PROMACTA Drug Patent Profile
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Which patents cover Promacta, and what generic alternatives are available?
Promacta is a drug marketed by Novartis and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and eight patent family members in forty countries.
The generic ingredient in PROMACTA 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
A generic version of PROMACTA was approved as eltrombopag olamine by ANNORA PHARMA on April 18th, 2024.
Summary for PROMACTA
International Patents: | 108 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 31 |
Patent Applications: | 249 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PROMACTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROMACTA |
What excipients (inactive ingredients) are in PROMACTA? | PROMACTA excipients list |
DailyMed Link: | PROMACTA at DailyMed |
Recent Clinical Trials for PROMACTA
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 |
Pharmacology for PROMACTA
Anatomical Therapeutic Chemical (ATC) Classes for PROMACTA
Paragraph IV (Patent) Challenges for PROMACTA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PROMACTA | Tablets | eltrombopag olamine | 12.5 mg and 25 mg | 022291 | 1 | 2014-02-04 |
PROMACTA | Tablets | eltrombopag olamine | 50 mg and 75 mg | 022291 | 1 | 2014-01-07 |
US Patents and Regulatory Information for PROMACTA
PROMACTA is protected by six US patents and one FDA Regulatory Exclusivity.
Patents protecting PROMACTA
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
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting PROMACTA
INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | RX | Yes | Yes | ⤷ 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 | ||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PROMACTA
When does loss-of-exclusivity occur for PROMACTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 9656
Estimated Expiration: ⤷ Sign Up
Patent: 7711
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07352608
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0721651
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 85831
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07002242
Estimated Expiration: ⤷ Sign Up
China
Patent: 1686930
Estimated Expiration: ⤷ Sign Up
Patent: 2688207
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Patent: 2697745
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Colombia
Patent: 60058
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 143
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0160206
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Cyprus
Patent: 17284
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 52237
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 009000253
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 077628
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0883
Estimated Expiration: ⤷ Sign Up
Patent: 4294
Estimated Expiration: ⤷ Sign Up
Patent: 0971018
Estimated Expiration: ⤷ Sign Up
Patent: 1400387
Estimated Expiration: ⤷ Sign Up
Patent: 1991590
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 52237
Estimated Expiration: ⤷ Sign Up
Patent: 90730
Estimated Expiration: ⤷ Sign Up
Patent: 18732
Estimated Expiration: ⤷ Sign Up
Patent: 18733
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Hong Kong
Patent: 36968
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 27209
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1891
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Patent: 8840
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Patent: 4602
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 19866
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Patent: 35078
Estimated Expiration: ⤷ Sign Up
Patent: 44713
Estimated Expiration: ⤷ Sign Up
Patent: 60289
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Patent: 10526140
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Patent: 14005302
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Patent: 15129195
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Patent: 17137343
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Patent: 19123747
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Patent: 21100968
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Patent: 23011888
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Jordan
Patent: 43
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 8072
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Mexico
Patent: 09011881
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Morocco
Patent: 236
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New Zealand
Patent: 0888
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Peru
Patent: 080773
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Patent: 121407
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Patent: 151953
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Poland
Patent: 52237
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 52237
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 52237
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South Africa
Patent: 0907710
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South Korea
Patent: 1475971
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Patent: 1537200
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Patent: 1632851
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Patent: 100020456
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Patent: 140049086
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Patent: 150008513
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Spain
Patent: 65179
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Taiwan
Patent: 39267
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Patent: 38674
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Patent: 0843742
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Patent: 1410240
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Ukraine
Patent: 261
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PROMACTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101537200 | ⤷ Sign Up | |
Chile | 2007002242 | FORMA DE DOSIFICACION FARMACEUTICA ORAL EN COMPRIMIDO, CAPSULA O GRANULO QUE COMPRENDE BIS-(MONOETANOLAMINA) DE ACIDO 3'-[(2Z)-[1-(3,4-DIMETILFENIL)-1,5-DIHIDRO-3-METIL-5-OXO-4H-PIRAZOL-4-ILIDENO]HIDRAZINO]-2'-HIDROXI[1-1'-BIFENIL]-3-CARBOXILICO; PRO | ⤷ Sign Up |
Hungary | 0302257 | ⤷ Sign Up | |
Hungary | E027209 | ⤷ Sign Up | |
New Zealand | 580888 | Compositions of eltrombopag olamine substantially free from coordinating metals or reducing sugars | ⤷ Sign Up |
Israel | 274602 | טבליות רוקחיות המכילות אלטרומבופאג אולמין, שיטות להכנתן ושימושן בהכנת תרופות לטיפול בתרומבוציטופניה (Pharmaceutical tablets containing eltrombopag olamine, methods for their preparation and use thereof in the preparation of medicaments for treating thrombocytopenia) | ⤷ Sign Up |
Hong Kong | 1055561 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROMACTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1294378 | 2010C/018 | Belgium | ⤷ Sign Up | PRODUCT NAME: ELTROMBOPAG, OPTIONNELLEMENT SOUS FORME DE SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS UN HYDRATE); AUTHORISATION NUMBER AND DATE: EU/1/10/612/001 20100315 |
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 |
1534390 | C20100006 | Estonia | ⤷ Sign Up | PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019 |
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 |
1294378 | SPC020/2010 | Ireland | ⤷ Sign Up | SPC020/2010: 20110308, EXPIRES: 20250310 |
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 |
1534390 | 91 3-2010 | Slovakia | ⤷ Sign Up | PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |