PROMACTA KIT Drug Patent Profile
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Which patents cover Promacta Kit, and what generic alternatives are available?
Promacta Kit is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has forty-two patent family members in twenty-eight countries.
The generic ingredient in PROMACTA KIT is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Promacta Kit
A generic version of PROMACTA KIT was approved as eltrombopag olamine by ANNORA PHARMA on April 18th, 2024.
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Summary for PROMACTA KIT
International Patents: | 42 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 31 |
DailyMed Link: | PROMACTA KIT at DailyMed |
Recent Clinical Trials for PROMACTA KIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, San Francisco | Phase 1 |
Food and Drug Administration (FDA) | Phase 1 |
University of California, Davis | Phase 1 |
Pharmacology for PROMACTA KIT
Paragraph IV (Patent) Challenges for PROMACTA KIT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PROMACTA KIT | For Oral Suspension | eltrombopag olamine | 12.5 mg/packet and 25 mg/packet | 207027 | 1 | 2022-04-22 |
US Patents and Regulatory Information for PROMACTA KIT
PROMACTA KIT is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting PROMACTA KIT
3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting PROMACTA KIT
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | AB | 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 PROMACTA KIT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROMACTA KIT
See the table below for patents covering PROMACTA KIT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 193619 | ⤷ Sign Up | |
Iceland | 2770 | ⤷ Sign Up | |
Hungary | 0800310 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROMACTA KIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1534390 | PA2010007,C1534390 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ELTROMBOPAGO OLAMINAS; REGISTRATION NO/DATE: EU/1/10/612/001, 2010-03-11 EU/1/10/612/002, 2010-03-11 EU/1/10/612/003, 2010-03-11 EU/1/10/612/004, 2010-03-11 EU/1/10/612/005, 2010-03-11 EU/1/10/612/006 20100311 |
1294378 | 300451 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT (MET INBEGRIP VAN EEN HYDRAAT), IN HET BIJZONDER ELTROMBOPAG OLAMINE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100315 |
1294378 | C201000022 | Spain | ⤷ Sign Up | PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/10/612/001-006; DATE OF AUTHORISATION: 20100315; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/10/612/001-006; DATE OF FIRST AUTHORISATION IN EEA: 20100315 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |