APREPITANT - Generic Drug Details

What are the generic sources for aprepitant and what is the scope of freedom to operate?

Aprepitant is the generic ingredient in four branded drugs marketed by Glenmark Speclt, Sandoz, Torrent, MSD, Heron Theraps Inc, and Msd Merck Co, and is included in seven NDAs. There are fifteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aprepitant has fifty-seven patent family members in thirty-seven countries.

There are twenty-six drug master file entries for aprepitant. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for APREPITANT

International Patents:	57
US Patents:	15
Tradenames:	4
Applicants:	6
NDAs:	7
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	186
Patent Applications:	6,875
Drug Prices:	Drug price trends for APREPITANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APREPITANT
What excipients (inactive ingredients) are in APREPITANT?	APREPITANT excipients list
DailyMed Link:	APREPITANT at DailyMed

See drug prices for APREPITANT

Recent Clinical Trials for APREPITANT

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

Sponsor	Phase
Montefiore Medical Center	PHASE4
Centre hospitalier de l'Universit de Montral (CHUM)	PHASE3
Rabin Medical Center	PHASE1

See all APREPITANT clinical trials

Generic filers with tentative approvals for APREPITANT

Applicant	Application No.	Strength	Dosage Form
		130MG/18ML	INJECTION, EMULSION
		130MG/18ML (7.2MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for APREPITANT

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

Anatomical Therapeutic Chemical (ATC) Classes for APREPITANT

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for APREPITANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APONVIE	Intravenous Emulsion	aprepitant	32 mg/4.4 mL	216457	1	2023-11-07
CINVANTI	Intravenous Emulsion	aprepitant	130 mg/18 mL	209296	1	2022-04-29
EMEND	for Oral Suspension	aprepitant	125 mg/Kit	207865	1	2016-11-23
EMEND	Capsule	aprepitant	40 mg, 80 mg and 125 mg	021549	1	2008-11-03

US Patents and Regulatory Information for APREPITANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes			Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes			Y
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes			Y
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes			Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006		DISCN	Yes	No			Y

Expired US Patents for APREPITANT

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	021549-002	Mar 26, 2003
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-003	Jun 30, 2006
Msd	EMEND	aprepitant	CAPSULE;ORAL	021549-002	Mar 26, 2003

EU/EMA Drug Approvals for APREPITANT

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 APREPITANT

Country	Patent Number	Title	Estimated Expiration
Australia	2002360824
Japan	2022092040
Hong Kong	1078017
Jordan	3060	تركيبه صيدلانيه لعامل مضاد لمستقبل التاكي كينين (PHARMACEUTICAL COMPOSITION OF A TECHYKININ RECEPTOR ANTAGONIST)
Colombia	5590887	COMPOSICION FARMACEUTICA NANOPARTICULADA DE UNA ANTAGONISTA DE RECEPTORES DE TAQUICININA
Peru	20030641	COMPOSICION NANOPARTICULADA DE 2-(R)-(1-(R)-(3,5-BIS(TRIFLUOROMETIL)FENIL)ETOXI)-3-(S)-(4-FLUORO)FENIL-4-(3-(5-OXO-1H,4H-1,2,4-TRIAZOLO)METIL MORFOLINA)

Supplementary Protection Certificates for APREPITANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	04C0010	France		PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111

Market Dynamics and Financial Trajectory for Aprepitant: An In-Depth Analysis

Last updated: December 7, 2025

Executive Summary

Aprepitant, marketed primarily under the brand Emend, is a neurokinin-1 (NK1) receptor antagonist used predominantly in the prophylaxis of chemotherapy-induced nausea and vomiting (CINV). Since its approval in 2003, Aprepitant has established a significant position within antiemetic therapy, driving substantial revenues amidst evolving oncology treatment landscapes. This report examines current market dynamics, revenue trajectories, competitive positioning, regulatory considerations, and future growth prospects for Aprepitant, providing essential insights for pharmaceutical stakeholders and investors.

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What Is the Market Landscape for Aprepitant?

1. Market Size and Revenue Estimates

Parameter	2022	2023 Estimated	CAGR (2023-2028)
Global antiemetics market	$4.2 billion	$4.6 billion	6.3%
Aprepitant-specific sales	~$350 million	~$380 million	~4.5%

Note: The antiemetics market includes various drug classes—serotonin receptor antagonists, NK1 antagonists, corticosteroids. Aprepitant accounts for approximately 8-9% of the total market.

