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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.

This drug has sixty-two patent family members in nine countries.

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

US ANDA Litigation and Generic Entry Outlook for Remodulin

A generic version of REMODULIN was approved as treprostinil by SANDOZ INC on November 30^th, 2017.

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Summary for REMODULIN

International Patents:	62
US Patents:	8
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	60
Clinical Trials:	27
Patent Applications:	527
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

Drug patent expirations by year for REMODULIN

Recent Clinical Trials for REMODULIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rhode Island Hospital	Phase 1/Phase 2
United Therapeutics	Phase 1/Phase 2
University of Rhode Island	Phase 1/Phase 2

See all REMODULIN clinical trials

Recent Litigation for REMODULIN

Identify potential future generic entrants

District Court Litigation

Case Name	Date
UNITED THERAPEUTICS CORPORATION v. WATSON LABORATORIES, INC.	2015-07-22
UNITED THERAPEUTICS CORPORATION v. TEVA PHARMACEUTICALS USA, INC.	2014-09-02
UNITED THERAPEUTICS CORPORATION v. SANDOZ, INC.	2012-03-14

See all REMODULIN litigation

PTAB Litigation

Petitioner	Date
Liquidia Technolgies, Inc.	2020-03-30
Liquidia Technologies, Inc.	2020-03-30
SteadyMed Ltd.	2015-10-02

See all REMODULIN litigation

Pharmacology for REMODULIN

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-[(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
15-AU-81
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-((s)-3-hydroxyoctyl)-2,3,3a,4,9,9a-hexahydro-1h-cyclopenta[b]naphthalen-5-yloxy)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
7JZ75N2NT6
81846-19-7
AC-30205
AC-30207
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)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-((3S)-3-hydroxyoctyl)-1H-benz(f)inden-5-yl)oxy)-, monosodium salt
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
API0005768
ARD-1550
AS-56085
AS-56364
BCP10253
BRD-K19706299-001-01-4
BW-15AU
C23H33O5.Na
CHEBI:50861
CHEBI:50863
CHEMBL1237119
CS-6170
CS-7872
CTK8G3571
D06213
D08628
DB00374
EX-A1414
EX-A1416
GTPL5820
HMS3648G07
HY-100441
HY-16504
LRX 15
LRX-15
Orenitram
PAJMKGZZBBTTOY-ZFORQUDYSA-N
Q18578845
Q3495231
Remodulin (TN)
RUM6K67ESG
Rumodolin
SCHEMBL4349618
SCHEMBL61996
sodium ({(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-2,3,3a,4,9,9a-hexahydro-1H-cyclopenta[b]naphthalen-5-yl}oxy)acetate
sodium 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)acetate
SR-01000946210
SR-01000946210-1
Treprostinil
Treprostinil (JAN/USAN/INN)
Treprostinil (sodium)
Treprostinil [USAN:INN]
Treprostinil free acid
Treprostinil monosodium salt
Treprostinil pound>>UT-15
Treprostinil sodium
treprostinilo
treprostinilum
Tresprostinil
Trevyent
Tyvaso
U 62840
U-62,840
U-62840
UNII-7JZ75N2NT6
UNII-RUM6K67ESG
Uniprost
UT-15
Viveta
Y0243
ZB1582
ZINC3800475

Paragraph IV (Patent) Challenges for REMODULIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
REMODULIN	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	treprostinil	021272	2012-12-07
REMODULIN	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	treprostinil	021272	2011-12-02

US Patents and Regulatory Information for REMODULIN

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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	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-003	Jul 30, 2018		RX	No	No	Start Trial	Start Trial				Start Trial
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	Start Trial	Start Trial		Y		Start Trial
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-004	Jul 30, 2018		RX	No	No	Start Trial	Start Trial				Start Trial
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-001	Jul 30, 2018		RX	No	No	Start Trial	Start Trial				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 REMODULIN

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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	Start Trial	Start Trial
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-001	May 21, 2002	Start Trial	Start Trial
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	Start Trial	Start Trial
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-003	May 21, 2002	Start Trial	Start Trial
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-003	May 21, 2002	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for REMODULIN

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Country	Patent Number	Estimated Expiration
Spain	2622471	Start Trial
Germany	602004028155	Start Trial
Spain	2198760	Start Trial
Germany	69816642	Start Trial
China	1917866	Start Trial
>Country	>Patent Number	>Estimated Expiration