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Generated: July 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204824

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NDA 204824 describes OTREXUP, which is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the OTREXUP profile page.

The generic ingredient in OTREXUP is methotrexate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methotrexate profile page.

Summary for NDA: 204824

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:13
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details

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
methotrexate
SOLUTION;SUBCUTANEOUS 204824 NDA Antares Pharma, Inc. 54436-010 54436-010-04 4 SYRINGE in 1 CARTON (54436-010-04) > .4 mL in 1 SYRINGE (54436-010-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength10MG/0.4ML (10MG/0.4ML)
Approval Date:Oct 11, 2013TE:RLD:Yes
Patent:► SubscribePatent Expiration:Apr 12, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Aug 10, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

Novartis
McKinsey
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Moodys
McKesson
Fish and Richardson
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Medtronic
Farmers Insurance
US Army

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 verifification 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.

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