Dacomitinib - Generic Drug Details
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What are the generic sources for dacomitinib and what is the scope of freedom to operate?
Dacomitinib
is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dacomitinib has ninety-four patent family members in forty-eight countries.
Two suppliers are listed for this compound.
Summary for dacomitinib
International Patents: | 94 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 35 |
Patent Applications: | 1,771 |
What excipients (inactive ingredients) are in dacomitinib? | dacomitinib excipients list |
DailyMed Link: | dacomitinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dacomitinib
Generic Entry Date for dacomitinib*:
Constraining patent/regulatory exclusivity:
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 dacomitinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
MedSIR | Phase 2 |
Daiichi Sankyo, Inc. | Phase 2 |
Shanghai Chest Hospital | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for dacomitinib
US Patents and Regulatory Information for dacomitinib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for dacomitinib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-003 | Sep 27, 2018 | ⤷ Try for Free | ⤷ Try for Free |
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | ⤷ Try for Free | ⤷ Try for Free |
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for dacomitinib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Pfizer Europe MA EEIG | Vizimpro | dacomitinib | EMEA/H/C/004779 Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. |
Authorised | no | no | no | 2019-04-02 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for dacomitinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Luxembourg | 93160 | ⤷ Try for Free | |
Hong Kong | 1105285 | METHOD FOR TREATING GEFITINIB RESISTANT CANCER | ⤷ Try for Free |
France | 16C1004 | ⤷ Try for Free | |
Poland | 1746999 | ⤷ Try for Free | |
Japan | 2007536368 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dacomitinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1848414 | C 2016 026 | Romania | ⤷ Try for Free | PRODUCT NAME: OSIMERTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1086; DATE OF NATIONAL AUTHORISATION: 20160202; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1086; DATE OF FIRST AUTHORISATION IN EEA: 20160202 |
1746999 | SPC/GB19/053 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: DACOMITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS DACOMITINIB MONOHYDRATE; REGISTERED: UK EU/1/19/1354(FOR NI) 20190404; UK PLGB 00057-1677 20190404; UK PLGB 00057-1678 20190404 |
1848414 | CR 2016 00033 | Denmark | ⤷ Try for Free | PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204 |
1746999 | C201930055 | Spain | ⤷ Try for Free | PRODUCT NAME: DACOMITINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1354; DATE OF AUTHORISATION: 20190402; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1354; DATE OF FIRST AUTHORISATION IN EEA: 20190402 |
1746999 | 122019000080 | Germany | ⤷ Try for Free | PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Dacomitinib
More… ↓