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 are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifteen patent family members in thirty-one 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® Generic Entry Outlook for Promacta Kit
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 13, 2026. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for PROMACTA KIT
International Patents: | 115 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 31 |
Formulation / Manufacturing: | see details |
DailyMed Link: | PROMACTA KIT at DailyMed |

DrugPatentWatch® Estimated Generic Entry Opportunity Date for PROMACTA KIT
Generic Entry Date for PROMACTA KIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;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 PROMACTA KIT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Food and Drug Administration (FDA) | Phase 1 |
University of California, San Francisco | Phase 1 |
Anjali Pawar | Phase 1 |
Pharmacology for PROMACTA KIT
Anatomical Therapeutic Chemical (ATC) Classes 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. mg/packet and 25 mg/packet | 207027 | 1 | 2022-04-22 |
US Patents and Regulatory Information for PROMACTA KIT
PROMACTA KIT is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROMACTA KIT is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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 PROMACTA KIT
Thrombopoietin mimetics
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | See Plans and Pricing | See Plans and Pricing |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | See Plans and Pricing | See Plans and Pricing |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | See Plans and Pricing | See Plans and Pricing |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-002 | Sep 27, 2018 | See Plans and Pricing | See Plans and Pricing |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | See Plans and Pricing | See Plans and Pricing |
>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 |
---|---|---|---|
Australia | 1295299 | See Plans and Pricing | |
Argentina | 040083 | COMPUESTO BIS-(MONOETANOLAMINA) DEL ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL) -1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDEN] HIDRAZINO] -2'-HIDROXI-[1,1'-BIFENIL]-3-CARBOXILICO, PROCEDIMIENTO PARA PREPARARLO, COMPOSICION FARMACEUTICA QUE LO COMPRENDE, PROCEDIMIENTO PARA PREPARAR DICHA COMPOSICION FARMAC | See Plans and Pricing |
Mexico | PA02011621 | MIMETICOS DE TROMBOPOYETINA. (THROMBOPOIETIN MIMETICS.) | See Plans and Pricing |
Israel | 152988 | 3' - {N' - [1 - (3,4 - DIMETHYLPHENYL) - 3 - METHYL - 5 - OXO - 1,5 - DIHYDROPYRAZOL - 4 - YLIDENE] HYDRAZINE} - 2' - HYDROXY - BIPHENYL - 3 - CARBOXYLIC ACID, 3' - {N' -[1- (3,4 - DIMETHYLPHENYL) - 3 - METHYL - 5 - OXO - 1,5 - DIHYDROPYRAZOL - 4 - YLIDENE] HYDRAZINE} - 2' - HYDROXY - 3' - (TETRAZOL - 5 - YL) - BIPHENYL COMPOUNDS AND THEIR DERIVATIVES AND THEIR USE IN THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS FOR TREATMENT OF HEMATOPOIETIC DISORDERS | See Plans and Pricing |
Australia | 2001274938 | See Plans and Pricing | |
Spain | 2294000 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROMACTA KIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1294378 | CA 2010 00017 | Denmark | See Plans and Pricing | |
1534390 | 91 3-2010 | Slovakia | See Plans and Pricing | PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315 |
1294378 | 10C0034 | France | See Plans and Pricing | PRODUCT NAME: ELTROMBOPAG EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (INCLUANT UN HYDRATE); REGISTRATION NO/DATE: EU/1/10/612/001 20100315 |
1294378 | 388 | Finland | See Plans and Pricing | |
1534390 | PA2010007,C1534390 | Lithuania | See Plans and Pricing | 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 | C300451 | Netherlands | See Plans and Pricing | PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |