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-four 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:	244
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for NINTEDANIB ESYLATE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No	⤷ 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 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	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014	⤷ Sign Up	⤷ Sign Up
>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
Eurasian Patent Organization	200500146	МОНОЭТАНСУЛЬФОНАТ 3-Z-[1-4-(N-((4-МЕТИЛПИПЕРАЗИН-1-ИЛ)МЕТИЛКАРБОНИЛ)-N-МЕТИЛАМИНО)АНИЛИНО)-1-ФЕНИЛМЕТИЛЕН]-6-МЕТОКСИКАРБОНИЛ-2-ИНДОЛИНОНА И ЕГО ПРИМЕНЕНИЕ В СОСТАВЕ ФАРМАЦЕВТИЧЕСКОЙ КОМПОЗИЦИИ	⤷ Sign Up
Denmark	2878297		⤷ Sign Up
China	105193720	CAPSULE PHARMACEUTICAL DOSAGE FORM COMPRISING A SUSPENSION FORMULATION OF AN INDOLINONE DERIVATIVE	⤷ Sign Up
European Patent Office	2157081		⤷ Sign Up
Saudi Arabia	1864	المركب indolinone-monoethanesulphonate methylene]-6-methoxycarbony1-2- N-methy1-amino) -anilino)-1-pheny1-methy1-amino)-anilino)-1pheny1-methy1-piperazin-1-y1)-methylcarbony1)-3-Z-[1-(4-(N))4-	⤷ Sign Up
South Korea	20170020557	인돌리논 유도체의 현탁 제형을 포함하는 캡슐 약제학적 투여 형태 (Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative)	⤷ Sign Up
>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	300725	Netherlands	⤷ Sign Up	PRODUCT NAME: NINTEDANIB, DE TAUTOMEREN DAARVAN EN DE ZOUTEN DAARVAN, IN HET BIJZONDER NINTEDANIB EN FYSIOLOGISCH AANVAARDBARE ZOUTEN DAARVAN, MET NAME NINEDANIBESILAAT; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141125
1224170	122015000023	Germany	⤷ Sign Up	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	CA 2015 00036	Denmark	⤷ Sign Up	PRODUCT NAME: NINTEDANIB ELLER EN TAUTOMER, BLANDINGERNE DERAF ELLER ET SALT DERAF, SAERLIGT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/979/001-004 20150115
1830843	1590034-3	Sweden	⤷ Sign Up	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	PA2015025,C1830843	Lithuania	⤷ Sign Up	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
1224170	17/2015	Austria	⤷ Sign Up	PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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