DEUCRAVACITINIB - Generic Drug Details
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What are the generic sources for deucravacitinib and what is the scope of freedom to operate?
Deucravacitinib
is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Deucravacitinib has sixty-three patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for DEUCRAVACITINIB
| International Patents: | 63 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 17 |
| Patent Applications: | 36 |
| What excipients (inactive ingredients) are in DEUCRAVACITINIB? | DEUCRAVACITINIB excipients list |
| DailyMed Link: | DEUCRAVACITINIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEUCRAVACITINIB
Generic Entry Date for DEUCRAVACITINIB*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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 DEUCRAVACITINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Phase 4 |
| Bristol-Myers Squibb | Early Phase 1 |
| Dartmouth-Hitchcock Medical Center | Early Phase 1 |
US Patents and Regulatory Information for DEUCRAVACITINIB
| 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 | 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 | ||
| Bristol | SOTYKTU | deucravacitinib | TABLET;ORAL | 214958-001 | Sep 9, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 DEUCRAVACITINIB
| 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 DEUCRAVACITINIB
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P20181937 | ⤷ Try a Trial | |
| South Korea | 20150081339 | ＩＬ-12, ＩＬ-23 및/또는 ＩＦＮα 반응의 조절제로서 유용한 아미드-치환된 헤테로시클릭 화합물 (AMIDE-SUBSTITUTED HETEROCYCLIC COMPOUNDS USEFUL AS MODULATORS OF IL-12, IL-23 AND/OR IFN ALPHα RESPONSES) | ⤷ Try a Trial |
| Hungary | E041750 | ⤷ Try a Trial | |
| Chile | 2015001231 | Compuestos heterocíclicos sustituidos con amida; composicion farmaceutica; útiles en el tratamiento de una enfermedad inflamatoria o autoinmune. | ⤷ Try a Trial |
| Poland | 3495358 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 201590917 | АМИДЗАМЕЩЕННЫЕ ГЕТЕРОЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ, ПРИМЕНИМЫЕ В КАЧЕСТВЕ МОДУЛЯТОРОВ ОТВЕТОВ, ОПОСРЕДУЕМЫХ IL-12, IL-23 И/ИЛИ IFNγ | ⤷ Try a Trial |
| Australia | 2018267545 | AMIDE-SUBSTITUTED HETEROCYCLIC COMPOUNDS USEFUL AS MODULATORS OF IL-12, IL-23 AND/OR IFN ALPHA RESPONSES | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DEUCRAVACITINIB
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 122023000049 | Germany | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1718 20230324 |
| 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 | 2023C/531 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND 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 | 2390505-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DEUCRAVACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1718 20230327 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
