VIZIMPRO Drug Patent Profile

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 three patents protecting this drug.

This drug has ninety-three patent family members in forty-eight countries.

The generic ingredient in VIZIMPRO is dacomitinib. One supplier is 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 September 27, 2032. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VIZIMPRO

International Patents:	93
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	5
Patent Applications:	2,722
Drug Prices:	Drug price information for VIZIMPRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIZIMPRO
What excipients (inactive ingredients) are in VIZIMPRO?	VIZIMPRO excipients list
DailyMed Link:	VIZIMPRO at DailyMed

See drug prices for VIZIMPRO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIZIMPRO

Constraining patent/regulatory exclusivity:

7,772,243

NDA:

211288

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

See all VIZIMPRO clinical trials

US Patents and Regulatory Information for VIZIMPRO

VIZIMPRO is protected by three US patents.

This potential generic entry date is based on patent 7,772,243.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,603,314
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes	10,603,314
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No	10,603,314
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes	10,596,162

Expired US Patents for VIZIMPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018	10,596,162
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018	10,596,162
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018	8,623,883
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018	10,603,314

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/004779Vizimpro, 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

International Patents for VIZIMPRO

See the table below for patents covering VIZIMPRO around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	E504299
Australia	2006210572	Method for treating gefitinib resistant cancer
Brazil	PI0606839	uso de uma composição farmacêutica compreendendo um inibidor irreversìvel de receptor de fator de crescimento epidérmico (egfr)
Canada	2596714	METHODE DE TRAITEMENT DU CANCER RESISTANT AU GEFITINIB (METHOD FOR TREATING GEFITINIB RESISTANT CANCER)

Supplementary Protection Certificates for VIZIMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	301004	Netherlands		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	PA2019016	Lithuania		PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999	122019000080	Germany		PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999	2019C/540	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER

VIZIMPRO (dacomitinib) Market Dynamics and Financial Trajectory: Exclusivity, Competition Risk, and Revenue Outlook

Last updated: July 30, 2026

VIZIMPRO (dacomitinib) has moved through its post-launch diffusion phase into a more competitive oncology small-molecule EGFR landscape marked by (1) sustained use driven by EGFR Exon 19 deletion and L858R metastatic NSCLC first-line adoption, (2) pressure from EGFR TKIs positioned on higher-convenience regimens and evolving sequencing, and (3) patent-driven constraints on generic entry. The product’s financial path is defined by how quickly the class shifts to competing next-gen TKIs and how long FDA exclusivity and patent barriers delay Paragraph IV ANDA risk.

How has VIZIMPRO performed financially since launch?

Answer: VIZIMPRO achieved meaningful early adoption in first-line EGFR-mutated metastatic NSCLC, then faced incremental share pressure as competing EGFR TKIs expanded and as treatment sequencing preferences matured. The trajectory depends on staying power in the first-line EGFR Ex19 del/L858R segment and resistance to erosion from alternative next-gen TKIs and later-line adoption.

What matters most for VIZIMPRO revenue: segment and line-of-therapy mix

Key drivers that determine monthly and quarterly billing:

• Patient eligibility: FDA-labeled population is limited to metastatic NSCLC with specific EGFR mutations (Exon 19 deletion or Exon 21 L858R).
• Line of therapy: Peak uptake typically occurs in first-line where next-gen TKIs displace chemotherapy.
• Continuity of therapy: Adherence and treatment duration influence net sales stability in oncology.
• Sequencing shifts: Switching patterns out of class after progression affects “second-line” drag or tail.

What is the commercial risk profile if EGFR treatment shifts?

Revenue sensitivity increases if prescribing drifts toward:

• Another next-gen EGFR TKI with competitive efficacy or tolerability positioning in real-world practice.
• Combination or strategy changes that reduce front-line TKI duration.
• More aggressive sequencing that moves dacomitinib to later lines at lower net price.

What is VIZIMPRO’s patent and exclusivity timeline affecting market duration?

Answer: VIZIMPRO’s market duration is governed by a bundle of composition, formulation, and method-of-use patents plus regulatory exclusivity (including NCE/marketing exclusivity and any relevant patent term adjustments), with additional protection layered through Orange Book-listed patents that block generic ANDAs absent a successful Paragraph IV.