[1] Market Research Future, 2023

2. Key Revenue Drivers

• Expanding oncology treatments: Increasing use of chemotherapeutic regimens and supportive care.
• Adoption of combination therapies: Aprepitant combined with 5-HT3 antagonists (like Ondansetron) and corticosteroids enhances antiemetic efficacy, improving prescription rates.
• Global expansion: Growing markets in emerging economies, notably China and India, steadily increasing prescriptions.

3. Competitive Landscape

Competitors	Market Share (2023)	Key Products	Status
Aprepitant (Emend)	~70%	Fosaprepitant (IV formulation), Rolapitant	Leading NK1 antagonists, patent-backed
Rolapitant (Varubi)	~20%	Rolapitant	Alternative NK1 receptor antagonist
Others	~10%	Traditional antiemetics (5-HT3 inhibitors, corticosteroids)	Non-NK1 drugs

[2] IMS Health Data, 2023

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What Are the Key Market Dynamics Influencing Aprepitant?

1. Patent Exclusivity and Generic Competition

• Patent Timeline: Aprepitant’s patent in the U.S. expired in 2029, but exclusivity-driven sales persist through ongoing IP protections in various jurisdictions.
• Generics Entry: Anticipated from 2029 onwards; potential to erode market share and price margins.

Patent Status	Jurisdiction	Expiration Year
Active	U.S., EU	2029 (expected)
Expired	Several emerging markets	N/A

Implication: Patent expiry may lead to price erosion and increased competition, impacting revenue projections.

2. Regulatory and Pricing Policies

• US and EU: Reimbursement strategies heavily influence market penetration. HEDIS (Healthcare Effectiveness Data and Information Set) measures favor combination therapies.
• Pricing Trends: Moderate price increases (~2-3%) annually in developed markets, driven by inflation and R&D costs; potential downward pressure from price control measures in Europe and emerging markets.

[3] FDA and EMA Regulatory Frameworks, 2022-2023

3. Prescriber Adoption and Clinical Guidelines

• National and international guidelines (e.g., NCCN, ASCO) strongly recommend NK1 receptor antagonists, including Aprepitant, in highly emetogenic chemotherapy protocols.
• Favorable real-world data enhances prescriber confidence, ensuring steady demand.

4. Innovations and Pipeline Developments

• Next-Generation NK1 Antagonists: Emerging compounds with improved efficacy, safety, and dosing convenience could challenge Aprepitant's dominance.
• Combination Therapies: Development of fixed-dose combinations may improve compliance and market share for Aprepitant.

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What Is the Financial Trajectory and Revenue Forecast?

1. Revenue Projections (2023-2028)

Year	Projected Revenue	CAGR	Key Factors Influencing Revenue
2023	~$380 million	4.5%	Continued adoption, market saturation
2024	~$400 million		Patent stability, expansion in emerging markets
2025	~$415 million		Increasing combination therapy use
2026	~$430 million		Prescriber familiarity, gradual price increases
2027	~$440 million		Approaching patent cliff
2028	~$435 million		Market plateau approaching

Note: The slight decline anticipated post-2027 reflects patent expiration effects and emergent competition.

2. Impact of Patent Expiry and Generics

• Price erosion estimates: 30-50% reduction in price post-patent expiry.
• Market share shifts: Increased competition from generics, with projected 20-25% market share retained by branded Aprepitant due to brand loyalty and formulations.

3. Revenue Scenarios

Scenario	Description	Estimated Revenue (2028)
Optimistic	Rapid adoption of combination therapies; delayed generic entry	~$540 million
Moderate	Steady growth with gradual competition impact	~$435 million
Pessimistic	Early generic entry; reduced market share	~$300 million

[4] Financial Modeling, Analyst Reports, 2023

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How Do Regulatory Policies and Reimbursement Strategies Affect Trajectory?

Region	Policy Impact	Reimbursement Status	Market Implication
U.S.	CMS code updates favor supportive care drugs	Medicare/Medicaid	Consistent reimbursement sustains sales
EU	Price negotiations tightened post-2020	Restricted pricing	Slight slowdown, but steady market
Emerging Markets	Growing healthcare access	Variable; often out-of-pocket	High growth potential

Key Regulatory & Reimbursement Trends

• US pathways favor maintenance of branded sales due to robust coverage.
• Price negotiations may limit growth in Europe but open opportunities in Asia-Pacific.
• Clinical guidelines increasingly support Aprepitant as standard of care, reinforcing market stability.

