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Treprostinil - Generic Drug Details

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Treprostinil is the generic ingredient in three branded drugs marketed by United Therap and is included in three NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-three patent family members in twelve countries.

There are twelve drug master file entries for treprostinil. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: treprostinil

Tradenames:3
Patents:20
Applicants:1
NDAs:3
Drug Master File Entries: see list12
Suppliers / Packagers: see list2
Bulk Api Vendors: see list16
Clinical Trials: see list33
Patent Applications: see list109
Drug Prices:see low prices
DailyMed Link:treprostinil at DailyMed

Pharmacology for Ingredient: treprostinil

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation

Tentative approvals for TREPROSTINIL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION1MG/ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013RXYesNo9,050,311► subscribeYY ► subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes► subscribe► subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013RXYesYes9,050,311► subscribeYY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: treprostinil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 20025,153,222► subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 20025,153,222► subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 20025,153,222► subscribe
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Non-Orange Book Patents for Generic Ingredient: treprostinil

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,278,901Compounds and methods for delivery of prostacyclin analogs► subscribe
8,748,657Process to prepare treprostinil► subscribe
8,252,839Compounds and methods for delivery of prostacyclin analogs► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: treprostinil

Country Document Number Estimated Expiration
Canada2307163► subscribe
Japan2011506599► subscribe
Canada2851309► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 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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