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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
QuintilesIMS
Baxter
Covington
Chubb
Daiichi Sankyo
Queensland Health
Boehringer Ingelheim
Dow

Generated: October 18, 2017

DrugPatentWatch Database Preview

REMODULIN Drug Profile

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Which patents cover Remodulin, and what generic Remodulin alternatives are available?

Remodulin is a drug marketed by United Therap and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-six patent family members in eleven countries.

The generic ingredient in REMODULIN is treprostinil. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for Tradename: REMODULIN

US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list23
Clinical Trials: see list23
Patent Applications: see list141
Drug Prices:see details
DailyMed Link:REMODULIN at DailyMed

Pharmacology for Tradename: REMODULIN

Ingredient-typeProstaglandins I
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002RXYesYes► Subscribe► Subscribe ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002RXYesYes► Subscribe► Subscribe ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002RXYesYes► Subscribe► Subscribe ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002RXYesNo► Subscribe► Subscribe ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: REMODULIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for REMODULIN

Drugname Dosage Strength RLD Submissiondate
treprostinil sodiumInjection1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vialRemodulin12/7/2012
treprostinil sodiumInjection10 mg/mL, 20 mL vialRemodulin12/2/2011

Non-Orange Book Patents for Tradename: REMODULIN

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
8,748,657Process to prepare treprostinil► Subscribe
9,278,901Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,536,363Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,252,839Compounds and methods for delivery of prostacyclin analogs► Subscribe
9,624,156Compounds and methods for delivery of prostacyclin analogs► Subscribe
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives► Subscribe
8,410,169Compounds and methods for delivery of prostacyclin analogs► Subscribe
7,384,978Compounds and methods for delivery of prostacyclin analogs► Subscribe
9,422,223Compounds and methods for delivery of prostacyclin analogs► Subscribe
9,327,031Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same► 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 Tradename: REMODULIN

Country Document Number Estimated Expiration
China101903324► Subscribe
Denmark1025083► Subscribe
Germany69816642► Subscribe
Canada2851309► Subscribe
South Korea20170081292► Subscribe
World Intellectual Property Organization (WIPO)2009033039► Subscribe
World Intellectual Property Organization (WIPO)2005007081► Subscribe
Japan3717053► Subscribe
Portugal1025083► Subscribe
South Korea20160048222► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
Deloitte
AstraZeneca
Argus Health
US Army
Citi
Julphar
Colorcon
Chinese Patent Office
Harvard Business School

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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