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-two 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
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

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	8,592,397
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,457,036
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	8,716,264

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
Australia	2009242451

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
0513200	SZ 7/2004	Austria

STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir DF): Market Dynamics and Financial Trajectory

Last updated: July 21, 2026

STRIBILD is an integrated once-daily, fixed-dose combination antiretroviral for HIV-1. Its market trajectory has shifted from rapid uptake in the early 2010s to long-tail decline risk as newer regimens and long-acting options gained share, with payer and guideline preference increasingly favoring newer single-tablet regimens and switch strategies. Financial performance depends on continued usage in treatment-naïve and switch populations, state of generic entry and parallel export dynamics, and intensity of formulary management after loss of exclusivity.

What market dynamics drive STRIBILD sales in HIV treatment today?

Answer: STRIBILD sales are driven by (1) formulary placement for ART initiation and switching, (2) resistance profile and tolerability compared with newer single-tablet regimens, (3) payers’ preference for regimens with fewer drug-drug interactions and simpler monitoring, and (4) competition from both branded successors and lower-cost generics and co-packs.

How do payer formularies affect STRIBILD volume?

Formulary placement is the primary near-term determinant of realized unit demand. Key dynamics:

• Stepped therapy and prior authorization (PA): Payers increasingly require documentation of prior regimen failure, resistance testing outcomes, or specific comorbidities before covering older integrase inhibitor combinations.
• Preferential listing of newer integrase backbones: Newer single-tablet regimens that reduce monitoring burden or improve interaction profiles commonly earn preferred status in commercial formularies, Medicaid managed care, and PBM tiers.
• Switching programs: Payers run cost and adherence initiatives that encourage switching from branded regimens to preferred generics or lower net-cost options.

What clinical factors shift utilization away from STRIBILD?

Clinical switching is sensitive to:

• Drug-drug interaction (DDI) burden from cobicistat: Cobicistat is a potent CYP3A inhibitor that can complicate comedications (statins, antiarrhythmics, anticonvulsants, certain antimycobacterials, and transplant-related drugs).
• Renal monitoring in tenofovir DF exposure: Tenofovir DF requires ongoing renal function monitoring; some competitors and formulations reduce long-term renal risk via different tenofovir prodrug choices (e.g., tenofovir alafenamide-based regimens).
• Virologic suppression stability: Patients already suppressed on STRIBILD create a “stickiness” cohort, but payers may still drive switches when net price advantages are large.

How do adherence and dosing format support STRIBILD?

The fixed-dose, once-daily regimen supports adherence. That said, adherence advantage has become a baseline expectation for newer single-tablet regimens; thus dosing convenience has less incremental value versus modern rivals.

When did STRIBILD peak, and how has demand decayed since?

Answer: STRIBILD’s peak demand occurred in the early-to-mid 2010s after launch and ramp, then trended down as competitors expanded and payers shifted to lower-cost options post-exclusivity.

Commercial ramp and life-cycle pattern

Typical HIV fixed-dose combination patterns apply:

• Initial adoption (launch years): Rapid uptake among treatment-naïve and switching patients seeking integrase-based regimens.
• Maturation (mid-cycle): Share stabilizes but payers become more price-focused as alternative single-tablet integrase regimens expand.
• Late life-cycle: Decline as generics enter and as newer regimens (including tenofovir alafenamide-based options and other integrase backbones) become preferred.

What drives the shape of the decline curve?

• Generic erosion timing: Once generic alternatives exist, net pricing drops quickly via tiering and discounting.
• Guideline changes: Guidelines move toward regimens with improved safety/tolerability profiles for long-term use.
• Patient churn: High-suppression stability slows absolute volume decline, but payer-driven switching accelerates it.

What is the financial trajectory for STRIBILD: revenue trend drivers and revenue exposure?

Answer: STRIBILD revenue is exposed primarily to: (1) net price erosion from generic competition, (2) formulary-driven volume changes, (3) patient churn rates in suppressed cohorts, and (4) contract and rebate intensity within PBM and payer channels.

Key revenue drivers to track

1. Realized net price vs. WAC: Generic-driven market pressure pushes down net price through rebates and payer negotiations.
2. Channel mix: Retail vs. specialty channel dynamics change with payer contracting and dispensing behavior.
3. Therapeutic switching cohort size: The size of the suppressed cohort that stays on STRIBILD governs decline slope.

What is the “stickiness” cohort risk?

• Patients virologically suppressed on STRIBILD often remain on therapy due to regimen stability.
• Payer pressure and adverse event rates can still force switches, but the timing is patient-specific and contract-specific.

How much competition does STRIBILD face from other HIV single-tablet regimens?

Answer: STRIBILD faces direct substitution from other fixed-dose integrase-based regimens, especially those with fewer interaction constraints and improved long-term renal/lipid profiles.

Direct competitor set (commercial substitution)

Most substitution risk comes from other once-daily single-tablet regimens used for initiation and switching, particularly integrase-based combinations with:

• different pharmacokinetic boosters (or reduced DDI complexity),
• improved long-term safety signals,
• better payer preference.

Indirect competition from newer modalities

• Long-acting and depot strategies: While long-acting options are expanding, uptake depends on eligibility and payer coverage; this still adds competitive pressure on long-term budgets even when the absolute share shift is gradual.

What patent and exclusivity status affects STRIBILD’s financial ceiling?

Answer: STRIBILD’s financial ceiling is defined by the expiration of regulatory exclusivities and patent protection on the combination and key components, with subsequent generic entry acting as the principal step-down event in revenue.

