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Serving leading biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Medtronic
Citi
Julphar
AstraZeneca
Boehringer Ingelheim
UBS
Healthtrust
Farmers Insurance

Generated: February 21, 2018

DrugPatentWatch Database Preview

PROMACTA Drug Profile

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When do Promacta patents expire, and what generic alternatives are available?

Promacta is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are fourteen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-seven patent family members in forty countries.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.

US Patents and Regulatory Information for PROMACTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No ➤ 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

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Paragraph IV (Patent) Challenges for PROMACTA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 50 mg and 75 mg ➤ Subscribe 1/7/2014
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2/4/2014

Non-Orange Book US Patents for PROMACTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,211,200 Metal complexes ➤ Sign Up
7,439,342 Thrombopoietin mimetics ➤ Sign Up
8,088,813 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) ➤ Sign Up
7,648,971 Thrombopoietin mimetics ➤ Sign Up
7,674,887 Thrombopoietin mimetics ➤ Sign Up
6,413,952 Agonizing dimeric cell-surface receptors with a receptor binding moiety and chelating metal ➤ Sign Up
7,335,649 Thrombopoietin mimetics ➤ Sign Up
8,846,024 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) ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for PROMACTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C020/2010 Ireland ➤ Sign Up SPC020/2010: 20110308, EXPIRES: 20250310
681 Luxembourg ➤ Sign Up 91681, EXPIRES: 20250311
C/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 20100311; UK EU1/10/612/002 20100311; UK EU1/10/612/003 20100311; UK EU1/10/612/004 20100311; UK EU1/10/612/005 20100311; UK EU1/10/612/006 20100311
1294378/01 Switzerland ➤ Sign Up PRODUCT NAME: ELTROMBOPAGUM; REGISTRATION NO/DATE: SWISSMEDIC 60122 23.06.2010
2010 00017 Denmark ➤ Sign Up
C0034 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 20100311
2010007 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
0100006 00032 Estonia ➤ Sign Up PRODUCT NAME: REVOLADE-ELTROMBOPAG; REG NO/DATE: C(2010)1662 11.03.2010
2010000037 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
2010007,C1534390 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Deloitte
Argus Health
McKesson
Queensland Health
Johnson and Johnson
McKinsey
Chinese Patent Office
Express Scripts

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 verifification 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.

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