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Treprostinil diolamine - Generic Drug Details

What are the generic drug sources for treprostinil diolamine and what is the scope of treprostinil diolamine patent protection?
Treprostinil diolamine is the generic ingredient in one branded drug marketed by United Therap and is included in one NDA. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Treprostinil diolamine has fifty-six patent family members in eight countries.

There are seventeen drug master file entries for treprostinil diolamine. Two suppliers are listed for this compound.

Summary for treprostinil diolamine

International Patents:	56
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	17
Suppliers / Packagers:	2
Bulk Api Vendors:	3
Clinical Trials:	73
Patent Applications:	14
Drug Prices:	see low prices
DailyMed Link:	treprostinil diolamine at DailyMed

Pharmacology for treprostinil diolamine

Ingredient-type	Prostaglandins I
Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Synonyms for treprostinil diolamine

2-(((1R,2R,3aS,9aS)-2-hydroxy-1-((S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl)oxy)acetic acid diethanolamine salt
2-((1R,2R,3aS,9aS)-2-Hydroxy-1-(3(S)-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta(b)naphthalen-5-yloxy)acetic acid diethanolamine salt
2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a
830354-48-8
Acetic acid, 2-(((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, compd. with 2,2'-iminobis(ethanol) (1:1)
AKOS030524397
CHEMBL2107815
D10430
DTXSID50232132
EX-A1418
H1FKG90039
Orenitram
RHWRWEUCEXUUAV-ZSESPEEFSA-N
SCHEMBL17222566
Treprostinil diethanolamine
Treprostinil diolamine (USAN)
Treprostinil diolamine [USAN]
UNII-H1FKG90039
UT-15C

US Patents and Regulatory Information for treprostinil diolamine

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Glossary

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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	203496-001	Dec 20, 2013		RX	Yes	No	➤ Sign Up	➤ Sign Up		Y		➤ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013		RX	Yes	Yes	➤ Sign Up	➤ Sign Up		Y		➤ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	No	➤ Sign Up	➤ Sign Up		Y		➤ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
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 treprostinil diolamine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013	➤ Sign Up	➤ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-004	Dec 20, 2013	➤ Sign Up	➤ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013	➤ Sign Up	➤ Sign Up
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-005	Oct 7, 2016	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for treprostinil diolamine

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.

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Patent No.	Title	Estimated Patent Expiration
8,536,363	Compounds and methods for delivery of prostacyclin analogs	➤ Sign Up
9,199,908	Compounds and methods for delivery of prostacyclin analogs	➤ Sign Up
9,624,156	Compounds and methods for delivery of prostacyclin analogs	➤ Sign Up
8,748,657	Process to prepare treprostinil	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for treprostinil diolamine

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Country	Document Number	Estimated Expiration
China	101780092	➤ Sign Up
South Korea	20100105852	➤ Sign Up
Austria	532520	➤ Sign Up
Japan	2016026155	➤ Sign Up
Country	Document Number	Estimated Expiration