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Last Updated: December 12, 2019

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Fosaprepitant dimeglumine - Generic Drug Details

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

Fosaprepitant dimeglumine is the generic ingredient in two branded drugs marketed by Merck And Co Inc, Apotex Inc, Baxter Hlthcare Corp, Be Pharms, Fresenius Kabi Usa, Lupin Ltd, Msn Labs Pvt Ltd, Mylan Labs Ltd, and Sungen Pharma, and is included in nine NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fosaprepitant dimeglumine has thirty-six patent family members in twenty-seven countries.

There are eleven drug master file entries for fosaprepitant dimeglumine. Thirteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for fosaprepitant dimeglumine

International Patents:	36
US Patents:	1
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	11
Suppliers / Packagers:	13
Bulk Api Vendors:	44
Clinical Trials:	11
Patent Applications:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fosaprepitant dimeglumine
DailyMed Link:	fosaprepitant dimeglumine at DailyMed

Recent Clinical Trials for fosaprepitant dimeglumine

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

Sponsor	Phase
Alliance for Clinical Trials in Oncology	Phase 3
National Cancer Institute (NCI)	Phase 3
Merck Sharp & Dohme Corp.	Phase 2

See all fosaprepitant dimeglumine clinical trials

Recent Litigation for fosaprepitant dimeglumine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
MERCK SHARP & DOHME CORP. v. MSN LABORATORIES PRIVATE LTD.	2018-01-16
MERCK SHARP & DOHME CORP. v. ACCORD HEALTHCARE, INC. USA	2012-06-01
MERCK SHARP & DOHME CORP. v. SANDOZ INC.	2012-05-31

See all fosaprepitant dimeglumine litigation

PTAB Litigation

Petitioner	Date
Apotex Inc.	2014-12-11

See all fosaprepitant dimeglumine litigation

Generic filers with tentative approvals for FOSAPREPITANT DIMEGLUMINE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	150MG	INJECTABLE;INJECTION
Start Trial	Start Trial	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	Neurokinin 1 Antagonists Cytochrome P450 3A4 Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers

Paragraph IV (Patent) Challenges for FOSAPREPITANT DIMEGLUMINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
EMEND	POWDER;INTRAVENOUS	fosaprepitant dimeglumine	022023	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
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	AP	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Baxter Hlthcare Corp	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	211860-001	Sep 5, 2019	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008		DISCN	Yes	No	Start Trial	Start Trial				Start Trial
Msn Labs Pvt Ltd	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	209965-001	Sep 5, 2019	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Lupin Ltd	FOSAPREPITANT DIMEGLUMINE	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	210689-001	Sep 5, 2019	AP	RX	No	No	Start Trial	Start Trial				Start Trial
>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	022023-002	Nov 12, 2010	Start Trial	Start Trial
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	Start Trial	Start Trial
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	Start Trial	Start Trial
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-002	Nov 12, 2010	Start Trial	Start Trial
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	Start Trial	Start Trial
Merck And Co Inc	EMEND	fosaprepitant dimeglumine	POWDER;INTRAVENOUS	022023-001	Jan 25, 2008	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fosaprepitant dimeglumine

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Country	Patent Number	Estimated Expiration
Brazil	9507046	Start Trial
Hungary	T76324	Start Trial
Poland	180522	Start Trial
Australia	1975095	Start Trial
China	1075812	Start Trial
Latvia	11688	Start Trial
>Country	>Patent Number	>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	Start Trial	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	Start Trial	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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