Details for New Drug Application (NDA): 204824
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NDA 204824 describes OTREXUP PFS, which is a drug marketed by Assertio Speclty and is included in one NDA. It is available from two suppliers. 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the methotrexate profile page.
Summary for 204824
| Tradename: | OTREXUP PFS |
| Applicant: | Assertio Speclty |
| Ingredient: | methotrexate |
| Patents: | 15 |
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: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 10MG/0.4ML (10MG/0.4ML) | ||||
| Approval Date: | Oct 11, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Mar 10, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 24, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | 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 |
|---|---|---|---|---|---|---|---|
| Assertio Speclty | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-001 | Oct 11, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-004 | Oct 11, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| Assertio Speclty | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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