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Last Updated: March 18, 2024

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-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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for nintedanib esylate
Generic Entry Date for nintedanib esylate*:
Constraining patent/regulatory exclusivity:
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
⤷  Try a Trial⤷  Try a TrialEQ 150MG BASECAPSULE;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 ClassKinase Inhibitor
Mechanism of ActionProtein 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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

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

International Patents for nintedanib esylate

Country Patent Number Title Estimated Expiration
Montenegro P45408 ⤷  Try a Trial
Japan 2005535684 ⤷  Try a Trial
Eurasian Patent Organization 015011 ПРИМЕНЕНИЕ 3-Z-[1-(4-(N-((4-МЕТИЛПИПЕРАЗИН-1-ИЛ)МЕТИЛКАРБОНИЛ)-N-МЕТИЛАМИНО)АНИЛИНО)-1-ФЕНИЛМЕТИЛЕН]-6-МЕТОКСИКАРБОНИЛ-2-ИНДОЛИНОНА ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРЕДУПРЕЖДЕНИЯ ФИБРОЗНЫХ ЗАБОЛЕВАНИЙ (USE OF 3-Z-[1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-ANILINO)-1-PHENYL-METHYLENE]-6-METHOXYCARBONYL-2-INDOLINONE, OR THE TAUTOMERS, THE DIASTEREOMERS, THE ENANTIOMERS, THE MIXTURES THEREOF AND THE SALTS THEREOF AS MEDICAMENT FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES) ⤷  Try a Trial
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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nintedanib esylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1830843 CA 2015 00036 Denmark ⤷  Try a 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 20150115
1830843 41/2015 Austria ⤷  Try a 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 122015000023 Germany ⤷  Try a Trial PRODUCT NAME: NINTEDANIB, DESSEN TAUTOMERE UND DESSEN SALZE, INSBESONDERE NINTEDANIB UND PHYSIOLOGISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170 C01224170/01 Switzerland ⤷  Try a Trial PRODUCT NAME: NINTEDANIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65330 13.08.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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