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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

NINLARO Drug Patent Profile


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Which patents cover Ninlaro, and what generic alternatives are available?

Ninlaro is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and nineteen patent family members in forty-five countries.

The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this compound. Additional details are available on the ixazomib citrate profile page.

DrugPatentWatch® Generic Entry Outlook for Ninlaro

Ninlaro was eligible for patent challenges on November 20, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 20, 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 NINLARO
Drug Prices for NINLARO

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for NINLARO
Generic Entry Date for NINLARO*:
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.

Recent Clinical Trials for NINLARO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 3
AIDS Malignancy ConsortiumPhase 2
Karyopharm Therapeutics IncPhase 1

See all NINLARO clinical trials

Pharmacology for NINLARO
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Paragraph IV (Patent) Challenges for NINLARO
Tradename Dosage Ingredient NDA Submissiondate
NINLARO CAPSULE;ORAL ixazomib citrate 208462 2019-11-20

US Patents and Regulatory Information for NINLARO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Takeda Pharms Usa NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 NINLARO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2178888 CA 2017 00014 Denmark ⤷  Free Forever Trial PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888 17C1011 France ⤷  Free Forever Trial PRODUCT NAME: IXAZOMIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET SES ESTERS TELS QUE LE CITRATE D'IXAZOMIB; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888 122017000025 Germany ⤷  Free Forever Trial PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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