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Last Updated: April 19, 2024

Nintedanib esylate - Generic Drug Details

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What are the generic drug sources for nintedanib esylate and what is the scope of patent protection?

Nintedanib esylate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nintedanib esylate has two hundred and forty-three patent family members in fifty-three countries.

There are eight drug master file entries for nintedanib esylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for nintedanib esylate

International Patents:	243
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	148
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nintedanib esylate
DailyMed Link:	nintedanib esylate at DailyMed

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

Generic Entry Date for nintedanib esylate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CAPSULE;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.

Generic filers with tentative approvals for NINTEDANIB ESYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 150MG BASE	CAPSULE;ORAL

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

Pharmacology for nintedanib esylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for NINTEDANIB ESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFEV	Capsules	nintedanib esylate	100 mg and 150 mg	205832	4	2018-10-15

US Patents and Regulatory Information for nintedanib esylate

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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
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>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 nintedanib esylate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for nintedanib esylate

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Country	Patent Number	Title	Estimated Expiration
China	1391557		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	0127081		⤷ Try a Trial
European Patent Office	1830843	MEDICAMENTS POUR LE TRAITEMENT OU LA PREVENTION DE MALADIES FIBROTIQUES (INDOLIDONE DERIVATIVES FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES)	⤷ Try a Trial
Australia	1023301		⤷ Try a Trial
Germany	10233500	3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylen]-6-methoxycarbonyl-2-indolinon-Monoethansulfonat und dessen Verwendung als Arzneimittel	⤷ Try a Trial
Croatia	P20020306	INDOLINONI SUPSTITUIRANI U POLOŽAJU 6, NJIHOVA PRIPRAVA I NJIHOVA UPOTREBA KAO FARMACEUTSKIH PRIPRAVAKA (6-POSITION SUBSTITUTED INDOLE, PRODUCTION AND USE THEREOF AS A MEDICAMENT)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for nintedanib esylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	122015000023	Germany	⤷ Try a Trial	PRODUCT NAME: NINTEDANIB, DESSEN TAUTOMERE UND DESSEN SALZE, INSBESONDERE NINTEDANIB UND PHYSIOLOGISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1830843	C 2015 026	Romania	⤷ Try a Trial	PRODUCT NAME: NINTEDANIB SAU UN TAUTOMER SAU AMESTECURI ALE ACESTORA SAU O SARE A ACESTORA, IN SPECIAL ESILAT DE NINTEDANIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/979/001-004; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/979/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20150115
1830843	1590034-3	Sweden	⤷ Try a Trial	PRODUCT NAME: NINTEDANIB, OR A TAUTOMER, THE MIXTURES THEREOF ORA SALT THEROF; IN PARTICULAR NINTEDANIB ESILATE; REG. NO/DATE: EU/1/14/979 20150119
1830843	00160	Estonia	⤷ Try a Trial
1830843	41/2015	Austria	⤷ Try a Trial	PRODUCT NAME: NINTEDANIB, ODER EIN TAUTOMER, EINE MISCHUNG HIEVON ODER EIN SALZ HIEVON; INBESONDERE NINTEDANIB ESILATE.; REGISTRATION NO/DATE: EU/1/14/979 20150119
1830843	PA2015025,C1830843	Lithuania	⤷ Try a Trial	PRODUCT NAME: NINTEDANIBAS ARBA JO TAUTOMERAS, ARBA JU MISINIAI, ARBA JO DRUSKA; KONKRECIAI NINTEDANIBO ESILATAS; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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