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 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 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.
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: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203496
*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: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 0.125MG BASE | ||||
| Approval Date: | Dec 20, 2013 | TE: | RLD: | Yes | |||||
| 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: | ⤷ Sign Up | Patent Expiration: | Dec 15, 2028 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 30, 2026 | Product Flag? | Substance Flag? | Y | Delist 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 | ⤷ Sign Up | ⤷ Sign Up |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-002 | Dec 20, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-003 | Dec 20, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-002 | Dec 20, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-004 | Dec 20, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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