Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 15, 2019

DrugPatentWatch Database Preview

REMODULIN Drug Profile

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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.

Drug patent expirations by year for REMODULIN
Drug Prices for REMODULIN

See drug prices for REMODULIN

Recent Clinical Trials for REMODULIN

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

SponsorPhase
University of Rhode IslandPhase 1/Phase 2
Rhode Island HospitalPhase 1/Phase 2
United TherapeuticsPhase 1/Phase 2

See all REMODULIN clinical trials

Recent Litigation for REMODULIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
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
PetitionerDate
SteadyMed Ltd.2015-10-02

See all REMODULIN litigation

Pharmacology for REMODULIN
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
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

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

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

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