Details for New Drug Application (NDA): 204824
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NDA 204824 describes OTREXUP PFS, which is a drug marketed by Otter Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the OTREXUP PFS profile page.
The generic ingredient in OTREXUP PFS is methotrexate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
The generic ingredient in OTREXUP PFS is methotrexate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
Summary for 204824
| Tradename: | OTREXUP PFS |
| Applicant: | Otter Pharms |
| Ingredient: | methotrexate |
| Patents: | 13 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204824
Generic Entry Date for 204824*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 204824
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for 204824
Suppliers and Packaging for NDA: 204824
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824 | NDA | Antares Pharma, Inc. | 54436-010 | 54436-010-01 | 1 SYRINGE in 1 CARTON (54436-010-01) / .4 mL in 1 SYRINGE |
| OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824 | NDA | Antares Pharma, Inc. | 54436-010 | 54436-010-01 | 1 SYRINGE in 1 CARTON (54436-010-01) / .4 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 10MG/0.4ML (10MG/0.4ML) | ||||
| Approval Date: | Oct 11, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 10, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 24, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 19, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 204824
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-008 | Mar 24, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-001 | Oct 11, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-004 | Oct 11, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-008 | Mar 24, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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