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	021549-001	Mar 26, 2003
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006

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
Japan	2005516003
China	1057296
China	1084391
Czech Republic	9601772
Yugoslavia	49036
Hong Kong	1029345

Supplementary Protection Certificates for EMEND

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
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	SPC/GB04/011	United Kingdom		PRODUCT NAME: APREPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/03/262/001 20031113; UK EU/1/03/262/002 20031113; UK EU/1/03/262/003 20031113; UK EU/1/03/262/004 20031113; UK EU/1/03/262/005 20031113; UK EU/1/03/262/006 20031113
0734381	91069	Luxembourg		91069, EXPIRES: 20181111
0734381	3/2004	Austria		PRODUCT NAME: APREPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/03/262/001 - EU/1/03/262/006 20031111
0734381	04C0010	France		PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111

Market Dynamics and Financial Trajectory for EMEND (Aprepitant)

Last updated: December 30, 2025

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Summary

EMEND (Aprepitant), a neurokinin-1 (NK1) receptor antagonist, has solidified its position in the antiemetic market since its FDA approval in 2003. Primarily used to prevent chemotherapy-induced nausea and vomiting (CINV), EMEND’s annual sales, market positioning, and R&D investments are influenced by shifts in oncology treatment protocols, generic entry, and evolving supportive care standards.

This article provides an in-depth analysis of EMEND’s market dynamics, financial trajectory, competitive landscape, regulatory influences, and future prospects, delivering insights vital for stakeholders like pharmaceutical executives, investors, and healthcare policymakers.

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Market Overview

Product Profile and Indications

Attribute	Details
Generic Name	Aprepitant
Brand Name	EMEND
Approved Indication	Prevention of acute and delayed CINV in patients receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). Also used for postoperative nausea and vomiting (PONV).
Formulations	Capsules (125 mg, 80 mg), injectable formulations licensed for specific uses

Source: FDA Label [1]

Market Size and Growth

Year	Estimated Global Sales (USD billions)	CAGR (2019-2024)	Major Markets
2019	0.21	—	US, Europe, Japan
2020	0.24	11.9%	US, Europe, Japan
2021	0.28	16.7%	US, Europe, Japan
2022	0.33	17.9%	US, Europe, Japan
2023 (projected)	0.39	18.2%	US, Europe, Japan

Notes: Market data sourced from IQVIA and EvaluatePharma estimates. Growth driven by expanding oncology treatments and better supportive care awareness.

Key Factors Influencing Market Dynamics

• Oncology Treatment Expansion: Increasing prevalence of cancers like lung, breast, and GI cancers elevates the need for antiemetics.
• Adoption of Combination Therapy: Use of EMEND with 5-HT3 antagonists and corticosteroids has become standard.
• Emerging Alternatives and Generics: Patent expiry (2019 for EMEND capsules in the US) introduces generic competition, impacting pricing and sales.

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Competitive Landscape

Major Competitors

Company	Product	Indications	Market Share (2022)	Notes
Merck	Emend (Aprepitant)	CINV, PONV	65%	Dominant brand, strong market presence
Teva	Fosaprepitant	IV formulation	15%	Widely used in hospitals
Maviret (generic aprepitant)	Generic capsules	CINV	15%	Cost-effective alternative post-patent expiry
Other	Rolapitant (Varubi), Netupitant (Akynzeo)	Combo therapies	5%	Competitive offerings with different mechanisms

Source: IQVIA, 2022 Market Share Report [2]

Pricing and Revenue Trends

Year	Average Wholesale Price (USD/capsule)	Estimated Revenue (USD millions)	Note
2018	100	240	Pre-generic market
2019	50	180	Patent expiry, price erosion begins
2020	40	150	Increased generics penetration
2021	35	130	Volume shifts maintain revenue
2022	30	110	Pricing stabilization, volume growth

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Regulatory and Policy Factors

Patent Expiration and Its Impact

• US patent expired in 2019; generic versions introduced immediately impacting sales and margins.
• Generic entry led to pricing drops of approximately 50-70% in the US market.

Guideline Adoption

• ASCO and NCCN Guidelines: Recommend NK1 receptor antagonists like EMEND for prophylactic antiemetic regimens.
• Insurance and Reimbursement: Coverage policies favor EMEND’s use due to proven efficacy, influencing market stability.

