ELTROMBOPAG OLAMINE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for eltrombopag olamine and what is the scope of freedom to operate?
Eltrombopag olamine
is the generic ingredient in three branded drugs marketed by Annora Pharma and Novartis, and is included in three NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Eltrombopag olamine has one hundred and eight patent family members in forty countries.
There are three drug master file entries for eltrombopag olamine. One supplier is listed for this compound.
Summary for ELTROMBOPAG OLAMINE
International Patents: | 108 |
US Patents: | 6 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 71 |
Clinical Trials: | 16 |
Patent Applications: | 465 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELTROMBOPAG OLAMINE |
What excipients (inactive ingredients) are in ELTROMBOPAG OLAMINE? | ELTROMBOPAG OLAMINE excipients list |
DailyMed Link: | ELTROMBOPAG OLAMINE at DailyMed |
Recent Clinical Trials for ELTROMBOPAG OLAMINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Taiwan University Hospital | Phase 2 |
Novartis | Phase 2 |
Cangzhou Central Hospital | Phase 4 |
Pharmacology for ELTROMBOPAG OLAMINE
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 |
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 ELTROMBOPAG OLAMINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | 022291-003 | Sep 8, 2009 | RX | Yes | Yes | ⤷ 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 | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
>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 ELTROMBOPAG OLAMINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | 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 | 022291-002 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027-001 | Aug 24, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ⤷ 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 ELTROMBOPAG OLAMINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1136968 | 新穎的藥物組合物 (NOVEL PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
Israel | 238840 | 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 |
European Patent Office | 2152237 | NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
South Korea | 101632851 | ⤷ Sign Up | |
China | 1652842 | 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 |
Taiwan | 201410240 | Pharmaceutical tablets, solid oral pharmaceutical dosage forms, pharmaceutical capsules and pharmaceutical granules comprising 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carbox | ⤷ Sign Up |
Taiwan | 200407128 | 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 ELTROMBOPAG OLAMINE
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 |
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 |
1534390 | C20100006 | Estonia | ⤷ Sign Up | PRODUCT NAME: REVOLADE-ELTROMBOPAG; AUTHORISATIN NO.: EMA/CHMP/697489/2018; AUTHORISATION DATE: 20181019 |
1294378 | 300451 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ELTROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT (MET INBEGRIP VAN EEN HYDRAAT), IN HET BIJZONDER ELTROMBOPAG OLAMINE; REGISTRATION NO/DATE: EU/1/10/612/001-006 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.