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 four patents protecting this drug.

This drug has ninety-four patent family members in forty-eight 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:	94
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	5
Patent Applications:	155
Drug Prices:	Drug price information 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

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 four US patents and two FDA Regulatory Exclusivities.

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
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No			Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes			Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes

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

International Patents for VIZIMPRO

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

Country	Patent Number	Title	Estimated Expiration
Austria	E533490
New Zealand	550796	4-phenylamino-quinazolin-6-yl-amides
Montenegro	01267	4-FENILAMINOKINAZOLIN-6-ILAMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Japan	4966923
Norway	2019035
World Intellectual Property Organization (WIPO)	2005107758

Supplementary Protection Certificates for VIZIMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1848414	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204
1848414	CA 2016 00033	Denmark		PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1746999	43/2019	Austria		PRODUCT NAME: DACOMITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DACOMITINIBMONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 (MITTEILUNG) 20190404
1746999	CR 2019 00043	Denmark		PRODUCT NAME: DACOMITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1354 20190404
1746999	2019C/540	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
1746999	705	Finland

Market Dynamics and Financial Trajectory for VIZIMPRO (Dacomitinib)

Introduction to VIZIMPRO

VIZIMPRO (dacomitinib) is a tyrosine kinase inhibitor (TKI) approved for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations. Here, we delve into the market dynamics and financial trajectory of this significant oncology drug.

Regulatory Approval and Market Authorization

VIZIMPRO received marketing authorization from the European Commission on April 2, 2019, for its use in treating EGFR-mutated NSCLC. This approval was based on data from the ARCHER 1050 clinical trial, which demonstrated a significant improvement in progression-free survival (PFS) compared to gefitinib, another TKI[1][4].

Clinical Efficacy and Competitive Landscape

The clinical efficacy of VIZIMPRO has been a key factor in its market positioning. The drug showed a more than five-month improvement in PFS over gefitinib in the ARCHER 1050 trial. This improvement, along with its manageable side effect profile, has made VIZIMPRO a preferred option for patients with EGFR-mutated NSCLC[1][4].

In the competitive landscape of oncology treatments, VIZIMPRO competes with other TKIs and targeted therapies. The market is highly dynamic, with continuous advancements in biomarker-driven therapies and the emergence of new treatments. However, VIZIMPRO's efficacy and safety profile have helped it maintain a strong position in the market.

Market Growth and Specialty Pharmacy Trends

The specialty pharmacy market, which includes drugs like VIZIMPRO, continues to grow rapidly. Specialty pharmaceuticals now account for more than 46% of the total spend on drugs in the U.S., despite being used for small and targeted patient populations. This trend is expected to persist, with costs for branded and specialty drugs, particularly in oncology and immunology, continuing to rise[3].

Financial Performance of Pfizer

Pfizer, the manufacturer of VIZIMPRO, has seen significant financial fluctuations in recent years, largely due to the impact of COVID-19-related products like Comirnaty and Paxlovid. In 2023, Pfizer reported full-year revenues of $58.5 billion, a decrease of 42% compared to 2022, primarily due to the decline in revenues from these COVID-19 products. However, excluding these contributions, Pfizer's revenues grew 7% operationally, driven by new product and indication launches, including contributions from VIZIMPRO[2].

Revenue Contributions

While VIZIMPRO is not explicitly highlighted as a major revenue driver in Pfizer's financial reports, it is part of the broader oncology portfolio that has contributed to the company's operational revenue growth. The acquisition of Seagen in 2023 further solidified Pfizer's position in the oncology market, which includes VIZIMPRO[2].

Cost and Pricing Dynamics

The cost of pharmaceuticals, including specialty drugs like VIZIMPRO, continues to be a significant concern for healthcare organizations. Despite efforts to manage drug prices, the forecast indicates a continued increase in pharmaceutical costs. For instance, Vizient’s Drug Price Forecast predicted a 4.92% increase in pharmaceutical prices in 2019, which, although slower than previous years, still represents a substantial impact on healthcare budgets[3].

Biosimilars and Generic Competition

The emergence of biosimilars and generic drugs is expected to influence the pricing dynamics of branded drugs like VIZIMPRO. However, the biosimilar market is still in its formative stage and has not yet had a significant impact on pricing behaviors. As more biosimilars enter the market, they may offer competitive pricing options, potentially affecting the market share of branded drugs[3].

Future Outlook and Growth Potential

Pfizer's ongoing commitment to oncology, including the development and marketing of VIZIMPRO, positions the company for future growth. The acquisition of Seagen and the realignment of Pfizer's commercial organization are strategic moves aimed at improving focus, speed, and execution in the oncology sector. These initiatives are expected to drive growth and enhance Pfizer's market presence in the coming years[2].

Key Takeaways

• Regulatory Approval: VIZIMPRO received EU marketing authorization in 2019 for the first-line treatment of EGFR-mutated NSCLC.
• Clinical Efficacy: The drug has shown significant improvement in PFS compared to other TKIs.
• Market Trends: Specialty pharmacy market growth, including oncology drugs, continues to drive pharmaceutical spending.
• Financial Performance: Pfizer's revenues, excluding COVID-19 products, have shown operational growth, with VIZIMPRO contributing to the oncology portfolio.
• Cost and Pricing: Pharmaceutical costs are expected to rise, with biosimilars potentially influencing future pricing dynamics.
• Future Outlook: Pfizer's strategic moves in oncology, including the Seagen acquisition, position the company for future growth.

FAQs

What is VIZIMPRO used for?

VIZIMPRO is used for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-activating mutations.

When did VIZIMPRO receive EU marketing authorization?

VIZIMPRO received EU marketing authorization on April 2, 2019[1][4].

How does VIZIMPRO compare to other TKIs in clinical trials?

VIZIMPRO showed a more than five-month improvement in progression-free survival (PFS) over gefitinib in the ARCHER 1050 clinical trial[1][4].

What is the impact of biosimilars on the pricing of branded drugs like VIZIMPRO?

Biosimilars are expected to influence pricing dynamics, but their current impact is minimal as the market is still in its formative stage[3].

How has Pfizer's financial performance been affected by VIZIMPRO and other oncology products?

Pfizer's revenues, excluding contributions from COVID-19 products, have shown operational growth driven by new product and indication launches, including contributions from its oncology portfolio, which includes VIZIMPRO[2].

Sources

1. Pfizer Inc. - VIZIMPRO® (dacomitinib) Receives Marketing Authorization in European Union (EU) for the First-Line Treatment of Adult Patients with EGFR-Mutated Non-Small Cell Lung Cancer.
2. Pfizer Inc. - Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance.
3. Managed Healthcare Executive - This Drug Spending Trend May Surprise You.
4. European Medicines Agency (EMA) - Vizimpro.