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Last Updated: March 29, 2024

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PROMACTA KIT Drug Patent Profile


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Which patents cover Promacta Kit, and when can generic versions of Promacta Kit launch?

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® 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:42
US Patents:1
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 Loss of Exclusivity (LOE) 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
University of California, DavisPhase 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 one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROMACTA KIT is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  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
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial 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

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 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 1032387 NOUVEAUX COMPLEXES METALLIQUES (NOVEL METAL COMPLEXES) ⤷  Try a Trial
Austria 445606 ⤷  Try a Trial
European Patent Office 1039906 COMPLEXES METALLIFERES AVEC DES EFFETS ANTIBACTERIENS ET ANTIFONGIQUES (METAL COMPLEXES WITH ANTIBACTERIAN AND FUNGICIDAL EFFECTS) ⤷  Try a Trial
Norway 330160 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9922732 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROMACTA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1294378 122010000037 Germany ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG SOWIE PHARMAZEUTISCH ANNEHMBARE SALZE, HYDRATE UND SOLVATE DAVON; NAT. REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311; FIRST REGISTRATION: EU EU/1/10/612/001-/006 20100311
1294378 2010/020 Ireland ⤷  Try a Trial PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE).; REGISTRATION NO/DATE: EU/1/10/612/001-006 20100311
1534390 PA2010007,C1534390 Lithuania ⤷  Try a Trial 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
1534390 C20100006 00032 Estonia ⤷  Try a Trial PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
1294378 C300451 Netherlands ⤷  Try a Trial 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.