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Last Updated: July 19, 2024

Pemetrexed disodium - Generic Drug Details


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What are the generic drug sources for pemetrexed disodium and what is the scope of patent protection?

Pemetrexed disodium is the generic ingredient in three branded drugs marketed by Lilly, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Nang Kuang Pharm Co, Prinston Inc, Qilu Pharm Hainan, Waverley Pharma Inc, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-four NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pemetrexed disodium has one patent family member in one country.

There are twenty-two drug master file entries for pemetrexed disodium. Nineteen suppliers are listed for this compound.

Recent Clinical Trials for pemetrexed disodium

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 3
Guangdong Association of Clinical TrialsPhase 3
Tianjin Medical University Cancer Institute and HospitalPhase 2

See all pemetrexed disodium clinical trials

Pharmacology for pemetrexed disodium
Medical Subject Heading (MeSH) Categories for pemetrexed disodium
Anatomical Therapeutic Chemical (ATC) Classes for pemetrexed disodium
Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ALIMTA For Injection pemetrexed disodium 750 mg/vial 021462 1 2016-10-06
ALIMTA For Injection pemetrexed disodium 1000 mg/vial 021462 1 2012-06-27
ALIMTA For Injection pemetrexed disodium 100 mg/vial 021462 1 2008-07-01
ALIMTA For Injection pemetrexed disodium 500 mg/vial 021462 2 2008-02-04

US Patents and Regulatory Information for pemetrexed disodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare PEMETREXED DISODIUM pemetrexed disodium POWDER;INTRAVENOUS 203485-001 May 25, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare PEMETREXED DISODIUM pemetrexed disodium SOLUTION;INTRAVENOUS 214408-004 Jul 19, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz PEMETREXED DISODIUM pemetrexed disodium SOLUTION;INTRAVENOUS 214657-001 May 26, 2022 RX Yes Yes ⤷  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 pemetrexed disodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 ⤷  Sign Up ⤷  Sign Up
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for pemetrexed disodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0432677 SPC/GB05/011 United Kingdom ⤷  Sign Up PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
0432677 7/2005 Austria ⤷  Sign Up PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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