Duvelisib - Generic Drug Details
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What are the generic sources for duvelisib and what is the scope of freedom to operate?
Duvelisib
is the generic ingredient in one branded drug marketed by Secura and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Duvelisib has one hundred and forty-eight patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for duvelisib
International Patents: | 148 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Clinical Trials: | 41 |
Patent Applications: | 1,869 |
Drug Prices: | Drug price trends for duvelisib |
What excipients (inactive ingredients) are in duvelisib? | duvelisib excipients list |
DailyMed Link: | duvelisib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for duvelisib
Generic Entry Date for duvelisib*:
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.
Recent Clinical Trials for duvelisib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 1/Phase 2 |
Novartis | Early Phase 1 |
Secura Bio, Inc. | Early Phase 1 |
US Patents and Regulatory Information for duvelisib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ 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 duvelisib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Secura Bio Limited | Copiktra | duvelisib | EMEA/H/C/005381 Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies. Follicular lymphoma (FL) that is refractory to at least two prior systemic therapies. |
Authorised | no | no | no | 2021-05-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for duvelisib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2663309 | ⤷ Try a Trial | |
Peru | 20141303 | PROCEDIMIENTO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS | ⤷ Try a Trial |
Singapore | 187426 | CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS | ⤷ Try a Trial |
New Zealand | 706506 | Heterocyclic compounds and uses thereof | ⤷ Try a Trial |
South Korea | 20100126287 | CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for duvelisib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2456444 | 2190502-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521 |
2456444 | 21C1052 | France | ⤷ Try a Trial | PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521 |
2456444 | 301140 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521 |
2456444 | 132021000000173 | Italy | ⤷ Try a Trial | PRODUCT NAME: DUVELISIB(COPIKTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1542, 20210521 |
2456444 | 2021C/546 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |