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Details for New Drug Application (NDA): 206940
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NDA 206940 describes VIBERZI, which is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the VIBERZI profile page.
The generic ingredient in VIBERZI is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.
The generic ingredient in VIBERZI is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.
Summary for 206940
| Tradename: | VIBERZI |
| Applicant: | Allergan Holdings |
| Ingredient: | eluxadoline |
| Patents: | 14 |
Generic Entry Opportunity Date for 206940
Generic Entry Date for 206940*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 206940
| Mechanism of Action | Opioid mu-Receptor Agonists |
Suppliers and Packaging for NDA: 206940
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIBERZI | eluxadoline | TABLET;ORAL | 206940 | NDA | Allergan, Inc. | 61874-075 | 61874-075-60 | 60 CARTON in 1 BOTTLE (61874-075-60) > 1 BLISTER PACK in 1 CARTON (61874-075-08) > 8 TABLET, FILM COATED in 1 BLISTER PACK |
| VIBERZI | eluxadoline | TABLET;ORAL | 206940 | NDA | Allergan, Inc. | 61874-100 | 61874-100-60 | 60 CARTON in 1 BOTTLE (61874-100-60) > 1 BLISTER PACK in 1 CARTON (61874-100-08) > 8 TABLET, FILM COATED in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 206940
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VIBERZI | TABLET;ORAL | eluxadoline | 206940 | 2019-05-28 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | May 27, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 27, 2020 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Patent: | Start Trial | Patent Expiration: | Mar 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Mar 14, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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