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-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 | 208462-003 | Nov 20, 2015 | RX | Yes | Yes | ⤷ 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 | ⤷ Sign Up | ||||
Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-001 | 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 | ||||
Takeda Pharms Usa | NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462-001 | Nov 20, 2015 | RX | Yes | No | ⤷ 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 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 | 208462-002 | 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 | 208462-003 | 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 |
---|---|---|---|
Cyprus | 2017016 | ⤷ Sign Up | |
Poland | 2178888 | ⤷ Sign Up | |
Japan | 2020055829 | ボロン酸エステル化合物およびその医薬組成物 (BORONATE ESTER COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS THEREOF) | ⤷ Sign Up |
Brazil | 122014008753 | compostos de éster boronato e composições farmacêuticas dos mesmos | ⤷ Sign Up |
Colombia | 6321289 | COMPUESTOS DE ESTER BORONATO Y COMPOSICIONES FARMACEUTICAS DE LOS MISMOS | ⤷ Sign Up |
Portugal | 2730581 | ⤷ 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 | 132017000051594 | Italy | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB E SUOI SALI ED ESTERI FARMACEUTICAMENTE ACCETTABILI, COME IXAZOMIB CITRATO(NINLARO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1094/001-003, 20161123 |
2178888 | C20170014 00227 | Estonia | ⤷ Sign Up | PRODUCT NAME: IKSASOMIIB;REG NO/DATE: EU/1/16/1094 23.11.2016 |
2178888 | 300871 | Netherlands | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN EN ESTERS DAARVAN, ZOALS IXAZOMIBCITRAAT; REGISTRATION NO/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 | 275 50004-2017 | Slovakia | ⤷ Sign Up | PRODUCT NAME: IXAZOMIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1094 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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