You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 13, 2024

Details for New Drug Application (NDA): 204824


✉ Email this page to a colleague

« Back to Dashboard


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.
Summary for 204824
Tradename:OTREXUP PFS
Applicant:Otter Pharms
Ingredient:methotrexate
Patents:14
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
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:RXDosage:SOLUTION;SUBCUTANEOUSStrength10MG/0.4ML (10MG/0.4ML)
Approval Date:Oct 11, 2013TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 10, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jan 24, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Mar 19, 2030Product Flag?YSubstance 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 204824-005 Nov 7, 2014 ⤷  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 204824-007 Mar 24, 2016 ⤷  Try a Trial ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 ⤷  Try a Trial ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 ⤷  Try a Trial ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.