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Generated: April 26, 2017

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Treprostinil - Generic Drug Details

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What are the generic sources for treprostinil and what is the scope of freedom to operate?

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

Treprostinil has seventy-three patent family members in twelve countries.

There are fifteen 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:23
Applicants:1
NDAs:3
Drug Master File Entries: see list15
Suppliers / Packagers: see list2
Bulk Api Vendors: see list16
Clinical Trials: see list33
Patent Applications: see list175
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
► Subscribe► SubscribeINJECTABLE;INJECTION1MG/ML
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;ORAL203496-001Dec 20, 2013RXYesNo9,393,203► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002RXYesNo9,593,066► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002RXYesNo8,658,694► Subscribe ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo8,747,897► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002RXYesNo6,765,117► SubscribeY ► Subscribe
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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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