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.

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:	65
Patent Applications:	2,707
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

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
Kenya Medical Research Institute	Phase 1
Centre for the AIDS Programme of Research in South Africa	Phase 1
University of Pittsburgh	Phase 1

See all ELVITEGRAVIR clinical trials

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					Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	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/002577 Vitekta 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
Czech Republic	2004764	4-Oxochinolinová sloučenina a její použití jako inhibitoru HIV-integrázy (4-Oxoquinoline compound and use thereof as HIV-integrase inhibitor)
Peru	20120361	COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN FORMAS CRISTALINAS DE ACIDO 6-(3-CLORO-2-FLUOROBENCIL)-1-[(S)-1-HIDROXIMETIL-2-METILPROPIL]-7-METOXI-4-OXO-1, 4-DIHIDROQUINOLINA-3-CARBOXILICO
Mexico	PA06013405	CRISTAL ESTABLE DEL COMPUESTO 4-OXOQUINOLINA. (STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND.)
Brazil	PI0510114	cristal estável de composto 4-oxoquinolina
New Zealand	551839	Stable crystal of 4-oxoquinoline compound

Supplementary Protection Certificates for ELVITEGRAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	122013000088	Germany		PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524
1564210	489	Finland
1564210	92307	Luxembourg		PRODUCT NAME: ELVITEGRAVIR SOUS TOUTES SES FORMES COMME PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 - STRIBILD-ELVITEGRAVIR/... 20130527
1564210	300624	Netherlands		PRODUCT NAME: ELVITEGRAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
1564210	C01564210/01	Switzerland		CHANGE OF ADDRESS OF THE OWNER: JAPAN TOBACCO INC., 1-1, TORANOMON 4-CHOME, MINATO-KU, TOKYO 105-6927, JP

ELVITEGRAVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Elvitegravir

Introduction to Elvitegravir

Elvitegravir is an antiretroviral drug that belongs to the class of integrase inhibitors, which are used in the treatment of HIV/AIDS. It works by blocking the integrase enzyme, preventing the integration of HIV's genetic material into the host cell's DNA[4].

Market Size and Growth

The global integrase inhibitors market, which includes elvitegravir, is projected to grow significantly. As of 2023, the market size was valued at US$ 14.7 billion and is expected to reach US$ 21.7 billion by 2030, growing at a compound annual growth rate (CAGR) of 5.7% from 2023 to 2030[1].

Segmentation and Dominant Players

The integrase inhibitors market is segmented by drug, route of administration, and distribution channel. Among the drugs, raltegravir is expected to dominate the market due to its high efficacy and safety profile. However, dolutegravir is the fastest-growing segment, driven by its increasing adoption as first-line therapy for HIV. Elvitegravir, although not the dominant player, is a significant component of combination therapies like Genvoya and Stribild[1].

Combination Therapies

Elvitegravir is often used in combination with other antiretroviral drugs. For example, Genvoya, a single-tablet regimen developed by Gilead Sciences, combines elvitegravir with cobicistat, emtricitabine, and tenofovir alafenamide. This combination has shown high efficacy and improved renal and bone safety parameters compared to TDF-based regimens[5].

Commercial Performance of Genvoya

Genvoya, which includes elvitegravir, has been a commercially successful product. In its first six months, Genvoya generated $302 million in worldwide sales, with sales nearly doubling in the second quarter compared to the first quarter[2].

Patent and Generic Entry

The patents protecting Genvoya, including those for elvitegravir, are set to expire in the future. The earliest estimated date for generic entry is April 6, 2033, although this can be influenced by various factors such as new patent filings, patent extensions, and generic licensing[2].

Clinical Efficacy and Safety

Elvitegravir has demonstrated strong clinical efficacy in various studies. For instance, in Study 145, elvitegravir showed an equivalent rate of viral suppression to raltegravir in treatment-experienced patients. In other studies, such as Study 236-0102 and Study 236-0103, elvitegravir-based regimens maintained high viral suppression rates comparable to other antiretroviral therapies[4].

