VIZIMPRO Drug Patent Profile
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When do Vizimpro patents expire, and what generic alternatives are available?
Vizimpro is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug.
This drug has ninety patent family members in forty-seven countries.
The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.
DrugPatentWatch® Generic Entry Outlook for Vizimpro
Vizimpro was eligible for patent challenges on September 27, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 26, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VIZIMPRO
| International Patents: | 90 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 5 |
| Patent Applications: | 276 |
| Drug Prices: | Drug price information for VIZIMPRO |
| What excipients (inactive ingredients) are in VIZIMPRO? | VIZIMPRO excipients list |
| DailyMed Link: | VIZIMPRO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VIZIMPRO
Generic Entry Date for VIZIMPRO*:
Constraining patent/regulatory exclusivity:
NDA:
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 VIZIMPRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Samsung Medical Center | Phase 2 |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 2 |
| Fondazione Ricerca Traslazionale | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for VIZIMPRO
US Patents and Regulatory Information for VIZIMPRO
VIZIMPRO is protected by four US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIZIMPRO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VIZIMPRO
Method for treating gefitinib resistant cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION
Method for treating gefitinib resistant cancer
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OF ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION
4-phenylamino-quinazolin-6-yl-amides
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
4-phenylamino-quinazolin-6-yl-amides
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
FDA Regulatory Exclusivity protecting VIZIMPRO
FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | 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 | Y | Y | ⤷ Try a Trial | ||
| Pfizer | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 | ||||
| >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 VIZIMPRO
| 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 VIZIMPRO
When does loss-of-exclusivity occur for VIZIMPRO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 04
Patent: 4-phenylamino-quinazolin-6-yl-amides.
Estimated Expiration: ⤷ Try a Trial
Argentina
Patent: 8652
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 05239878
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 3490
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0510604
Patent: 4-fenilamino-quinazolin-6-il-amidas
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 65812
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷ Try a Trial
China
Patent: 72688
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 27
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0110958
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 12127
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 46999
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 066976
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1237
Patent: 4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷ Try a Trial
Patent: 0601849
Patent: 4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 46999
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0084551
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 0500103
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷ Try a Trial
Honduras
Patent: 05000192
Patent: 4-FENILAMINO-QUINAZOLIN -6-IL-AMIDAS
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 06432
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 900039
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8822
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 05757
Estimated Expiration: ⤷ Try a Trial
Patent: 66923
Estimated Expiration: ⤷ Try a Trial
Patent: 07536368
Estimated Expiration: ⤷ Try a Trial
Patent: 09007363
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDE
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 746999
Estimated Expiration: ⤷ Try a Trial
Patent: 2019016
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 0127
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3566
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 06012756
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS. (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES.)
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 267
Patent: 4-FENILAMINOKINAZOLIN-6-ILAMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 632
Patent: 4- PHENYLAMINO-QUINAZOLINE-6-YL-AMIDES
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 28967
Patent: 4-Fenylamino-chinazoline-6-yl-amiden.
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0796
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 0600262
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS.
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 9692
Estimated Expiration: ⤷ Try a Trial
Patent: 19035
Estimated Expiration: ⤷ Try a Trial
Patent: 065626
Estimated Expiration: ⤷ Try a Trial
Panama
Patent: 31901
Patent: 4-FENILLAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 060215
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 46999
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 46999
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 119
Patent: 4-FENILAMINO-HINAZOLIN-6-IL-AMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 46999
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0609012
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 0885835
Estimated Expiration: ⤷ Try a Trial
Patent: 070008683
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷ Try a Trial
Patent: 080095915
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 74553
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 34865
Estimated Expiration: ⤷ Try a Trial
Patent: 0540163
Patent: 4-Phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 06360
Patent: 4-PHENYLAMINO-QUINAZOLINE-6-YL-AMIDES
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 706
Patent: 4-ФЕНІЛАМІНОХІНАЗОЛІН-6-ІЛАМІДИ[4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛАМИДЫ (4-PHENYLAMINOQUINAZOLIN-6-YL AMIDES)
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 885
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS REFERENCIA CRUZADA A SOLICITUD(ES) RELACIONADA(S)
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering VIZIMPRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Montenegro | 01267 | 4-FENILAMINOKINAZOLIN-6-ILAMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES) | ⤷ Try a Trial |
| Cyprus | 1111676 | ⤷ Try a Trial | |
| South Africa | 200706804 | Method for treating gefitinib resistant cancer | ⤷ Try a Trial |
| China | 102886045 | Method for treating gefitinib resistant cancer | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIZIMPRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1746999 | 2019/043 | Ireland | ⤷ Try a Trial | 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 | PA2019016,C1746999 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402 |
| 1746999 | 122019000080 | Germany | ⤷ Try a Trial | PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402 |
| 1746999 | 705 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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