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: | 21 |
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 | 61874-075-08 | 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. | 61874-075 | 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: | AB | RLD: | Yes | ||||
Patent: | 10,188,632 | Patent Expiration: | Mar 14, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 10,213,415 | Patent Expiration: | Mar 14, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patented Use: | TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE) | ||||||||
Patent: | 11,007,179 | 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 | ⤷ Try for Free |
Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-002 | May 27, 2015 | 8,772,325 | ⤷ Try for Free |
Abbvie | VIBERZI | eluxadoline | TABLET;ORAL | 206940-001 | May 27, 2015 | 10,213,415 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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