Elvitegravir - Generic Drug Details

What are the generic drug sources for elvitegravir and what is the scope of freedom to operate?

Elvitegravir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elvitegravir has ninety-two patent family members in thirty-six countries.

There are six drug master file entries for elvitegravir. There is one tentative approval for this compound.

Summary for elvitegravir

International Patents:	92
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	66
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for elvitegravir
DailyMed Link:	elvitegravir at DailyMed

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

Constraining patent/regulatory exclusivity:

7,635,704*PED

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 elvitegravir

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

Sponsor	Phase
CONRAD	PHASE1
Eastern Virginia Medical School	PHASE1
Centers for Disease Control and Prevention	PHASE1

See all elvitegravir clinical trials

Generic filers with tentative approvals for ELVITEGRAVIR

Applicant	Application No.	Strength	Dosage Form
		120MG	TABLET
		90MG	TABLET
		6MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for elvitegravir

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for elvitegravir

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	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No	8,981,103*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No	7,635,704*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	8,981,103*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	7,176,220*PED				Y

EU/EMA Drug Approvals for elvitegravir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences International Ltd	Vitekta	elvitegravir	EMEA/H/C/002577Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.	Withdrawn	no	no	no	2013-11-13

International Patents for elvitegravir

Country	Patent Number	Title	Estimated Expiration
Norway	20190051	Stabil krystall av 4-oxoquinolinforbindelse
Mexico	PA04006553	COMPUESTO DE 4-OXOQUINOLINA Y USO DEL MISMO COMO INHIBIDOR DE INTEGRASA DE VIH. (4-OXOQUINOLINE COMPOUND AND ITS USE AS HIV INTEGRASE INHIBITOR.)
Slovakia	2662004	Zlúčenina s obsahom 4-oxochinolínu a jej použitie ako inhibítora integráz (4-Oxoquinoline compound and its utilisation as integrase inhibitor)
Lithuania	3281939

Supplementary Protection Certificates for elvitegravir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	203 5022-2013	Slovakia		PRODUCT NAME: ELVITEGRAVIR ALEBO JEHO HYDRAT, SOLVAT, TAUTOMER ALEBO FARMACEUTICKY PRIJATELNA SOL; NAT. REGISTRATION NO/DATE: EU/1/13/830/001 - EU/1/13/830/002 20130527; FIRST REGISTRATION: EU EU/1/13/830/001 - EU/1/13/830/002 20130527
1564210	132013902209844	Italy		PRODUCT NAME: COMPRENDENTE IL PRODOTTO ELVITEGRAVIR COME UNO DEI PRINCIPI ATTIV(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/830/001-002, 20130524
1564210	C20130029 00095	Estonia		CHANGE OF OWNER'S ADDRESS
1564210	1390052-7	Sweden		PRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524; PERIOD OF VALIDITY (FROM - UNTIL): 2023-11-21 - 2028-05-26

Market Dynamics and Financial Trajectory for Elvitegravir

Last updated: February 13, 2026

Elvitegravir is an integrase strand transfer inhibitor (INSTI) primarily marketed as part of combination products for the treatment of HIV-1 infection. It is manufactured by Gilead Sciences and gained FDA approval in 2012. As of 2023, it remains a significant component within several antiretroviral (ART) regimens. The following analysis details the current market landscape, revenue generation, competitive positioning, and future growth potential.

---

What is the Current Market Size and Revenue for Elvitegravir?

Gilead's leading product containing elvitegravir is the fixed-dose combination (FDC) Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) and Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide). Combined, these products accounted for approximately $2.3 billion in sales in 2022 globally, with the majority generated in the U.S. and Europe.

Revenue Breakdown (2022):

Product	Estimated Sales (USD)	Percentage of Total Elvitegravir-Containing Sales
Genvoya	$1.5 billion	65%
Stribild	$0.8 billion	35%

Note: Genvoya's shift towards the TAF formulation increases its market share over Stribild, which contains TDF.

Market Share and Trends:

• Genvoya's market share is climbing due to better safety profile, particularly regarding renal and bone toxicity associated with tenofovir disoproxil fumarate (TDF).
• The overall market for integrase inhibitors (INSTIs) was valued at approximately $8 billion in 2022 globally, with elvitegravir accounting for around 28–30% of INSTI sales.

