EMEND Drug Patent Profile

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

Emend is a drug marketed by MSD, Msd Merck Co, and Merck And Co Inc. and is included in three NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has forty-eight patent family members in thirty-seven countries.

The generic ingredient in EMEND is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emend

A generic version of EMEND was approved as fosaprepitant dimeglumine by FRESENIUS KABI USA on June 9^th, 2016.

Summary for EMEND

International Patents:	48
US Patents:	1
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,349
Drug Prices:	Drug price information for EMEND
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMEND
What excipients (inactive ingredients) are in EMEND?	EMEND excipients list
DailyMed Link:	EMEND at DailyMed

See drug prices for EMEND

Pharmacology for EMEND

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

Paragraph IV (Patent) Challenges for EMEND

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMEND	for Oral Suspension	aprepitant	125 mg/Kit	207865	1	2016-11-23
EMEND	Injection	fosaprepitant dimeglumine	150 mg/vial	022023	2	2012-01-25
EMEND	Capsule	aprepitant	40 mg, 80 mg and 125 mg	021549	1	2008-11-03

US Patents and Regulatory Information for EMEND

EMEND is protected by three 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
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006		DISCN	Yes	No			Y
Msd Merck Co	EMEND	aprepitant	FOR SUSPENSION;ORAL	207865-001	Dec 17, 2015		RX	Yes	Yes			Y
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008		DISCN	Yes	No
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003	AB	RX	Yes	No			Y
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003	AB	RX	Yes	Yes			Y
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	AP	RX	Yes	Yes

Expired US Patents for EMEND

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-001	Mar 26, 2003

EU/EMA Drug Approvals for EMEND

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Emend	aprepitant	EMEA/H/C/000527Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.	Authorised	no	no	no	2003-11-11

International Patents for EMEND

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

Country	Patent Number	Title	Estimated Expiration
Iceland	7276
Norway	308742
World Intellectual Property Organization (WIPO)	9516679
Iceland	2617
China	1063630
Czech Republic	295410	Polymorfní forma 2-(R)-(1-(R)-(3,5-bis(trifluormetyl)fenyl)ethoxy)-3-(S)-(4-fluor)fenyl-4-(3-(5-oxo-1H,4H-1,2,4-triazol)methylmorfolinu s antagonistickým účinkem na tachykininové receptory (Polymorphic form of the tachykinin receptor antagonist 2-(R)-(1-(R) -(3,5-bis(trifluoromethyl) phenyl)ethoxy)-3-(S)-(4-fluoro) phenyl-4-(3-5 (-oxo-1H,4H-1,2,4,-triazolo) methylmorpholine)
Taiwan	247275

Supplementary Protection Certificates for EMEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0734381	91069	Luxembourg		91069, EXPIRES: 20181111
0748320	SPC/GB08/021	United Kingdom		PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111
0734381	PA2004002,C0734381	Lithuania		PRODUCT NAME: 5-(((2R,3S)-2-((1R)-1-(3,5-BIS(TRIFLUORMETIL)FENIL)ETOKSI)-3-(4-FLUORFENIL)-4-MORFOLINIL)METIL)-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO/DATE: EU/1/03/262/001, 2003 11 11, EU/1/03/262/002, 2003 11 11, EU/1/03/262/003, 2003 11 11, EU/1/03/262/004, 2003 11 11, EU/1/03/262/005, 2003 11 11, EU/1/03/262/006 20031111
0734381	CA 2004 00009	Denmark
0734381	04C0010	France		PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
0734381	PA2004002	Lithuania		PRODCUT NAME: 5-[[(2R,3S)-2-[(1R)-1-[3,5-BIS(TRIFLUORMETIL)FENIL]ETOKSI]-3-(4-FLUORFENIL)-4-MORFOLINIL]METIL]-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO./DATE: EU/1/03/262/001-006/20031111
0734381	SPC005/2004	Ireland		SPC005/2004: 20050504, EXPIRES: 20181110

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EMEND

Last updated: July 27, 2025

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Introduction

EMEND (fosaprepitant dimeglumine), marketed by Merck & Co., Inc., is an intravenously administered neurokinin-1 (NK1) receptor antagonist primarily used to prevent chemotherapy-induced nausea and vomiting (CINV). Since its FDA approval in 2003, EMEND has played a pivotal role in supportive cancer care, aligning with the rising demand for effective antiemetic therapies amid expanding oncology treatments. This analysis evaluates the current market dynamics and projected financial trajectory for EMEND, considering patent landscapes, competitive forces, regulatory pathways, and evolving healthcare trends.

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Market Overview and Demand Drivers

The global antiemetics market is expanding, driven by increased cancer prevalence, evolving chemotherapy regimens, and heightened focus on patient quality of life. The International Agency for Research on Cancer (IARC) estimates that new cancer cases will reach 28.4 million globally in 2040, a significant increase from 18.1 million in 2018 (1). This growth underpins sustained demand for supportive care medications such as EMEND.

EMEND’s core indication—preventing CINV—is highly prevalent, especially with multi-agent chemotherapy protocols. The drug's efficacy in reducing both acute and delayed nausea and vomiting makes it a standard component of antiemetic regimens, cementing its position within oncology supportive care standards.

Market Segments and Geographic Spread

North America remains the largest market due to high cancer incidence, advanced healthcare infrastructure, and strong adoption of novel supportive care agents. Europe also contributes significantly, driven by high cancer prevalence and stringent clinical guidelines endorsing NK1 receptor antagonists. Asia-Pacific presents emerging opportunities due to increasing cancer rates, healthcare expenditure, and rising awareness.

