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Last Updated: July 11, 2020

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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 one branded drug marketed by Lilly and is included in one NDA. 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 eighteen patent family members in eleven countries.

There are twenty-nine drug master file entries for pemetrexed disodium. One supplier is listed for this compound. There are three tentative approvals for this compound.

Recent Clinical Trials for pemetrexed disodium

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

SponsorPhase
NRG OncologyPhase 3
BeiGenePhase 3
Merck Sharp & Dohme Corp.Phase 2

See all pemetrexed disodium clinical trials

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

Pharmacology for pemetrexed disodium
Medical Subject Heading (MeSH) Categories for pemetrexed disodium
Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM
Tradename Dosage Ingredient NDA Submissiondate
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 2016-10-06
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 2012-06-27
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 2008-07-01
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 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
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start 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 pemetrexed disodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007   Start Trial   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004   Start Trial   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004   Start Trial   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007   Start Trial   Start Trial
>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   Start Trial PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
0432677 7/2005 Austria   Start Trial 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Dow
Harvard Business School
Colorcon
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.