Details for New Drug Application (NDA): 207695
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NDA 207695 describes EUCRISA, which is a drug marketed by Anacor Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the EUCRISA profile page.
The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the crisaborole profile page.
The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the crisaborole profile page.
Summary for 207695
| Tradename: | EUCRISA |
| Applicant: | Anacor Pharms Inc |
| Ingredient: | crisaborole |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207695
Generic Entry Date for 207695*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;TOPICAL |
*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: 207695
| Mechanism of Action | Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 207695
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EUCRISA | crisaborole | OINTMENT;TOPICAL | 207695 | NDA | Pfizer Laboratories Div Pfizer Inc | 55724-211 | 55724-211-11 | 1 TUBE in 1 CARTON (55724-211-11) / 100 g in 1 TUBE |
| EUCRISA | crisaborole | OINTMENT;TOPICAL | 207695 | NDA | Pfizer Laboratories Div Pfizer Inc | 55724-211 | 55724-211-21 | 1 TUBE in 1 CARTON (55724-211-21) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 2% | ||||
| Approval Date: | Dec 14, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 23, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 14, 2022 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 23, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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