Details for New Drug Application (NDA): 206940
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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: | Abbvie |
| Ingredient: | eluxadoline |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 | 61874-075-16 | 2 BLISTER PACK in 1 CARTON (61874-075-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK (61874-075-08) |
| VIBERZI | eluxadoline | TABLET;ORAL | 206940 | NDA | Allergan, Inc. | 61874-075 | 61874-075-60 | 1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | May 27, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 10,188,632 | Patent Expiration: | Mar 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,007,179 | Patent Expiration: | Mar 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,090,291 | Patent Expiration: | Mar 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 206940
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-001 | May 27, 2015 | 9,205,076 | ⤷ Start Trial |
| Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | 10,213,415 | ⤷ Start Trial |
| Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | 8,772,325 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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