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Last Updated: June 4, 2020

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VELETRI Drug Profile


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

Veletri is a drug marketed by Actelion Pharms Ltd and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in fifteen countries.

The generic ingredient in VELETRI is epoprostenol sodium. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Veletri

A generic version of VELETRI was approved as epoprostenol sodium by TEVA PHARMS USA on April 23rd, 2008.

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Drug patent expirations by year for VELETRI
Drug Prices for VELETRI

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Recent Clinical Trials for VELETRI

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SponsorPhase
Duke UniversityPhase 4

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Recent Litigation for VELETRI

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

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Pharmacology for VELETRI
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Synonyms for VELETRI
(5Z,13E,8R,9S,11R,12R,15S)-6,9-Epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic acid sodium salt
35121-78-9
4K04IQ1OF4
4UA76
61849-14-7
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
Epoprostenol sodium
Epoprostenol sodium [USAN:BAN]
Epoprostenol Sodium Salt, (5Z,9alpha,11alpha,13E,15S)-Isomer
Epoprostenolsodium
Flolan
Floran
HMS1361K18
HMS3648L14
LMHIPJMTZHDKEW-XQYLJSSYSA-M
LS-176206
NCGC00167427-01
Prosta-5,13-dien-1-oic acid, 6,9-epoxy-11,15-dihydroxy-, sodium salt, (5Z,9alpha,11alpha,13E,15S)-
Prostacyclin sodium
Prostacyclin sodium salt
prostaglandin I2
PROSTAGLANDIN I2 Na
Prostaglandin I2 sodium
Prostaglandin X sodium
Q27259818
SCHEMBL41344
Sodium (5Z,13E,15S)-6,9alpha-epoxy-11alpha,15-dihydroxyprosta-5,13-dien-1-oate
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
Paragraph IV (Patent) Challenges for VELETRI
Tradename Dosage Ingredient NDA Submissiondate
VELETRI INJECTABLE;INJECTION epoprostenol sodium 022260 2017-03-31

US Patents and Regulatory Information for VELETRI

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 022260-002 Jun 28, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Actelion Pharms Ltd VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 RX Yes Yes   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Medtronic
Johnson and Johnson
Dow
Merck

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