SOTYKTU Drug Patent Profile
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When do Sotyktu patents expire, and what generic alternatives are available?
Sotyktu is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug.
This drug has sixty-three patent family members in thirty-six countries.
The generic ingredient in SOTYKTU is deucravacitinib. One supplier is listed for this compound. Additional details are available on the deucravacitinib profile page.
DrugPatentWatch® Generic Entry Outlook for Sotyktu
Sotyktu will be eligible for patent challenges on September 9, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 9, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SOTYKTU
International Patents: | 63 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 1 |
Patent Applications: | 21 |
Drug Prices: | Drug price information for SOTYKTU |
What excipients (inactive ingredients) are in SOTYKTU? | SOTYKTU excipients list |
DailyMed Link: | SOTYKTU at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SOTYKTU
Generic Entry Date for SOTYKTU*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
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.
Recent Clinical Trials for SOTYKTU
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dartmouth-Hitchcock Medical Center | Early Phase 1 |
Bristol-Myers Squibb | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for SOTYKTU
US Patents and Regulatory Information for SOTYKTU
SOTYKTU is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SOTYKTU is ⤷ Try a Trial.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SOTYKTU
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY
FDA Regulatory Exclusivity protecting SOTYKTU
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958-001 | Sep 9, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958-001 | Sep 9, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958-001 | Sep 9, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958-001 | Sep 9, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for SOTYKTU
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Bristol-Myers Squibb Pharma EEIG | Sotyktu | deucravacitinib | EMEA/H/C/005755 Treatment of moderate-to-severe plaque psoriasis in adults. |
Authorised | no | no | no | 2023-03-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for SOTYKTU
See the table below for patents covering SOTYKTU around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Finland | C20230028 | ⤷ Try a Trial | |
Portugal | 3495358 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2014074661 | ⤷ Try a Trial | |
Peru | 20150944 | COMPUESTOS HETEROCICLICOS SUSTITUIDOS CON AMIDA UTILES COMO MODULADORES DE LAS RESPUESTAS DE INTERLEUCINA 12(IL-12), INTERLEUCINA 23 (IL-23) Y/O INTERFERON ALFA (IFN(alfa)) | ⤷ Try a Trial |
Eurasian Patent Organization | 028814 | АМИДЗАМЕЩЕННЫЕ ГЕТЕРОЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ, ПРИМЕНИМЫЕ В КАЧЕСТВЕ МОДУЛЯТОРОВ ОТВЕТОВ, ОПОСРЕДУЕМЫХ IL-12, IL-23 И/ИЛИ IFNα (AMIDE-SUBSTITUTED HETEROCYCLIC COMPOUNDS USEFUL AS MODULATORS OF IL-12, IL-23 AND/OR IFNα RESPONSES) | ⤷ Try a Trial |
Taiwan | 201422593 | Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFN &agr; responses | ⤷ Try a Trial |
Japan | 6407159 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SOTYKTU
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2922846 | 122023000049 | Germany | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1718 20230324 |
2922846 | 2390505-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1718 20230327 |
2922846 | 27/2023 | Austria | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1718 (MITTEILUNG) 20230327 |
2922846 | LUC00313 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1718 20230327 |
2922846 | CA 2023 00024 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1718 20230327 |
2922846 | PA2023523 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DEUKRAVACITINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1718 20230324 |
2922846 | CR 2023 00024 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1718 20230327 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |