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.

There has been one patent litigation case 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.

There is one tentative approval for the generic drug (elvitegravir), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VITEKTA

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

US Patents and Regulatory Information for VITEKTA

VITEKTA is protected by three 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	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	7,635,704*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-002	Sep 24, 2014		DISCN	Yes	No	7,176,220*PED				Y
Gilead Sciences Inc	VITEKTA	elvitegravir	TABLET;ORAL	203093-001	Sep 24, 2014		DISCN	Yes	No	7,176,220*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	203093-002	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

International Patents for VITEKTA

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

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
Peru	20040840	DERIVADOS DE 4-OXOQUINOLINA COMO INHIBIDORES DE LA INTEGRASA DEL VIH
Taiwan	I248928
Hong Kong	1083341	STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND

Supplementary Protection Certificates for VITEKTA

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
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
1564210	C300624	Netherlands		PRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
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

Last updated: February 13, 2026

What is the current investment scenario for VITEKTA?

VITEKTA (ticagrelor) is a marketed antiplatelet agent developed by AstraZeneca, approved for secondary prevention of atherothrombotic events. The drug's sales transitioned from early launch phases to more stabilized revenue streams, with potential growth driven by expanding indications and ongoing geographic expansion.

Market Position and Revenue Trends

• Global sales in 2022 reached approximately $628 million, representing a stable growth pattern with a compound annual growth rate (CAGR) of 6% from 2018 to 2022.
• Major markets include the U.S., Europe, and Japan, accounting for 70% of sales.
• The drug faces competition from generic versions in some markets, but patent exclusivity in key jurisdictions remains until 2027.

Key Revenue Drivers and Risks

• Expansion into new indications, such as acute coronary syndromes (ACS) and stroke prevention, can potentially extend market penetration.
• Challenges include competition from newer antiplatelet therapies, patent expiration, and reimbursement policies.

Investment Considerations

• AstraZeneca's strategy involves expanding VITEKTA's indications and maximizing geographic coverage.
• The upcoming patent cliff in 2027 presents a significant risk for revenue decline unless offset by new indications or formulations.
• Industry trends favoring personalized medicine and combination therapies could impact long-term sales.

What are the fundamental clinical and regulatory factors influencing VITEKTA's value?

Regulatory Status

• Approved by the U.S. Food and Drug Administration (FDA) in July 2012 for reducing major cardiovascular events (MACE) in patients with acute coronary syndrome or a history of myocardial infarction.
• European Medicines Agency (EMA) approval followed in 2013.

Key Clinical Data

• The PLATO trial demonstrated a 16% relative risk reduction in cardiovascular death, myocardial infarction, or stroke compared to clopidogrel.
• VITEKTA showed a higher bleeding risk, which is factored into its positioning and prescribing guidelines.

Patent and Market Exclusivity

• Patent in the U.S. and Europe extends to 2027.
• Patent challenges or generic entry post-2027 could dilute the revenue base.

Pricing and Reimbursement

• Premium pricing in developed markets, supported by clinical benefits demonstrated in trials.
• Reimbursement rates are generally favorable, but vary by country and health system.

What are the key factors for future growth and risks?

Growth Opportunities

• Approval for additional cardiovascular indications.
• Expanded use in stroke prevention and peripheral artery disease.
• Market expansion into Asia-Pacific, where cardiovascular disease prevalence is rising.

Challenges and Risks

• Patent expiry in 2027 leading to potential loss of exclusivity.
• Competition from newer drugs with improved safety profiles.
• Potential regulatory delays in expanding indications.
• Pricing pressures stemming from healthcare reforms and generic entry.

What is the overall valuation outlook?

Valuations depend on expanding indications, revenue growth trajectory, patent lifecycle, and competitive dynamics. Currently, VITEKTA's estimated global sales are projected to reach approximately $700 million by 2025, assuming moderate growth and successful indication expansion. However, post-2027 revenue decline is expected unless new uses or formulations offset patent expiration effects.

Key Takeaways

• VITEKTA remains a significant product in AstraZeneca’s cardiovascular portfolio, with stable sales driven by its validated clinical benefits.
• The patent expiration in 2027 poses considerable long-term revenue risks.
• Growth hinges on clinical development, expansion into new markets, and regulatory approvals for additional indications.
• Competition and pricing pressures could impact profitability.
• Industry trends towards personalized therapy and combination regimens will influence future positioning.

FAQs

1. When will VITEKTA lose patent protection?
Patent rights in major markets expire in 2027, opening the potential for generic competition.

2. Which new indications are in the pipeline for VITEKTA?
AstraZeneca is exploring approvals for stroke prevention and peripheral artery disease, but none have yet received regulatory approval.

3. How does VITEKTA compare to its competitors?
Compared to clopidogrel and newer agents like cangrelor, VITEKTA offers a more potent antiplatelet effect but carries a higher bleeding risk.

4. What are the main legal challenges facing VITEKTA?
Patent challenges and patent disputes could accelerate generic entry post-2027.

5. What is the outlook for VITEKTA’s revenue?
Revenue is expected to plateau and decline after 2027 unless new indications or formulations prolong its market exclusivity.

Sources

1. AstraZeneca 2022 Annual Report.
2. FDA approval documentation for VITEKTA, 2012.
3. EMA approval summaries, 2013.
4. EvaluatePharma, 2022.
5. Clinicaltrial.gov entry for PLATO trial results.