VITEKTA Drug Patent Profile

When do Vitekta patents expire, and when can generic versions of Vitekta launch?

Vitekta is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in VITEKTA is elvitegravir. There are six drug master file entries for this compound. Additional details are available on the elvitegravir profile page.

DrugPatentWatch^® Generic Entry Outlook for Vitekta

Vitekta 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.

Indicators of Generic Entry

Summary for VITEKTA

International Patents:	92
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	82
Patent Applications:	1,182
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VITEKTA
DailyMed Link:	VITEKTA at DailyMed

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

NDA:

203093

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.

US Patents and Regulatory Information for VITEKTA

VITEKTA is protected by three US patents.

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	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
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 VITEKTA

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 VITEKTA

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

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 VITEKTA

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

VITEKTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VITEKTA (Elvitegravir)

Overview of VITEKTA

VITEKTA, also known as elvitegravir, is an HIV-1 integrase strand transfer inhibitor used in combination with other antiretroviral drugs, typically an HIV protease inhibitor, to treat HIV-1 infection in treatment-experienced adults[4][5].

Market Size and Growth

The global HIV drugs market, within which VITEKTA operates, was valued at USD 31.6 billion in 2022 and is projected to grow to USD 70.93 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 9.4% during the forecast period of 2024-2031. This growth is driven by the increasing prevalence of HIV infections, rising awareness about HIV, and advancements in antiretroviral therapy (ART)[1].

Segment Analysis

Integrase inhibitors, the class of drugs to which VITEKTA belongs, are expected to hold a significant market share. These drugs, including raltegravir, elvitegravir, dolutegravir, bictegravir, and cabotegravir, are widely used in the initial treatment of HIV due to their low risk of side effects and effectiveness. This segment is anticipated to offer lucrative opportunities for HIV drug providers, including those offering VITEKTA[1].

Distribution Channels

The demand for HIV drugs, including VITEKTA, is also influenced by distribution channels. Online pharmacies are expected to see a significant rise in demand, driven by increasing internet penetration, the growing preference for convenience in purchasing drugs, and the adoption of telehealth and telemedicine practices. This trend is likely to generate new business opportunities for HIV drug providers[1].

Regional Market Dynamics

North America, particularly the United States and Canada, is expected to be a leading region for HIV drugs due to the high prevalence of HIV infections, developed healthcare infrastructure, and the presence of key HIV drug suppliers. However, the Asia Pacific region, especially India and China, is also emerging as a significant market driven by increasing awareness, supportive government initiatives, and growing healthcare spending[1].

Financial Performance of Gilead Sciences

Gilead Sciences, the manufacturer of VITEKTA, has historically seen strong financial performance from its antiviral products, including those for HIV. In the second quarter of 2016, Gilead's antiviral product sales, which include HIV drugs, were $7.1 billion. Specifically, sales of TAF-based products like Genvoya, Descovy, and Odefsey, which are related to VITEKTA in terms of therapeutic class, saw increases due to their efficacy and lower side effect profiles[2].

Challenges and Opportunities

While VITEKTA and other HIV drugs face challenges such as side effects, toxicity in long-term treatments, and issues of drug resistance, they also present several opportunities. The launch of new HIV awareness and prevention initiatives by governments and public health organizations is expected to boost sales. Additionally, the rising emphasis on early testing and diagnostics for HIV infections will create new business scope for HIV drug companies, including those offering VITEKTA[1].

Side Effects and Safety Profile

VITEKTA has a relatively favorable safety profile compared to other antiretroviral drugs. The most common adverse reactions reported in clinical studies include diarrhea, nausea, and headache, with a low discontinuation rate due to adverse events (3% in the VITEKTA group vs. 4% in the raltegravir group)[4].

Regulatory Approval and Market Access

VITEKTA gained FDA approval in 2014 for use in treatment-experienced HIV-1 infected adults in combination with other antiretroviral agents. This approval has been crucial for its market presence and accessibility to patients[5].

Competitive Landscape

The HIV drugs market is highly competitive, with multiple players offering various antiretroviral therapies. However, the integrase inhibitor class, to which VITEKTA belongs, remains a key segment due to its efficacy and safety profile. The competitive nature of the market is expected to drive innovation and potentially reduce prices, making treatments more accessible to a broader patient population[1].

Financial Trajectory

Given the overall growth of the HIV drugs market and the specific segment of integrase inhibitors, the financial trajectory for VITEKTA is likely to be positive. As more patients are diagnosed and treated, and as awareness and access to treatment increase, the demand for effective and safe HIV drugs like VITEKTA will continue to rise.

Key Takeaways

• Market Growth: The global HIV drugs market is projected to grow significantly, driven by increasing prevalence and advancements in ART.
• Segment Performance: Integrase inhibitors, including VITEKTA, are expected to hold a significant market share due to their efficacy and safety.
• Distribution Trends: Online pharmacies and telehealth practices will play a crucial role in the distribution of HIV drugs.
• Regional Dynamics: North America and the Asia Pacific region are key markets for HIV drugs.
• Financial Performance: Gilead Sciences has seen strong financial performance from its antiviral products, including those related to VITEKTA.
• Challenges and Opportunities: Despite challenges, the market presents opportunities driven by awareness initiatives and early testing.

FAQs

1. What is VITEKTA used for? VITEKTA (elvitegravir) is used in combination with other antiretroviral drugs to treat HIV-1 infection in treatment-experienced adults.

2. What is the projected growth of the HIV drugs market? The global HIV drugs market is projected to grow from USD 34.57 billion in 2023 to USD 70.93 billion by 2031, with a CAGR of 9.4% during the forecast period.

3. Which region is expected to lead in HIV drugs demand? North America, particularly the United States and Canada, is expected to be the leading region for HIV drugs demand.

4. What are the common side effects of VITEKTA? The most common adverse reactions reported include diarrhea, nausea, and headache.

5. When did VITEKTA gain FDA approval? VITEKTA gained FDA approval in 2014 for use in treatment-experienced HIV-1 infected adults in combination with other antiretroviral agents.

Sources

1. SkyQuestT: HIV Drugs Market Growth, Size & Share Analysis | 2031
2. BusinessWire: Gilead Sciences Announces Second Quarter 2016 Financial Results
3. PubMed: The economics of follow-on drug research and development
4. RxList: Vitekta (Elvitegravir Tablets): Side Effects, Uses, Dosage
5. Nasdaq: Gilead's HIV Drugs Tybost and Vitekta Get FDA Clearance - Analyst Blog