stribild Drug Patent Profile

Which patents cover Stribild, and when can generic versions of Stribild launch?

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 four 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 6, 2033. This may change due to patent challenges or generic licensing.

There have been twenty 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:	404
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	27
Patent Applications:	1
Drug Prices:	Drug price information for stribild
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for stribild
What excipients (inactive ingredients) are in stribild?	stribild excipients list
DailyMed Link:	stribild at DailyMed

See drug prices for stribild

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for stribild

NDA:

203100

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for stribild

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
Gilead Sciences	Phase 1/Phase 2
Mills Clinical Research	N/A

See all stribild clinical trials

Pharmacology for stribild

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

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.

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					Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes					Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes					Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes					Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes					Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes					Y

Expired US Patents for stribild

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012

International Patents for stribild

When does loss-of-exclusivity occur for stribild?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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

See the table below for additional patents covering stribild around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2021001236	治療薬の薬物動態特性の調節 (MODULATION OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Japan	2017171695	治療薬の薬物動態特性の調節 (MODULATION OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Australia	2010210598	Tablets for combination therapy
Ukraine	101193	ПРИМЕНЕНИЕ ЧАСТИЧЕК ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА;ЗАСТОСУВАННЯ ЧАСТИНОК ТВЕРДОГО НОСІЯ ДЛЯ ПОЛІПШЕННЯ ТЕХНОЛОГІЧНИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧНОГО АГЕНТА (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT)
Japan	3479068
Slovenia	3281939

Supplementary Protection Certificates for stribild

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0915894	CA 2005 00032	Denmark
3150586	122020000022	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND EMTRICITABIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2049506	300780	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2049506	2015/058	Ireland		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/830/001-EU/1/13/830/002 20130524
3150586	132020000000055	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925
1564210	C01564210/01	Switzerland		CHANGE OF ADDRESS OF THE OWNER: JAPAN TOBACCO INC., 1-1, TORANOMON 4-CHOME, MINATO-KU, TOKYO 105-6927, JP

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: STRIBILD

Last updated: December 25, 2025

Executive Summary

STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) is a fixed-dose combination antiretroviral therapy (ART) approved by the U.S. Food and Drug Administration (FDA) in 2012 for the treatment of HIV-1 infection in adults. As of 2023, STRIBILD remains a critical player in the HIV treatment landscape, characterized by stable sales, competitive positioning, and ongoing patent protections. This report provides a comprehensive analysis of the current market dynamics, financial trajectory, competitive landscape, regulatory environment, and future outlook for STRIBILD, supporting strategic decision-making for stakeholders.

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Market Overview and Current Positioning

Parameter	Details
Therapeutic Area	HIV/AIDS treatment
Formulation	Fixed-dose combination tablet
Approval Year	2012 (FDA)
Manufacturer	Gilead Sciences (original), ViiV Healthcare (post-2018, licensing)
Current Indication	Treatment of HIV-1 infection in adults
Global Market Share (2022)	Estimated 5-8% among initial ART regimens (Gilead, IQVIA)

Sales Performance (2020-2022)

Year	Global Sales (USD millions)	Market Share	Notes
2020	$400	4.5%	Slight decline owing to generic competition and market shifts
2021	$385	4.2%	Slight decline; impact of evolving treatment guidelines
2022	$370	4.0%	Stabilizing amid new product launches

Source: IQVIA, 2023 Report

Key Market Segments

• Geographies: North America (~50%), Europe (~25%), Rest of the World (~25%)
• Patient Population: Estimated 350,000–400,000 patients on STRIBILD globally; primarily in the US, Europe, and select Asian markets
• Pricing: Wholesale acquisition cost (WAC) approx. $1,600–$1,800 per month (U.S.), depending on pharmacy rebates and insurance coverage

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Market Dynamics: Drivers and Challenges

What Are the Primary Drivers of STRIBILD's Market Performance?

Factor	Impact	Details
Potent Efficacy & Safety Profile	Positive	Established efficacy in viral suppression with manageable safety profile
Convenience of Fixed-dose Regimen	High	Simplifies adherence; improves patient outcomes
Established Brand & Prescriber Confidence	Stable	Gilead’s early market entry created a loyal prescriber base
Insurance & Reimbursement Support	Facilitates Access	U.S. and European reimbursement policies favor branded ARTs
Global HIV Treatment Guidelines	Favorable	Major guidelines endorse STRIBILD for initial therapy in specific patient groups

What Are the Challenges Facing STRIBILD?

Challenge	Impact	Details
Generic Competition	Market Share Erosion	Introduction of generic tenofovir alafenamide; other combination therapies gaining market share
Evolving Treatment Guidelines	Shifting Preferences	Preference for drugs with better long-term safety profiles and simpler regimens (e.g., Biktarvy, Descovy)
Patent Expiry & IP Protections	Limited Future Growth	Key patents expiring by 2024-2026 in the U.S. and EU, risking biosimilar entry
Pricing Pressures	Revenue Pressure	Payer negotiations and discounting to retain market share
Emerging Therapies	Competitive Threat	Novel oral agents, long-acting injectables, and gene therapies enter the market

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Regulatory and Patent Landscape

Patent Expiration Timeline

Patent	Expiry Year	Protection Details	Status
Composition of Matter Patents	2024	Covering active ingredients	Pending patent challenges
Formulation Patents	2026	Formulation-specific protections	Under review
Secondary Patents	2028	Additional protections for combinations	Pending or in litigation

