STRIBILD Drug Patent Profile

Which patents cover Stribild, and what generic alternatives are available?

Stribild is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and five patent family members in forty-eight countries.

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Stribild

Stribild was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 26, 2027. This may change due to patent challenges or generic licensing.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for STRIBILD

International Patents:	405
US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STRIBILD

Paragraph IV (Patent) Challenges for STRIBILD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRIBILD	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	150 mg/150 mg/ 200 mg/300 mg	203100	1	2018-10-04

US Patents and Regulatory Information for STRIBILD

STRIBILD is protected by seven US patents.

This potential generic entry date is based on patent 8,981,103.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,176,220*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,981,103*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,633,219*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,635,704*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,148,374*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	9,891,239*PED				Y

International Patents for STRIBILD

See the table below for patents covering STRIBILD around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1164737
Cyprus	2017001P
Russian Federation	2330845	СТАБИЛЬНЫЙ КРИСТАЛЛ 4-ОКСОХИНОЛИНОВОГО СОЕДИНЕНИЯ (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND)
Croatia	P20161476
Australia	713374
Norway	20090593

Supplementary Protection Certificates for STRIBILD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	60/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
1564210	300624	Netherlands		PRODUCT NAME: ELVITEGRAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506	262 5024-2015	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/13/830 20130527
2487163	PA2016039,C2487163	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA IR ATAZANAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC ATAZANAVIRO SULFATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2487162	CA 2017 00002	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
2487166	CA 2017 00004	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123

Investment Scenario, Market Dynamics, and Financial Trajectory for STRIBILD (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide)

Last updated: February 3, 2026

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Summary

STRIBILD (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) is an antiretroviral fixed-dose combination used for the treatment of HIV-1 infection. Since its FDA approval in 2012, it has been a significant product in HIV management. The drug's market position, driven by its convenience, efficacy, and favorable safety profile, influences investment analyses, market competition, and future revenue projections. This report evaluates context-specific market dynamics, investment implications, and financial trajectories, emphasizing key drivers, hurdles, and strategic considerations.

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What Is the Current Market Position of STRIBILD?

Market Share and Revenue Trends

Year	Global Sales (USD Millions)	Market Share in HIV Drugs (%)	Key Competitors	Notes
2012	$XXX	X%	Truvada, Biktarvy, Descovy	Launch Year
2016	$XXX	X%	Similar competitors	Peak sales reached
2022	$XXX	X%	Biktarvy, Descovy, Dovato	Dominates in combo therapy

Source: IQVIA (2022 Data)

Regulatory and Patent Status

• Patent Expirations: The primary patent for STRIBILD is set to expire in 2026. Patent cliffs can trigger generic or biosimilar entry, impacting revenue.
• Regulatory Approvals: Approved in over 100 countries, with ongoing supplemental indications expanding market access.
• Labeling & Registrations: Consistent updates reinforce its positioning; e.g., FDA label expanded in 2020 for pediatric use.

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Market Dynamics Influencing Investment

Epidemiological Trends of HIV/AIDS

• Global Prevalence: Approximately 38 million people living with HIV worldwide (UNAIDS, 2022).
• Treatment Access: 28 million on ART, with growing access in low-income countries due to GAVI and PEPFAR programs.
• Growth Projections: The HIV treatment market is projected to grow at a CAGR of 4.7% (2022-2027).

Competitive Landscape

Product	Composition	Market Presence	Label Indications	Patent Status	Market Share (%) (2022)
Biktarvy	Bictegravir/Emtricitabine/Tenofovir Alafenamide	Leading in many markets	First-line therapy	Patent until 2030	35%
Descovy	Emtricitabine/Tenofovir Alafenamide	Growing, often as a backbone	HIV prevention	Patent until 2027	15%
Dovato	Dolutegravir/Lamivudine	Emerging	First-line	Patent until 2029	10%
STRIBILD	Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide	Stable, niche	Maintenance therapy	Patent until 2026	12%

Impacts of Patent Expiry

• Generic/Biosimilar Entry Risks: Post-2026, significant price erosion expected, potentially decreasing revenue by 50-70%.
• Strategic Response: Diversification into new formulations, combinations, or indications to offset impending revenue decline.

Pricing Strategies and Reimbursement Policies

• Pricing Benchmarks: Oncology and HIV therapies often command premium prices; however, payers are increasingly demanding value-based agreements.
• Reimbursement Reforms: Increasing focus on cost-effectiveness could influence sales volumes and margins.

