Details for New Drug Application (NDA): 209472
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The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pemetrexed profile page.
Summary for 209472
Tradename: | PEMFEXY |
Applicant: | Eagle Pharms |
Ingredient: | pemetrexed |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209472
Generic Entry Date for 209472*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 209472
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Suppliers and Packaging for NDA: 209472
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PEMFEXY | pemetrexed | SOLUTION;INTRAVENOUS | 209472 | NDA | Eagle Pharmaceuticals, Inc. | 42367-531 | 42367-531-33 | 1 VIAL in 1 CARTON (42367-531-33) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/20ML (25MG/ML) | ||||
Approval Date: | Feb 8, 2020 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 28, 2035 | Product Flag? | Substance Flag? | Y | Delist Request? |
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