Details for New Drug Application (NDA): 220149
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NDA 220149 describes ICOTYDE, which is a drug marketed by Janssen Biotech 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 ICOTYDE profile page.
The generic ingredient in ICOTYDE is icotrokinra hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the icotrokinra hydrochloride profile page.
The generic ingredient in ICOTYDE is icotrokinra hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the icotrokinra hydrochloride profile page.
Summary for 220149
| Tradename: | ICOTYDE |
| Applicant: | Janssen Biotech |
| Ingredient: | icotrokinra hydrochloride |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220149
Generic Entry Date for 220149*:
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.
Suppliers and Packaging for NDA: 220149
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ICOTYDE | icotrokinra hydrochloride | TABLET;ORAL | 220149 | NDA | Janssen Biotech, Inc. | 57894-201 | 57894-201-07 | 1 BLISTER PACK in 1 CARTON (57894-201-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK (57894-201-01) |
| ICOTYDE | icotrokinra hydrochloride | TABLET;ORAL | 220149 | NDA | Janssen Biotech, Inc. | 57894-201 | 57894-201-30 | 1 BOTTLE in 1 CARTON (57894-201-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Mar 17, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 17, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 14, 2041 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WHO WEIGH AT LEAST 40 KG WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 19, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WHO WEIGH AT LEAST 40 KG WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY | ||||||||
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