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How Are Competitive and Pipeline Dynamics Shaping Future Growth?

1. Patent Expiry and Generic Competition

• Introduction of generics post-2029 could reduce revenues by 50% over five years.
• Market share loss driven by price competition; existing contracts and formulary placements influence the pace.

2. Emerging Thrusts in Research and Development

• Next-gen drugs: Investigations into Kinin receptor modulation and combination antiemetic regimens.
• New formulations: ORAL, IV, and long-acting options aim to improve patient adherence and expand use.

3. Market Expansion via New Indications

• Studies evaluating Aprepitant for postoperative nausea, radiation therapy, and other off-label uses offer revenue opportunities if approved.

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Comparison with Alternative Therapies

Drug Class	Mechanism	Advantages	Limitations
NK1 Antagonists	Block NK1 receptors	High efficacy in CINV	Cost, patent protection
5-HT3 Receptor Antagonists	Block serotonin receptors	Well-established	Less effective for delayed CINV
Corticosteroids	Anti-inflammatory	Cost-effective	Side effects with prolonged use
Combination Regimens	Synergistic effects	Improved efficacy	Increased complexity

Aprepitant vs Rolapitant	Parameter	Aprepitant	Rolapitant
Half-life		9-13 hours	7 days
Drug Interactions		CYP3A4 inhibitor	Minimal CYP interactions
Pricing		Slightly higher	Lower, generic options imminent

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Key Considerations for Stakeholders

• Patent life: Critical for revenue projections; patent expiry in 2029 signals potential revenue erosion.
• Market penetration: Established leader; however, emerging competition and generics threaten future sales.
• Regulatory landscape: Price controls and reimbursement policies influence profit margins.
• Pipeline and innovation: Opportunities in new formulations, indications, and combination therapies to sustain growth.
• Global expansion: Growing markets in Asia-Pacific and Latin America present substantial upside.

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Key Takeaways

• Aprepitant remains a dominant NK1 receptor antagonist, holding approximately 70% of the antiemetics market share as of 2023.
• Revenue is projected to reach ~$430 million by 2028 before patent expiry, with modest CAGR (~4.5%) driven by growing adoption.
• Patent expiration in 2029 is set to usher in generic competition, potentially halving revenues unless offset by new formulations or indications.
• Pricing, regulatory policies, and clinical guidelines significantly influence sales trajectory, especially in cost-sensitive emerging markets.
• Innovation through combination therapies and new formulations is vital to sustain growth amidst growing competition and patent cliffs.

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FAQs

1. When does Aprepitant's patent expire, and what are the implications?
Patent protection in the U.S. and EU is expected to expire in 2029. Post-expiry, generic drugs are anticipated to enter the market, likely reducing Aprepitant’s sales by 50% or more unless new indications or formulations extend lifecycle.

2. How does Aprepitant compare to other NK1 receptor antagonists?
Aprepitant offers a well-established efficacy profile, convenient dosing, and a strong position in combination therapy. Rolapitant, its primary competitor, has a longer half-life, reducing dosing frequency, and fewer drug interactions, offering alternative considerations.

3. What are the key growth opportunities for Aprepitant?
Expansion into new indications such as postoperative nausea, development of long-acting formulations, and entry into emerging markets are promising avenues.

4. How do regulatory policies influence Aprepitant's market trajectory?
Reimbursement strategies and pricing negotiations directly impact sales volume and profitability, especially in cost-sensitive regions where price controls are stringent.

5. What impact will generics have post-2029?
Generics could capture a significant portion of the market, leading to reduced prices and profit margins. Therefore, maintaining competitive differentiation and exploring patent extensions or new indications are strategic imperatives.

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References

1. Market Research Future. "Global Anti-Emetics Market Forecast to 2028." 2023.
2. IMS Health Data. "Pharmaceutical Market Share Analysis," 2023.
3. FDA and EMA Regulatory Updates. "Supportive Care Drugs," 2022-2023.
4. Financial Analyst Reports. "Aprepitant Market Forecast," 2023.
5. NCCN Clinical Practice Guidelines in Oncology. "Antiemetics," 2023.

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This comprehensive analysis provides a strategic overview of Aprepitant’s market and financial trajectory, critical for stakeholders aiming to optimize clinical and investment decisions.