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OFEV Drug Profile
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» See Plans and PricingWhen 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
Summary for OFEV
| International Patents: | 244 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 170 |
| Patent Applications: | 92 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OFEV |
| DailyMed Link: | OFEV at DailyMed |
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 Class | Kinase Inhibitor |
| Mechanism of Action | Protein 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 |
International Patents for OFEV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2007302697 | Start Trial |
| Australia | 1023301 | Start Trial |
| European Patent Office | 2313087 | Start Trial |
| Eurasian Patent Organization | 008684 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
