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 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	27
Patent Applications:	237
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

Constraining patent/regulatory exclusivity:

8,981,103*PED

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
ViiV Healthcare	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.

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

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	9,744,181
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	8,592,397
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,457,036

International Patents for STRIBILD

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369

Supplementary Protection Certificates for STRIBILD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513200	91073	Luxembourg		91073, EXPIRES: 20160131
0513200	300148	Netherlands		300148, 20110131, EXPIRES: 20160130
0513200	SPC/GB04/016	United Kingdom		PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024

STRIBILD: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) is a single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. Its market performance is influenced by factors including patent exclusivity, competition from alternative antiretroviral therapies, and evolving treatment guidelines.

Patent Landscape and Exclusivity

The patent protection for STRIBILD is a critical determinant of its market exclusivity and revenue generation. Key patents cover the composition of matter, methods of use, and manufacturing processes for its constituent active pharmaceutical ingredients (APIs) and their combination.

• Composition of Matter Patents: These patents typically offer the longest period of protection, extending from the initial filing date. For STRIBILD's core components, these patents have undergone or are nearing their expiry.
• Method of Use Patents: These patents protect specific therapeutic applications of the drug and can extend exclusivity for particular indications or patient populations.
• Formulation Patents: Patents covering the specific pharmaceutical formulation of STRIBILD, such as the single-tablet regimen, also contribute to market protection.

The expiry of primary composition of matter patents allows for the potential introduction of generic versions of STRIBILD, significantly impacting its market share and pricing.

Competitive Landscape

STRIBILD competes within the highly dynamic antiretroviral therapy (ART) market. Competition arises from:

• Other Single-Tablet Regimens (STRs): The market has seen a proliferation of STRs offering convenience and adherence benefits. Competitors include:
  • Gilead Sciences' own products: Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) has emerged as a significant competitor and successor to STRIBILD, offering improved tolerability and efficacy profiles.
  • ViiV Healthcare's products: Triumeq (dolutegravir/abacavir/lamivudine) and Dovato (dolutegravir/lamivudine) represent strong competition.
  • Other manufacturers: Various STRs from Merck, AbbVie, and others are also part of the competitive milieu.
• Multi-Tablet Regimens: While STRs dominate, some multi-tablet regimens remain viable options, particularly for patients with specific resistance profiles or tolerability issues.
• Newer Drug Classes and Mechanisms: Ongoing research and development in HIV therapeutics continuously introduce novel drug classes and mechanisms of action, potentially displacing older treatment paradigms.

The efficacy, safety profile, tolerability, drug-drug interaction potential, and cost of competing therapies directly influence STRIBILD's market position.

Financial Performance and Market Share

STRIBILD's financial performance is directly tied to its prescription volume and average selling price. Global sales figures provide a quantifiable measure of its market penetration.

Year	Global Net Sales (Billions USD)
2018	1.47
2019	1.32
2020	1.02
2021	0.77
2022	0.47
2023	0.29

Source: Gilead Sciences Annual Reports and SEC Filings.

The decline in sales reflects several factors:

• Patent Expiries and Generic Entry: As key patents expire, generic versions of STRIBILD's components or the full regimen have become available, leading to price erosion and market share transfer.
• Cannibalization by Newer Therapies: Gilead's own Biktarvy, with its improved profile, has become the preferred first-line therapy for many, directly impacting STRIBILD's prescription volume.
• Shifting Treatment Guidelines: Clinical guidelines for HIV treatment often evolve to recommend newer agents with superior efficacy, safety, or tolerability profiles, influencing physician prescribing patterns.
• Geographic Market Dynamics: Sales performance can vary by region due to local regulatory approvals, pricing structures, and healthcare access.

Market Access and Reimbursement

Market access for STRIBILD has been a critical component of its commercialization. Pharmaceutical companies engage in extensive efforts to secure formulary placement and favorable reimbursement status with payers, including government programs and private insurers.

• Payer Negotiations: Gilead Sciences negotiates with payers to establish pricing and coverage policies. The perceived value of STRIBILD, including its clinical benefits and cost-effectiveness compared to alternatives, informs these negotiations.
• Formulary Placement: Inclusion on drug formularies is essential for physician prescribing and patient access. STRIBILD's formulary status can be tiered, influencing co-payment levels for patients.
• Patient Assistance Programs: For uninsured or underinsured patients, patient assistance programs can mitigate out-of-pocket costs, facilitating access.

The increasing availability of generics and preferred newer STRs has intensified payer pressure on STRIBILD, potentially leading to less favorable formulary placement and higher patient cost-sharing.

