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, Arthur Grp, 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, 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-three 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:	23
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	17
Patent Applications:	1,299
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
Fujian Shengdi Pharmaceutical Co., Ltd.	Phase 3
Xijing Hospital	N/A
University of Lahore	Phase 3

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
Msn	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	209965-001	Sep 5, 2019	AP	RX	No	No
Lupin Ltd	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	210689-001	Sep 5, 2019	AP	RX	No	No
Apotex	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	205020-001	Sep 5, 2019		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	7,214,692
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	7,214,692
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	5,716,942

International Patents for fosaprepitant dimeglumine

Country	Patent Number	Title	Estimated Expiration
China	112243376	福沙匹坦的组合物和制备方法 (Fosaprepitant composition and preparation method thereof)
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

Fosaprepitant dimeglumine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fosaprepitant Dimeglumine

Introduction to Fosaprepitant Dimeglumine

Fosaprepitant dimeglumine, marketed under the brand name EMEND, is a crucial drug in the prevention of nausea and vomiting associated with highly and moderately emetogenic chemotherapy (HEC and MEC). It is a prodrug of aprepitant, rapidly converting to the active antiemetic agent upon intravenous administration.

Market Size and Growth Projections

The Fosaprepitant Dimeglumine API market has been experiencing significant growth and is anticipated to continue this upward trajectory. As of 2023, the market size was valued at several billion USD, with projections indicating it will reach even higher values by 2031. This growth is driven by increasing demand for effective antiemetic treatments in oncology[1].

Market Segmentation

The market for Fosaprepitant Dimeglumine API is segmented based on several key factors:

• Type: The market is categorized into products with purity ≥98% and those with purity <98%.
• Application: The primary application is in Fosaprepitant Dimeglumine injections, with other applications also being considered.
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Clinical Efficacy and Tolerability

Fosaprepitant dimeglumine has demonstrated high clinical efficacy in preventing nausea and vomiting in patients undergoing chemotherapy. In large, randomized phase III clinical trials, a single intravenous dose of 150 mg fosaprepitant was shown to be effective and well-tolerated when combined with other antiemetic agents like dexamethasone and a serotonin 5-HT3 receptor antagonist. It was found to be noninferior to an oral aprepitant-based regimen in adult cancer patients undergoing HEC treatment[2][3].

Regulatory Approvals

A significant milestone in the market dynamics of fosaprepitant dimeglumine was the FDA approval in 2016 for its use in preventing delayed nausea and vomiting in adults receiving moderately emetogenic chemotherapy (MEC). This approval marked it as the first and only intravenous NK1 receptor antagonist approved in the U.S. for this indication[3].

Economic Value and Cost-Effectiveness

Studies have evaluated the economic value of fosaprepitant dimeglumine in antiemetic regimens. A decision tree model and budget impact analysis in China showed that while fosaprepitant dimeglumine had a similar treatment effect to aprepitant, it was cost-effective at the current willingness-to-pay threshold. The inclusion of fosaprepitant dimeglumine in the National Reimbursement Drug List (NRDL) led to a slight increase in medical insurance payments but expanded coverage to more patients[4].

Market Drivers and Restraints

Drivers

• Increasing Incidence of Cancer: The rising number of cancer cases globally increases the demand for effective antiemetic treatments.
• Advancements in Chemotherapy: More patients are undergoing chemotherapy, which necessitates better management of chemotherapy-induced nausea and vomiting (CINV).
• Regulatory Approvals: FDA approvals and inclusion in national reimbursement lists enhance market accessibility and acceptance[1][3].

Restraints

• Cost and Budget Impact: The introduction of fosaprepitant dimeglumine can increase medical expenditure, although it may be cost-effective in the long run.
• Adverse Reactions: Common adverse reactions such as fatigue, diarrhea, and neutropenia can affect patient compliance and overall market growth[3][4].

Key Players and Market Competition

The market for fosaprepitant dimeglumine is competitive, with several key players involved:

• Merck: As the original developer and marketer of EMEND, Merck holds a significant market share.
• Dr. Reddy’s Laboratories Ltd.: Known for its generic and API offerings.
• Tecoland Corporation: Another major player in the API market.
• Wisdom Pharmaceutical Co. Ltd.: Specializes in pharmaceutical APIs and intermediates.
• Glenmark Pharmaceuticals: A global pharmaceutical company with a strong presence in the API market[1].

