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 twenty-three patent family members in forty-six 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 has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for NINLARO
| International Patents: | 223 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 42 |
| Clinical Trials: | 48 |
| Drug Prices: | Drug price information for NINLARO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NINLARO |
| What excipients (inactive ingredients) are in NINLARO? | NINLARO excipients list |
| DailyMed Link: | NINLARO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| Genentech, Inc. | Phase 1/Phase 2 |
| Rajshekhar Chakraborty, MD | Phase 1/Phase 2 |
| Takeda | Phase 4 |
Pharmacology for NINLARO
| Drug Class | Proteasome Inhibitor |
| Mechanism of Action | Proteasome Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NINLARO
Paragraph IV (Patent) Challenges for NINLARO
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NINLARO | Capsules | ixazomib citrate | 2.3 mg, 3 mg and 4 mg | 208462 | 1 | 2019-11-20 |
US Patents and Regulatory Information for NINLARO
NINLARO is protected by nine US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NINLARO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NINLARO
Proteasome inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Proteasome inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Proteasome inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Proteasome inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Proteasome inhibitors and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Boronate ester compounds and pharmaceutical compositions thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Proteasome inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Boronate ester compounds and pharmaceutical compositions thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Proteasome inhibitors and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
| 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 | 208462-001 | Nov 20, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-002 | Nov 20, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-003 | Nov 20, 2015 | 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 |
International Patents for NINLARO
When does loss-of-exclusivity occur for NINLARO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 7824
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07357338
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0721905
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 95082
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 08002159
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1772507
Estimated Expiration: ⤷ Try a Trial
Patent: 2961387
Estimated Expiration: ⤷ Try a Trial
Patent: 5837608
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0120745
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 13386
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 78888
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 10010015
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8622
Estimated Expiration: ⤷ Try a Trial
Patent: 1070247
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 78888
Estimated Expiration: ⤷ Try a Trial
Patent: 27347
Estimated Expiration: ⤷ Try a Trial
Patent: 10987
Estimated Expiration: ⤷ Try a Trial
France
Patent: C1011
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0125599
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 43595
Estimated Expiration: ⤷ Try a Trial
Patent: 82924
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 700018
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3641
Estimated Expiration: ⤷ Try a Trial
Patent: 2290
Estimated Expiration: ⤷ Try a Trial
Patent: 2291
Estimated Expiration: ⤷ Try a Trial
Patent: 2292
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 61488
Estimated Expiration: ⤷ Try a Trial
Patent: 10535759
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 178888
Estimated Expiration: ⤷ Try a Trial
Patent: 2017010
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 0013
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 1991
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 0871
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 2693
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 014500053
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 78888
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 78888
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 435
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201508712Q
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 78888
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1000348
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1474831
Estimated Expiration: ⤷ Try a Trial
Patent: 1831674
Estimated Expiration: ⤷ Try a Trial
Patent: 100059811
Estimated Expiration: ⤷ Try a Trial
Patent: 140042932
Estimated Expiration: ⤷ Try a Trial
Patent: 140042933
Estimated Expiration: ⤷ Try a Trial
Patent: 150010802
Estimated Expiration: ⤷ Try a Trial
Patent: 160040735
Estimated Expiration: ⤷ Try a Trial
Patent: 170004031
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 90606
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 40641
Estimated Expiration: ⤷ Try a Trial
Patent: 11972
Estimated Expiration: ⤷ Try a Trial
Patent: 42594
Estimated Expiration: ⤷ Try a Trial
Patent: 0914460
Estimated Expiration: ⤷ Try a Trial
Patent: 1425320
Estimated Expiration: ⤷ Try a Trial
Patent: 1425321
Estimated Expiration: ⤷ Try a Trial
Patent: 1700482
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 10000060
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 536
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering NINLARO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 122014008753 | compostos de éster boronato e composições farmacêuticas dos mesmos | ⤷ Try a Trial |
| Argentina | 100011 | COMPUESTOS DE ÉSTER BORONATO Y COMPOSICIONES FARMACÉUTICAS DE LOS MISMOS | ⤷ Try a Trial |
| Norway | 20061197 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NINLARO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2178888 | 275 50004-2017 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: IXAZOMIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1094 20161123 |
| 2178888 | C02178888/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017 |
| 2178888 | 17C1011 | France | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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