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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Express Scripts
Baxter
Colorcon
Deloitte
Covington
Teva
Dow
Accenture

Generated: August 20, 2017

DrugPatentWatch Database Preview

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Which drugs does patent 8,497,393 protect, and when does it expire?


Patent ► Subscribe protects REMODULIN, TYVASO, and ORENITRAM, and is included in three NDAs. There have been zero Paragraph IV challenges on Orenitram, , and Tyvaso.

This patent has twelve patent family members in six countries.

Summary for Patent: ► Subscribe

Title:Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Abstract: This present invention relates to an improved process to prepare prostacyclin derivatives. One embodiment provides for an improved process to convert benzindene triol to treprostinil via salts of treprostinil and to purify treprostinil.
Inventor(s): Batra; Hitesh (Herndon, VA), Tuladhar; Sudersan M. (Silver Spring, MD), Penmasta; Raju (Herndon, VA), Walsh; David A. (Palmyra, VA)
Assignee: United Therapeutics Corporation (Silver Spring, MD)
Application Number:13/548,446
Patent Claim Types:
see list of patent claims
Compound; Process;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002RXYesNo► Subscribe► SubscribeY
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002RXYesNo► Subscribe► SubscribeY
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002RXYesNo► Subscribe► SubscribeY
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002RXYesYes► Subscribe► SubscribeY
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009RXYesYes► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: ► Subscribe

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
8,242,305Process to prepare treprostinil, the active ingredient in remodulin► Subscribe
9,156,786Process to prepare treprostinil, the active ingredient in remodulin.RTM.► Subscribe
8,748,657Process to prepare treprostinil► Subscribe
9,593,066Process to prepare treprostinil, the active ingredient in remodulin.RTM.► Subscribe
9,604,901Process to prepare treprostinil, the active ingredient in Remodulin.RTM.► 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 Patent: ► Subscribe

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
South Korea20170081292► Subscribe
South Korea20160048222► Subscribe
South Korea101614465► Subscribe
South Korea20100105852► Subscribe
Japan2014114317► 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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Serving 500+ biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Argus Health
Fish and Richardson
Dow
Accenture
Johnson and Johnson
Cerilliant
Colorcon
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 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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