APRETUDE Drug Patent Profile

Which patents cover Apretude, and when can generic versions of Apretude launch?

Apretude is a drug marketed by Viiv Hlthcare and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in thirty-eight countries.

The generic ingredient in APRETUDE is cabotegravir. One supplier is listed for this compound. Additional details are available on the cabotegravir profile page.

DrugPatentWatch^® Generic Entry Outlook for Apretude

Apretude was eligible for patent challenges on January 21, 2025.

Indicators of Generic Entry

Summary for APRETUDE

International Patents:	158
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	5
Patent Applications:	831
Drug Prices:	Drug price information for APRETUDE
What excipients (inactive ingredients) are in APRETUDE?	APRETUDE excipients list
DailyMed Link:	APRETUDE at DailyMed

See drug prices for APRETUDE

Recent Clinical Trials for APRETUDE

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

Sponsor	Phase
PPD	Phase 3
GlaxoSmithKline	Phase 3
ViiV Healthcare	Phase 3

See all APRETUDE clinical trials

US Patents and Regulatory Information for APRETUDE

APRETUDE is protected by four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y	Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y	Y
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes

Expired US Patents for APRETUDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021

EU/EMA Drug Approvals for APRETUDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ViiV Healthcare B.V.	Vocabria	cabotegravir	EMEA/H/C/004976Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA	Authorised	no	no	no	2020-12-17
ViiV Healthcare B.V.	Apretude	cabotegravir	EMEA/H/C/005756Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2023-09-15

International Patents for APRETUDE

When does loss-of-exclusivity occur for APRETUDE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Montenegro

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering APRETUDE around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	E516026
Australia	2006239177	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Brazil	PI0610030	composto, processo para a preparação de um composto, método de tratamento de uma infecção por hiv em um humano, uso de um composto, e, composição farmacêutica
Brazil	PI0617842	composto ou um sal farmaceuticamente aceitável ou um solvato do mesmo, e, composição farmacêutica
Canada	2606282	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASEINHIBITORY ACTIVITY)
Canada	2626956	DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITE D'INHIBITION SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE)

Supplementary Protection Certificates for APRETUDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	C300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117	CA 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140116
1874117	PA2014021	Lithuania		PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
1874117	C20140020 00130	Estonia		PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117	202 50006-2014	Slovakia		PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121

Market Dynamics and Financial Trajectory for APRETUDE

Last updated: March 23, 2026

What is APRETUDE?

APRETUDE (aprepitant) is a neurokinin-1 receptor antagonist indicated for preventing chemotherapy-induced nausea and vomiting (CINV). It is marketed primarily under the brand Emend by Merck & Co. The drug has also gained approval for postoperative nausea and vomiting (PONV) prevention. Introduced in 2003, APRETUDE’s patent protection was anticipated to expire between 2023 and 2025, opening potential for generic competition.

Market Size and Growth Drivers

Global CINV Management Market

The global market for CINV management was valued at approximately USD 1.1 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030, driven by:

• Increasing cancer prevalence
• Rising adoption of combination anti-emetic regimens
• Expanding healthcare infrastructure in emerging markets

Key Market Segments

Segment	Market Share (2022)	CAGR (2023-2030)	Drivers
Chemotherapy-Induced Nausea and Vomiting (CINV)	70%	6-8%	Rising cancer incidence, improved awareness
Postoperative Nausea and Vomiting (PONV)	30%	5-7%	Expanding surgical procedures, increased awareness of PONV management

Regional Trends

• North America held over 50% of the market in 2022, driven by widespread adoption of anti-emetic protocols and advanced healthcare infrastructure.
• Europe accounts for approximately 25%, with regulatory approval of APRETUDE for PONV in several countries.
• Asia-Pacific shows high growth potential, expected to grow at 8-10% CAGR from 2023 onward, due to increased cancer treatment and surgical procedures.

