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: | 42 |
| 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
*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 |
|---|---|
| Peking Union Medical College Hospital | Phase 1/Phase 2 |
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 1/Phase 2 |
| Secura Bio | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for duvelisib
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 | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|
| Malaysia | 172151 | CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS | ⤷ Sign Up |
| Australia | 2009204487 | Certain chemical entities, compositions and methods | ⤷ Sign Up |
| New Zealand | 619727 | Heterocyclic compounds and uses thereof | ⤷ Sign Up |
| Malaysia | 159955 | CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS | ⤷ Sign Up |
| Israel | 206789 | תרכובת אמידית ציקלית מותמרת, תכשיר פרמצבטי המכיל את התרכובת ושימוש בתרכובת או תכשיר הפרמצבטי בהכנת תרופות (Substituted cyclic amide compound, a pharmaceutical composition comprising it and use of the compound or the pharmaceutical composition in the preparation of a medicament) | ⤷ Sign Up |
| South Korea | 101653842 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for duvelisib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2456444 | 2021C/546 | Belgium | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521 |
| 2456444 | CA 2021 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521 |
| 2456444 | 21C1052 | France | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521 |
| 2456444 | PA2021526 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519 |
| 2456444 | 301140 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521 |
| 2456444 | LUC00237 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU1/21/1542 20210521 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
