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Last Updated: March 19, 2024

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, 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 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 two patent family members in two countries.

There are eleven drug master file entries for fosaprepitant dimeglumine. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for fosaprepitant dimeglumine

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Recent Clinical Trials for fosaprepitant dimeglumine

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

SponsorPhase
Fujian Shengdi Pharmaceutical Co., Ltd.Phase 3
Xijing HospitalN/A
University of LahorePhase 3

See all fosaprepitant dimeglumine clinical trials

Generic filers with tentative approvals for FOSAPREPITANT DIMEGLUMINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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 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
Chia Tai Tianqing FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 212143-001 Mar 3, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Be Pharms FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 212309-001 Sep 5, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 203939-001 Dec 8, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 211860-001 Sep 5, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 211160-001 Dec 9, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-001 Jan 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-001 Jan 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-002 Nov 12, 2010 ⤷  Try a Trial ⤷  Try a Trial
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-002 Nov 12, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fosaprepitant dimeglumine

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

Supplementary Protection Certificates for fosaprepitant dimeglumine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0748320 SPC/GB08/021 United Kingdom ⤷  Try a 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 ⤷  Try a 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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