Details for New Drug Application (NDA): 022468
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NDA 022468 describes FOLOTYN, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FOLOTYN profile page.
The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.
The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pralatrexate profile page.
Summary for 022468
| Tradename: | FOLOTYN |
| Applicant: | Acrotech Biopharma |
| Ingredient: | pralatrexate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022468
Generic Entry Date for 022468*:
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: 022468
Suppliers and Packaging for NDA: 022468
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468 | NDA AUTHORIZED GENERIC | Fresenius Kabi USA, LLC | 65219-550 | 65219-550-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-550-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468 | NDA AUTHORIZED GENERIC | Fresenius Kabi USA, LLC | 65219-552 | 65219-552-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-552-02) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 20MG/ML (20MG/ML) | ||||
| Approval Date: | Sep 24, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 31, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 31, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 40MG/2ML (20MG/ML) | ||||
| Approval Date: | Sep 24, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 31, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA | ||||||||
Expired US Patents for NDA 022468
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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