FOSAPREPITANT DIMEGLUMINE - Generic Drug Details

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What are the generic drug sources for fosaprepitant dimeglumine and what is the scope of patent protection?

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
Prof. Dr. Fridoon Jawad Ahmad	Phase 3

See all FOSAPREPITANT DIMEGLUMINE clinical trials

Generic filers with tentative approvals for FOSAPREPITANT DIMEGLUMINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	210625-001	Jan 12, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Labs Ltd	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	204015-002	Sep 5, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Navinta Llc	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	212957-002	Aug 20, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	205020-001	Sep 5, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FOSAPREPITANT DIMEGLUMINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	⤷ Sign Up	⤷ Sign Up
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	⤷ Sign Up	⤷ Sign Up
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	⤷ Sign Up	⤷ Sign Up
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FOSAPREPITANT DIMEGLUMINE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019221815		⤷ Sign Up
China	112243376	福沙匹坦的组合物和制备方法 (Fosaprepitant composition and preparation method thereof)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FOSAPREPITANT DIMEGLUMINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748320	SPC/GB08/021	United Kingdom	⤷ Sign Up	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
0748320	08C0019	France	⤷ Sign Up	PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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