are fifty-five patent family members on LUPIN drugs in sixteen countries and seven hundred and forty-five supplementary protection certificates in seventeen countries.

Summary for Lupin

International Patents:	55
US Patents:	8
Tradenames:	202
Ingredients:	182
NDAs:	248
Patent Litigation for Lupin:	See patent lawsuits for Lupin
PTAB Cases with Lupin as petitioner:	See PTAB cases with Lupin as petitioner

Drugs and US Patents for Lupin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213512-006	Mar 17, 2023		DISCN	No	No
Lupin Ltd	CLOMIPRAMINE HYDROCHLORIDE	clomipramine hydrochloride	CAPSULE;ORAL	209294-002	Nov 21, 2018	AB	RX	No	No
Lupin	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	208741-004	Aug 11, 2023		DISCN	No	No
Lupin	ORPHENADRINE CITRATE	orphenadrine citrate	TABLET, EXTENDED RELEASE;ORAL	040284-001	Jun 19, 1998	AB	RX	No	Yes
Lupin	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	077670-003	Feb 6, 2007	AB	RX	No	No
Lupin Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	078946-002	Mar 21, 2013	AB	RX	No	No

Expired US Patents for Lupin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	4,800,079
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,667,344
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,040,344
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	5,844,002
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	5,225,183
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	5,605,674

Paragraph IV (Patent) Challenges for LUPIN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	for Injection	200 mcg/vial		2015-05-01
	for Oral Suspension	500 mg/5 mL		2014-07-22
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Delayed-release Tablets	20 mg		2015-06-03
	Injection	250 mcg/0.5 mL, 1 mL PFS		2012-03-30
	Inhalation Solution	Eq. 0.015 mg base/2 mL		2009-10-01

International Patents for Lupin Drugs

Country	Patent Number	Estimated Expiration
China	105288650
European Patent Office	2268269
Japan	2015110671
Japan	2012072160
New Zealand	589290
Russian Federation	2747757

Supplementary Protection Certificates for Lupin Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0418716	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1663240	93382	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
0810209	C300283	Netherlands		PRODUCT NAME: DARUNAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER DARUNAVIR ETHANOLAAT; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
1280520	C300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Lupin
• Lupin Atlantis
• Lupin Ltd
• Lupin Pharms

Pharmaceutical Competitive Landscape Analysis: Lupin – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, Lupin Limited has emerged as a formidable player, carving out a significant niche for itself in the global market. This Indian multinational pharmaceutical company has consistently demonstrated its ability to innovate, adapt, and grow in an increasingly competitive landscape. Let's delve into Lupin's market position, strengths, and strategic insights to understand what sets this company apart and how it continues to thrive in the pharmaceutical industry.

The Lupin Story: From Humble Beginnings to Global Healthcare Leader

Lupin's journey began in 1968 when Dr. Desh Bandhu Gupta founded the company in Mumbai, India. What started as a small venture has now blossomed into a global pharmaceutical powerhouse[1]. The company's evolution is a testament to the power of vision, innovation, and unwavering commitment to improving health outcomes worldwide.

A Legacy of Innovation and Growth

Over the decades, Lupin has consistently pushed the boundaries of pharmaceutical research and development. The company's focus on creating affordable, high-quality medicines has been the cornerstone of its success. Today, Lupin stands tall as a leader in generics, branded generics, complex generics, active pharmaceutical ingredients (APIs), biosimilars, and specialty medicines[2].

Lupin's Global Footprint: Expanding Horizons

Lupin's reach extends far beyond its Indian roots. The company has established a strong presence in key markets around the world, including:

1. United States
2. Europe
3. Japan
4. Australia
5. South Africa
6. Philippines
7. Brazil
8. Mexico

This global expansion has not only diversified Lupin's revenue streams but also positioned it as a truly international pharmaceutical company[3].

Dominating the US Market

"As of March 2024, Lupin is the third-largest pharmaceutical company in the US by filled prescriptions, with a 5.2 per cent market share in generic scripts."[2]

Lupin's success in the United States, the world's largest pharmaceutical market, is particularly noteworthy. The company's US business has shown robust growth, with a 33.8% year-on-year increase driven by products like gSpiriva[2]. This strong performance in the US market has been a key factor in Lupin's overall growth and improved margins.

Lupin's Product Portfolio: Diversity and Specialization

Lupin's product offerings span a wide range of therapeutic areas, showcasing the company's versatility and commitment to addressing diverse healthcare needs.

Key Therapeutic Areas

1. Respiratory
2. Cardiovascular
3. Anti-diabetic
4. Anti-infective
5. Gastrointestinal
6. Central Nervous System
7. Women's Health

This diverse portfolio allows Lupin to cater to various patient needs and market demands, ensuring a stable and growing revenue stream[4].

Focus on Complex Generics and Biosimilars

Lupin has strategically positioned itself in the high-growth areas of complex generics and biosimilars. The company's investment in these segments demonstrates its forward-thinking approach and commitment to staying at the forefront of pharmaceutical innovation[3].

Research and Development: The Heart of Lupin's Success

At the core of Lupin's success lies its robust research and development capabilities. The company operates seven R&D sites across multiple countries, including India, the US, and the Netherlands[7].

