DrugPatentWatch Database Preview

REMODULIN Drug Profile

  Purchase this report

or, see our see our flat-rate plans

« Back to Dashboard

Which patents cover Remodulin, and what generic alternatives are available?

Remodulin is a drug marketed by United Therap and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-seven patent family members in nine countries.

The generic ingredient in REMODULIN is treprostinil. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the treprostinil profile page.

Summary for REMODULIN

International Patents:	57
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	24
Clinical Trials:	23
Patent Applications:	158
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REMODULIN
DailyMed Link:	REMODULIN at DailyMed

Pharmacology for REMODULIN

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

Synonyms for REMODULIN

((1R,2R,3aS,9aS)-2-hydroxy-1-((3S)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1H-cylopent(b)naphthalen-5-yl)oxy)acetate

({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetic acid

(1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy- 1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl] oxy]acetic acid

[[(1R,2R,3aS,9aS)-2-Hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphtalen-5-yl]oxy]acetic acid

[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(S)-3-hydroxyoctyl]-1H-benzo[f]indene-5-yl]oxy]acetic acid

[[(1R,2R,3aS,9aS)-2,3,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid

[1R-[1|A(S*),2|A,3a|A,9a|A]]-[[2,3,3a,4,9,9a-| section signexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz[f]inden-5-yl]oxy]acetic Acid

15 AU81

15AU

15AU81

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

2-[[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-5-yl]oxy]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]acetic Acid

2-[[(2R,3R,3aS,9aS)-2-hydroxy-3-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[g]naphthalen-8-yl]oxy]acetic acid

2-{[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H,2H,3H,3aH,4H,9H,9aH-cyclopenta[b]naphthalen-5-yl]oxy}acetic acid

2025AH

289480-64-4

289480-64-4 (Sodium salt)

81846-19-7

AC1OCF2J

Acetic acid, (((1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-

Acetic acid, ((2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-(3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, (1R-(1alpha(S*),2beta,3aalpha,9aalpha))-

AKOS027470173

BRD-K19706299-001-01-4

BW 15AU

C23H33O5.Na

CHEBI:50861

CHEMBL1237119

CS-7872

CTK8G3571

D01WUA

D06213

DB00374

EX-A1414

GTPL5820

HMS3648G07

HY-100441

LRX 15

LRX-15

MolPort-027-720-928

Orenitram

PAJMKGZZBBTTOY-ZFORQUDYSA-N

Remodulin (TN)

RP17714

RUM6K67ESG

SCHEMBL4349618

SR-01000946210

SR-01000946210-1

treprost

Treprostinil

Treprostinil (JAN/USAN/INN)

Treprostinil (USAN/INN)

Treprostinil [USAN:INN]

Treprostinil pound>>UT-15

Treprostinil sodium

treprostinilo

treprostinilum

Tresprostinil

Trevyent

Tyvaso

U 62840

U-62,840

UNII-RUM6K67ESG

Uniprost

UT-15

Viveta

Y0243

ZINC3800475

US Patents and Regulatory Information for REMODULIN

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	021272-004	May 21, 2002	AP	RX	Yes	Yes				Y
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-001	May 21, 2002	AP	RX	Yes	Yes
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-003	May 21, 2002	AP	RX	Yes	Yes
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes			Y

  Purchase this report

or, see our see our flat-rate plans

Expired US Patents for REMODULIN

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
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-001	May 21, 2002
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-003	May 21, 2002
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002

Paragraph IV (Patent) Challenges for REMODULIN

Drugname	Dosage	Strength	RLD	Submissiondate
	Injection	1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial		2012-12-07
	Injection	10 mg/mL, 20 mL vial		2011-12-02

Non-Orange Book US Patents for REMODULIN

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
7,384,978	Compounds and methods for delivery of prostacyclin analogs
9,878,972	Compounds and methods for delivery of prostacyclin analogs
7,544,713	Compounds and methods for delivery of prostacyclin analogs
8,232,316	Compounds and methods for delivery of prostacyclin analogs

  Purchase this report

or, see our see our flat-rate plans

International Patents for REMODULIN

Country	Document Number	Estimated Expiration
Germany	602004028155
Austria	473736
China	1822826
China	101265226