Fosaprepitant dimeglumine - Generic Drug Details

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

Fosaprepitant dimeglumine is the generic ingredient in three branded drugs marketed by Merck And Co Inc, Accord Hlthcare, Apotex, Aspiro, Baxter Hlthcare Corp, Be Pharms, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Geneyork Pharms, Lupin Ltd, MSN, Mylan Labs Ltd, Navinta Llc, Piramal Critical, Praxgen, Qilu Pharm Hainan, Sandoz, Teva Pharms Usa, and Steriscience, and is included in twenty-one NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fosaprepitant dimeglumine has two patent family members in two countries.

There are eleven drug master file entries for fosaprepitant dimeglumine. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fosaprepitant dimeglumine

International Patents:	2
US Patents:	2
Tradenames:	3
Applicants:	21
NDAs:	21
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	18
Patent Applications:	1,003
Drug Prices:	Drug price trends for fosaprepitant dimeglumine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fosaprepitant dimeglumine
What excipients (inactive ingredients) are in fosaprepitant dimeglumine?	fosaprepitant dimeglumine excipients list
DailyMed Link:	fosaprepitant dimeglumine at DailyMed

See drug prices for fosaprepitant dimeglumine

Recent Clinical Trials for fosaprepitant dimeglumine

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

Sponsor	Phase
Qilu Pharmaceutical Co., Ltd.	PHASE3
Fujian Shengdi Pharmaceutical Co., Ltd.	Phase 3
Xijing Hospital	N/A

See all fosaprepitant dimeglumine clinical trials

Generic filers with tentative approvals for FOSAPREPITANT DIMEGLUMINE

Applicant	Application No.	Strength	Dosage Form
		UNKNOWN	UNKNOWN

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 fosaprepitant dimeglumine

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 fosaprepitant dimeglumine

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

Paragraph IV (Patent) Challenges for FOSAPREPITANT DIMEGLUMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMEND	Injection	fosaprepitant dimeglumine	150 mg/vial	022023	2	2012-01-25

US Patents and Regulatory Information for fosaprepitant dimeglumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Qilu Pharm Hainan	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	213106-001	Sep 8, 2020	AP	RX	No	No
Navinta Llc	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	212957-002	Aug 20, 2020		DISCN	No	No
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008		DISCN	Yes	No
Eugia Pharma	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	210625-001	Jan 12, 2021	AP	RX	No	No
Piramal Critical	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	214683-001	May 16, 2023		DISCN	No	No

Expired US Patents for fosaprepitant dimeglumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	5,538,982
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	5,512,570
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	5,691,336*PED
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	5,716,942
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	5,512,570

International Patents for fosaprepitant dimeglumine

Country	Patent Number	Title	Estimated Expiration
China	112243376
World Intellectual Property Organization (WIPO)	2019221815

Supplementary Protection Certificates for fosaprepitant dimeglumine

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

Market Dynamics and Financial Trajectory for FOSAPREPITANT DIMEGLUMINE

Last updated: July 28, 2025

Introduction
Fosaprepitant dimeglumine, an intravenous prodrug of fosaprepitant, functions as a neurokinin-1 (NK1) receptor antagonist primarily approved to prevent chemotherapy-induced nausea and vomiting (CINV). Since its market introduction, the drug’s positioning within supportive cancer care and its evolving competitive landscape significantly influence its financial trajectory. This comprehensive analysis explores current market dynamics and forecasts the financial outlook for fosaprepitant dimeglumine over the next five years.

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Regulatory Status and Market Approval

Fosaprepitant dimeglumine received approval from the U.S. Food and Drug Administration (FDA) in 2003 under the brand name Emend IV, expanding the antiemetic options for chemotherapy patients. Regulatory approvals in key markets such as Europe, Japan, and emerging economies have bolstered its global reach. The drug’s label covers various chemotherapy regimens, including highly emetogenic treatments, positioning it as a preferred option for oncologists.

In recent years, regulatory agencies have approved various formulations and dosing regimens, broadening its applicability. The European Medicines Agency (EMA) approved fosaprepitant in 2004 for combination use in CINV prevention, emphasizing its therapeutic versatility.

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Market Drivers

1. Increasing Prevalence of Cancer and Chemotherapy Use
   The global incidence of cancer continues to rise, with the World Health Organization (WHO) estimating 19.3 million new cases in 2020. As chemotherapy remains a cornerstone of cancer treatment, the proportion of patients experiencing nausea and vomiting necessitating antiemetics drives demand for NK1 receptor antagonists like fosaprepitant.

2. Evolving Oncology Treatment Protocols
   Updated guidelines from the American Society of Clinical Oncology (ASCO) and Multinational Association of Supportive Care in Cancer (MASCC) emphasize the importance of comprehensive antiemetic regimens, often including NK1 receptor antagonists. This clinical endorsement sustains global demand, especially in high-dose and multi-drug chemotherapies.

3. Expanding Indications and Combination Therapies
   Fosaprepitant's utilization in combination with other antiemetics (e.g., 5-HT3 antagonists and corticosteroids) enhances efficacy, prompting broader adoption. Investigational uses in postoperative nausea and other off-label applications further fuel incremental market growth.

4. Advancements in Oncology Drug Delivery
   Advocacy for easier, intravenous administration methods enhances fosaprepitant’s appeal in hospital settings, especially with compatibility for infusion devices, reducing administration errors and improving patient compliance.

