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				⤷ 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	205832-001	Oct 15, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	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
>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	205832-002	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	205832-001	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
Serbia	52653	DERIVATI INDOLINONA ZA LEČENJE ILI PREVENCIJU FIBROZNIH OBOLJENJA (INDOLIDONE DERIVATIVES FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES)	⤷ Sign Up
Serbia	51013	INDOLINON SUPSTITUISAN NA POZICIJI 6, NJEGOVO DOBIJANJE I NJEGOVA UPOTREBA KAO LEKA (6-POSITION SUBSTITUTED INDOLINE, PRODUCTION AND USE THEREOF AS A MEDICAMENT)	⤷ Sign Up
Slovakia	6462002	6-POSITION SUBSTITUTED INDOLINE, PRODUCTION AND USE THEREOF AS A MEDICAMENT	⤷ Sign Up
Bulgaria	65983		⤷ 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	C01224170/01	Switzerland	⤷ Sign Up	PRODUCT NAME: NINTEDANIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65330 13.08.2015
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
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
1830843	C300747	Netherlands	⤷ Sign Up	PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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