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REMODULIN Drug Profile

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When do Remodulin patents expire, and what generic alternatives are available?

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

The generic ingredient in REMODULIN is treprostinil. There are eighteen 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

US Patents:	8
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	28
Clinical Trials:	23
Patent Applications:	161
Drug Prices:	Drug price information for REMODULIN
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	021272-004	May 21, 2002	AP	RX	Yes	Yes
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-001	Jul 30, 2018		RX	No	No
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes
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	021272-003	May 21, 2002	AP	RX	Yes	Yes			Y

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	021272-004	May 21, 2002
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-002	May 21, 2002
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-003	May 21, 2002
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-003	May 21, 2002

Paragraph IV (Patent) Challenges for REMODULIN

Drugname	Dosage	Strength	RLD	Date
	Injection	1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial
	Injection	10 mg/mL, 20 mL vial

International Patents for REMODULIN

Country	Document Number	Estimated Expiration
South Korea	101161889
European Patent Office	3287434
World Intellectual Property Organization (WIPO)	2009078965
South Korea	20170081292
Spain	2622471
Japan	2007514750
Japan	5043433