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Market Dynamics and Competitive Landscape

Patent and Market Exclusivity

EMEND’s patent protection historically provided Merck with a competitive moat, though patent expirations have begun to erode exclusivity. While the fundamental molecule fosaprepitant remains under patent, formulation patents, manufacturing processes, and combination product patents contribute to market protection. Notably, generic versions of oral aprepitant, a related NK1 antagonist, have entered multiple markets, exerting price pressure on branded EMEND formulations.

Generic Competition and Price Erosion

The introduction of generics typically precipitates significant revenue declines for branded drugs. The first generic entries of oral aprepitant date back to the late 2010s, with branded EMEND sales diminishing accordingly. However, intravenous formulations like EMEND remain protected longer due to formulation-specific patents, potentially prolonging market exclusivity in certain regions.

Emerging and Conventional Competitors

Beyond generic aprepitant, other antiemetics—including dexamethasone and olanzapine—offer adjunct or alternative therapies, diversifying the antiemetic landscape. Recently, newer agents such as netupitant and rolapitant have gained approval, challenging EMEND’s market dominance. However, clinicians favor EMEND due to its proven profile and integration into standard regimens.

Regulatory and Reimbursement Environment

Regulatory agencies like the FDA and EMA maintain rigorous approval standards, influencing drug adoption. Reimbursement policies, especially in developed markets, largely favor branded medications with demonstrated superior efficacy and safety profiles, benefitting EMEND. Cost-effectiveness assessments influence formulary decisions, notably where generic options are available at lower prices.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Merck’s antiemetic portfolio, led by EMEND, historically generated annual sales exceeding $500 million worldwide pre-generics era (2). The 2010s saw a gradual decline due to generic competition and market saturation. Nevertheless, EMEND remains a vital support therapy, with brand loyalty and clinical guideline recommendations fueling residual revenues.

Current and Future Revenue Drivers

• Patent Cliffs and Generic Entry: Expected patent expiration for IV EMEND formulations in key jurisdictions from 2024-2026 will likely accelerate revenue decline unless new formulations, indications, or markets offset this impact (3).

• New Indications and Line Extensions: Merck has explored additional mounting uses, such as potential application in postoperative nausea or other supportive care scenarios, which could extend the revenue lifecycle.

• Geographic Expansion: Emerging markets, especially in Asia-Pacific, offer growth opportunities as healthcare infrastructure improves and oncology services expand.

• Pricing Strategies: Merck employs tiered pricing, patient assistance programs, and value-based pricing in different regions to sustain market share.

Financial Forecast and Market Share Projections

Industry analysts project EMEND’s global sales to decline at a compound annual growth rate (CAGR) of approximately 3-5% post-2024, driven by generics and competitive entrants (4). However, in specific niche markets and clinical settings, the drug’s premium efficacy sustains a significant share, stabilizing revenues temporarily before broader generic penetration.

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Regulatory Trends and Innovation Pathways

The pharmaceutical landscape increasingly favors biosimilar and innovative drug development, pressuring branded drugs like EMEND. Merck’s strategic focus on differentiating EMEND through new formulations, delivery platforms (such as biosimilar conjugates), and expanding indications aims to mitigate revenue erosion.

Regulatory pathways for combination therapies, real-world evidence submissions, and accelerated approvals in emerging markets further influence EMEND’s market trajectory. Continuous post-marketing surveillance and adherence to evolving guidelines remain critical for maintaining market relevance.

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Conclusion

The market dynamics for EMEND are characterized by a mature therapeutic profile with impending patent expirations that threaten its leading revenue position. Yet, strategic initiatives—such as expanding indications, geographic penetration, and formulation innovations—may cushion declines. The drug’s financial trajectory reflects a typical lifecycle for branded oncology supportive care agents, with a shift toward generics and competition expected over the next five years.

Success for Merck hinges on balancing patent protections, innovating within the supportive care landscape, and navigating an increasingly competitive environment. Overall, EMEND’s future prospects remain cautiously optimistic, supported by clinical necessity and evolving healthcare paradigms.

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Key Takeaways

• EMEND remains a critical antiemetic but faces revenue challenges due to patent expirations and generic competition.
• Geographic expansion, new indications, and formulation innovations are vital strategies to sustain financial performance.
• The antiemetics market is highly competitive, with emerging agents and biosimilars affecting future sales.
• Merck’s ability to adapt via policy engagement and clinical differentiation will influence EMEND’s long-term market share.
• Industry trends toward personalized medicine and healthcare affordability will shape the future landscape for supportive care drugs like EMEND.

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FAQs

1. When will EMEND face generic competition in major markets?
The patent for IV EMEND in key jurisdictions is expected to expire around 2024-2026, facilitating generic entry and challenging branded sales.

2. Can EMEND be used for indications beyond CINV?
Potential expansion into other supportive care areas, such as postoperative nausea, is under investigation, which could open additional revenue streams.

3. How does EMEND compare to oral aprepitant?
EMEND’s IV formulation offers quick, reliable administration in clinical settings; oral aprepitant provides convenience but faces similar generic competition.

4. What are the main drivers of EMEND's market decline?
Patent expiry, generic competition, and emerging alternatives like netupitant/Palonosetron combinations are primary factors impacting revenue.

5. What strategic measures can Merck take to prolong EMEND’s market relevance?
Investing in new indications, formulations, biosimilars, and geographic expansion will be crucial to sustaining profitability amid market challenges.

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References

1. IARC. Global Cancer Statistics 2018. Lyon: International Agency for Research on Cancer; 2018.
2. Merck Annual Reports. 2010-2022.
3. Evaluate Phama. EMEND (fosaprepitant) patent expiry projections. 2022.
4. IQVIA. Global Oncology Supportive Care Market Report. 2022.