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Serving leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
Medtronic
Argus Health
Cipla
Johnson and Johnson
Cerilliant
McKinsey
Colorcon
Federal Trade Commission

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203496

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NDA 203496 describes ORENITRAM, which is a drug marketed by United Therap and is included in one NDA. It is available from two suppliers. There are fourteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ORENITRAM profile page.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil diolamine profile page.

Summary for 203496

Tradename:1
Applicant:1
Ingredient:1
Patents:14

Pharmacology for NDA: 203496

Ingredient-typeProstaglandins I
Physiological EffectVasodilation

Suppliers and Packaging for NDA: 203496

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496 NDA United Therapeutics Corp. 66302-300 66302-300-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-01)
ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496 NDA United Therapeutics Corp. 66302-300 66302-300-10 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 0.125MG BASE
Approval Date:Dec 20, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2019
Regulatory Exclusivity Use:DOSING INFORMATION ADDED TO THE LABELING PROVIDING INFORMATION ON TRANSITIONING FROM SUBCUTANEOUS OR INTRAVENOUS ROUTES OF ADMINISTRATION OF TREPROSTINIL
Regulatory Exclusivity Expiration:Dec 20, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM
Regulatory Exclusivity Expiration:Jan 28, 2019
Regulatory Exclusivity Use:UPDATED INFORMATION ADDED TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING PROVIDING DOSAGE RECOMMENDATIONS FOR INTERRUPTIONS AND DISCONTINUATION OF THERAPY

Expired Orange Book Patents for NDA: 203496

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013► Subscribe► Subscribe
United TherapORENITRAMtreprostinil diolamineTABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Healthtrust
Fish and Richardson
US Army
Farmers Insurance
AstraZeneca
McKesson
Colorcon
Mallinckrodt
Teva
US Department of Justice

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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