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Market Challenges

1. Generic Competition
   Patent expirations, notably in mature markets, have led to the entry of generic versions of fosaprepitant. Generic competition exerts downward pressure on pricing, reducing profit margins for branded formulations.

2. Emergence of Oral TKIs and Other Anti-Emetics
   Newer oral agents with comparable efficacy and improved convenience are gaining traction. These alternatives pose competitive threats, especially from oral NK1 antagonists like aprepitant, which, despite different formulations, compete directly with IV fosaprepitant.

3. Pricing Pressures and Cost-Containment Initiatives
   Health systems and payers prioritize cost-effective treatments. Reimbursement constraints and substitution with less expensive generics limit revenue growth, necessitating strategic differentiation.

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Financial Trajectory and Revenue Forecasts

Historical Market Performance
Since its launch, fosaprepitant’s infrared sales peaked in the late 2010s, driven by high global chemotherapy rates. In 2021, the antiemetic market was valued at approximately USD 1.2 billion, with fosaprepitant constituting a significant segment, particularly in North America and Europe [1].

Projected Growth Factors
Despite the challenges posed by generics and competition, the antiemetic market is anticipated to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, reaching USD 1.6-1.8 billion by 2028 [2].

Fosaprepitant's global market share is expected to decline gradually due to generic erosion. However, innovations such as new formulations, expanded indications, and regional market penetrations (e.g., Asia-Pacific) could offset some revenue decline.

Forecasted Revenue Trends

• 2023-2025: Moderate decline in revenue due to generic competition and pricing pressure. Nonetheless, incremental sales from emerging markets and off-label uses might sustain overall revenues.
• 2026-2028: Stabilization facilitated by strategic collaborations, introduction of biosimilars, and potential label expansions could partially offset generic losses, maintaining revenues between USD 250-350 million annually.

Profitability Outlook
Branded formulations' profit margins are likely to compress, but strategic cost management and product differentiation could sustain profitability levels. Partnerships with regional distributors and inclusion in combination regimens will be pivotal for revenue resilience.

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Competitive Landscape

Major pharmaceutical companies, including Merck & Co. and Helsinn Healthcare, dominate the fosaprepitant market. The presence of generics by multiple manufacturers exerts competitive pressure, compelling brand owners to innovate through dosing improvements, combination therapies, or extended indications.

Emerging branded competitors developing oral NK1 antagonists with comparable efficacy introduce further competitive complexity, prompting strategic focus on patient compliance and convenience.

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Global Market Penetration and Regional Dynamics

• North America: Leading revenue contributor due to high chemotherapy rates and advanced healthcare infrastructure. However, reimbursement restrictions and widespread generic use challenge margins.
• Europe: Similar dynamics as North America with high adoption but increasing generic substitution.
• Asia-Pacific: Rapidly expanding markets driven by increasing cancer incidence, improving healthcare access, and favorable regulatory environments present significant growth opportunities.
• Latin America and Middle East: Niche but growing markets with increasing healthcare investments.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investing in formulation innovations, expanding indications, and strategic regional collaborations could sustain revenue streams.
• Investors: Vigilance around patent landscapes, generic entrants, and emerging alternatives is crucial. Diversification into pipeline products or combination therapies may mitigate risks.
• Healthcare Providers: Adoption of guideline-endorsed antiemetic protocols will influence market demand.

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Key Takeaways

• The global fosaprepitant dimeglumine market remains substantial, propelled by the rising incidence of chemotherapy and evolving supportive care guidelines.
• Patent expirations and generic competition exert downward pricing pressures, challenging brand market share longevity.
• The market's future hinges on regional expansion, formulation innovation, and integrating fosaprepitant into combination regimens.
• Anticipated moderate growth in the broader antiemetic market sustains revenue opportunities, particularly in emerging regions.
• Strategic differentiation and clinical endorsements remain critical for maintaining financial viability amid competitive pressures.

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FAQs

1. What is the primary therapeutic use of fosaprepitant dimeglumine?
Fosaprepitant dimeglumine is primarily used to prevent chemotherapy-induced nausea and vomiting (CINV) in patients undergoing highly emetogenic chemotherapeutic regimens.

2. How does the patent landscape affect fosaprepitant's market potential?
Patent expirations have led to a proliferation of generic competitors, reducing profitability for brand manufacturers but expanding access and coverage in cost-sensitive markets, influencing overall market dynamics.

3. What are the main competitors to fosaprepitant in the antiemetic market?
Oral NK1 antagonists like aprepitant (generic and branded), 5-HT3 receptor antagonists, corticosteroids, and emerging combination therapies serve as key competitors.

4. How might regional healthcare policies influence fosaprepitant sales?
Reimbursement policies, clinical guideline adoption, and healthcare spending priorities in regions like North America, Europe, and Asia-Pacific shape demand and pricing strategies.

5. What future developments could impact fosaprepitant’s financial trajectory?
Innovations such as new formulations, expanded indications, biosimilars, and integration into multi-modal supportive care regimens could influence sales growth or decline.

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Sources

[1] Allied Market Research. (2022). Anti-Emetics Market Report.
[2] Grand View Research. (2023). Global Anti-Emetics Market Size and Forecast.