BINIMETINIB - Generic Drug Details

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

Binimetinib is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Binimetinib has two hundred and thirty-one patent family members in fifty-five countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for BINIMETINIB

International Patents:	231
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	94
Patent Applications:	3,165
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BINIMETINIB
What excipients (inactive ingredients) are in BINIMETINIB?	BINIMETINIB excipients list
DailyMed Link:	BINIMETINIB at DailyMed

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

Generic Entry Date for BINIMETINIB^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 BINIMETINIB

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

Sponsor	Phase
Merck Sharpe & Dohme LLC	Phase 2
National Cancer Center, Japan	Phase 2
Accord Healthcare, Inc.	Phase 3

See all BINIMETINIB clinical trials

Generic filers with tentative approvals for BINIMETINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	15MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for BINIMETINIB

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BINIMETINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEKTOVI	Tablets	binimetinib	15 mg	210498	3	2022-06-27

US Patents and Regulatory Information for BINIMETINIB

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BINIMETINIB

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	⤷ Sign Up	⤷ Sign Up
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	⤷ Sign Up	⤷ Sign Up
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for BINIMETINIB

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Mektovi	binimetinib	EMEA/H/C/004579 Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	Authorised	no	no	no	2018-09-20
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for BINIMETINIB

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Country	Patent Number	Title	Estimated Expiration
Slovenia	2470526		⤷ Sign Up
Hong Kong	1214254	抑制劑的製備和包含抑制劑的製劑 (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR MEK MEK)	⤷ Sign Up
Tunisia	2012000081	COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS	⤷ Sign Up
Argentina	099630	PREPARACIÓN DE UN INHIBIDOR DE MEK Y FORMULACIÓN QUE LO COMPRENDE	⤷ Sign Up
Poland	2727918		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BINIMETINIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2727918	122019000023	Germany	⤷ Sign Up
1482932	132019000000043	Italy	⤷ Sign Up	PRODUCT NAME: BINIMETINIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(MEKTOVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1315, 20180924
1482932	PA2019007,C1482932	Lithuania	⤷ Sign Up	PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1482932	CR 2019 00011	Denmark	⤷ Sign Up	PRODUCT NAME: BINIMETINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1315 20180924
1482932	334 8-2019	Slovakia	⤷ Sign Up	PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.