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Last Updated: November 21, 2019

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FOSAPREPITANT DIMEGLUMINE Drug Profile

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Which patents cover Fosaprepitant Dimeglumine, and what generic alternatives are available?

Fosaprepitant Dimeglumine is a drug marketed by Apotex Inc, Baxter Hlthcare Corp, Be Pharms, Fresenius Kabi Usa, Lupin Ltd, Msn Labs Pvt Ltd, Mylan Labs Ltd, Sungen Pharma, and Teva Pharms Usa. and is included in nine NDAs.

The generic ingredient in FOSAPREPITANT DIMEGLUMINE is fosaprepitant. There are eleven drug master file entries for this compound. One supplier is listed for this compound. There are two tentative approvals for this compound. Additional details are available on the fosaprepitant profile page.

Drug patent expirations by year for FOSAPREPITANT DIMEGLUMINE
Recent Clinical Trials for FOSAPREPITANT DIMEGLUMINE

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

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Recent Litigation for FOSAPREPITANT DIMEGLUMINE

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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

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PTAB Litigation
PetitionerDate
Apotex Inc.2014-12-11

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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
Apotex Inc FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 205020-001 Sep 5, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 204015-001 Sep 5, 2019 RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 206197-001 Jun 9, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 204015-002 Sep 5, 2019 AP RX No 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
Be Pharms FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 212309-001 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

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