What patents protect dacomitinib and VIZIMPRO?

VIZIMPRO’s IP estate generally covers:

• The dacomitinib compound (composition of matter).
• Salt forms and crystalline forms (if claimed).
• Formulations and dosage forms (tablets, dissolution/particle size approaches).
• Therapeutic methods tied to EGFR mutation subsets and treatment regimens.

Data note: A complete, itemized Orange Book and specific patent number-to-expiration mapping is required to produce a legally actionable exclusivity table. Without the Orange Book listing contents in the prompt, the patent-by-patent timeline cannot be stated accurately.

When does VIZIMPRO lose exclusivity and face generic entry risk?

Answer: Generic entry risk is tied to:

• Expiration of the last Orange Book “blocking” patent (or loss of patent enforceability via litigation or settlement terms).
• Any regulatory exclusivity periods that extend launch beyond patent expiry.
• Paragraph IV challenge timing and any “automatic” 180-day exclusivity triggers if challengers win.

Data note: A numeric “first potential generic launch date” cannot be produced without the exact Orange Book blocking patent expirations and exclusivity codes.

What generic entry risks exist for VIZIMPRO after Paragraph IV ANDA challenges?

Answer: Generic risk is binary: either challengers have a pathway to a market entry date that is legally defensible, or patent listings and litigation prevent launch. The practical risk profile depends on whether a challenger can certify non-infringement/invalidity against specific Orange Book patents and whether a settlement triggers a delayed launch.

What typically determines Paragraph IV impact on the dacomitinib market?

• Which patents are challenged: composition-of-matter generally blocks launch longer than narrow formulation claims.
• Settlement terms: pay-for-delay can extend the effective barrier beyond statutory expiry dates.
• Court outcomes: a win for the brand can stop all pending ANDAs tied to the same certification.

Data note: The prompt does not include Paragraph IV case dockets, declaratory judgments, settlement announcements, or Orange Book patent lists. Without those, specific litigation timelines and challenger identities cannot be enumerated.

What is the Orange Book status of VIZIMPRO?

Answer: VIZIMPRO’s branded status is controlled by Orange Book listings that identify patent numbers, expiration dates, and whether patents are “listed” for the approved drug product(s).

Data note: The prompt does not provide the Orange Book listing contents for VIZIMPRO. A precise status statement requires the exact list of patents and their expirations.

How does VIZIMPRO compare with competing EGFR TKIs on market dynamics?

Answer: VIZIMPRO competes inside the next-generation EGFR TKI set, where prescriber behavior is shaped by efficacy perception, tolerability management, dosing convenience, and how clinicians sequence after prior TKI exposure.

What competitive forces most affect VIZIMPRO share?

• Tolerability-driven switching: Real-world discontinuation rates can move market share even when head-to-head efficacy is close.
• Convenience and adherence: Dosing schedules influence persistence.
• Patient comorbidities: Dose modifications for rash and diarrhea risk can affect clinician preference.
• Evolving guideline positioning: Treatment guidelines and payor policies influence which agent becomes “default.”

What formulations are protected by VIZIMPRO’s patent estate?

Answer: The practical scope of formulation protection determines how generics can design around. If only the compound is protected, generics can still launch with different formulations at the earliest compound-expiry date. If multiple formulation and method claims are listed, launch can be delayed even after compound expiry.

Data note: Without the Orange Book formulation/method patents enumerated, a claim-to-expiry formulation table cannot be provided.

What method-of-use patents apply to VIZIMPRO’s approved EGFR mutation indications?

Answer: Method-of-use protection typically covers treatment of patients with specific EGFR mutations, which can delay certain “carve-out” or design-around strategies.

Data note: Without patent numbers and claims, it is not possible to list method-of-use claim scope or validity posture.

What litigation affects VIZIMPRO’s generic and biosimilar risk?

Answer: Dacomitinib is a small molecule; biosimilar risk does not apply. Litigation affects generic entry through Paragraph IV ANDAs and any related district court actions.

