Details for New Drug Application (NDA): 209472
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NDA 209472 describes PEMFEXY, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the PEMFEXY profile page.
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.
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: | 3 |
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: | ⤷ Get Started Free | Patent Expiration: | Feb 19, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 19, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR USE IN THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Feb 19, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR USE IN THE TREATMENT OF PATIENTS WITH MALIGNANT PLEURAL MESOTHELIOMA | ||||||||
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