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Last Updated: January 27, 2020

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NINLARO Drug Profile

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When do Ninlaro patents expire, and what generic alternatives are available?

Ninlaro is a drug marketed by Millennium Pharms and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and thirteen 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.

US ANDA Litigation and 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.

Indicators of Generic Entry

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Summary for NINLARO
International Patents:213
US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 56
Clinical Trials: 39
Drug Prices: Drug price information for NINLARO
DailyMed Link:NINLARO at DailyMed
Drug patent expirations by year for NINLARO
Drug Prices for NINLARO

See drug prices for NINLARO

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
M.D. Anderson Cancer CenterPhase 2
Andrew Yee, MDPhase 2
Alliance Foundation Trials, LLC.Phase 2

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
Millennium Pharms NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Millennium Pharms NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Millennium Pharms NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Millennium Pharms NINLARO ixazomib citrate CAPSULE;ORAL 208462-003 Nov 20, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Millennium Pharms NINLARO ixazomib citrate CAPSULE;ORAL 208462-001 Nov 20, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Millennium Pharms NINLARO ixazomib citrate CAPSULE;ORAL 208462-002 Nov 20, 2015 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 NINLARO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2178888 17/2017 Austria   Start Trial PRODUCT NAME: IXAZOMIB UND PHARMAZEUTISCH ANNEHMBARE SALZE UND ESTER DAVON, WIE AUCH IXAZOMIB-CITRAT; REGISTRATION NO/DATE: EU/1/16/1094/ 001-003 (MITTEILUNG) 20161123
2178888 PA2017010,C2178888 Lithuania   Start Trial PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR ESTERIS, TOKS KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121
2178888 300871 Netherlands   Start Trial PRODUCT NAME: IXAZOMIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN, ZOALS IXAZOMIBCITRAAT; REGISTRATION NO/DATE: EU/1/16/1094 20161123
2178888 CA 2017 00014 Denmark   Start Trial PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888 CR 2017 00014 Denmark   Start Trial PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF, HERUNDER IXAZOMIBCITRAT; REG. NO/DATE: EU/1/16/1094 20161123
2178888 2017/016 Ireland   Start Trial PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: EU/1/16/1094 20161121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Medtronic
AstraZeneca
Harvard Business School
Colorcon

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