Gilead Sciences Company Profile

What is the competitive landscape for GILEAD SCIENCES

GILEAD SCIENCES has twenty-seven approved drugs.

There are eighty-five US patents protecting GILEAD SCIENCES drugs.

There are two thousand two hundred and seven patent family members on GILEAD SCIENCES drugs in sixty-one countries and three hundred and fifty-one supplementary protection certificates in twenty countries.

Summary for Gilead Sciences

International Patents:	2207
US Patents:	85
Tradenames:	21
Ingredients:	20
NDAs:	27
Patent Litigation for Gilead Sciences:	See patent lawsuits for Gilead Sciences
PTAB Cases with Gilead Sciences as patent owner:	See PTAB cases with Gilead Sciences as patent owner

Drugs and US Patents for Gilead Sciences

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	11,116,783*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	9,085,573*PED				Y
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes	10,071,985		Y	Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	11,116,783*PED				Y
Gilead Sciences Inc	BIKTARVY	bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210251-001	Feb 7, 2018		RX	Yes	Yes	10,385,067
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-002	Aug 28, 2019		RX	Yes	Yes	8,580,765*PED				Y

Expired US Patents for Gilead Sciences

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	ODEFSEY	emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate	TABLET;ORAL	208351-001	Mar 1, 2016	6,838,464
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	8,716,264
Gilead Sciences Inc	ZYDELIG	idelalisib	TABLET;ORAL	205858-002	Jul 23, 2014	8,492,389
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	8,716,264
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,457,036
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	9,018,192

Paragraph IV (Patent) Challenges for GILEAD SCIENCES drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	600 mg/200 mg/300 mg		2008-12-29
	Tablets	150 mg, 200 mg, and 250 mg		2012-05-17
	Tablets	150 mg, 150 mg, 200 mg, 300 mg		2018-10-04
	Tablets	300 mg		2010-01-26
	Tablets	200 mg/25 mg/300 mg		2015-05-20
	Tablets	150 mg		2015-12-09

International Patents for Gilead Sciences Drugs

Country	Patent Number	Estimated Expiration
Luxembourg	92864
Eurasian Patent Organization	201490903
Poland	2487166
Lithuania	C3150586
Canada	2893843
Eurasian Patent Organization	032358

Supplementary Protection Certificates for Gilead Sciences Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3347352	202240051	Slovenia		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; NATIONAL AUTHORISATION NUMBER: EU/1/22/1671; DATE OF NATIONAL AUTHORISATION: 20220817; AUTHORITY FOR NATIONAL AUTHORISATION: EU
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
2487166	2016C/065	Belgium		PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123
2822954	PA2018511,C2822954	Lithuania		PRODUCT NAME: BIKTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC NATRIO BIKTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/18/1289 20180621
2487162	284 1-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/DARUNAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/967 20141121
1761540	300867	Netherlands		PRODUCT NAME: IDELALISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/938 20140919

Similar Applicant Names

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

• Gilead
• Gilead Sciences
• Gilead Sciences Inc

Gilead Sciences: Market Position, Strengths, & Strategic Insights

Last updated: March 18, 2026

What is Gilead Sciences' Market Position?

Gilead Sciences ranks as a leading biopharmaceutical company specializing in antiviral medications for HIV/AIDS, hepatitis B and C, oncology, and inflammatory diseases. As of 2022, Gilead held approximately 11% of the global HIV market share, with revenues surpassing $27 billion. Its hepatitis C franchise, led by Harvoni and Epclusa, generated over $6 billion annually before patent expirations reduced sales. The company also invests heavily in oncology and COVID-19 treatments, including remdesivir.

Revenue Breakdown (2022)

Product Segment	Revenue (USD billion)	Market Share / Position
HIV/AIDS	14	Largest globally in antiretroviral therapy
Hepatitis C (HCV)	6	Leading in direct-acting antivirals (DAAs)
Oncology	4	Growing portfolio, includes Trodelvy
COVID-19 (Remdesivir)	2	Significant initial contributor
Other (Inflammatory, etc.)	1	Niche development focus

Gilead maintains dominance in HIV and HCV markets but faces increasing competition in oncology and emerging segments.

How Does Gilead Structure Its Strengths?