Geographical Market Analysis

The market for fosaprepitant dimeglumine is spread across various geographical regions, each with its own dynamics:

• North America: A mature market with high demand due to advanced healthcare systems.
• Europe: Similar to North America, with a strong focus on cancer treatment and antiemetic therapies.
• Asia-Pacific: Rapidly growing due to increasing cancer incidence and improving healthcare infrastructure.
• South America and Middle East & Africa: Emerging markets with growing demand for antiemetic treatments[1].

Financial Trajectory

The financial trajectory of the fosaprepitant dimeglumine market is positive, driven by increasing demand and expanding market segments. Here are some key financial aspects:

• Revenue Growth: The market is expected to grow significantly from 2023 to 2031, driven by the increasing incidence of cancer and the need for effective antiemetic treatments.
• Cost-Effectiveness: Despite initial higher costs, fosaprepitant dimeglumine regimens have been shown to be cost-effective in the long term, especially in regions with strong healthcare reimbursement systems[1][4].

Adverse Reactions and Safety Profile

The safety profile of fosaprepitant dimeglumine is generally well-tolerated, with common adverse reactions including fatigue, diarrhea, neutropenia, and asthenia. Infusion-site reactions are also reported but are relatively rare[3].

Impact on Medical Insurance and Healthcare Systems

The inclusion of fosaprepitant dimeglumine in national reimbursement lists can lead to a slight increase in medical insurance payments. However, this increase is often offset by the expanded coverage and improved health outcomes for patients undergoing chemotherapy[4].

Future Outlook

The future outlook for the fosaprepitant dimeglumine market is promising, driven by ongoing research, regulatory approvals, and increasing demand for effective antiemetic treatments. As cancer treatment protocols evolve, the role of fosaprepitant dimeglumine is likely to remain significant.

Key Takeaways

• Market Growth: The fosaprepitant dimeglumine market is expected to grow significantly from 2023 to 2031.
• Clinical Efficacy: Fosaprepitant dimeglumine is highly effective in preventing CINV.
• Cost-Effectiveness: Despite higher initial costs, it is cost-effective in the long term.
• Regulatory Approvals: FDA approvals and inclusion in national reimbursement lists are crucial for market growth.
• Geographical Dynamics: The market is spread across various regions, each with its own growth potential.

FAQs

What is fosaprepitant dimeglumine used for?

Fosaprepitant dimeglumine is used for the prevention of nausea and vomiting associated with highly and moderately emetogenic chemotherapy (HEC and MEC)[2][3].

How does fosaprepitant dimeglumine work?

It is a prodrug of aprepitant, rapidly converting to the active antiemetic agent upon intravenous administration, which blocks the substance P/NK1 receptor pathway to prevent vomiting[2][5].

What are the common adverse reactions associated with fosaprepitant dimeglumine?

Common adverse reactions include fatigue, diarrhea, neutropenia, asthenia, and infusion-site reactions[3].

Is fosaprepitant dimeglumine cost-effective?

Yes, despite initial higher costs, fosaprepitant dimeglumine regimens have been shown to be cost-effective in the long term, especially in regions with strong healthcare reimbursement systems[4].

Which companies are key players in the fosaprepitant dimeglumine market?

Key players include Merck, Dr. Reddy’s Laboratories Ltd., Tecoland Corporation, Wisdom Pharmaceutical Co. Ltd., and Glenmark Pharmaceuticals[1].

Sources

1. Market Research Intellect: Fosaprepitant Dimeglumine API Market Size, Scope And Forecast.
2. PubMed: Fosaprepitant Dimeglumine: A Review in the Prevention of Nausea.
3. Merck: FDA Approves Merck's Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection.
4. NCBI: Economic Value of Fosaprepitant-Containing Regimen in the Prevention of Chemotherapy-Induced Nausea and Vomiting.
5. FDA: Focinvez (Fosaprepitant Injection) NDA/BLA Multi-Disciplinary Review and Evaluation.