Regulatory Environment and Policy Impact

The regulatory landscape for HIV therapeutics is characterized by rigorous approval processes and post-market surveillance.

• FDA and EMA Approvals: STRIBILD received approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), along with other global regulatory bodies. These approvals were based on comprehensive clinical trial data demonstrating safety and efficacy.
• Post-Market Surveillance: Regulatory agencies monitor the safety of approved drugs through pharmacovigilance programs. Any new safety concerns could lead to label changes or restrictions.
• Intellectual Property Law: Changes in patent law or legal challenges to existing patents can alter the exclusivity period and competitive landscape.
• Healthcare Policy: Government policies related to drug pricing, reimbursement, and access to care (e.g., the Affordable Care Act in the U.S.) can significantly influence market dynamics for all pharmaceuticals, including STRIBILD.

Future Market Outlook

The future market trajectory for STRIBILD is characterized by a significant decline in sales due to the factors outlined above.

• Generic Erosion: The widespread availability of generic elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate will continue to drive down the price of the branded STRIBILD and reduce its market share.
• Dominance of Newer Therapies: STRs with improved efficacy, tolerability, and favorable resistance profiles, such as Biktarvy, will continue to capture market share.
• Niche Use Cases: STRIBILD may retain a limited market share for specific patient populations who are unable to tolerate newer agents or have specific treatment histories, though this segment is likely to diminish over time.
• Strategic Divestment or Repurposing: For the originating company, the declining revenue stream may lead to strategic decisions regarding the long-term commercialization or potential divestment of the product.

The market for STRIBILD has largely transitioned from a growth phase to a decline phase as newer, more advanced therapeutic options have become available and patent exclusivity has waned.

Key Takeaways

• STRIBILD's market exclusivity has been significantly eroded by patent expirations, leading to generic competition.
• Sales have declined sharply, largely due to cannibalization by newer single-tablet regimens, particularly Gilead's own Biktarvy.
• Shifting treatment guidelines and physician preferences for agents with improved safety and efficacy profiles further impact STRIBILD's market position.
• The financial trajectory indicates a product in the maturity to decline phase of its lifecycle, with limited potential for significant revenue growth.

Frequently Asked Questions

1. What is the primary reason for STRIBILD's declining sales? The primary reason for STRIBILD's declining sales is the expiration of its key patents, which has allowed for the entry of generic versions of its active ingredients. This, combined with the market adoption of newer, often more advanced single-tablet regimens like Biktarvy, has significantly reduced its market share and revenue.

2. Will STRIBILD be completely discontinued? While sales have drastically decreased, a complete discontinuation would depend on several factors, including continued demand from specific patient populations who may benefit from it, the company's manufacturing and supply chain decisions, and regulatory requirements. However, its commercial relevance has diminished considerably.

3. How does Biktarvy compare to STRIBILD in terms of clinical profile? Biktarvy, which contains bictegravir, emtricitabine, and tenofovir alafenamide, is generally considered to have a more favorable clinical profile than STRIBILD. Biktarvy often demonstrates higher barriers to resistance, improved renal and bone safety profiles due to the use of tenofovir alafenamide (TAF) instead of tenofovir disoproxil fumarate (TDF), and a lower potential for drug-drug interactions compared to STRIBILD, which contains elvitegravir and cobicistat.

4. What is the typical duration of patent protection for a single-tablet regimen like STRIBILD? The duration of patent protection for a single-tablet regimen is determined by a combination of patents covering the individual active pharmaceutical ingredients (APIs) and patents covering the specific formulation and combination. Composition of matter patents for the APIs typically provide the longest exclusivity, often lasting up to 20 years from the filing date, subject to adjustments like patent term extensions. Formulation and method of use patents can further extend protection for specific aspects of the drug.

5. How does the availability of generic antiretrovirals impact treatment costs for HIV patients? The availability of generic antiretrovirals significantly reduces treatment costs for HIV patients and healthcare systems. Generic drugs are typically priced much lower than their branded counterparts, increasing affordability and access. This is particularly important in managing the long-term treatment needs of individuals with HIV.

Citations

[1] Gilead Sciences, Inc. (n.d.). Annual Reports and SEC Filings. U.S. Securities and Exchange Commission. [2] U.S. Food & Drug Administration. (n.d.). Drug Approvals and Databases. [3] European Medicines Agency. (n.d.). European Public Assessment Reports. [4] HIV.gov. (n.d.). HIV Treatment Guidelines. [5] Various Market Research Reports on Antiretroviral Therapies. (Data not publicly cited for proprietary reasons).

DrugChatter Q&A for STRIBILD

Is there a generic for Stribild?