Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
McKinsey
Dow
Express Scripts
Merck

Last Updated: January 27, 2023

Eltrombopag olamine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic sources for eltrombopag olamine and what is the scope of patent protection?

Eltrombopag olamine is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight 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 seventy-eight patent family members in forty-two countries.

There are three drug master file entries for eltrombopag olamine. One supplier is listed for this compound.

Summary for eltrombopag olamine
International Patents:178
US Patents:8
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 69
Clinical Trials: 15
Patent Applications: 707
Formulation / Manufacturing:see details
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

SponsorPhase
Cangzhou Central HospitalPhase 4
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 4
Institute of Hematology & Blood Diseases HospitalPhase 4

See all eltrombopag olamine clinical trials

Paragraph IV (Patent) Challenges for ELTROMBOPAG OLAMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROMACTA KIT For Oral Suspension eltrombopag olamine 12. 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 022291-001 Nov 20, 2008 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 See Plans and Pricing See Plans and Pricing
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 See Plans and Pricing See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-002 Sep 27, 2018 See Plans and Pricing See Plans and Pricing
Novartis PROMACTA KIT eltrombopag olamine FOR SUSPENSION;ORAL 207027-001 Aug 24, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for eltrombopag olamine

Country Patent Number Title Estimated Expiration
Germany 60140224 See Plans and Pricing
Taiwan I538674 See Plans and Pricing
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) See Plans and Pricing
Israel 201891 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for eltrombopag olamine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534390 91 3-2010 Slovakia See Plans and Pricing PRODUCT NAME: ELTROMBOPAG; REGISTRATION NO/DATE: EU/1/10/612/001 - EU/1/10/612/006 20100315
1294378 SPC/GB10/026 United Kingdom See Plans and Pricing 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
1294378 CA 2010 00017 Denmark See Plans and Pricing
1294378 2010C/018 Belgium See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Dow
Express Scripts
Boehringer Ingelheim
Colorcon

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.