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Dacomitinib - Generic Drug Details
» See Plans and Pricing
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 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 29 |
| Patent Applications: | 697 |
| 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 |
|---|---|
| Samsung Medical Center | Phase 2 |
| Shanghai Chest Hospital | Phase 2 |
| Pfizer | Phase 4 |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005107758 | Start Trial |
| Mexico | PA06012756 | Start Trial |
| Spain | 2374553 | Start Trial |
| Norway | 20065626 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for dacomitinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1746999 | 350 16-2019 | Slovakia | Start Trial | PRODUCT NAME: DAKOMITINIB; REGISTRATION NO/DATE: EU/1/19/1354 20190404 |
| 1746999 | 122019000080 | Germany | Start Trial | PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402 |
| 1746999 | 301004 | Netherlands | Start Trial | PRODUCT NAME: DACOMITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT ERVAN, IN HET BIJZONDER DACOMITINIB MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1354 20190404 |
| 1746999 | 132019000000119 | Italy | Start Trial | PRODUCT NAME: DACOMITINIB E SUOI SALI ED ESTERI(VIZIMPRO ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1354, 20190404 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
