ALUNBRIG Drug Patent Profile

Which patents cover Alunbrig, and what generic alternatives are available?

Alunbrig is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.

This drug has ninety patent family members in thirty-nine countries.

The generic ingredient in ALUNBRIG is brigatinib. One supplier is listed for this compound. Additional details are available on the brigatinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Alunbrig

Alunbrig was eligible for patent challenges on April 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 10, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ALUNBRIG

International Patents:	90
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	10
Patent Applications:	1,541
Drug Prices:	Drug price information for ALUNBRIG
What excipients (inactive ingredients) are in ALUNBRIG?	ALUNBRIG excipients list
DailyMed Link:	ALUNBRIG at DailyMed

See drug prices for ALUNBRIG

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

Constraining patent/regulatory exclusivity:

10,385,078

NDA:

208772

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 ALUNBRIG

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

Sponsor	Phase
Intergroupe Francophone de Cancerologie Thoracique	Phase 2
Takeda	Phase 1/Phase 2
Princess Maxima Center for Pediatric Oncology	Phase 1/Phase 2

See all ALUNBRIG clinical trials

Pharmacology for ALUNBRIG

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

US Patents and Regulatory Information for ALUNBRIG

ALUNBRIG is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,385,078.

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
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	9,273,077
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No	9,012,462			Y
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	Yes	9,273,077

EU/EMA Drug Approvals for ALUNBRIG

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 ALUNBRIG

When does loss-of-exclusivity occur for ALUNBRIG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Peru

Philippines

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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

See the table below for additional patents covering ALUNBRIG around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2300013
Croatia	P20171534
Lithuania	C2300013
South Korea	20110010801	PHOSPHOROUS DERIVATIVES AS KINASE INHIBITORS

Supplementary Protection Certificates for ALUNBRIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	132019000000069	Italy		PRODUCT NAME: BRIGATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ALUNBRIG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1264, 20181126
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	363 50014-2019	Slovakia		OWNER(S): TAKEDA PHARMACEUTICAL COMPANY LIMITED, CHUO-KU, OSAKA-SHI, OSAKA, JP; PREDCHADZAJUCI MAJITEL: DYAX CORP., LEXINGTON, MA, US; DATUM ZAPISU DO REGISTRA: 4.4.2022

Market Dynamics and Financial Trajectory for ALUNBRIG

Introduction to ALUNBRIG

ALUNBRIG, also known as brigatinib, is a next-generation tyrosine kinase inhibitor (TKI) developed by Takeda Pharmaceutical Company Limited. It is specifically designed to target and inhibit anaplastic lymphoma kinase (ALK) genetic alterations, primarily used in the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC)[3].

Market Size and Growth Projections

The global ALUNBRIG market has been witnessing significant growth. As of 2023, the market size was valued at approximately $182.9 million. It is projected to reach $349.7 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period of 2024-2030[1].

Another report indicates that the market size was valued at $100 million in 2023 and is expected to grow to $194.87 million by 2031, with a CAGR of 10% from 2024 to 2031. This growth is driven by increasing clinical applications, rising incidence of ALK-positive NSCLC, and positive clinical trial results[4].

Key Drivers of Market Growth

Several factors are driving the growth of the ALUNBRIG market:

Increasing Incidence of ALK-positive NSCLC

The rising incidence of ALK-positive NSCLC, particularly in younger and non-smoking populations, is a significant driver. Early detection and better diagnostic tools are making it possible to identify and treat this condition more effectively[4].

Regulatory Approvals

ALUNBRIG has gained regulatory approvals in major markets such as the U.S., Canada, and the European Union. This has expanded its market reach and facilitated access to new patient populations. For instance, the U.S. FDA granted priority review for ALUNBRIG as a first-line treatment for ALK+ metastatic NSCLC in 2020[3].

Clinical Trial Outcomes

Positive outcomes from clinical trials, such as the Phase 3 ALTA-1L trial, have demonstrated the superiority of ALUNBRIG over other ALK inhibitors like crizotinib in terms of progression-free survival (PFS). These results have bolstered the drug's reputation and adoption[3].

