ninlaro Drug Patent Profile
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When do Ninlaro patents expire, 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-four 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
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Questions you can ask:
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Summary for ninlaro
| International Patents: | 224 |
| 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
*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 |
|---|---|
| Rajshekhar Chakraborty, MD | Phase 1/Phase 2 |
| Genentech, Inc. | Phase 1/Phase 2 |
| Takeda | Phase 4 |
Pharmacology for ninlaro
| Drug Class | Proteasome Inhibitor |
| Mechanism of Action | Proteasome Inhibitors |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Proteasome inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Boronate ester compounds and pharmaceutical compositions thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Proteasome inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-002 | Nov 20, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-003 | Nov 20, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-001 | Nov 20, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-001 | Nov 20, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-002 | Nov 20, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-003 | Nov 20, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 ninlaro
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-002 | Nov 20, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-001 | Nov 20, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-003 | Nov 20, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-003 | Nov 20, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-001 | Nov 20, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-002 | Nov 20, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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
Patent: COMPUESTOS DE ACIDO BORONICO Y ESTER BORONICO INHIBIDORES DE LA PROTEASOMA, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USOS DE LOS MISMOS PARA EL TRATAMIENTO DEL CANCER.
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07357338
Patent: Proteasome inhibitors
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0721905
Patent: INIBIDORES DE PROTEASSOMA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 95082
Patent: INHIBITEURS DE PROTEASOMES (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 08002159
Patent: Compuestos derivados de n-(((1r, 4r)-4-aminociclohexil)metil) sulfonaminas sustituidas con heterociclos, antagonistas del receptor npy y5; composicion farmaceutica que comprende a dichos compuestos, utiles para tratar anorexia y obesidad.
Estimated Expiration: ⤷ Sign Up
China
Patent: 1772507
Patent: Proteasome inhibitors
Estimated Expiration: ⤷ Sign Up
Patent: 2961387
Patent: Proteasome inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 5837608
Patent: 蛋白酶体抑制剂及其组合物和用途 (Proteasome inhibitor and composition and application thereof)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0120745
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 13386
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 78888
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 10010015
Patent: INHIBIDORES DE PROTEASOMA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8622
Patent: ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 1070247
Patent: ИНГИБИТОРЫ ПРОТЕАСОМ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 78888
Patent: INHIBITEURS DE PROTÉASOMES (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 27347
Patent: Inhibiteurs de protéasome (Proteasome inhibitors)
Estimated Expiration: ⤷ Sign Up
Patent: 10987
Patent: PROCÉDÉ POUR LA SYNTHÈSE D'INHIBITEURS DE PROTÉASOMES (PROCESS FOR THE SYNTHESIS OF PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
France
Patent: C1011
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0125599
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 43595
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 82924
Patent: 蛋白酶體抑制劑 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 700018
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3641
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷ Sign Up
Patent: 2290
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷ Sign Up
Patent: 2291
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷ Sign Up
Patent: 2292
Patent: מעכבי פרוטיאזום (Proteasome inhibitors)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 61488
Estimated Expiration: ⤷ Sign Up
Patent: 10535759
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 178888
Estimated Expiration: ⤷ Sign Up
Patent: 2017010
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0013
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 1991
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 0871
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2693
Patent: Boron-containing proteasome inhibitors
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 014500053
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 78888
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 78888
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 435
Patent: INHIBITORI PROTEAZOMA (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201508712Q
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 78888
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1000348
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1474831
Estimated Expiration: ⤷ Sign Up
Patent: 1831674
Estimated Expiration: ⤷ Sign Up
Patent: 100059811
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 140042932
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 140042933
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 150010802
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Patent: 160040735
Patent: 프로테아좀 억제제 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 170004031
Patent: 프로테아좀 억제제 (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 90606
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 40641
Estimated Expiration: ⤷ Sign Up
Patent: 11972
Estimated Expiration: ⤷ Sign Up
Patent: 42594
Estimated Expiration: ⤷ Sign Up
Patent: 0914460
Patent: Proteasome inhibitors
Estimated Expiration: ⤷ Sign Up
Patent: 1425320
Patent: Proteasome inhibitors
Estimated Expiration: ⤷ Sign Up
Patent: 1425321
Patent: Proteasome inhibitors
Estimated Expiration: ⤷ Sign Up
Patent: 1700482
Patent: Proteasome inhibitors
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 10000060
Patent: PROTEASOME INHIBITORS
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 536
Patent: ІНГІБІТОРИ ПРОТЕАСОМ[ИНГИБИТОРЫ ПРОТЕАСОМ (PROTEASOME INHIBITORS)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Philippines | 12014500053 | PROTEASOME INHIBITORS | ⤷ Sign Up |
| Japan | 6110813 | ⤷ Sign Up | |
| Hong Kong | 1244811 | 硼酸酯化合物及其醫藥組合物 (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF) | ⤷ Sign Up |
| Ecuador | SP10010015 | INHIBIDORES DE PROTEASOMA | ⤷ Sign Up |
| Japan | 5566380 | ⤷ Sign Up | |
| Argentina | 095249 | INHIBIDORES DE PROTEASOMAS Y USO DE LOS MISMOS | ⤷ Sign Up |
| Spain | 2330008 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ninlaro
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2178888 | LUC00013 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB ET SELS ET ESTERS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI, TEL QUE LE CITRATE D'IXAZOMIB; AUTHORISATION NUMBER AND DATE: EU/1/16/&1094 20161123 |
| 2178888 | SPC/GB17/030 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REGISTERED: UK EU/1/16/1094/001(NI) 20161123; UK EU/1/16/1094/002(NI) 20161123; UK EU/1/16/1094/003(NI) 20161123; UK PLGB 15475/0059 20161123; UK PLGB 15475/0060 20161123; UK PLGB 15475/0061 20161123 |
| 2178888 | 122017000025 | Germany | ⤷ Sign Up | PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121 |
| 2178888 | 1790016-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF, SUCH AS IXAZOMIB CITRATE; REG. NO/DATE: EU/1/16/1094 20161123 |
| 2178888 | C02178888/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65959 03.02.2017 |
| 2178888 | C20170014 00227 | Estonia | ⤷ Sign Up | PRODUCT NAME: IKSASOMIIB;REG NO/DATE: EU/1/16/1094 23.11.2016 |
| 2178888 | 275 50004-2017 | Slovakia | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1094 20161123 |
| >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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