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VIZIMPRO Drug Profile
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» See Plans and PricingWhen do Vizimpro patents expire, and what generic alternatives are available?
Vizimpro is a drug marketed by Pfizer Inc and is included in one NDA. There are two patents protecting this drug.
This drug has fifty-three patent family members in forty-four countries.
The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.
US ANDA Litigation and Generic Entry Outlook for Vizimpro
Vizimpro will be eligible for patent challenges on September 27, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 27, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VIZIMPRO
| International Patents: | 53 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 68 |
| Clinical Trials: | 1 |
| Patent Applications: | 2 |
| Drug Prices: | Drug price information for VIZIMPRO |
| DailyMed Link: | VIZIMPRO at DailyMed |
Generic Entry Opportunity Date for VIZIMPRO
Generic Entry Date for VIZIMPRO*:
Constraining patent/regulatory exclusivity:
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 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 |
|---|---|
| Pfizer | Phase 2 |
| National Cancer Centre, Singapore | Phase 2 |
Synonyms for VIZIMPRO
| (2E)-N-[4-(3-chloro-4-fluoroanilino)-7-methoxyquinazolin-6-yl]-4-(piperidin-1-yl)but-2-enamide |
| (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl]-4-(1-piperidinyl)-2-butenamide |
| (2e)-N-{4-[(3-Chloro-4-Fluorophenyl)amino]-7-Methoxyquinazolin-6-Yl}-4-(Piperidin-1-Yl)but-2-Enamide |
| (E)-N-(4-((3-chloro-4-fluorophenyl)aMino)-7-Methoxyquinazolin-6-yl)-4-(piperidin-1-yl)but-2-enaMide |
| (E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl]-4-(piperidin-1-yl)but-2-enamide |
| (E)-N-[4-[(3-chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl]-4-piperidin-1-ylbut-2-enamide |
| 1110813-31-4 |
| 1110813-31-4 pound not PF 299804 pound not PF-299804 |
| 2-Butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-methoxy-6-quinazolinyl)-4-(1-piperidinyl)-, (2E)- |
| 2XJX250C20 |
| AB0035896 |
| ABP000126 |
| AC-25915 |
| AKOS025401818 |
| AOB87383 |
| AOB87735 |
| BC261945 |
| BCP02530 |
| BDBM112499 |
| C24H25ClFN5O2 |
| CHEBI:132268 |
| CHEBI:91466 |
| CHEMBL2110732 |
| CS-0500 |
| D09883 |
| D5450 |
| Dacomitinib |
| Dacomitinib (INN) |
| Dacomitinib (PF299804, PF-00299804) |
| Dacomitinib (PF299804, PF299) |
| Dacomitinib (PF299804) |
| Dacomitinib [USAN:INN] |
| Dacomitinib anhydrous |
| Dacomitinib, PF299804 |
| dacomitinibum |
| DB11963 |
| DTXSID50149493 |
| EX-A030 |
| GTPL7422 |
| HY-13272 |
| J-500784 |
| MFCD19443734 |
| MLS006011275 |
| NCGC00263185-09 |
| PF 00299804 |
| PF 00299804-03 |
| PF-00299804 |
| PF-00299804 dacomitinib |
| PF-00299804-03 |
| PF-299 |
| PF-299804 |
| PF-299804 (Dacomitinib PF-00299804) |
| pf00299804 |
| PF299 |
| PF299804 |
| PF299804|||PF299 |
| Q-4059 |
| QCR-174 |
| RL00451 |
| s2727 |
| SB21754 |
| SC-94589 |
| SMR004703025 |
| SW219155-1 |
| UNII-2XJX250C20 |
| US8623883, No. 2 |
| Y0338 |
| ZINC72266312 |
US Patents and Regulatory Information for VIZIMPRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer Inc | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-002 | Sep 27, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | VIZIMPRO | dacomitinib | TABLET;ORAL | 211288-001 | 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 VIZIMPRO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20065626 | Start Trial |
| Taiwan | 200540163 | Start Trial |
| Honduras | 2005000192 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIZIMPRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1746999 | CR 2019 00043 | Denmark | Start Trial | PRODUCT NAME: DACOMITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1354 20190404 |
| 1746999 | 43/2019 | Austria | Start 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 |
