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ALUNBRIG Drug Profile

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

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

This drug has seventy-five patent family members in thirty-five 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 will be eligible for patent challenges on April 28, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	75
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	45
Clinical Trials:	8
Patent Applications:	292
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 Generic Entry Opportunity Date for ALUNBRIG

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
The Children's Tumor Foundation	Phase 2
Scott R. Plotkin, MD, PhD	Phase 2
Takeda	Phase 2

See all ALUNBRIG clinical trials

Pharmacology for ALUNBRIG

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

US Patents and Regulatory Information for ALUNBRIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ariad	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No
Ariad	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	Yes
Ariad	ALUNBRIG	brigatinib	TABLET;ORAL	208772-003	Oct 2, 2017		RX	Yes	Yes
Ariad	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No
Ariad	ALUNBRIG	brigatinib	TABLET;ORAL	208772-001	Apr 28, 2017		RX	Yes	No				Y

International Patents for ALUNBRIG

Country	Patent Number	Estimated Expiration
Japan	2011523646
European Patent Office	3760618
Lithuania	3209647
Norway	2019024
Japan	2017186345

Supplementary Protection Certificates for ALUNBRIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2300013	C201930036	Spain		PRODUCT NAME: BRIGATINIB, O SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1264; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1264; DATE OF FIRST AUTHORISATION IN EEA: 20181122
2300013	CA 2019 00028	Denmark		PRODUCT NAME: BRIGATINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/18/1264 20181126
2300013	19C1033	France		PRODUCT NAME: BRIGATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013	2019/031	Ireland		PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013	2019C/525	Belgium		PRODUCT NAME: BRIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126