Side Effects and Drug Interactions

Common side effects of elvitegravir include headache, weakness, dizziness, and gastrointestinal issues. It also has potential drug interactions, particularly when used with other antiretroviral agents. Additionally, elvitegravir is not recommended during pregnancy due to lower drug levels in the third trimester[4].

Market Drivers

The growth of the integrase inhibitors market, including elvitegravir, is driven by several factors:

• Increasing Adoption as First-Line Therapy: The increasing use of integrase inhibitors as first-line therapy for HIV is a significant driver.
• Rising Prevalence of HIV/AIDS: The growing number of HIV/AIDS cases globally contributes to the demand for effective treatments.
• Government Initiatives: Government programs aimed at improving HIV treatment and prevention also boost the market[1].

Market Restraints and Challenges

Despite the growth, the market faces some challenges:

• Side Effects and Safety Concerns: The need to develop drugs with fewer side effects and better safety profiles is a key challenge.
• Patent Expirations: The impending expiration of patents for drugs like Genvoya could lead to generic competition, affecting market dynamics.
• Regulatory Hurdles: Ensuring compliance with regulatory requirements and managing patent litigation are ongoing challenges[1].

Regional Insights

The global integrase inhibitors market is segmented by region, with different regions showing varying levels of market penetration and growth. Understanding regional dynamics is crucial for market players to tailor their strategies accordingly[1].

Key Players and Collaborations

Major pharmaceutical companies such as Gilead Sciences, ViiV Healthcare, Merck & Co., and others are key players in the integrase inhibitors market. Collaborations and agreements among these companies, as well as with research institutions, are common and drive innovation and market growth[1].

Financial Trajectory

Given the projected growth of the integrase inhibitors market, the financial trajectory for elvitegravir, particularly through combination therapies like Genvoya, is positive. The market's expected growth to US$ 21.7 billion by 2030 indicates a robust financial future for elvitegravir and related products.

Key Takeaways

• Market Growth: The integrase inhibitors market, including elvitegravir, is expected to grow significantly, driven by increasing adoption and government initiatives.
• Combination Therapies: Elvitegravir is often used in combination with other antiretroviral drugs, enhancing its efficacy and market appeal.
• Patent and Generic Considerations: The expiration of patents and potential generic entry will shape the market dynamics in the future.
• Clinical Efficacy: Elvitegravir has demonstrated strong clinical efficacy, making it a valuable component of HIV treatment regimens.
• Challenges: The market faces challenges related to side effects, safety concerns, and regulatory hurdles.

FAQs

Q: What is the current market size of the integrase inhibitors market? A: The global integrase inhibitors market size was valued at US$ 14.7 billion in 2023[1].

Q: What is the projected growth rate of the integrase inhibitors market? A: The market is expected to grow at a CAGR of 5.7% from 2023 to 2030[1].

Q: Which combination therapy includes elvitegravir and has shown high efficacy? A: Genvoya, which combines elvitegravir with cobicistat, emtricitabine, and tenofovir alafenamide, has shown high efficacy and improved safety parameters[5].

Q: When is the earliest estimated date for generic entry of Genvoya? A: The earliest estimated date for generic entry of Genvoya is April 6, 2033[2].

Q: What are some common side effects of elvitegravir? A: Common side effects include headache, weakness, dizziness, and gastrointestinal issues[4].

Sources

1. Coherent Market Insights - Integrase Inhibitors Market Size, Trends and Forecast to 2030
2. DrugPatentWatch - When will the GENVOYA patents expire, and when will generic versions be available?
3. Market Research Pulse - Elvitegravir Combination Drugs Market Trends, Scope And Outlook
4. Aidsmap - Elvitegravir
5. Gilead Sciences - US Food and Drug Administration Approves Gilead’s Single-Tablet Regimen Genvoya for Treatment of HIV-1 Infection