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VELETRI Drug Profile
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» See Plans and PricingWhen 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.
Summary for VELETRI
| International Patents: | 19 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 21 |
| Clinical Trials: | 1 |
| Patent Applications: | 606 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VELETRI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VELETRI |
| DailyMed Link: | VELETRI at DailyMed |
Recent Clinical Trials for VELETRI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 4 |
Recent Litigation for VELETRI
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ACTELION PHARMACEUTICALS LTD. v. SUN PHARMACEUTICAL INDUSTRIES, INC. | 2017-07-07 |
Pharmacology for VELETRI
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
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 |
International Patents for VELETRI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1993557 | Start Trial |
| Cyprus | 1117128 | Start Trial |
| Poland | 1993557 | Start Trial |
| South Korea | 20090004867 | Start Trial |
| Russian Federation | 2423130 | Start Trial |
| Slovenia | 1993557 | Start Trial |
| China | 101410119 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