Impressive R&D Statistics

• 911 active patents
• R&D expenditure of ₹1,280 crores in FY23 (7.69% of revenue)
• 437 ANDA filings and 45 First-to-file applications[2][5]

These numbers highlight Lupin's commitment to innovation and its ability to bring new, cutting-edge products to market consistently.

Manufacturing Excellence: The Backbone of Lupin's Operations

Lupin's manufacturing capabilities are a crucial component of its competitive advantage. The company operates 15 state-of-the-art manufacturing facilities across various locations[7].

Global Manufacturing Network

1. India
2. United States
3. Brazil
4. Mexico

These facilities adhere to the highest quality standards and best practices in environmental health and safety, ensuring the production of high-quality, affordable medicines[1].

Market Position: A Leader in Multiple Segments

Lupin has established itself as a leader in several key pharmaceutical segments:

1. 13th largest generic company globally
2. 3rd largest pharmaceutical company in the US by prescriptions
3. 6th largest in the Indian pharmaceutical market
4. Market leader in the anti-TB segment
5. Leading API manufacturer supplying to over 70 countries[5][7]

This diverse leadership position across various segments and geographies underscores Lupin's strength and versatility in the pharmaceutical industry.

Financial Performance: A Testament to Lupin's Strategy

Lupin's financial performance reflects its strong market position and effective business strategies.

Key Financial Highlights

• Annual sales of $2 billion in FY23
• Revenue growth of 2.19% over the last five years
• EBITDA positive for the past five years[5]

While the company has faced some challenges, including a loss in FY22 due to various factors, its overall financial trajectory remains positive, with strong growth in key markets like the US.

Strategic Initiatives: Paving the Way for Future Growth

Lupin has implemented several strategic initiatives to ensure continued growth and market leadership:

1. Expansion of complex generics and biosimilar portfolio
2. Focus on new product launches in regulated markets
3. Investment in R&D for innovative therapies
4. Adoption of advanced technologies
5. Expansion in emerging markets
6. Strengthening partnerships with medical practitioners and universities[3]

These initiatives demonstrate Lupin's proactive approach to addressing market challenges and capitalizing on new opportunities.

Challenges and Risk Factors: Navigating the Pharmaceutical Landscape

While Lupin has demonstrated strong performance, it faces several challenges and risks:

1. Regulatory uncertainties
2. Patent expirations
3. Intense competition in the generics market
4. Pricing pressures, especially in the US market
5. Dependence on the US market for a significant portion of revenue
6. Potential delays in product approvals or launches[5]

Addressing these challenges will be crucial for Lupin's continued success and growth in the coming years.

Lupin's Competitive Advantages: What Sets It Apart

Several factors contribute to Lupin's competitive edge in the pharmaceutical industry:

1. Strong R&D capabilities
2. Diverse product portfolio
3. Global manufacturing network
4. Leadership in key therapeutic areas
5. Strong presence in both developed and emerging markets
6. Focus on complex generics and biosimilars
7. Commitment to quality and affordability

These advantages position Lupin well to navigate the challenges of the pharmaceutical industry and capitalize on future growth opportunities.

Future Outlook: Lupin's Path Forward

As Lupin looks to the future, several key areas will likely drive its growth and success:

1. Continued expansion in the US generics market
2. Further development of complex generics and biosimilars
3. Strengthening its position in emerging markets
4. Investment in innovative therapies and technologies
5. Strategic partnerships and collaborations
6. Focus on operational efficiency and cost optimization

By focusing on these areas, Lupin aims to strengthen its market position and drive sustainable growth in the coming years.

Key Takeaways

1. Lupin has evolved from a small Indian company to a global pharmaceutical leader, ranking 13th among generic companies worldwide.
2. The company's success is driven by its strong R&D capabilities, diverse product portfolio, and global manufacturing network.
3. Lupin holds leadership positions in key markets, including being the 3rd largest pharmaceutical company in the US by prescriptions.
4. The company's focus on complex generics, biosimilars, and emerging markets positions it well for future growth.
5. While facing challenges such as regulatory uncertainties and pricing pressures, Lupin's strategic initiatives and competitive advantages provide a solid foundation for continued success.

FAQs

1. What is Lupin's primary focus in terms of product development? Lupin focuses on generics, branded generics, complex generics, APIs, biosimilars, and specialty medicines across various therapeutic areas.

2. How significant is Lupin's presence in the US market? Lupin is the third-largest pharmaceutical company in the US by filled prescriptions, with a 5.2% market share in generic scripts as of March 2024.

3. What are some of Lupin's key therapeutic areas? Lupin specializes in respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health products.

4. How much does Lupin invest in Research and Development? In FY23, Lupin invested ₹1,280 crores in R&D, which represented 7.69% of its revenue.

5. What are some of the main challenges Lupin faces in the pharmaceutical industry? Lupin faces challenges such as regulatory uncertainties, patent expirations, intense competition in the generics market, and pricing pressures, particularly in the US market.

Sources cited: [1] https://www.lupin.com/about-us/ [2] https://www.business-standard.com/markets/news/lupin-hits-new-high-up-2-market-capitalsation-nears-rs-1-trillion-124082700433_1.html [3] https://www.lupin.com/esg-report/business-review.php [4] https://www.globaldata.com/company-profile/lupin-ltd/ [5] https://www.equentis.com/blog/lupin-share-price-analysis-all-you-need-to-know/ [7] https://en.wikipedia.org/wiki/Lupin_Limited