---

What Are the Key Growth Drivers for Elvitegravir?

Increasing Adoption of Fixed-Dose Combinations

Gilead's strategy emphasizes combination products enhancing adherence. Genvoya, with its TAF regimen, is preferred over older formulations due to fewer side effects.

Patent Protection and Market Exclusivity

Patents protecting Genvoya and its components extend until at least 2028 in key markets. This limits generic competition and sustains revenue streams.

Geographic Expansion

• The drug is increasingly adopted in emerging markets, supported by Gilead’s licensing agreements and pricing strategies.
• However, pricing and affordability limit access in low-income countries.

Pipeline and Formulation Innovation

• Development of long-acting injectable formulations involving integrase inhibitors, potentially including elvitegravir, could reshape its future market positioning.
• Clinical trials exploring such formulations are ongoing.

---

How Is Competition Impacting Elvitegravir’s Market Trajectory?

Main Competitors

• Bictegravir (Biktarvy): Markets as a 3-drug combination with higher efficacy and tolerability.
• Dolutegravir (Tivicay, as part of Biktarvy): The dominant INSTI with broad adoption.
• Raltegravir (Isentress): First-generation INSTI with reduced market share.

Competitive Advantages and Disadvantages

• Advantages: Once-daily dosing, potent activity, favorable side effect profile (especially with TAF-based formulations).
• Disadvantages: Patent expiration risks, competition from newer INSTIs, and potential future generic availability.

Patent Expiry and Generic Entry

• The primary patents covering Genvoya are set to expire by 2028, after which generic versions are expected to reduce pricing significantly.
• Gilead is preparing for this shift by investing in pipeline innovations and alternative formulations.

---

What Future Opportunities Could Influence Elvitegravir’s Financial Trajectory?

Long-Acting Analogues and Delivery Systems

• Phase 2/3 trials of long-acting injectables involving elvitegravir could enable sustained-release formulations.
• Such formulations could command premium pricing, extend market exclusivity, and improve adherence.

Expanding Indications and Preventive Use

• Investigations for pre-exposure prophylaxis (PrEP) could diversify revenue.
• Regulatory approvals in these spaces remain pending or in early stages.

Pricing and Reimbursement Policies

• Cost containment measures in high-income countries could pressure profit margins.
• Elsewhere, expanding insurance coverage varies significantly.

---

Summary of Financial Outlook

Factor	Impact
Patent protection	Sustains current revenues until at least 2028
Generic competition	Likely to lead to revenue decline post-2028
Pipeline innovations	Potentially renews growth opportunities
Market expansion	Supports incremental growth in emerging regions
Competition from newer INSTIs	May limit future growth prospects

---

Key Takeaways

• Elvitegravir's primary sales derive from Genvoya and Stribild, with combined global revenues estimated at $2.3 billion in 2022.
• Market share is driven by its inclusion in fixed-dose combinations with favorable safety profiles, particularly advancements towards TAF-based formulations.
• Patent expiration in 2028 poses a significant risk of revenue erosion due to anticipated generic competition.
• Long-acting injectable formulations and new indications are potential growth avenues.
• Intense competition from bictegravir and dolutegravir, which provide similar or superior efficacy, is influencing its market position.

---

FAQs

1. When will generic versions of Elvitegravir-based products enter the market?
Patent protections for Genvoya expire around 2028 in major markets, after which generics are expected to enter.

2. Are there any ongoing clinical trials for elvitegravir?
Yes. Trials are evaluating long-acting formulations—including injectables—and exploring new indications such as PrEP.

3. How does elvitegravir compare to other INSTIs?
It offers comparable efficacy with a favorable safety profile, especially in TAF formulations. However, bictegravir and dolutegravir are often preferred due to higher barriers to resistance and broader data sets.

4. What regions are seeing the fastest growth for elvitegravir?
High-income markets like the U.S. and Europe lead, with increasing adoption in select emerging markets facilitated by licensing and pricing strategies.

5. What will influence elvitegravir's long-term market success?
Pipeline development, patent protections, competition, and evolving treatment guidelines will determine its future trajectory.

---

Sources
[1] Gilead Sciences Financial Reports 2022
[2] IQVIA HIV Market Data 2022
[3] U.S. FDA Approval Documents for Genvoya and Stribild
[4] Industry Analysis Reports: HIV Antiretroviral Market 2022