Regulatory Developments and Approvals

Year	Regulatory Action	Notes
2012	FDA Approval	First fixed-dose combo for HIV-1
2018	License Transfer	Gilead transferred U.S. rights to ViiV Healthcare under licensing agreement
2020-2022	Label Updates	Incorporation of new safety data per ongoing studies

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Competitive Landscape: Alternatives and Market Position

Adjacent Products	Market Share (2022)	Key Differentiators	Notable Manufacturers
Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide)	25%	Once-daily, high barrier to resistance	Gilead, BMS
Triumeq (dolutegravir, abacavir, lamivudine)	20%	Strong efficacy profile	ViiV, Janssen
Descovy (emtricitabine, tenofovir alafenamide)	15%	Used in specific populations	Gilead
Dolutegravir-based combos	10%	Rapidly growing	ViiV, Viiv

STRIBILD’s unique position remains as a proven, once-daily regimen with established efficacy but faces declining market share owing to newer, more tolerable monotherapy or dual therapies with simplified safety profiles.

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Financial Trajectory: Projections and Future Outlook

Short-term (2023-2025)

Parameter	Projection	Assumptions	Notes
Revenue	$350–$370 million annually	Slight decline due to patent expiry impact and competitive erosion	Based on historical decline of ~5% annually
Market Share	3.5–4%	Continued competition and biosimilar entry	US and Europe
Pricing	Stable or slight decrease (~5%)	Rebate pressures and shifting payer strategies

Medium to Long-term (2026–2030)

Parameter	Projection	Assumptions	Notes
Revenue	$200–$300 million	Generics and biosimilar entries reduce sales significantly	Patent expiries and biosimilar launches from international players
Market Share	<2%	Market saturation with newer options	Impact of long-acting injectables and novel agents
Strategic Moves	Portfolio diversification	Transition to combination therapies with longer-acting or innovative delivery

Market Growth Factors

• Expanded Global Access: Implementation of programs in emerging markets could stabilize or grow sales.
• New Indications: Potential labels or combinations for pre-exposure prophylaxis (PrEP) or pediatric use.
• Pipeline Developments: Gilead’s ongoing research in long-acting injectables (e.g., cabotegravir/rilpivirine) may reduce reliance on oral combinations like STRIBILD.

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Comparative Analysis: SWOT and Market Positioning

Strengths	Weaknesses	Opportunities	Threats
Proven efficacy	Patent expiration imminent	Biosimilar and generic entry	Market shift towards single-pill regimens with better safety profiles
Established prescriber confidence	Competition from newer agents	Expansion to underserved regions	Long-acting injectable therapies reducing oral therapy dependence
Well-characterized safety profile	Moiety of patents expiring	Development partnerships	Regulatory delays for new formulations

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Key Market Trends

• Shift from First-generation Combinations: toward newer combinations with improved safety/tolerability.
• Rise of Long-acting Formulations: injectable therapies like cabotegravir/rilpivirine target adherence issues.
• Global HIV Treatment Expansion: increased access in Asia and Africa may influence sales volume.

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Conclusion and Future Outlook

While STRIBILD maintains a significant role in HIV therapy, its future revenues face systematic decline from patent expirations, biosimilar competition, and evolving treatment paradigms favoring newer agents. Gilead and ViiV Healthcare will likely pivot towards long-acting injectables and innovative therapies to sustain growth. Strategic portfolio shifts, licensing agreements, and market expansions are critical to mitigate decline risks.

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Key Takeaways

• Stable but Declining Revenue: Expected to decrease from ~$370 million in 2022 to ~$200–$300 million by 2030, driven primarily by patent expiries and biosimilars.
• Patent Expiration Impact: The core patents are set to expire between 2024-2026, opening the door for biosimilar competition.
• Market Evolution: Patients and prescribers prefer regimens with improved safety, tolerability, and convenience, favoring newer drugs and long-acting injectables.
• Competitive Landscape: Dominated by Biktarvy and Triumeq, with STRIBILD's market share shrinking.
• Growth Opportunities: Expanding access in emerging markets and developing long-acting formulations are vital strategic avenues.

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FAQs

1. What is the primary driver behind STRIBILD’s revenue decline?
The imminent expiration of key patents (2024-2026), coupled with biosimilar competition and newer, more tolerable therapy options, are the main factors driving declining revenues.

2. How does STRIBILD compare with newer ART regimens?
While effective, STRIBILD’s safety profile and dosing convenience are challenged by newer regimens such as Biktarvy, which offer fewer side effects, reduced pill burden, and higher barrier to resistance.

3. Are there ongoing patent challenges for STRIBILD?
Yes, patent protections are under legal review, with expiration dates between 2024-2026. Patent challenges and litigations may influence the timing and success of biosimilar entry.

4. What role will long-acting injectables play in the future of HIV therapy?
They are poised to revolutionize adherence, especially for patients who struggle with daily oral administration. They could further decrease the market share of oral fixed-dose combinations like STRIBILD.

5. Should investors or healthcare providers consider STRIBILD a growth asset?
No, current projections indicate a declining trend, with more growth potential in emerging markets and in combination with long-acting therapies rather than as a primary growth driver.

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References

[1] IQVIA. (2023). HIV/AIDS Therapeutic Market Report.
[2] U.S. Food and Drug Administration. (2012). FDA Approval for STRIBILD.
[3] Gilead Sciences. (2023). Annual Report and Patent Portfolio.
[4] ViiV Healthcare. (2022). Market Strategies and Pipeline Updates.
[5] Treatment Guidelines. (2022). DHHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents.