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Treprostinil diolamine - Generic Drug Details
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What are the generic drug sources for treprostinil diolamine and what is the scope of patent protection?
Treprostinil diolamine
is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Treprostinil diolamine has fifty-eight patent family members in eight countries.
There are nineteen drug master file entries for treprostinil diolamine. One supplier is listed for this compound.
Summary for treprostinil diolamine
| International Patents: | 58 |
| US Patents: | 13 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 2 |
| Clinical Trials: | 2 |
| Patent Applications: | 15 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for treprostinil diolamine |
| DailyMed Link: | treprostinil diolamine at DailyMed |
Recent Clinical Trials for treprostinil diolamine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| United Therapeutics | Phase 2 |
| Stanford University | Phase 2 |
| United Therapeutics | Phase 1 |
Pharmacology for treprostinil diolamine
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Paragraph IV (Patent) Challenges for TREPROSTINIL DIOLAMINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ORENITRAM | TABLET, EXTENDED RELEASE;ORAL | treprostinil diolamine | 203496 | 2016-05-19 |
US Patents and Regulatory Information for treprostinil diolamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-003 | Dec 20, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-003 | Dec 20, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-003 | Dec 20, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-002 | Dec 20, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-001 | Dec 20, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for treprostinil diolamine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-001 | Dec 20, 2013 | Start Trial | Start Trial |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-004 | Dec 20, 2013 | Start Trial | Start Trial |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-005 | Oct 7, 2016 | Start Trial | Start Trial |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-002 | Dec 20, 2013 | Start Trial | Start Trial |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496-002 | Dec 20, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for treprostinil diolamine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2014114317 | Start Trial |
| Japan | 5841554 | Start Trial |
| Canada | 2710205 | Start Trial |
| Canada | 2736406 | Start Trial |
| China | 102697790 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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.
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