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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Merck
Mallinckrodt
Johnson and Johnson
Colorcon

Last Updated: September 25, 2023

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-seven US patents protecting UNITED THERAP drugs. There is one tentative approval on UNITED THERAP drugs.

There are one hundred and ninety-five 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 ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial
United Therap TYVASO DPI treprostinil POWDER;INHALATION 214324-003 May 23, 2022 RX Yes No 10,130,685 ⤷  Try a Trial Y ⤷  Try a Trial
United Therap REMODULIN treprostinil SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208276-001 Jul 30, 2018 DISCN No No 10,076,505 ⤷  Try a Trial Y ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-001 Dec 20, 2013 RX Yes No 8,349,892 ⤷  Try a Trial Y ⤷  Try a Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes 9,358,240 ⤷  Try a Trial ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No 8,747,897 ⤷  Try a Trial Y ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-003 May 21, 2002 AP RX Yes Yes 10,695,308 ⤷  Try a Trial ⤷  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 203496-003 Dec 20, 2013 5,153,222 ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 6,765,117 ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 5,153,222 ⤷  Try a Trial
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 203496-003 Dec 20, 2013 6,765,117 ⤷  Try a Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 6,765,117 ⤷  Try a Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-004 May 21, 2002 6,765,117 ⤷  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 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
➤ Subscribe Injection 10 mg/mL, 20 mL vial ➤ Subscribe 2011-12-02
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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