Drug Portfolio and Innovation

• HIV/AIDS: Gilead’s portfolio includes Biktarvy, Descovy, and Truvada. These combined medications dominate the global market, with relatively low resistance development and high patient adherence rates.
• HCV: Harvoni and Epclusa were first-to-market mitogens, capturing significant market share. Patent protection lasted through 2020–2021, after which sales declined due to generic entry.
• COVID-19: Remdesivir, approved for COVID-19 treatment, became the first authorized antiviral therapy. It remains a key product, though demand lessens as vaccines dominate.

R&D Focus

Gilead invests roughly 20% of annual revenue into R&D, prioritizing antiviral, oncology, and inflammation treatments. The company holds approximately 1,200 active patents, with 600 granted in the U.S. and 600 internationally.

Strategic Collaborations and Acquisitions

Key acquisitions include Morphosys’ rights to Trodelvy (2021) for triple-negative breast cancer, complementing Gilead’s oncology portfolio. Collaborations with Galapagos strengthened immunology offerings, notably filgotinib, leading to FDA submission in 2022.

Manufacturing and Supply Chain

Gilead controls end-to-end supply chains for core antiviral medications, ensuring high-quality production and regulatory compliance. It maintains manufacturing facilities in the U.S. and Ireland, with capacity expanded for COVID-related products.

What Are Gilead’s Strategic Strengths?

• Market Leadership in HIV: Gilead's sustained market dominance results from early innovation, robust pipeline, and global reach.
• High-Barrier Patents: Long-term patent protections provide pricing power in core segments.
• Product Diversification: Expansion into oncology and inflammation lowers dependency on antiviral markets.
• Global Presence: Direct operations in over 30 countries facilitate access to diverse markets.
• R&D Investment: Consistent focus on innovative therapies sustains competitive advantage.

Where Are Gilead’s Strategic Opportunities and Challenges?

Opportunities

• Oncology Growth: Expansion through acquisitions like Trodelvy and pipeline development positions Gilead in a high-growth area.
• Emerging Infectious Diseases: Investment in antiviral platforms offers potential for new therapeutic candidates against viruses like hepatitis B, cytomegalovirus, and future pandemics.
• Geographic Expansion: Increased focus on emerging markets may drive sales, especially in regions with rising HIV and HCV prevalence.

Challenges

• Patent Expirations: Loss of exclusivity for key products like Harvoni diminishes revenues, increasing generic competition.
• Pricing Pressure: Growing demands for lower drug prices in the U.S. and EU threaten profit margins.
• Pipeline Risks: R&D failures or delays in oncology and inflammatory therapies could hinder growth.
• Competition: Companies such as Merck, GSK, and AbbVie expand their antiviral and oncology offerings, pressuring Gilead’s market share.

What Are Gilead’s Strategic Initiatives?

• Pipeline Expansion: Focus on cell therapy, oncology, and new antiviral agents.
• Partnerships: Collaborations with biotech firms for innovative therapies, including cell and gene therapy.
• Digital Transformation: Adoption of data analytics and personalized medicine approaches to optimize R&D and commercial efforts.
• Manufacturing Optimization: Enhancing capacities to meet increasing demand and reduce costs.

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Key Takeaways

• Gilead maintains market leadership mainly through its antiviral portfolio, especially in HIV and hepatitis C.
• Patent expirations and generic competition challenge revenue streams.
• Diversification into oncology and inflammation is progressing through acquisitions and R&D.
• Strategic collaborations and pipeline updates underpin growth prospects.
• Market share in core segments remains high, but competitive pressure increases across all segments.

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FAQs

1. What are Gilead's main revenue drivers?
   HIV medications and hepatitis C antivirals account for the majority of Gilead’s revenue.

2. How does Gilead’s patent portfolio impact its market position?
   Long-lasting patents provide exclusivity, enabling premium pricing and high margins; patent expirations pose revenue risks.

3. What is Gilead doing to expand in oncology?
   The company acquired Trodelvy and expanded collaborations, focusing on solid tumor therapies and immuno-oncology.

4. What are the key risks facing Gilead?
   Patent expirations, generic drug competition, regulatory hurdles, and competitive market entries.

5. What growth areas does Gilead target?
   Oncology, emerging infectious diseases, and expanding into emerging markets.

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References

1. Gilead Sciences. (2022). Annual Report. https://gilead.com/investors/financial-information/annual-reports
2. IQVIA. (2022). Top Global HIV and HCV Market Data.
3. U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
4. Statista. (2022). Gilead Sciences Revenue Breakdown.
5. Bloomberg. (2022). Gilead’s Strategic Portfolio Analysis.