Ixazomib citrate - Generic Drug Details
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What are the generic drug 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-three patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for ixazomib citrate
International Patents: | 223 |
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 | ⤷ 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 | ⤷ 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 | ||
Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-001 | Nov 20, 2015 | RX | Yes | No | ⤷ 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 ixazomib citrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103497210 | Boronate ester compounds and pharmaceutical compositions thereof | ⤷ Try a Trial |
Hong Kong | 1198253 | 硼酸酯及其藥劑學成分 (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF) | ⤷ Try a Trial |
Hong Kong | 1182924 | 蛋白酶體抑制劑 (PROTEASOME INHIBITORS) | ⤷ Try a Trial |
Ukraine | 115131 | СПОЛУКИ БОРОНАТНОГО ЕФІРУ І ЙОГО ФАРМАЦЕВТИЧНІ РЕЦЕПТУРИ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ixazomib citrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2178888 | PA2017010,C2178888 | Lithuania | ⤷ Try a 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 | 122017000025 | Germany | ⤷ Try a Trial | PRODUCT NAME: LXAZOMIB UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE UND ESTER WIE LXAZOMIBCITRAT; REGISTRATION NO/DATE: EU/1/16/1094 20161121 |
2178888 | 300871 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: IXAZOMIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN, ZOALS IXAZOMIBCITRAAT; REGISTRATION NO/DATE: EU/1/16/1094 20161123 |
2178888 | C20170014 00227 | Estonia | ⤷ Try a Trial | PRODUCT NAME: IKSASOMIIB;REG NO/DATE: EU/1/16/1094 23.11.2016 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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