Data note: No case list, court dockets, or settlement announcements are provided in the prompt; therefore litigation events cannot be accurately listed.

What FDA regulatory milestones matter for VIZIMPRO’s market trajectory?

Answer: For a marketed TKI, FDA milestones relevant to financial trajectory include:

• Initial approval date and labeling,
• Any supplemental indications or label expansions,
• Any exclusivity-changing regulatory events.

Data note: The prompt does not provide FDA review history, supplemental approval dates, or exclusivity grant dates necessary for an exact milestone timeline.

Which companies are challenging VIZIMPRO, and what are the likely launch scenarios?

Answer: The likely commercial outcomes divide into:

1. Successful brand enforcement: no generic launch until patent/regulatory expiry.
2. Partial carve-out: launch limited to non-blocked strengths or dosing forms.
3. Early settlement entry: launch occurs on a negotiated date, often with design-around requirements.
4. Generic win: launch can occur before the latest patent expiry if invalidity/non-infringement is sustained.

Data note: Challenger identities and scenario-specific dates require the Paragraph IV filing details and associated court/settlement records.

How strong is the patent estate for VIZIMPRO versus typical small-molecule TKI risk?

Answer: Dacomitinib’s strength should be evaluated as a “stack” of Orange Book patents that can include:

• One or more composition-of-matter patents,
• Follow-on formulation patents,
• Method-of-use patents tied to labeled populations.

A strong estate translates to fewer generic launch vectors and higher leverage for brand settlements.

Data note: Without the patent stack and expiry dates, “strong vs weak” cannot be scored with actual counts, jurisdictions, and expiration ladders.

VIZIMPRO regional exclusivity: where is it most protected?

Answer: Market exclusivity outside the US is governed by local patent term adjustments, national phase filings, and enforcement intensity. US is typically decisive for near-term generic launch timing via ANDAs and Orange Book listings.

Data note: The prompt does not include international patent filing data, EP/WO designations, or granted terms.

Net revenue exposure: what portion of oncology EGFR sales does VIZIMPRO represent?

Answer: VIZIMPRO exposure depends on:

• Its penetration in eligible first-line EGFR-mutated NSCLC patients,
• Formulary positioning and payer coverage,
• Competition-driven net price erosion and rebates.

Data note: No company financial statements, net sales numbers, or payer contract data are included in the prompt. A quantified revenue exposure model cannot be produced.

Key commercial readouts to track next for VIZIMPRO (instrumented for decision-making)

Even without numeric revenue data, the market can be monitored through predictable leading indicators:

• Share in EGFR Ex19 del/L858R first-line: trends in prescriptions and persistence.
• Time-on-therapy and discontinuation causes: rash/diarrhea management can dictate switching.
• Formulary status: tier placement, prior authorization policies, and step therapy rules.
• Net price changes: reimbursement headwinds as competition expands.
• Patent/litigation cadence: any new Paragraph IV filings, district court decisions, or stipulations.

Key Takeaways

• VIZIMPRO’s financial trajectory is structurally driven by first-line adoption in EGFR Ex19 del/L858R metastatic NSCLC and by erosion from competing next-gen EGFR TKIs as real-world tolerability and sequencing preferences evolve.
• Generic entry risk is determined by the Orange Book blocking patent set and the outcome of Paragraph IV litigation or settlements, not by compound expiry alone.
• A legally actionable exclusivity and generic-launch timeline cannot be stated from the prompt because Orange Book listing contents, patent-by-patent expiration dates, and litigation records are not provided.

FAQs

1. When can generic VIZIMPRO launch in the US if all patents expire?
2. Do Orange Book formulation patents delay generic dacomitinib tablets even after compound expiry?
3. What sequencing choices reduce or increase VIZIMPRO first-line demand?
4. Are there any biosimilar risks for dacomitinib?
5. Which competitive EGFR TKIs most directly threaten VIZIMPRO share through tolerability and dosing?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
2. FDA Labels and Drug Approval Packages for VIZIMPRO (dacomitinib). U.S. Food and Drug Administration. (Database).

DrugChatter Q&A for VIZIMPRO

Pfizer vizimpro patent expiration date?
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