Flexible Subscriptions to Match your Budget and Timeline See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Mallinckrodt
Baxter
Express Scripts
Medtronic

Last Updated: June 27, 2022

Details for New Drug Application (NDA): 203496


✉ Email this page to a colleague

« Back to Dashboard

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 nineteen 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
DrugPatentWatch® Estimated 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
Physiological Effect Vasodilation
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 Corporation 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 Corporation 66302-300 66302-300-02 1 BLISTER PACK in 1 CARTON (66302-300-02) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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:Oct 18, 2022
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
Regulatory Exclusivity Expiration:Oct 18, 2026
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
Patent:See Plans and PricingPatent 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 203496-004 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 See Plans and Pricing See Plans and Pricing
>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

Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Baxter
Colorcon
Moodys
Mallinckrodt

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.