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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 18^th, 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

Drug patent expirations by year for PROMACTA KIT

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
University of California, Davis	Phase 1

See all PROMACTA KIT clinical trials

Pharmacology for PROMACTA KIT

Drug Class	Thrombopoietin Receptor Agonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Thrombopoietin Receptor Agonists UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B15 Inhibitors UGT2B7 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

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)
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Glossary

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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
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ 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

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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
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	⤷ 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	207027-001	Aug 24, 2015	⤷ 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.

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Country	Patent Number	Title	Estimated Expiration
Czech Republic	303176	Trombopoetinové mimetikum, farmaceutický prostredek s jeho obsahem a použití tohoto mimetika (Thrombopoietin mimetic, pharmaceutical composition containing thereof and use of such mimetic)	⤷ Sign Up
Mexico	PA02011621	MIMETICOS DE TROMBOPOYETINA. (THROMBOPOIETIN MIMETICS.)	⤷ Sign Up
Japan	3813875		⤷ Sign Up
New Zealand	533308	Thrombopoietin mimetics	⤷ Sign Up
South Korea	101090643		⤷ Sign Up
Norway	2010017		⤷ Sign Up
European Patent Office	2206533	Bis-(monoéthanolamine) de l'acide 3'- (2z)- 1-(3,4-diméthylphenyl)-1,5-dihydro-3-méthyl-5-oxo-4h-pyrazol-4-ylidène hydrazino -2'-hydroxy- 1,1'-biphényl -3-carboxylique (3'- (2z)- 1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene hydrazino -2'-hydroxy- 1,1'-biphenyl -3-carboxylic acid bis-(monoethanolamine))	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PROMACTA KIT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534390	91 3-2010	Slovakia	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1294378	SPC020/2010	Ireland	⤷ Sign Up	SPC020/2010: 20110308, EXPIRES: 20250310
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
1294378	2010/020	Ireland	⤷ Sign Up	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	C 2010 013	Romania	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/612/001, RO EU/1/10/612/002, RO EU/1/10/612/003, RO EU/1/10/612/004, RO EU/1/10/612/005, RO EU/1/10/612/006; DATE OF NATIONAL AUTHORISATION: 20100311; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/612/001, EMEA EU/1/10/612/002, EMEA EU/1/10/612/003, EMEA EU/1/10/612/004, EMEA EU/1/10/612/005, EMEA EU/1/10/612/006; DATE OF FIRST AUTHORISATION IN EEA: 20100311
1294378	CA 2010 00017	Denmark	⤷ Sign Up
1294378	SPC/GB10/026	United Kingdom	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100315; UK EU1/10/612/002 20100315; UK EU1/10/612/003 20100315; UK EU1/10/612/004 20100315; UK EU1/10/612/005 20100315; UK EU1/10/612/006 20100315
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description