Duvelisib - Generic Drug Details
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What are the generic drug 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 |
| Secura Bio | Early Phase 1 |
| Emory University | 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 | 211155-002 | 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 | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | 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 |
|---|---|---|---|
| New Zealand | 612909 | Processes for preparing isoquinolinones and solid forms of isoquinolinones | ⤷ Try a Trial |
| Japan | 2017061547 | イソキノリノンの調製方法及びイソキノリノンの固体形態 (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES) | ⤷ Try a Trial |
| Russian Federation | 2010132257 | НЕКОТОРЫЕ ХИМИЧЕСКИЕ СТРУКТУРЫ, КОМПОЗИЦИИ И СПОСОБЫ | ⤷ 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 | PA2021526 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519 |
| 2456444 | C202130064 | Spain | ⤷ Try a Trial | PRODUCT NAME: DUVELISIB; NATIONAL AUTHORISATION NUMBER: EU/1/21/1542; DATE OF AUTHORISATION: 20210519; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1542; DATE OF FIRST AUTHORISATION IN EEA: 20210519 |
| 2456444 | CA 2021 00045 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
