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-two patent family members in forty-eight countries.
Two suppliers are listed for this compound.
Summary for dacomitinib
| International Patents: | 92 |
| 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 |
|---|---|
| Daiichi Sankyo, Inc. | Phase 2 |
| MedSIR | Phase 2 |
| Shanghai Chest Hospital | Phase 1/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 | 211288-002 | Sep 27, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-003 | Sep 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| Mexico | PA06012756 | 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS. (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES.) | ⤷ Try a Trial |
| Guatemala | 200500103 | 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS | ⤷ Try a Trial |
| Norway | 2019035 | ⤷ Try a Trial | |
| Lithuania | PA2019016 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dacomitinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1848414 | 93160 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204 |
| 1746999 | PA2019016,C1746999 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402 |
| 1746999 | 19C1052 | France | ⤷ Try a Trial | 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 | 43/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: DACOMITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DACOMITINIBMONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 (MITTEILUNG) 20190404 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
