IXAZOMIB CITRATE - Generic Drug Details
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What are the generic sources for ixazomib citrate and what is the scope of patent protection?
Ixazomib citrate
is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ixazomib citrate has two hundred and twenty-four patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for IXAZOMIB CITRATE
International Patents: | 224 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 42 |
Clinical Trials: | 37 |
Patent Applications: | 617 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IXAZOMIB CITRATE |
DailyMed Link: | IXAZOMIB CITRATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IXAZOMIB CITRATE
Generic Entry Date for IXAZOMIB CITRATE*:
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.
Recent Clinical Trials for IXAZOMIB CITRATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
AIDS Malignancy Consortium | Phase 2 |
Sun Yat-sen University | Phase 2 |
Takeda | Phase 2 |
Pharmacology for IXAZOMIB CITRATE
Drug Class | Proteasome Inhibitor |
Mechanism of Action | Proteasome Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IXAZOMIB CITRATE
Paragraph IV (Patent) Challenges for IXAZOMIB CITRATE
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 IXAZOMIB CITRATE
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-002 | 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 | ⤷ 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 | 208462-002 | Nov 20, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 IXAZOMIB CITRATE
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IXAZOMIB CITRATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 173722 | PROTEASOME INHIBITORS AND METHODS OF USING THE SAME | ⤷ Sign Up |
Japan | 2010535759 | ⤷ Sign Up | |
China | 103450241 | Borate compound and medicine composition thereof | ⤷ Sign Up |
Hong Kong | 1091839 | PROTEASOME INHIBITORS AND METHODS OF USING THE SAME | ⤷ Sign Up |
European Patent Office | 2733147 | Composés de borates esters et compositions pharmaceutiques contenant des composés (Boronate ester compounds and pharmaceutical compositions thereof) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IXAZOMIB CITRATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2178888 | CR 2017 00014 | Denmark | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB OG FARMACEUTISK ACCEPTABLE SALTE OG ESTERE DERAF, HERUNDER IXAZOMIBCITRAT; 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 | 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 | PA2017010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: IKSAZOMIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR ESTERIAI, PAVYZDZIUI KAIP IKSAZOMIBO CITRATAS; REGISTRATION NO/DATE: EU/1/16/1094 20161121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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