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Details for New Drug Application (NDA): 022260
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NDA 022260 describes VELETRI, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VELETRI profile page.
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.
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.
Summary for 022260
| Tradename: | VELETRI |
| Applicant: | Actelion Pharms Ltd |
| Ingredient: | epoprostenol sodium |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022260
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 022260
Suppliers and Packaging for NDA: 022260
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-402 | 66215-402-01 | 1 VIAL in 1 CARTON (66215-402-01) > 10 mL in 1 VIAL |
| VELETRI | epoprostenol sodium | INJECTABLE;INJECTION | 022260 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-403 | 66215-403-01 | 1 VIAL in 1 CARTON (66215-403-01) > 10 mL in 1 VIAL |
Paragraph IV (Patent) Challenges for 022260
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VELETRI | INJECTABLE;INJECTION | epoprostenol sodium | 022260 | 2017-03-31 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5MG BASE/VIAL | ||||
| Approval Date: | Jun 27, 2008 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Feb 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/VIAL | ||||
| Approval Date: | Jun 28, 2012 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Mar 15, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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