Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Citi
Queensland Health
Cantor Fitzgerald
Moodys
Accenture
Argus Health
Baxter
Daiichi Sankyo
Covington

Generated: October 23, 2017

DrugPatentWatch Database Preview

United Therap Company Profile

« Back to Dashboard

What is the competitive landscape for UNITED THERAP, and when can generic versions of UNITED THERAP drugs launch?

UNITED THERAP has three approved drugs.

There are twenty-three US patents protecting UNITED THERAP drugs and there have been three Paragraph IV challenges on UNITED THERAP drugs in the past three years.

There are one hundred and one patent family members on UNITED THERAP drugs in twelve countries.

Summary for Applicant: United Therap

International Patents:101
US Patents:23
Tradenames:3
Ingredients:2
NDAs:3
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► SubscribeY ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002RXYesNo► Subscribe► Subscribe ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► 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
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-005Oct 7, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for United Therap

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-003Dec 20, 2013► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-001May 21, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-004May 21, 2002► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-001Dec 20, 2013► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-002May 21, 2002► Subscribe► Subscribe
United Therap
REMODULIN
treprostinil
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021272-003May 21, 2002► Subscribe► Subscribe
United Therap
TYVASO
treprostinil
SOLUTION;INHALATION022387-001Jul 30, 2009► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-002Dec 20, 2013► Subscribe► Subscribe
United Therap
ORENITRAM
treprostinil diolamine
TABLET, EXTENDED RELEASE;ORAL203496-004Dec 20, 2013► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for UNITED THERAP drugs

Drugname Dosage Strength Tradename Submissiondate
treprostinil
Extended-release Tablets0.25 mg and 1 mg
ORENITRAM
5/19/2016
treprostinil
Extended-release Tablets2.5 mg
ORENITRAM
12/24/2015
treprostinil sodium
Inhalation Solution0.6 mg/mL, 2.9 mL ampules
TYVASO
4/13/2015
treprostinil sodium
Injection1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial
REMODULIN
12/7/2012
treprostinil sodium
Injection10 mg/mL, 20 mL vial
REMODULIN
12/2/2011

Non-Orange Book Patents for United Therap

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
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives► Subscribe
8,536,363Compounds 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
7,384,978Compounds and methods for delivery of prostacyclin analogs► Subscribe
8,748,657Process to prepare treprostinil► Subscribe
9,156,786Process to prepare treprostinil, the active ingredient in remodulin.RTM.► Subscribe
9,624,156Compounds and methods for delivery of prostacyclin analogs► Subscribe
6,528,688 Prostacyclin derivatives► Subscribe
8,232,316Compounds and methods for delivery of prostacyclin analogs► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for United Therap Drugs

Country Document Number Estimated Expiration
Germany60004181► Subscribe
European Patent Office2711024► Subscribe
South Korea20060021862► Subscribe
Canada2365890► Subscribe
South Korea20140075805► Subscribe
Japan2010538092► Subscribe
European Patent Office2427054► Subscribe
China102697790► Subscribe
European Patent Office1628654► Subscribe
Japan2016006066► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Cipla
Chinese Patent Office
Queensland Health
Fuji
Farmers Insurance
QuintilesIMS
Deloitte
Novartis

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot