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Last Updated: November 2, 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, 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.

Drug Prices for FOSAPREPITANT DIMEGLUMINE

See drug prices for FOSAPREPITANT DIMEGLUMINE

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
bahria international hospitalPhase 3

See all FOSAPREPITANT DIMEGLUMINE clinical trials

Generic filers with tentative approvals for FOSAPREPITANT DIMEGLUMINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpUNKNOWNUNKNOWN

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

Anatomical Therapeutic Chemical (ATC) Classes for FOSAPREPITANT DIMEGLUMINE
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
Lupin Ltd FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 210689-001 Sep 5, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Labs Ltd FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 204015-001 Sep 5, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Steriscience FOCINVEZ fosaprepitant dimeglumine SOLUTION;INTRAVENOUS 216686-001 Aug 22, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Chia Tai Tianqing FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 212143-001 Mar 3, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma FOSAPREPITANT DIMEGLUMINE fosaprepitant dimeglumine POWDER;INTRAVENOUS 210625-001 Jan 12, 2021 AP RX 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

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 022023-002 Nov 12, 2010 ⤷  Sign Up ⤷  Sign Up
Merck And Co Inc EMEND fosaprepitant dimeglumine POWDER;INTRAVENOUS 022023-002 Nov 12, 2010 ⤷  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

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

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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