elvitegravir - Profile

What are the generic 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 is one tentative approval for this compound.

Summary for elvitegravir

International Patents:	92
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for elvitegravir

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

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.

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.

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	203093-001	Sep 24, 2014		DISCN	Yes	No					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No					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
Russian Federation	2004121464	СОЕДИНЕНИЕ 4-ОКСОХИНОЛИНА И ЕГО ПРИМЕНЕНИЕ В КАЧЕСТВЕ ИНГИБИТОРА ВИЧ ИНТЕГРАЗЫ
World Intellectual Property Organization (WIPO)	2005113508
Norway	2022032
Taiwan	200600097	Stable crystal of 4-oxoquinoline compound technical field of the invention

Supplementary Protection Certificates for elvitegravir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	PA2016038	Lithuania		PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
1564210	CA 2013 00058	Denmark		PRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524
1564210	SPC/GB13/065	United Kingdom		PRODUCT NAME: ELVITEGRAVIR; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
1564210	489	Finland

Last updated: February 12, 2026

What is elvitegravir and its current development status?

Elvitegravir is an integrase strand transfer inhibitor (INSTI) used primarily in treating HIV-1 infection. Marketed under the brand name Vitekta by Gilead Sciences, it is combined with other antiretroviral agents in fixed-dose formulations, notably in the Stribild and Genvoya regimens. Its approval by the FDA occurred in 2012, with subsequent approval in other markets. As of 2023, elvitegravir remains a component in Gilead’s HIV portfolio, but the standalone drug is no longer marketed; emphasis has shifted toward fixed-dose combination therapies.

Gilead’s strategy involves integrating elvitegravir within multi-drug regimens, sharing market share with competitors like Dolutegravir (Gilead’s own Tivicay) and Bictegravir (Biktarvy). No major new formulations or indications have been approved recently, but ongoing research explores resistance profiles and potential combinations.

How does elvitegravir compare with other HIV therapies in the market?

Parameter	Elvitegravir	Dolutegravir	Bictegravir
Market Presence	Established, but diminished	Leading INSTI, dominant in market	Third-generation INSTI, growing presence
FDA Approval Year	2012	2013	2018
Resistance Barrier	Moderate	High	High
Dosing Schedule	Once daily (with boosting agents)	Once daily	Once daily
Drug Interactions	Significant with CYP3A4 inducers	Less than elvitegravir	Similar to dolutegravir

Elvitegravir's market position is declining relative to newer INSTIs. Its moderate resistance barrier and significant drug interaction profile reduce its attractiveness for future investment. Competition has shifted toward drugs with fewer interactions and higher barriers to resistance.

What are the key patent and regulatory considerations?

Elvitegravir's initial patents expire between 2028 and 2032, depending on jurisdiction. Gilead holds formulation patents, but patent challenges and generic development are ongoing in some markets. Regulatory focus has shifted to fixed-dose formulations, with no recent patents or approvals for standalone elvitegravir. Orphan drug or new indication opportunities are limited, given the competitive landscape.

What are the market dynamics and sales trends?

Gilead reported peak sales of Vitekta at approximately $200 million in 2013. Sales declined sharply over subsequent years, with minimal contribution by 2020. The shift to combination therapies utilizing other INSTIs has reduced demand for elvitegravir standalone formulations. Overall HIV drug sales revenue for Gilead remains high, but reliance on elvitegravir has waned.

Market share for elvitegravir-based products in HIV treatment is less than 10%. The competitive landscape includes generics in some regions, and the emergence of newer INSTIs further suppresses demand. The global HIV drug market is projected to grow, reaching $23 billion by 2027 (Research and Markets), but elvitegravir's contribution diminishes within this scope.

What are the research and development prospects?

No active clinical trials for new indications or formulations of elvitegravir exist. Gilead’s focus has shifted to next-generation INSTIs with higher resistance barriers and better safety profiles. The drug’s profile limits its standalone use, reducing R&D investment.

However, research on resistance pathways and long-term safety continues. Innovations in delivery mechanisms or combination regimens could theoretically extend its lifecycle, but no such initiatives are publicly underway.

How should investors interpret elvitegravir’s fundamentals today?

Elvitegravir presents limited investment potential as a standalone product. Its declining sales, expiration of key patents, and competitive pressure from newer drugs weaken its prospects. Opportunities may exist within Gilead’s broader HIV pipeline, but elvitegravir-specific assets have minimal strategic relevance.

In licensing negotiations, generic manufacturers and biosimilar players explore patent challenges, particularly in markets with time-tested generic access policies. Yet, current market trends favor drugs with higher resistance barriers and easier administration, favoring newer INSTIs.

What are the strategic risks and regulatory hurdles?

Patent expiry risks include potential generic entry post-2028. Regulatory hurdles for new formulations or indications are high, with minimal likelihood of approval for standalone use. Ongoing resistance issues could diminish any residual utility.

Pharmaceutical companies seeking to develop integrase inhibitors must justify differentiation from established competitors like dolutegravir and bictegravir. Cost-effective manufacturing and favorable safety profiles are essential for market entry.

Key Takeaways

• Elvitegravir remains part of established combination therapies but is declining as a standalone treatment.
• Market share and sales have sharply decreased, with no recent clinical advancements.
• Patent protections are nearing expiration, raising generic competition risks.
• The drug faces competition from newer INSTIs offering higher resistance barriers and fewer drug interactions.
• Investment opportunities are minimal unless innovative formulations or new indications emerge.

FAQs

1. Is elvitegravir a good investment today?
   No. Its declining sales, patent expiries, and competition from newer drugs limit its investment appeal.

2. What challenges face elvitegravir’s future?
   Patent expiration, generic competition, and availability of superior INSTIs.

3. Are there ongoing clinical trials for elvitegravir?
   No. Current research focuses on resistance and safety, not new formulations.

4. Can elvitegravir be repurposed for other indications?
   No current evidence suggests new indications; its use remains confined to HIV treatment.

5. When do key patents for elvitegravir expire?
   Typically between 2028 and 2032, depending on jurisdiction and specific patent protections.

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References
[1] Gilead Sciences. Vitekta (elvitegravir) prescribing information. 2012.
[2] Research and Markets. HIV Drugs Market Forecast 2023-2027. 2023.
[3] U.S. Food & Drug Administration. Drug approvals and safety updates. 2012-2023.