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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-two US patents protecting UNITED THERAP drugs.

There are one hundred and five patent family members on UNITED THERAP drugs in twelve countries.

Summary for United Therap

International Patents:	105
US Patents:	22
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	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-001	May 21, 2002	AP	RX	Yes	Yes	9,593,066			Y
United Therap	TYVASO	treprostinil	SOLUTION;INHALATION	022387-001	Jul 30, 2009		RX	Yes	Yes	9,339,507		Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No	8,410,169		Y
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	9,278,901

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	021272-004	May 21, 2002	5,153,222
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-002	May 21, 2002	6,765,117
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013	5,153,222
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013	6,765,117

Paragraph IV (Patent) Challenges for UNITED THERAP drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	10 mg/mL, 20 mL vial		2011-12-02
	Inhalation Solution	0.6 mg/mL, 2.9 mL ampules		2015-04-13
	Extended-release Tablets	0.25 mg and 1 mg		2016-05-19
	Injection	1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial		2012-12-07
	Extended-release Tablets	2.5 mg		2015-12-24

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
8,765,813	Use of treprostinil to treat and prevent ischemic lesions
8,536,363	Compounds and methods for delivery of prostacyclin analogs
9,624,156	Compounds and methods for delivery of prostacyclin analogs
9,878,972	Compounds and methods for delivery of prostacyclin analogs

International Patents for United Therap Drugs

Country	Document Number	Estimated Expiration
Japan	5851691
Canada	2526534
Canada	2710205
Japan	5190200

Similar Applicant Names

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

• United Biomedcl
• United Guardian
• United Therap