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Last Updated: October 21, 2020

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Pemetrexed - Generic Drug Details

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What are the generic sources for pemetrexed and what is the scope of freedom to operate?

Pemetrexed is the generic ingredient in three branded drugs marketed by Actavis Llc, Eagle Pharms, and Lilly, and is included in three NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pemetrexed has twenty-five patent family members in fourteen countries.

There are twenty-nine drug master file entries for pemetrexed. There are twelve tentative approvals for this compound.

Recent Clinical Trials for pemetrexed

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

SponsorPhase
Shanghai Cancer Hospital, ChinaPhase 2
University Hospital, BrestPhase 3
Janssen Research & Development, LLCPhase 3

See all pemetrexed clinical trials

Generic filers with tentative approvals for PEMETREXED
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGINJECTABLE;INJECTION
  Start Trial  Start Trial1GINJECTABLE;INJECTION
  Start Trial  Start Trial100MGINJECTABLE;INJECTION

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

US Patents and Regulatory Information for pemetrexed

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Llc PEMETREXED pemetrexed SOLUTION;INTRAVENOUS 208419-001 Aug 21, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eagle Pharms PEMFEXY pemetrexed SOLUTION;INTRAVENOUS 209472-001 Feb 8, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Actavis Llc PEMETREXED pemetrexed SOLUTION;INTRAVENOUS 208419-002 Aug 21, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Actavis Llc PEMETREXED pemetrexed SOLUTION;INTRAVENOUS 208419-003 Aug 21, 2020 RX Yes Yes   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

Supplementary Protection Certificates for pemetrexed

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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Merck
Harvard Business School
Moodys
Express Scripts

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