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PEMFEXY Drug Profile
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» See Plans and PricingWhen 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 is one patent protecting this drug.
This drug has eighteen patent family members in eleven countries.
The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Additional details are available on the pemetrexed profile page.
US ANDA Litigation and Generic Entry Outlook for Pemfexy
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 twelve 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: | 18 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PEMFEXY |
| DailyMed Link: | PEMFEXY at DailyMed |
US Patents and Regulatory Information for PEMFEXY
| 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 | 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 |
International Patents for PEMFEXY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2015178501 | Start Trial |
| Japan | 5469706 | Start Trial |
| Austria | 359823 | Start Trial |
| Denmark | 1313508 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PEMFEXY
| 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 |
