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Last Updated: May 17, 2022

PEMFEXY Drug Patent Profile


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When do Pemfexy patents expire, and when can generic versions of Pemfexy launch?

Pemfexy is a drug marketed by Eagle Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-five patent family members in fourteen countries.

The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed profile page.

DrugPatentWatch® Generic Entry Outlook for Pemfexy

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 28, 2035. This may change due to patent challenges or generic licensing.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are sixteen tentative approvals for the generic drug (pemetrexed), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for PEMFEXY
International Patents:25
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 15
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for PEMFEXY
What excipients (inactive ingredients) are in PEMFEXY?PEMFEXY excipients list
DailyMed Link:PEMFEXY at DailyMed
Drug patent expirations by year for PEMFEXY
DrugPatentWatch® Estimated Generic Entry Opportunity Date for PEMFEXY
Generic Entry Date for PEMFEXY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PEMFEXY

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

SponsorPhase
Southwest Oncology GroupPhase 2/Phase 3
National Cancer Institute (NCI)Phase 2/Phase 3
Novartis PharmaceuticalsPhase 3

See all PEMFEXY clinical trials

Pharmacology for PEMFEXY

US Patents and Regulatory Information for PEMFEXY

PEMFEXY is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PEMFEXY is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PEMFEXY

Crystalline forms of pemetrexed diacid and manufacturing processes therefor
Patent Number: See Plans and Pricing
Patent Expiration: 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
Eagle Pharms PEMFEXY pemetrexed SOLUTION;INTRAVENOUS 209472-001 Feb 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eagle Pharms PEMFEXY pemetrexed SOLUTION;INTRAVENOUS 209472-001 Feb 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

International Patents for PEMFEXY

When does loss-of-exclusivity occur for PEMFEXY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 62383
Estimated Expiration: See Plans and Pricing

Patent: 15436
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 12193
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1405
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 51603
Estimated Expiration: See Plans and Pricing

Patent: 1619161
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PEMFEXY around the world.

Country Patent Number Title Estimated Expiration
Canada 2962383 FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR) See Plans and Pricing
Cyprus 1107649 See Plans and Pricing
Canada 3015436 FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR) See Plans and Pricing
Japan 2017019852 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
Germany 60127970 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PEMFEXY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Mallinckrodt
McKinsey
Johnson and Johnson
Harvard Business School

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.