Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Dow
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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.

Recent Clinical Trials for fosaprepitant dimeglumine

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

SponsorPhase
Alliance for Clinical Trials in OncologyPhase 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 NameDate
MERCK SHARP & DOHME CORP. v. MSN LABORATORIES PRIVATE LTD.2018-01-16
MERCK SHARP & DOHME CORP. v. ACCORD HEALTHCARE, INC. USA2012-06-01
MERCK SHARP & DOHME CORP. v. SANDOZ INC.2012-05-31

See all fosaprepitant dimeglumine litigation

PTAB Litigation
PetitionerDate
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 Trial150MGINJECTABLE;INJECTION
  Start Trial  Start TrialUNKNOWNUNKNOWN

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

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

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

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

Supplementary Protection Certificates for fosaprepitant dimeglumine

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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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
McKesson
Merck
McKinsey
Baxter

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