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Last Updated: April 19, 2024

United Therap Company Profile


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What is the competitive landscape for UNITED THERAP, and what generic alternatives to UNITED THERAP drugs are available?

UNITED THERAP has five approved drugs.

There are twenty-nine US patents protecting UNITED THERAP drugs. There is one tentative approval on UNITED THERAP drugs.

There are two hundred and seven patent family members on UNITED THERAP drugs in twenty-two countries.

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 REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-002 Jul 30, 2018 DISCN No No 9,713,599 ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes 8,410,169 ⤷  Try a Trial Y ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-007 Sep 28, 2023 RX Yes Yes 7,999,007 ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for United Therap

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 5,153,222 ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 5,153,222 ⤷  Try a Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 6,521,212 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for UNITED THERAP drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial ➤ Subscribe 2012-12-07
➤ Subscribe Extended-release Tablets 2.5 mg ➤ Subscribe 2015-12-24
➤ Subscribe Injection 10 mg/mL, 20 mL vial ➤ Subscribe 2011-12-02
➤ Subscribe Inhalation Solution 0.6 mg/mL, 2.9 mL ampules ➤ Subscribe 2015-04-13
➤ Subscribe Extended-release Tablets 0.25 mg and 1 mg ➤ Subscribe 2016-05-19
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