Details for New Drug Application (NDA): 205266
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NDA 205266 describes ODOMZO, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ODOMZO profile page.
The generic ingredient in ODOMZO is sonidegib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sonidegib phosphate profile page.
The generic ingredient in ODOMZO is sonidegib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sonidegib phosphate profile page.
Summary for 205266
| Tradename: | ODOMZO |
| Applicant: | Sun Pharm |
| Ingredient: | sonidegib phosphate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205266
Generic Entry Date for 205266*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 205266
| Mechanism of Action | Smoothened Receptor Antagonists |
Suppliers and Packaging for NDA: 205266
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-303 | 47335-303-15 | 30 CAPSULE in 1 BOTTLE (47335-303-15) |
| ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-303 | 47335-303-83 | 30 CAPSULE in 1 BOTTLE (47335-303-83) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jul 24, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 30, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 15, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 24, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF BASAL CELL CARCINOMA | ||||||||
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