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
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 |

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
Sponsor | Phase |
---|---|
Southwest Oncology Group | Phase 2/Phase 3 |
National Cancer Institute (NCI) | Phase 2/Phase 3 |
Novartis Pharmaceuticals | Phase 3 |
Pharmacology for PEMFEXY
Drug Class | Folate Analog Metabolic Inhibitor |
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |