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Last Updated: April 3, 2020

DrugPatentWatch Database Preview

OFEV Drug Profile


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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-four 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.

US ANDA Litigation and 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for OFEV
Drug Prices for OFEV

See drug prices for OFEV

Generic Entry Opportunity Date for OFEV
Generic Entry Date for OFEV*:
Constraining patent/regulatory exclusivity:
NDA:
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 ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for OFEV
(3Z)-2,3-Dihydro-3-[[[4-[methyl[2-(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-1H-indole-6-carboxylic acid methyl ester ethanesulfonate
(Z)-Methyl 3-((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)-phenylamino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
(Z)-methyl 3-((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenylamino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
1160294-26-7
1H-Indole-6-carboxylic acid, 2,3-dihydro-3-(((4-(methyl(2-(4-methyl-1-piperazinyl)acetyl)amino)phenyl)amino)phenylmethylene)-2-oxo-, methyl ester, (3Z)-, ethanesulfonate (1:1)
3-[[4-[methyl-[2-(4-methyl-1-piperazinyl)-1-oxoethyl]amino]anilino]-phenylmethylidene]-2-oxo-1H-indole-6-carboxylic acid methyl ester
3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone
42F62RTZ4G
4CA-0650
656247-17-5
656247-18-6
928326-83-4
A1-04307
A16197
AB0035905
AB1006397
ABP000857
AC-25071
AC-28120
ACN-030189
ACN-050740
AK170374
AK323741
AKOS005145820
AKOS025149444
AKOS025401745
AKOS025402006
AKOS026750205
AM84929
AOB5742
BCP01744
BCP09316
BCP09963
BCP9000405
BDBM50026612
BIBF 1120
BIBF 1120 (esylate)
BIBF 1120 esylate
BIBF 1120; VARGATEF; INTEDANIB
BIBF 1120|||Intedanib|||Vargatef
BIBF-1120
BIBF1120
Bibf1120 - Vargatef
BIBF1120 (Vargatef)
BIBF1120,BIBF-1120,Vargatef/
BIBF1120,Vargatef
BRD-K49075727-001-01-0
C31H33N5O4
cc-88
CHEBI:85164
CHEBI:85170
CHEBI:91413
CHEMBL2136735
CHEMBL3039504
CS-0104
CS-3475
D10481
DB-125760
DB09079
DTXSID20918936
DTXSID40215873
EBD48532
EC-000.2311
ethanesulfonic acid;methyl (3Z)-3-[[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]anilino]-pheny
ethanesulfonic acid;methyl (3Z)-3-[[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]anilino]-phenylmethylidene]-2-oxo-1H-indole-6-carboxylate
ethanesulfonic acid;methyl 2-hydroxy-3-[N-[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]phenyl]-C-phenylcarbonimidoyl]-1H-indole-6-carboxylate
EX-A2818
EX-A341
FT-0670358
FT-0696830
FT-0772497
G6HRD2P839
GTPL5936
HMS3244B06
HMS3244B10
HMS3244B14
HMS3654A05
HSDB 8339
HY-11106
HY-50904
Intedanib
J-502642
KS-000004AN
KS-00000LA8
KS-1434
KS-1447
Methyl (3Z)-3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino) (phenyl)methylidene)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate ethanesulfonate
Methyl (3Z)-3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylidene)-2-oxo-2,3-dihydro-1h-indole-6-carboxylate
methyl (3Z)-3-[({4-[N-methyl-2-(4-methylpiperazin-1-yl)acetamido]phenyl}amino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
methyl (3Z)-3-[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}anilino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
methyl (3Z)-3-[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}anilino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate ethanesulfonate
Methyl (3Z)-3-[[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]anilino]-phenylmethylidene]-2-oxo-1H-indole-6-carboxylate
methyl (Z)-3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
Methyl (Z)-3-[[[4-[N-methyl-2-(4-methylpiperazin-1-yl)acetamido]phenyl]amino](phenyl)methylene]-2-oxoindoline-6-carboxylate
Methyl 2-hydroxy-3-[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}anilino)(phenyl)methylidene]-3H-indole-6-carboxylate
MLS006010165
NCGC00263156-01
NCGC00263156-02
NCGC00389321-03
Nintedanib
Nintedanib (BIBF 1120)
Nintedanib (BIBF-1120)
Nintedanib (USAN/INN)
Nintedanib [USAN:INN]
Nintedanib Esilate
Nintedanib esylate
Nintedanib Esylate(BIBF-1120)
Nintedanib ethanesulfonate
Nintedanib Ethanesulfonate Salt
NSC-753000
NSC753000
PubChem20543
Q15149723
Q27158380
Q27163267
QCR-43
s1010
s5234
SB11190
SC-85732
SC-90632
SCHEMBL1535871
SCHEMBL2278759
SCHEMBL431006
SCHEMBL431007
SCHEMBL753253
SMR004701273
SW218301-2
SYN1091
Tube722
UNII-42F62RTZ4G
UNII-G6HRD2P839
Vargatef
Vargatef Base
Vargatef, BIBF 1120
X7367
XZXHXSATPCNXJR-ZIADKAODSA-N
Y0352
ZINC000100014909
ZINC100014909
ZINC22449469
Paragraph IV (Patent) Challenges for OFEV
Tradename Dosage Ingredient NDA Submissiondate
OFEV CAPSULE;ORAL nintedanib esylate 205832 2018-10-15

US Patents and Regulatory Information for 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   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for OFEV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1224170 17/2015 Austria   Start Trial PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1830843 41/2015 Austria   Start 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
1224170 SPC/GB15/018 United Kingdom   Start Trial PRODUCT NAME: NINTEDANIB*, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE. *NINTEDANIB IS 3-Z-(1-(4-N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-A; REGISTERED: UK EU/1/14/954/001 20141125; UK EU/1/14/954/002 20141125; UK EU/1/14/954/003 20141125; UK EU/1/14/954/004 20141125
1830843 CR 2015 00036 Denmark   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Colorcon
AstraZeneca
Harvard Business School
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.