BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Covington
Teva
US Department of Justice
Fuji
QuintilesIMS
Colorcon
Baxter
Harvard Business School
Accenture
Medtronic

Generated: January 20, 2018

DrugPatentWatch Database Preview

United Therap Company Profile

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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 fifteen patent family members on UNITED THERAP drugs in twelve countries.

Summary for United Therap
International Patents:115
US Patents:23
Tradenames:3
Ingredients:2
NDAs:3

Drugs and US Patents for United Therap

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;ORAL 203496-003 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for United Therap

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for UNITED THERAP drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 0.25 mg and 1 mg ➤ Subscribe 5/19/2016
➤ Subscribe Extended-release Tablets 2.5 mg ➤ Subscribe 12/24/2015
➤ Subscribe Inhalation Solution 0.6 mg/mL, 2.9 mL ampules ➤ Subscribe 4/13/2015
➤ Subscribe Injection 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial ➤ Subscribe 12/7/2012
➤ Subscribe Injection 10 mg/mL, 20 mL vial ➤ Subscribe 12/2/2011

Non-Orange Book US 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
8,536,363 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
9,327,031 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same ➤ Subscribe
6,441,245 Process for stereoselective synthesis of prostacyclin derivatives ➤ Subscribe
9,156,786 Process to prepare treprostinil, the active ingredient in remodulin.RTM. ➤ Subscribe
8,242,305 Process to prepare treprostinil, the active ingredient in remodulin ➤ Subscribe
8,765,813 Use of treprostinil to treat and prevent ischemic lesions ➤ Subscribe
6,528,688 Prostacyclin derivatives ➤ Subscribe
9,624,156 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
8,232,316 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
7,384,978 Compounds and methods for delivery of prostacyclin analogs ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for United Therap Drugs

Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Cipla
Medtronic
McKinsey
Johnson and Johnson
Baxter
Merck
Boehringer Ingelheim
Novartis
Chubb

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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