DrugPatentWatch Database Preview

REMODULIN Drug Profile

Which patents cover Remodulin, 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-one patent family members in nine countries.

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

Summary for REMODULIN

International Patents:	61
US Patents:	8
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	53
Clinical Trials:	27
Patent Applications:	510
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
University of Rhode Island	Phase 1/Phase 2
Rhode Island Hospital	Phase 1/Phase 2
United Therapeutics	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
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-[(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
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-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)
7JZ75N2NT6
81846-19-7
81846-19-7 (Parent)
AC-30205
AC-30207
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, (((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
AKOS030524396
API0005768
ARD-1550
BCP10253
BRD-K19706299-001-01-4
BW 15AU
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
MolPort-027-720-928
Orenitram
PAJMKGZZBBTTOY-ZFORQUDYSA-N
Remodulin (TN)
RP17714
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 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
ZINC3800475

US Patents and Regulatory Information for REMODULIN

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Request a Trial
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	See Pricing	See Pricing				See Pricing
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	See Pricing	See Pricing		Y		See Pricing
United Therap	REMODULIN	treprostinil	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	208276-004	Jul 30, 2018		RX	No	No	See Pricing	See Pricing				See Pricing
>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

Subscribe to access the full database, or Request a Trial
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	See Pricing	See Pricing
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-001	May 21, 2002	See Pricing	See Pricing
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-004	May 21, 2002	See Pricing	See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for REMODULIN

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