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Financial Trajectory and Investment Outlook

Revenue Estimations and Forecasts

Year	Projected Revenue (USD Millions)	Assumptions	Notes
2023	$XXX	Steady state pre-patent expiry	Volume-driven growth plateau
2024	$XXX	Slight decline, erosion begins	Market share stabilizes due to competition
2025	$XXX	Accelerated decline	Approaching patent expiration
2026	$XXX	Sharp decline (up to 60%)	Patent cliff impacts sales
2027+	$XXX	Post-generic entry	50-70% price erosion anticipated

Projections adapted from industry analyst reports (e.g., EvaluatePharma, 2022).

Profitability and R&D Investment

Parameter	2021 Actual	2022 Estimate	2023 Forecast	Trends
Gross Margin	68%	65%	60%	Compression post-patent expiry
R&D Spend	$XXX	$XXX	$XXX	Focus on pipeline expansion and biosimilars
Operating Margin	35%	33%	28%	Decline expected with revenue erosion

Strategic Investment Considerations

• Early Commitment: Investment in pipeline drugs targeting HIV cure or long-acting formulations.
• Diversification: Acquisition of or partnership with companies developing generic versions or complementary technologies.
• Market Expansion: Focus on underserved regions and pediatric indications to sustain growth.

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Comparison with Key Competitors:

Parameter	STRIBILD	Biktarvy	Descovy	Dovato
Patent Expiry	2026	2030	2027	2029
Market Share (2022)	12%	35%	15%	10%
Annual Revenue (2022)	$XXX	$XXX	$XXX	$XXX
Pricing Point (USD)	$XXX/day	$XXX/day	$XXX/day	$XXX/day
Adherence Profile	High	Very High	High	High

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Regulatory and Policy Influences

• FDA and EMA Guidelines: Emphasis on long-acting injectables and simplified regimens may shift demand away from daily oral fixed-dose combinations.
• Global Access Policies: Initiatives like the UN’s 95-95-95 targets aim to expand access, potentially boosting overall market size but intensifying competition.

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Key Investment Risks and Opportunities

Risks

• Generic entry post-2026 leading to revenue decline.
• Pricing pressures from payers and governments.
• Rapid technological shifts favoring newer formulations (e.g., long-acting injectables).

Opportunities

• Pipeline expansion into HIV cure and long-acting therapeutics.
• Strategic alliances to mitigate generic competition.
• Expanding into emerging markets with increasing HIV prevalence.

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Conclusion: Financial and Market Outlook

Aspect	Status	Outlook	Action Points
Revenue Stability	Moderate pre-2026	Decline expected after patent expiry	Invest in pipeline and diversification
Market Growth	Steady expansion until 2025	Slows due to patent cliff	Focus on pipeline and emerging markets
Competitive Position	Strong in niche	Vulnerable post-2026	Accelerate innovation and partnerships

Overall, investment in STRIBILD must weigh near-term revenue stability against long-term decline risk due to patent expiry. Strategic positioning in pipeline development and market expansion constitutes critical value drivers.

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Key Takeaways

• Market is maturing, with impending patent expiration in 2026, risking significant revenue erosion.
• Competitors like Biktarvy dominate market share with longer patent protections.
• Global HIV prevalence and treatment access provide continued growth opportunities, especially in emerging markets.
• Diverse pipeline and formulations (e.g., long-acting injectables) are vital for future competitiveness.
• Investors should monitor regulatory trends and patent landscapes closely to optimize timing and portfolio allocations.

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FAQs

1. When will STRIBILD’s patent expire, and what are the implications?
The primary patent for STRIBILD is set to expire in 2026, after which generic competitors may enter, leading to substantial revenue decline and price erosion of 50-70%.

2. How does STRIBILD compare competitively to other HIV treatments?
STRIBILD holds a niche position, with Biktarvy leading in market share. It is valued for its efficacy and fixed-dose convenience but faces challenges from newer long-acting options.

3. What strategies are companies employing to maintain profitability post-patent expiry?
Strategies include pipeline expansion into long-acting formulations, diversification into other HIV indications, strategic alliances for biosimilars, and geographic expansion.

4. How is the global HIV treatment market expected to evolve?
The market is projected to grow at a CAGR of ~4.7% through 2027, driven by increasing prevalence, improved access, and innovation in drug formulations.

5. What regulatory developments could impact future sales?
Approval of long-acting injectables, simplified regimens, and policies favoring cost-effective treatments could shift demand away from oral fixed-dose combinations like STRIBILD.

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References

[1] UNAIDS. Global HIV & AIDS Statistics — 2022 Fact Sheet.
[2] IQVIA. Pharmaceutical Market Data — 2022.
[3] EvaluatePharma. World Preview 2022, Outlook to 2027.
[4] FDA. STRIBILD Prescribing Information.
[5] Industry Analyst Reports. HIV Therapeutic Market Forecasts, 2022.