DACOMITINIB - Generic Drug Details
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What are the generic 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
*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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | 211288-001 | 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 | 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 | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | ⤷ 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 |
|---|---|---|---|
| Slovenia | 1746999 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2006084058 | ⤷ Sign Up | |
| Norway | 20074366 | ⤷ Sign Up | |
| Costa Rica | 8727 | 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS | ⤷ Sign Up |
| Austria | E533490 | ⤷ Sign Up | |
| Montenegro | 01267 | 4-FENILAMINOKINAZOLIN-6-ILAMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES) | ⤷ Sign Up |
| Hungary | S1900039 | ⤷ 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 | 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 |
| 1848414 | C 2016 026 | Romania | ⤷ Sign Up | 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 | C 2019 039 | Romania | ⤷ Sign Up | PRODUCT NAME: DACOMITINIB; NATIONAL AUTHORISATION NUMBER: EU/1/19/1354; DATE OF NATIONAL AUTHORISATION: 20190402; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1354; DATE OF FIRST AUTHORISATION IN EEA: 20190402 |
| 1848414 | 300824 | Netherlands | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204 |
| 1746999 | 2019C/540 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER |
| 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 | C01746999/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: WARNER-LAMBERT COMPANY LLC, US |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
