DACOMITINIB - Generic Drug Details

What are the generic sources for dacomitinib and what is the scope of patent protection?

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-four patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for DACOMITINIB

International Patents:	94
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

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
MedSIR	Phase 2
Daiichi Sankyo, Inc.	Phase 2
Shanghai Chest Hospital	Phase 1/Phase 2

See all DACOMITINIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DACOMITINIB

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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

International Patents for DACOMITINIB

Country	Patent Number	Title	Estimated Expiration
Croatia	P20110958
China	113952338	治疗吉非替尼耐药性癌症的方法 (Method for treating gefitinib resistant cancer)
Morocco	28632	4- PHENYLAMINO-QUINAZOLINE-6-YL-AMIDES
Netherlands	1028967	4-Fenylamino-chinazoline-6-yl-amiden.

Supplementary Protection Certificates for DACOMITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	C20190030 00298	Estonia		PRODUCT NAME: DAKOMITINIIB;REG NO/DATE: EU/1/19/1354 04.04.2019
1746999	19C1052	France		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	2019C/540	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
1848414	C20160024 00190	Estonia		PRODUCT NAME: OSIMERTINIIB;REG NO/DATE: EU/1/16/1086 04.02.2016

DACOMITINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dacomitinib

Introduction

Dacomitinib, marketed under the brand name Vizimpro, is a second-generation tyrosine kinase inhibitor (TKI) approved for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. Here, we delve into the market dynamics and financial trajectory of dacomitinib, examining its cost-effectiveness, market positioning, and financial implications.

Approval and Clinical Efficacy

Dacomitinib was approved by the FDA in September 2018 based on the results of the ARCHER 1050 trial, which demonstrated a significant improvement in progression-free survival (PFS) compared to gefitinib. The trial showed a median PFS of 14.7 months for dacomitinib versus 9.2 months for gefitinib, with a hazard ratio of 0.59[5].

Cost-Effectiveness Analysis

The cost-effectiveness of dacomitinib has been evaluated in several studies across different healthcare systems.

Comparison with Gefitinib

In a study conducted in the Netherlands, dacomitinib was found to yield 0.37 more quality-adjusted life years (QALYs) than gefitinib, but at an incremental cost of €68,001. This resulted in an incremental cost-effectiveness ratio (ICER) of €181,558 per QALY. However, dacomitinib was not considered cost-effective at a threshold of €80,000 per QALY[2].

Chinese Healthcare System Perspective

A study from the Chinese healthcare system perspective found that dacomitinib was associated with higher costs and QALY gains compared to gefitinib. The ICER was calculated to be CNY 58,947 per QALY, indicating that dacomitinib is a cost-effective treatment strategy in this setting, with a 97% probability of being cost-effective in probabilistic sensitivity analysis[3].

Other Comparisons

In another analysis, dacomitinib resulted in a gain of 0.3377 QALYs and an incremental cost of US$6,665 compared to gefitinib, suggesting varying levels of cost-effectiveness depending on the healthcare system and economic models used[4].

Market Positioning

Dacomitinib competes in the market with other EGFR TKIs such as gefitinib, afatinib, and osimertinib. Its approval for first-line treatment in patients with specific EGFR mutations positions it as a preferred option for this patient subgroup.

Competitive Landscape

• Gefitinib: While gefitinib is a first-generation EGFR TKI, dacomitinib has shown superior PFS in clinical trials, making it a more attractive option for patients with EGFR exon 19 deletion or exon 21 L858R substitution mutations[5].
• Afatinib and Osimertinib: These second-generation and third-generation EGFR TKIs, respectively, also compete in the market. However, dacomitinib's unique efficacy profile and side effect management strategies differentiate it from these competitors[1][2].

Financial Implications

The financial trajectory of dacomitinib is influenced by several factors, including its pricing, market demand, and reimbursement policies.

Pricing and Costs

The cost of dacomitinib treatment is significant, with estimated annual costs per patient ranging from €32,900 to €45,000, depending on the healthcare system and treatment duration[2].

<blockquote>
"The costs per patient per year for Dacomitinib are around €32.900"[2].
</blockquote>

Reimbursement and Access

Reimbursement policies vary by country and can significantly impact the financial viability of dacomitinib. In some regions, the drug may be reimbursed based on its cost-effectiveness, while in others, it may face stringent criteria for reimbursement[2][3].

Market Demand

The demand for dacomitinib is driven by the prevalence of EGFR-mutation-positive NSCLC. Between 9.1% and 20% of all NSCLC patients have EGFR activating mutations, providing a substantial market for this drug[2].

Sensitivity and Uncertainty Analysis

Sensitivity analyses have shown that the cost-effectiveness of dacomitinib is most responsive to variations in drug prices, utility values, and healthcare resource use. A significant price reduction would be necessary for dacomitinib to meet cost-effectiveness thresholds in some settings[2][3].

Policy Implications

The cost-effectiveness and financial trajectory of dacomitinib have important policy implications. Healthcare systems must weigh the benefits of improved survival and quality of life against the high costs of the drug. This often involves complex decision-making processes, including considerations of budget impact and societal willingness to pay[2][3].

Conclusion

Dacomitinib's market dynamics and financial trajectory are complex and multifaceted. While it offers significant clinical benefits, particularly in terms of PFS, its high cost poses challenges for cost-effectiveness and reimbursement. The drug's positioning in the market is strong due to its efficacy profile, but ongoing research and long-term data are necessary to fully understand its financial implications.

Key Takeaways

• Dacomitinib is approved for first-line treatment of EGFR-mutation-positive NSCLC.
• It has shown superior PFS compared to gefitinib in clinical trials.
• Cost-effectiveness varies by healthcare system, with higher costs but also higher QALY gains.
• Pricing and reimbursement policies significantly impact its financial trajectory.
• Market demand is driven by the prevalence of EGFR-mutation-positive NSCLC.

FAQs

Q: What is the primary indication for dacomitinib?

A: Dacomitinib is approved for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations.

Q: How does dacomitinib compare to gefitinib in terms of progression-free survival?

A: Dacomitinib has shown a significant improvement in progression-free survival (PFS) compared to gefitinib, with a median PFS of 14.7 months versus 9.2 months for gefitinib.

Q: Is dacomitinib cost-effective in all healthcare systems?

A: No, the cost-effectiveness of dacomitinib varies by healthcare system. While it is considered cost-effective in some settings, it may not meet cost-effectiveness thresholds in others due to its high cost.

Q: What are the common adverse reactions associated with dacomitinib?

A: Common adverse reactions include diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

Q: How does the pricing of dacomitinib impact its market dynamics?

A: The high pricing of dacomitinib significantly impacts its market dynamics, affecting its cost-effectiveness and reimbursement. A substantial price reduction would be necessary for it to meet cost-effectiveness thresholds in some settings.