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Last Updated: February 27, 2021

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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 four approved drugs.

There are twenty-four US patents protecting UNITED THERAP drugs.

There are one hundred patent family members on UNITED THERAP drugs in nine 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 ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No 9,604,901   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No 9,393,203   Start Trial Y   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes 8,497,393   Start Trial Y Y   Start Trial
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-002 Jul 30, 2018 RX No No 9,593,066   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No 8,747,897   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No 8,349,892   Start Trial Y   Start 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 203496-004 Dec 20, 2013 5,153,222   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 6,756,033   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 5,153,222   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 5,153,222   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 5,153,222   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 6,521,212   Start 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 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
➤ 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
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:

Johnson and Johnson
McKinsey
Express Scripts
Mallinckrodt
Dow
Baxter

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