DACOMITINIB - Generic Drug Details
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What are the generic drug sources for dacomitinib and what is the scope of patent protection?
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 | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 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 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 |
---|---|---|---|
Austria | E533490 | ⤷ Sign Up | |
Croatia | P20110958 | ⤷ Sign Up | |
China | 113952459 | 治疗吉非替尼耐药性癌症的方法 (Method for treating gefitinib resistant cancer) | ⤷ Sign Up |
New Zealand | 556673 | Method for treating gefitinib and/or erlotinib resistant cancer with an EGFR inhibitor | ⤷ Sign Up |
Georgia, Republic of | P20084551 | 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES | ⤷ Sign Up |
European Patent Office | 1746999 | 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2006084058 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DACOMITINIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1746999 | 2019/043 | Ireland | ⤷ Sign Up | PRODUCT NAME: DACOMITINIB MONOHYDRATE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1354/001 EU/1/19/1354/002 EU/1/19/1354/003 20190402 |
1746999 | 2019C/540 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER |
1848414 | CR 2016 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204 |
1746999 | 19C1052 | France | ⤷ Sign Up | PRODUCT NAME: DACOMITINIB, Y COMPRIS UN DE SES HYDRATES, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/19/1354 20190404 |
1746999 | C201930055 | Spain | ⤷ Sign Up | 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 | 1990044-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: DACOMITINIB OR APHARMACEUTICAL ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/19/1354 20190404 |
1746999 | SPC/GB19/053 | United Kingdom | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |