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Last Updated: June 6, 2020

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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-two US patents protecting UNITED THERAP drugs.

There are ninety-nine 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 203496-003 Dec 20, 2013 RX Yes Yes 9,593,066   Start Trial Y   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 AP RX Yes Yes 7,999,007   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-005 Oct 7, 2016 RX Yes No 8,410,169   Start Trial Y   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 RX Yes No 8,497,393   Start Trial Y Y   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes 10,376,525   Start Trial   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 RX Yes Yes 8,410,169   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 REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-002 May 21, 2002 6,765,117   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-004 Dec 20, 2013 6,765,117   Start Trial
United Therap REMODULIN treprostinil INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021272-001 May 21, 2002 5,153,222   Start Trial
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 6,765,117   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-003 Dec 20, 2013 6,765,117   Start Trial
United Therap ORENITRAM treprostinil diolamine TABLET, EXTENDED RELEASE;ORAL 203496-002 Dec 20, 2013 5,153,222   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 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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