NINTEDANIB ESYLATE - Generic Drug Details

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

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
		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

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

Expired US Patents for NINTEDANIB ESYLATE

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

International Patents for NINTEDANIB ESYLATE

Country	Patent Number	Title	Estimated Expiration
Australia	2003254376	3-Z-(1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-ANILINO)-1-PHENYL-METHYLENE)-6-METHOXYCARBONYL-2-INDOLINONE-MONOETHANESULPHONATE AND THE USE THEREOF AS A PHARMACEUTICAL COMPOSITION
European Patent Office	2878297	Médicaments pour le traitement ou la prévention des maladies fibrogènes (Medicaments for the treatment or prevention of fibrotic diseases)
Israel	184125	שימוש ב- 3- z - [ -1- ( 4-(n-((4-מתיל- פיפרזין-1-יל)-מתילקרבוניל)-n-מתיל-אמינו) אנילינו) -1- פניל- מתילן]- 6 מתוקסיקרבוניל- 2- אינדולינון להכנת תרופה למניעה או טיפול בפיברוסיס ריאתית אדיופטית (Use of 3-z-[1-(4-(n-((4-methyl-piperazin-1-yl)- methylcarbonyl)-n-methyl-amino)-anilino)-1-phenyl-methylene]-6 methoxycarbonyl-2-indolinone for the preparation of a medicaments for the prevention or treatment of idiopathic pulmonary fibrosis)
Eurasian Patent Organization	201001857	ФАРМАЦЕВТИЧЕСКАЯ ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ НЕМЕДЛЕННОГО ВЫСВОБОЖДЕНИЯ ПРОИЗВОДНОГО ИНДОЛИНОНА
Canada	2493310	3-Z-[1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-ANILINO)-1-PHENYL-METHYLENE]-6-METHOXYCARBONYL-2-INDOLINONE-MONOETHANESULFONATE ET UTILISATION EN TANT QUE COMPOSITION PHARMACEUTIQUE (3-Z-[1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-ANILINO)-1-PHENYL-METHYLENE]-6-METHOXYCARBONYL-2-INDOLINONE-MONOETHANESULPHONATE AND THE USE THEREOF AS A PHARMACEUTICAL COMPOSITION)
Austria	439342

Supplementary Protection Certificates for NINTEDANIB ESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	17/2015	Austria		PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1830843	C300747	Netherlands		PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115
1224170	PA2015015,C1224170	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170	1590015-2	Sweden		PRODUCT NAME: NINTEDANIB, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE; REG. NO/DATE: EU/1/14/954 20141121
1830843	300747	Netherlands		PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER, DE MENGSELS DAARVAN OF EEN ZOUT DAARVAN; IN HET BIJZONDER NINTEDANIBESILAAT; REGISTRATION NO/DATE: EU/1/14/979 20150115
1830843	122015000052	Germany		PRODUCT NAME: NINTEDANIB ODER EIN TAUTOMER, DIE MISCHUNGEN HIERVON, ODER EIN SALZ HIERVON, INSBESONDERE NINTEDANIB-ESILAT; REGISTRATION NO/DATE: EU/1/14/979/001-004 20150115