Strategic Alliances and R&D Investments

Pharmaceutical companies, including Takeda, are investing heavily in research and development to enhance medication formulations and delivery systems. Strategic alliances and acquisitions are also contributing to market expansion by fostering innovation and increasing market reach[4].

Financial Performance of Takeda Pharmaceutical

Takeda's financial performance provides insights into the commercial success of ALUNBRIG.

Revenue Growth

In the fiscal year ended March 31, 2023, Takeda's revenue increased by 12.8% to 4,027.5 billion JPY, partly due to the strong performance of its core therapeutic areas, including Oncology. ALUNBRIG specifically saw a significant increase, with sales growing by 55% in fiscal year 2021 compared to the previous year[2][5].

Operating Profit and Net Profit

Takeda's operating profit and net profit also showed positive trends. For the fiscal year ended March 31, 2023, the operating profit increased by 6.4%, and the net profit for the year rose by 37.7% compared to the previous fiscal year[2].

Segmentation and Application

The ALUNBRIG market is segmented based on type (tablets, capsules, injectables, oral suspensions) and application (non-small cell lung cancer, ALK-positive lung cancer, metastatic cancer, refractory cancer). Geographically, the market spans regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[4].

Competitive Landscape

Takeda is the primary player in the ALUNBRIG market. The company's strong research and development capabilities, along with its robust pipeline of potential therapies, position it well in the competitive landscape of oncology treatments[1].

Challenges and Opportunities

Despite the positive growth trajectory, there are challenges to consider:

Generic Erosion and Competition

The oncology segment faces intense competition, and generic erosion can impact sales of certain products. For instance, Takeda experienced a decline in revenue from some oncology products due to generic competition in the fiscal year ended March 31, 2023[2].

Regulatory and Market Access

Regulatory approvals and market access are crucial for the continued growth of ALUNBRIG. Any changes in regulatory environments or challenges in accessing new markets could impact the drug's sales.

Future Outlook

The future outlook for ALUNBRIG is promising, driven by its expanding clinical applications, positive clinical trial results, and increasing awareness among patients and healthcare professionals. As diagnostic tools improve and the incidence of ALK-positive NSCLC rises, the demand for effective treatments like ALUNBRIG is expected to grow.

Key Takeaways

• The ALUNBRIG market is projected to grow significantly, with a CAGR of 6.7% from 2024 to 2030.
• Positive clinical trial outcomes and regulatory approvals are key drivers of market growth.
• Takeda's strong financial performance and investments in R&D support the drug's commercial success.
• The market is segmented by type and application, with a global reach across various regions.
• Despite challenges like generic erosion, the future outlook for ALUNBRIG remains positive.

Frequently Asked Questions (FAQs)

What is ALUNBRIG used for?

ALUNBRIG is used for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC), particularly in patients who have progressed on or are intolerant to crizotinib[3].

Who is the primary manufacturer of ALUNBRIG?

Takeda Pharmaceutical Company Limited is the primary manufacturer of ALUNBRIG[1].

What is the projected market size of ALUNBRIG by 2030?

The ALUNBRIG market is expected to reach $349.7 million by 2030[1].

What are the key drivers of the ALUNBRIG market growth?

Key drivers include increasing clinical applications, rising incidence of ALK-positive NSCLC, positive clinical trial results, and regulatory approvals[4].

In which regions is the ALUNBRIG market segmented?

The ALUNBRIG market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[4].

Cited Sources:

1. Global Alunbrig Market Research Report 2024 - Valuates Reports
2. Summary of Financial Statements for the Fiscal Year Ended March 31, 2023 - Takeda Pharmaceutical
3. Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG - Takeda Pharmaceutical
4. Alunbrig Market Market Size, Global Trends | Forecast 2024-2031 - Market Research Intellect
5. Takeda Delivers Strong FY2021 Results; Continued Growth Momentum Expected in FY2022 - BioSpace

Last updated: 2024-12-16