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.
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
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 Trial | 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 | ⤷ 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 | ⤷ 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 | 205832-001 | 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 | ⤷ 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 |
| 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 |
|---|---|---|---|
| Uruguay | 27904 | 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 SU UTILIZACIÓN COMO MEDICAMENTO | ⤷ Try a Trial |
| Japan | 2014208712 | インドリノン誘導体の懸濁液製剤を含むカプセル医薬投薬形態 (CAPSULE PHARMACEUTICAL DOSAGE FORM COMPRISING SUSPENSION FORMULATION OF INDOLINONE DERIVATIVE) | ⤷ Try a Trial |
| European Patent Office | 1224170 | INDOLINONES SUBSTITUEES EN POSITION 6, LEUR PREPARATION ET LEUR UTILISATION EN TANT QUE MEDICAMENTS (6-POSITION SUBSTITUTED INDOLINE, PRODUCTION AND USE THEREOF AS A MEDICAMENT) | ⤷ Try a Trial |
| Argentina | 026036 | INDOLINONAS SUSTITUIDAS EN POSICION 6, SU PREPARACION Y SU UTILIZACION COMO MEDICAMENTOS | ⤷ Try a Trial |
| South Korea | 100857734 | ⤷ Try a Trial | |
| Norway | 20161634 | 3-Z-[1-(4-(N-((4-metyl-piperazin-1-yl)-metylkarbonyl)-N-metyl-amino)-anilino)-1-fenyl-metylen]-6-metoksykarbonyl-2-indolinon, tautomerene, diastereomerene, enantiomerene, blandinger derav og saltene derav, og i kombinasjon med en ytterligere farmakologisk aktiv substans, for anvendelse i forebygging eller behandling av fibrose ved revmatoid artritt | ⤷ 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 | 00160 | Estonia | ⤷ Try a Trial | |
| 1830843 | 15C0046 | France | ⤷ Try a Trial | PRODUCT NAME: NINTEDANIB,SES TAUTOMERES ET LEURS MELANGES AINSI QUE LES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE NINTEDANIB ET PLUS PARTICULIEREMENT L'ESILATE; REGISTRATION NO/DATE: EU/1/14/979 20150119 |
| 1224170 | C01224170/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: NINTEDANIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65330 13.08.2015 |
| 1224170 | 2015/017 | Ireland | ⤷ Try a Trial | PRODUCT NAME: VARGATEF-NINTEDANIB, THE TAUTOMERS AND THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121 |
| 1224170 | SPC/GB15/018 | United Kingdom | ⤷ Try a 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 | C20150026 00160 | Estonia | ⤷ Try a Trial | PRODUCT NAME: NINTEDANIIB;REG NO/DATE: EU/1/14/979 19.01.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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