Brigatinib - Generic Drug Details

What are the generic sources for brigatinib and what is the scope of freedom to operate?

Brigatinib is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brigatinib has ninety patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for brigatinib

International Patents:	90
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	29
Patent Applications:	1,537
What excipients (inactive ingredients) are in brigatinib?	brigatinib excipients list
DailyMed Link:	brigatinib at DailyMed

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

Constraining patent/regulatory exclusivity:

10,385,078

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 brigatinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
ETOP IBCSG Partners Foundation	Phase 2
Yonsei University	Phase 2
Nuvalent Inc.	Phase 1/Phase 2

See all brigatinib clinical trials

Pharmacology for brigatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inducers Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for brigatinib

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for brigatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	No	9,273,077
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No	10,385,078		Y	Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No	9,611,283
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-002	Apr 28, 2017		RX	Yes	No	9,611,283
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	Yes	9,012,462			Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	Yes	9,611,283

EU/EMA Drug Approvals for brigatinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Alunbrig	brigatinib	EMEA/H/C/004248 Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.	Authorised	no	no	no	2018-11-22

International Patents for brigatinib

Country	Patent Number	Title	Estimated Expiration
Lithuania	3209647
Cyprus	1119534
Netherlands	300990
Croatia	P20201343
Norway	2300013
China	102105150	Phosphorous derivatives as kinase inhibitors
Japan	2018065864	キナーゼ阻害剤としてのリン誘導体 (PHOSPHOROUS DERIVATIVES AS KINASE INHIBITORS)

Supplementary Protection Certificates for brigatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	31/2019	Austria		PRODUCT NAME: BRIGATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 (MITTEILUNG) 20181126
2300013	PA2019510	Lithuania		PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	CA 2019 00028	Denmark		PRODUCT NAME: BRIGATINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	SPC/GB19/036	United Kingdom		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/18/1264 (NI) 20181126; UK PLGB 15475/0037 20181126; UK PLGB 15475/0038 20181126; UK PLGB 15475/0039 20181126; UK PLGB 15475/0075 20181126
2300013	PA2019510,C2300013	Lithuania		PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	2019C/525	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013	2019024	Norway		PRODUCT NAME: BRIGATINIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/18/1264 20181218

Market Dynamics and Financial Trajectory for Brigatinib

Introduction to Brigatinib

Brigatinib, marketed as Alunbrig, is a next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) used primarily in the treatment of ALK-positive non-small cell lung cancer (NSCLC). Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global brigatinib tablet market has been experiencing steady growth. As of 2023, the market size was valued at USD 179 million. It is projected to reach USD 286.4 million by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 7.0% during this period[4].

Market Segmentation

The brigatinib tablet market is segmented based on several key factors:

By Type

• The market is primarily split into three dosage types: 30mg, 50mg, and 180mg[1][4].

By Application

• The primary applications are in hospitals and pharmacies[1][4].

By Geography

• Major regions include the United States, Europe, China, Japan, India, Southeast Asia, Latin America, and the Middle East and Africa[1].

Driving Factors

Several factors are driving the growth of the brigatinib market:

Increasing Incidence of ALK-Positive NSCLC

• The rising incidence of ALK-positive NSCLC is a significant driver, as brigatinib is specifically targeted at this patient population[4].

Advancements in Targeted Cancer Therapies

• Continuous advancements in targeted cancer therapies have improved the efficacy and safety profile of brigatinib, making it a preferred option for treating ALK-positive NSCLC[4].

Competitive Landscape

The market for ALK TKIs is competitive, with several key players:

Major Players

• ARIAD Pharmaceuticals, now part of Takeda Pharmaceutical Company, is a major player in the brigatinib market[1].

Comparative Analysis

• Brigatinib competes with other ALK TKIs such as crizotinib, alectinib, ceritinib, and lorlatinib. Studies have shown that brigatinib offers superior efficacy in terms of progression-free survival (PFS) and overall survival compared to some of these competitors[2][3][5].

Cost-Effectiveness and Financial Considerations

The cost-effectiveness of brigatinib is a critical aspect of its market dynamics:

Cost-Effectiveness Analysis

• Studies have indicated that while brigatinib is more expensive than some of its competitors, it offers significant gains in quality-adjusted life years (QALYs). For instance, brigatinib was found to be cost-effective beyond willingness-to-pay thresholds of $236,000 per QALY compared to crizotinib and alectinib[3].