What patent estate dynamics typically matter for fixed-dose combinations?

• Combination patents: Cover the specific multi-active composition or key intermediate compounds.
• Formulation patents: Fixed-dose tablet composition, stability, and dissolution properties.
• Method-of-use patents: Indications, dosing regimens, or therapeutic use claims.
• Process/manufacturing patents: Methods that can delay generic development.

How exclusivity interacts with generic launch timing

• Orange Book listing status and exclusivity expiry determine the earliest generic launch pathways.
• Even after patent expiry, real-world launch depends on NDA/ANDA litigation and settlement outcomes.

What generic entry risks exist for STRIBILD and how do they change pricing?

Answer: Generic entry risks are high for legacy ART regimens after patent cliffs, with rapid net pricing compression driven by formulary switching and contract repricing.

How generic launch usually impacts market share

• Tier movement: Generics typically move preferred or lower cost-sharing tiers, causing fast switching at the payer level.
• Contract repricing: PBMs and health plans renegotiate pharmacy benefit drug lists and reimbursement models.
• Wholesale price pressure: WAC declines after entry, with net price decline amplified by competitive rebates.

How does STRIBILD compare commercially with tenofovir DF vs. tenofovir alafenamide strategies?

Answer: Tenofovir DF regimens face structural adoption headwinds versus tenofovir alafenamide-based regimens as prescribers and payers favor improved long-term safety and monitoring simplification.

Commercial impact of renal monitoring and tolerability

• Tenofovir DF can require more intensive renal monitoring, which adds friction for both providers and payers.
• Tenofovir alafenamide regimens often align with payer preference for “maintenance with fewer monitoring burdens,” which can shift share even when virologic outcomes are comparable.

What litigation and settlement factors can influence STRIBILD’s financial path?

Answer: For legacy HIV fixed-dose combinations, patent litigation and Paragraph IV outcomes typically shape launch timing and can produce “delay or carve-out” effects that temporarily extend revenue.

What settlement outcomes tend to matter commercially

• Staggered launch dates: Settlement can delay entry while permitting later-launch generic products.
• Geographic or product-form scope: Some settlements limit which strengths or formulations can launch, affecting revenue rate of decline.
• Authorized generics or supply agreements: If an authorized generic is introduced, revenue erosion can be faster than expected.

What is the Orange Book status of STRIBILD and what does it imply for exclusivity?

Answer: The Orange Book status determines listed patents and exclusivity periods controlling ANDA/505(b)(2) launch eligibility. For a legacy product, the critical question is whether any listed patents remain enforceable for the combination and for relevant dosage forms.

Why Orange Book listings matter for revenue modeling

• The last-to-expire patent drives the “cliff” date for generic risk.
• Exclusivity supplements patent protection and can extend revenue even if some patents fall earlier.

How do manufacturing and supply dynamics affect STRIBILD pricing and availability?

Answer: Supply stability matters because ART coverage is continuous; shortages can temporarily boost pricing and channel allocations, but sustained shortages are uncommon for established oral fixed-dose regimens.

What to monitor

• Batch recall events: Can alter short-term pharmacy availability and shift prescriptions to alternative regimens.
• Contract manufacturing transitions: Can change lead times and distribution terms.
• Parallel import and cross-border pricing: Can create price pressure in secondary markets.

Key timeline: market and financial milestones for STRIBILD

Answer: STRIBILD follows a typical ART lifecycle: launch ramp, maturity, then decline driven by formulary competition and generic entry after patent/exclusivity expiry.

Milestone	Financial relevance	Business implication
Launch and initial ramp	Revenue growth from adoption	Build field penetration and payer contracting
Mid-cycle maturity	Share stabilized; rebates rise	Protect formulary position; manage PA criteria
Patent/exclusivity expiration	Generic risk rises	Model step-down and contract renegotiations
ANDA litigation/settlement	Launch delay or staged erosion	Reprice pipeline risk and competitive entry timeline
Generic uptake	Rapid net price compression	Reassess portfolio value and potential switches to newer regimens

Key Takeaways

• STRIBILD’s market dynamics are primarily payer- and guideline-driven, with volume influenced by formulary tiers, PA requirements, and switching programs for suppressed patients.
• Its financial trajectory is shaped by the timing of patent/exclusivity cliffs, generic entry, and settlement outcomes that can delay or accelerate erosion.
• Long-term adoption has faced structural substitution pressure from newer fixed-dose regimens, particularly those built on tenofovir alafenamide strategies that reduce monitoring friction.
• For revenue exposure, the key variables are net price compression, patient churn rates, and contract intensity in specialty pharmacy and Medicaid managed care.

FAQs

1. How do PBM rebate structures typically accelerate STRIBILD net price erosion after generic entry?
2. Which patient segments are least likely to switch off STRIBILD after payer formulary changes?
3. What competitive impact do tenofovir alafenamide-based single-tablet regimens have on STRIBILD market share?
4. How does cobicistat-driven drug-drug interaction risk affect prescribing patterns and payer coverage criteria?
5. What indicators best forecast the timing of STRIBILD volume decline in specialty pharmacy channels?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (STRIBILD listings). FDA.
2. FDA. Drug Approval Package: STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate). FDA.
3. FDA. Guidance for Industry: Patient Labeling for Prescription Drug Products Using a Standardized Format. FDA.

DrugChatter Q&A for STRIBILD

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