Competitive Landscape

Key Players

• Merck & Co. (Emend)
• Heron Therapeutics (Rolesym)
• Helsinn Healthcare (Akynzeo)
• Pfizer (Netupitant/Palonosetron)

Market Share Distribution

Company	Market Share (2022)	Key Products
Merck	~65%	Emend (aprepitant)
Heron Therapeutics	~20%	Rolesym (aprepitant + palonosetron)
Helsinn Healthcare	~10%	Akynzeo (netupitant + palonosetron)
Others	~5%	Various generics and combination products

Patent Expiry and Generic Entry

APRETUDE's patent protection ended in 2023 in key markets like the U.S. and Europe. This has led to the emergence of generic versions in multiple territories, primarily impacting pricing and market share.

Financial Trajectory

Revenue and Sales Trends

Year	Approximate Revenue (USD billion)	Notes
2018	1.2	Peak sales phase, driven by combination use
2019	1.1	Slight decline as patent cliffs approach
2020	1.0	Market saturation, COVID-19 impact
2021	0.9	Entry of generics in some markets, pricing pressure
2022	0.8	Continued generics entry, regional market shifts

Future Projections

Forecasts suggest:

• Revenue decline of 10-15% annually during 2023-2025 as generic competition expands
• Stabilization in revenues in mature markets due to prescribed brand loyalty
• Potential growth in emerging markets due to increased cancer treatment adoption

Pricing Dynamics

Post-patent expiration, generic versions could reduce prices by 50-70% in major markets. This pressure could lead Merck to:

• Launch value-based pricing strategies
• Focus on new formulations or indications
• Increase marketing efforts in emerging markets

Regulatory and Policy Factors

• US FDA approved generic aprepitant brands shortly after patent expiry in 2023.
• European Medicines Agency (EMA) approvals align with US timelines.
• Pricing regulations in Europe and the US favor cost containment, pressuring revenue margins.
• Expanded labeling for new indications may present revenue opportunities.

R&D and Pipeline Insights

While APRETUDE remains the dominant anti-emetic for CINV, Merck invests in next-generation anti-emetics with improved efficacy and safety profiles. Pipeline candidates include:

• Neurokinin-1 antagonists with longer half-life
• Combinations with NK1 antagonists and other agents for broader anti-emetic coverage
• Capsules or infusion formulations for convenience

Key Challenges

• Intense price competition from generics
• Market saturation in North America and Europe
• Regulatory barriers for new indications
• Competitive innovation from new drug classes

Strategic Recommendations

• Differentiate through formulation improvements and combination therapies
• Expand presence in emerging markets with tailored pricing strategies
• Invest in clinical trials for additional indications
• Pursue partnership deals for pipeline expansion

Key Takeaways

• APRETUDE's global market peaked pre-2023; patent expiry introduced significant generic competition.
• Revenue declined approximately 10-15% annually post-patent expiration.
• The market continues to grow driven by increasing cancer cases, despite pricing pressures and saturation.
• Merck's strategic focus shifts toward pipeline innovation and emerging markets.
• Price competition from generics remains a primary challenge, with potential for future growth through new indications and formulations.

FAQs

What is the primary indication for APRETUDE?

Prevention of chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV).

When did APRETUDE lose patent protection in major markets?

It expired in 2023 in key markets such as the US and Europe.

How has generic entry affected APRETUDE’s revenue?

Generic competition reduced revenues by approximately 10-15% annually post-2023, with prices dropping by up to 70% in some regions.

What are the growth prospects in emerging markets?

High, driven by increasing cancer treatments and surgical procedures; prices are more flexible, and regulatory barriers are lower.

What strategic moves can Merck adopt to sustain its portfolio?

Focus on pipeline expansion, leverage combination therapies, and expand into emerging markets with differentiated pricing.

References

1. MarketsandMarkets. (2022). Anti-Emetics Market Analysis.
2. Merck & Co. Annual Reports 2018–2022.
3. U.S. Food and Drug Administration. (2023). Generic Drug Approvals.
4. European Medicines Agency. (2023). Market Authorizations and Approvals.
5. Grand View Research. (2023). Global Oncology Supportive Care Market.

DrugChatter Q&A for APRETUDE

Can Apretude be used as an injectable PrEP?