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

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Last Updated: October 18, 2019

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Epoprostenol sodium - Generic Drug Details

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What are the generic drug sources for epoprostenol sodium and what is the scope of freedom to operate?

Epoprostenol sodium is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Glaxosmithkline Llc, and Actelion Pharms Ltd, and is included in three NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Epoprostenol sodium has eighteen patent family members in fourteen countries.

There are seven drug master file entries for epoprostenol sodium. Three suppliers are listed for this compound.

Recent Clinical Trials for epoprostenol sodium

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SponsorPhase
GlaxoSmithKlinePhase 4
ActelionPhase 4
United TherapeuticsPhase 4

See all epoprostenol sodium clinical trials

Recent Litigation for epoprostenol sodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
ACTELION PHARMACEUTICALS LTD. v. SUN PHARMACEUTICAL INDUSTRIES, INC.2017-07-07

See all epoprostenol sodium litigation

Pharmacology for epoprostenol sodium
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for epoprostenol sodium
Synonyms for epoprostenol sodium
(5Z,13E,8R,9S,11R,12R,15S)-6,9-Epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic acid sodium salt
(5Z,9|A,11|A,13E,15S)-6,9-epoxy-11,15-Dihydroxy-prosta-5,13-dien-1-oic Acid Sodium Salt
4K04IQ1OF4
4UA76
61849-14-7
91284-07-0
AC1O4BXH
ACT-385781A
AKOS024457370
BML1-F10
C20H31NaO5
C20H31O5.Na
CAS-61849-14-7
CHEMBL962
Cyclo-Prostin
DSSTox_CID_26617
DSSTox_GSID_46617
DSSTox_RID_81769
DTXSID3046617
EINECS 263-273-7
Epoprostenol sodium [USAN:BAN]
Epoprostenol Sodium Salt, (5Z,9alpha,11alpha,13E,15S)-Isomer
Epoprostenolsodium
Flolan
Floran
HMS1361K18
HMS3648L14
LMHIPJMTZHDKEW-XQYLJSSYSA-M
LS-176206
MolPort-006-132-470
NCGC00167427-01
Prosta-5,13-dien-1-oic acid, 6,9-epoxy-11,15-dihydroxy-, sodium salt, (5Z,9alpha,11alpha,13E,15S)-
prostacyclin
Prostacyclin sodium
Prostacyclin sodium salt
PROSTAGLANDIN I2 Na
Prostaglandin I2 sodium
Prostaglandin X sodium
SCHEMBL41344
Sodium (5Z,13E,15S)-6,9alpha-epoxy-11alpha,15-dihydroxyprosta-5,13-dien-1-oate
sodium (5Z)-5-[(3aR,4R,5R,6aS)-5-hydroxy-4-[(E,3S)-3-hydroxyoct-1-enyl]-3,3a,4,5,6,6a-hexahydrocyclopenta[b]furan-2-ylidene]pentanoate
Sodium (Z)-(3aR,4R,5R,6aS)-hexahydro-5-hydroxy-4-((E)-(3S)-3-hydroxy-1-octenyl)-2H-cyclopenta(b)furan-delta(sup 2,delta)-valerate
sodium (Z)-5-((3aR,4R,5R,6aS)-5-hydroxy-4-((S,E)-3-hydroxyoct-1-enyl)hexahydro-2H-cyclopenta[b]furan-2-ylidene)pentanoate
Sodium prostacyclin
Tox21_112431
U 53,217A
U-53,217A
U-53217A
UNII-4K04IQ1OF4
V0155
Veletri

US Patents and Regulatory Information for epoprostenol sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms Usa EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-002 Apr 23, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-002 Jun 28, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Actelion Pharms Ltd VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 AP RX Yes Yes   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 epoprostenol sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995   Start Trial   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995   Start Trial   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995   Start Trial   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995   Start Trial   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-001 Sep 20, 1995   Start Trial   Start Trial
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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