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Last Updated: June 27, 2022

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

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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
Drug patent expirations by year for PROMACTA KIT
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

SponsorPhase
Food and Drug Administration (FDA)Phase 1
University of California, San FranciscoPhase 1
Anjali PawarPhase 1

See all PROMACTA KIT clinical trials

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

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 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 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

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