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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dacomitinib has fifty-five patent family members in forty-five countries.
Two suppliers are listed for this compound.
Summary for dacomitinib
| International Patents: | 55 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 77 |
| Clinical Trials: | 34 |
| Patent Applications: | 1,909 |
| What excipients (inactive ingredients) are in dacomitinib? | dacomitinib excipients list |
| DailyMed Link: | dacomitinib at DailyMed |
Recent Clinical Trials for dacomitinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Chest Hospital | Phase 1/Phase 2 |
| Genome Institute of Singapore | Phase 2 |
| Cancer Science Institute of Singapore | Phase 2 |
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 | 211288-001 | Sep 27, 2018 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for dacomitinib
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P20110958 | See Plans and Pricing | |
| Eurasian Patent Organization | 200601849 | 4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ | See Plans and Pricing |
| Honduras | 2005000192 | 4-FENILAMINO-QUINAZOLIN -6-IL-AMIDAS | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dacomitinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1746999 | 2019C/540 | Belgium | See Plans and Pricing | PRODUCT NAME: DACOMITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404 |
| 1746999 | C 2019 039 | Romania | See Plans and Pricing | 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 |
| 1746999 | 2019/043 | Ireland | See Plans and Pricing | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
