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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Moodys
Dow
Mallinckrodt
Johnson and Johnson
Chinese Patent Office
Chubb
Teva

Generated: July 18, 2018

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 one supplier. There are thirteen 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 seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the treprostinil diolamine profile page.
Summary for 203496
Tradename:ORENITRAM
Applicant:United Therap
Ingredient:treprostinil diolamine
Patents:13
Generic Entry Opportunity Date for 203496
Generic Entry Date for 203496*:
Constraining patent/regulatory exclusivity:
Dosage::
TABLET, EXTENDED RELEASE;ORAL

*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: 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 N 66302-300-01
ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496 NDA United Therapeutics Corp. 66302-300 N 66302-300-10

Profile 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: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
Patent:➤ Try a Free TrialPatent Expiration:Jul 30, 2026Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 203496

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Queensland Health
Teva
Johnson and Johnson
Moodys
Mallinckrodt
Healthtrust
AstraZeneca
Chinese Patent Office

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.