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PROMACTA KIT Drug Patent Profile

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When do Promacta Kit patents expire, 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
Formulation / Manufacturing:	see details
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
Anjali Pawar	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

Anatomical Therapeutic Chemical (ATC) Classes for PROMACTA KIT

B02BX	Other systemic hemostatics
B02B	VITAMIN K AND OTHER HEMOSTATICS
B02	ANTIHEMORRHAGICS
B	Blood and blood forming organs

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

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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
Germany	60139354		⤷ Sign Up
Czech Republic	20023852		⤷ Sign Up
Portugal	1864981		⤷ Sign Up
China	101342169		⤷ Sign Up
World Intellectual Property Organization (WIPO)	0189457		⤷ Sign Up
Spain	2301215		⤷ Sign Up
Malaysia	142390	3' - [(2Z)-[1-(3,4-DIMETHYLPHENYL)-1,5- DIHYDRO-3- METHYL-5-0XO-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	PA2010007	Lithuania	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; 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	122010000037	Germany	⤷ Sign Up	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
1534390	C20100006 00032	Estonia	⤷ Sign Up	PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
1294378	SPC020/2010	Ireland	⤷ Sign Up	SPC020/2010: 20110308, EXPIRES: 20250310
1294378	10C0034	France	⤷ Sign Up	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	23/2010	Austria	⤷ Sign Up	PRODUCT NAME: ELTROMBOPAG, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS UND SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/612/001-EU/1/10/612/006 (MITTEILUNG) 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description