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Last Updated: May 27, 2022

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-two drug master file entries for pemetrexed disodium. One supplier is 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
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 See Plans and Pricing See Plans and Pricing
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 See Plans and Pricing See Plans and Pricing
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 See Plans and Pricing See Plans and Pricing
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 See Plans and Pricing See Plans and Pricing
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for pemetrexed disodium

Country Patent Number Title Estimated Expiration
Slovenia 1313508 See Plans and Pricing
Japan 2018197265 新規な葉酸代謝拮抗薬の組み合わせ療法 (NOVEL ANTIFOLATE COMBINATION THERAPIES) See Plans and Pricing
Cyprus 1107649 See Plans and Pricing
Portugal 1313508 See Plans and Pricing
Japan 2012180381 NOVEL ANTIFOLATE COMBINATION THERAPIES See Plans and Pricing
Australia 6968801 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pemetrexed disodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0432677 7/2005 Austria See Plans and Pricing PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677 SPC/GB05/011 United Kingdom See Plans and Pricing 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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Dow
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