OFEV Drug Patent Profile

When do Ofev patents expire, and when can generic versions of Ofev launch?

Ofev is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty patent family members in fifty-one countries.

The generic ingredient in OFEV is nintedanib esylate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Ofev

Ofev was eligible for patent challenges on October 15, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 7, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (nintedanib esylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for OFEV

International Patents:	240
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Patent Applications:	114
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OFEV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OFEV
What excipients (inactive ingredients) are in OFEV?	OFEV excipients list
DailyMed Link:	OFEV at DailyMed

See drug prices for OFEV

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

NDA:

205832

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.

Pharmacology for OFEV

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OFEV

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

Paragraph IV (Patent) Challenges for OFEV

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 OFEV

OFEV is protected by five US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OFEV

FDA Regulatory Exclusivity protecting OFEV

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

International Patents for OFEV

When does loss-of-exclusivity occur for OFEV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OFEV around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	208954	צורת מינון רוקחית שהינה קפסולה המכילה הרכב תרחיפי של נגזרת אינדולינון (Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative)
Slovenia	1224170
Peru	20040704	MONOETANOSULFONATO DE 3-Z-[1-(4-(N-((4-METIL-PIPERAZINA-1-IL)-METILCARBONIL)-N-METIL-AMINO)-ANILINO)-1-FENIL-METILEN]-6-METOXICARBONIL-2-INDOLINONA Y PREPARACION DE MEDICAMENTOS QUE LOS COMPRENDEN
Canada	2495350	UTILISATION D'INHIBITEUR LCK POUR LE TRAITEMENT D'AFFECTIONSIMMUNOLOGIQUES (USE OF LCK INHIBITOR FOR TREATMENT OF IMMUNOLOGIC DISEASES)
South Africa	200202764	6-position substituted indoline, production and use thereof as a medicament.

Supplementary Protection Certificates for OFEV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1830843	254 5015-2015	Slovakia		PRODUCT NAME: NINTEDANIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150119
1830843	CR 2015 00036	Denmark		PRODUCT NAME: NINTEDANIB ELLER EN TAUTOMER, BLANDINGERNE DERAF ELLER ET SALT DERAF, SAERLIGT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/979/001-004 20150119
1224170	CR 2015 00019	Denmark		PRODUCT NAME: NINTEDANIB, TAUTOMERERNE OG SALTENE DERAF, SAERLIGT NINTEDANIB OG FYSIOLOGISK ACCEPTABLE SALTE DERAF, SPECIFIKT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/954/001-004 20141121
1224170	300725	Netherlands		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
1830843	00160	Estonia