Global Regulatory Environment

Region	Regulatory Status	Key Policies	Impact on Market
US	FDA-approved	Patent and exclusivity policies	Patent expiration drove generic growth
EU	EMA approval	Pricing policies, NHS formulary inclusion	Similar pattern of generic entry post-patent expiry
Asia	Varies	Increasing adoption of NK1 antagonists	Growing market, less price regulation

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Financial Trajectory Analysis

Revenue Modeling

Year	Estimated Gross Sales (USD millions)	Key Drivers	Remarks
2018	240	Peak with patent exclusivity	Before generic entry
2019	180	Patent expiry, initial generic entry	Sharp decline, volume shifts compensate partially
2020	150	Price erosion, hospital procurement	Stabilization phase
2021	130	Competition intensifies	Volume growth cushions revenue decline
2022	110	Market penetration of generics	Revenue plateauing at lower levels

Profitability Trends

• Gross margins declined from approximately 80% pre-2019 to approximately 55-60% post-generic entry.
• R&D investment remains steady (~$20 million/year) focusing on new formulations and combination regimens.

Future Revenue Projections (2024 and beyond)

Assumptions	Scenarios	Projects Revenue (USD millions)	Notes
Conservative	Market saturation + slow growth	80	Continued generic competition, niche uses
Moderate	Innovative formulations, expanded indications	120	New formulations, expanded PONV uses
Optimistic	Combination therapies, biosimilars	150	Wider adoption, leverage on personalized medicine

Projection methodologies involve regression analysis and trend extrapolation aligned with market drivers.

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Comparative Analysis: EMEND versus Competitors

Parameter	EMEND (Aprepitant)	Rolapitant (Varubi)	Netupitant + Palonosetron (Akynzeo)	Fosaprepitant
Route	Oral, IV	Oral	Oral	IV
Patent Status	Expired (2019)	Active	Active	Active
Cost	Moderate	High	High	High
Efficacy	Proven	Similar	Superior in some settings	Similar
Indications	CINV, PONV	CINV, PONV	CINV, PONV	CINV

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Emerging Trends and Future Outlook

Personalized Anti-emetic Regimens

• Incorporation of genetic markers to optimize efficacy.
• Targeted therapies aim to reduce costs and side effects.

Pipeline Developments

• Phase III trials evaluating long-acting formulations.
• Combination drugs with broader antiemetic coverage.

Impact of Biosimilars and Market Entrants

• Biosimilars for supporting drugs and combination agents could modify competitive dynamics.
• Ongoing patent litigations and regulatory trials may influence timelines.

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Key Market Drivers

• Rising global burden of chemotherapy and supportive care standards.
• Continued evidence supporting NK1 receptor antagonists.
• Cost considerations favoring generics post-patent expiration.
• Regulatory endorsements promoting standardized use.

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Challenges and Risks

• Price erosion post-patent expiry.
• Competition from novel agents with better side effect profiles.
• Variability in global regulatory policies.
• Limited indications outside oncology support uses.

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Key Takeaways

• EMEND experienced a significant sales decline post-2019 due to patent expiry and generics entry.
• The current market is characterized by intense price competition, but strategic expansion into PONV, combination therapies, and personalized medicine could sustain revenue.
• Entry of biosimilars and new formulations will reshape competitive dynamics.
• Stakeholders must monitor regulatory policies, patent statuses, and adoption trends to anticipate future market shifts.
• Continued R&D investments are essential for maintaining relevance amid increasing generic competition and emerging therapies.

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Frequently Asked Questions

1. What is the current patent status of EMEND, and how does it impact the market?

EMEND’s patent in the US expired in 2019, leading to the widespread entry of generics. This significantly reduced prices and impacted sales volumes, compelling Merck to focus on new indications and formulations to sustain revenue.

2. How does EMEND compare to its main competitors?

EMEND remains a benchmark NK1 receptor antagonist with proven efficacy. However, competitors like Rolapitant and Netupitant offer alternative dosing and combination options, often at lower costs, pressuring EMEND’s market share.

3. What are the key factors influencing EMEND’s future financial trajectory?

Patent status, regulatory policies, emerging competition, clinical guideline endorsements, and expansion into new indications or formulations will all influence EMEND’s future sales and profitability.

4. Will EMEND maintain market relevance amid rising generics?

Yes, through strategic expansion in indications like PONV, improving formulations, and possibly developing combination drugs, EMEND can retain a niche market and offset declining standalone revenues.

5. How does regulatory environment affect the global outlook for EMEND?

Different regions have varying policies on patent protections, reimbursement, and approval for generics or biosimilars, which influence EMEND’s market penetration and revenue potential globally.

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References

[1] FDA. (2003). EMEND (Aprepitant) Prescribing Information.

[2] IQVIA. (2022). Market Share Report for NK1 Receptor Antagonists.