Incremental Cost-Effectiveness Ratio (ICER)

• The base-case ICER for brigatinib versus crizotinib was estimated at $217,607 per QALY gained, highlighting the higher costs associated with brigatinib but also its superior efficacy[3].

Treatment Costs

• The total costs associated with brigatinib treatment are higher due to its longer treatment duration and superior efficacy. For example, the total cost difference between brigatinib and crizotinib was estimated to be around $210,519, driven by the increased time on treatment with brigatinib[3].

Clinical Efficacy and Impact on Market

The clinical efficacy of brigatinib has been a significant factor in its market success:

Prolonged Progression-Free Survival

• Brigatinib has demonstrated a 51% reduction in the risk of disease progression or death compared to crizotinib, with a hazard ratio of 0.49 (95% CI, 0.35-0.68)[5].

Long-Term Follow-Up

• Long-term follow-up data from the ALTA-1L trial have reinforced brigatinib's effectiveness, showing it delayed disease progression by more than two years and significantly reduced the risk of disease progression in patients with baseline brain metastasis[5].

Regulatory Approvals and Global Availability

Brigatinib has received regulatory approvals in several regions:

FDA Approval

• Brigatinib is approved by the FDA for the treatment of people with ALK-positive metastatic NSCLC whose disease has progressed on or were intolerant of crizotinib[5].

Global Submissions

• Takeda Pharmaceutical Company is working to submit the updated data from the ALTA-1L trial to regulatory authorities globally to expand the availability of brigatinib for ALK-positive NSCLC patients worldwide[5].

Future Outlook

The future outlook for the brigatinib market is promising:

Technological Innovations

• Ongoing technological innovations and advancements are expected to further optimize the performance of brigatinib, potentially expanding its applications in the downstream market[1].

Market Expansion

• The market is expected to grow as brigatinib becomes more widely available and accepted as a first-line treatment for ALK-positive NSCLC patients[4].

Key Takeaways

• Market Growth: The global brigatinib tablet market is projected to reach USD 286.4 million by 2030, with a CAGR of 7.0%.
• Segmentation: The market is segmented by type (30mg, 50mg, 180mg) and application (hospitals, pharmacies).
• Driving Factors: Increasing incidence of ALK-positive NSCLC and advancements in targeted cancer therapies.
• Cost-Effectiveness: Brigatinib is cost-effective beyond certain willingness-to-pay thresholds despite higher costs.
• Clinical Efficacy: Demonstrated superior PFS and overall survival compared to competitors.
• Regulatory Approvals: Approved by the FDA and undergoing global regulatory submissions.

FAQs

Q: What is the expected market size of the brigatinib tablet market by 2030?

• The global brigatinib tablet market is expected to reach USD 286.4 million by 2030[4].

Q: What is the CAGR of the brigatinib tablet market from 2023 to 2030?

• The brigatinib tablet market is expected to exhibit a CAGR of 7.0% from 2023 to 2030[4].

Q: What are the primary driving factors for the brigatinib tablet market?

• The primary driving factors are the increasing incidence of ALK-positive NSCLC and advancements in targeted cancer therapies[4].

Q: How does brigatinib compare to other ALK TKIs in terms of cost-effectiveness?

• Brigatinib is cost-effective beyond certain willingness-to-pay thresholds despite being more expensive than some competitors, offering significant gains in QALYs[3].

Q: What are the key clinical benefits of brigatinib over its competitors?

• Brigatinib has demonstrated a 51% reduction in the risk of disease progression or death compared to crizotinib and significantly improved PFS and overall survival[5].

Sources

1. Global Brigatinib Tablet Market Research Report 2022 - Market Size, Current Insights and Development Trends[1].
2. Cost-effectiveness of ensartinib, crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib - Frontiers in Public Health[2].
3. The cost-effectiveness of brigatinib in adult patients with ALK-positive non-small cell lung cancer - PubMed[3].
4. Brigatinib Tablet Market- Forecast From 2024 To 2032 - Business Research Insights[4].
5. Brigatinib Maintains PFS Benefit in Frontline ALK+ NSCLC at Long-Term Follow-Up - OncLive[5].

Last updated: 2024-12-16