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Last Updated: November 2, 2024

Omacetaxine mepesuccinate - Generic Drug Details


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What are the generic sources for omacetaxine mepesuccinate and what is the scope of patent protection?

Omacetaxine mepesuccinate is the generic ingredient in one branded drug marketed by Teva Pharms Intl and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omacetaxine mepesuccinate has twenty-one patent family members in twelve countries.

There are two drug master file entries for omacetaxine mepesuccinate.

Summary for omacetaxine mepesuccinate
International Patents:21
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 69
Clinical Trials: 16
Patent Applications: 3,648
What excipients (inactive ingredients) are in omacetaxine mepesuccinate?omacetaxine mepesuccinate excipients list
DailyMed Link:omacetaxine mepesuccinate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for omacetaxine mepesuccinate
Generic Entry Date for omacetaxine mepesuccinate*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for omacetaxine mepesuccinate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 1/Phase 2
University of Colorado, DenverPhase 1/Phase 2
The University of Hong KongPhase 2

See all omacetaxine mepesuccinate clinical trials

Paragraph IV (Patent) Challenges for OMACETAXINE MEPESUCCINATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYNRIBO for Injection omacetaxine mepesuccinate 3.5 mg/vial 203585 1 2016-10-26

US Patents and Regulatory Information for omacetaxine mepesuccinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 DISCN 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 omacetaxine mepesuccinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for omacetaxine mepesuccinate

Country Patent Number Title Estimated Expiration
Japan 4794816 ⤷  Sign Up
Denmark 1443933 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 03020252 ⤷  Sign Up
European Patent Office 1443933 TRAITEMENT DE LA LEUCEMIE MYELOIDE CHRONIQUE, RESISTANTE OU INTOLERANTE AU STI571, IMPLIQUANT L'HOMOHARRINGTONINE SEUL OU EN COMBINAISON AVEC D'AUTRES AGENTS (TREATMENT OF CHRONIC MYELOGENOUS LEUKEMIA, RESISTANT OR INTOLERANT TO STI571, INVOLVING HOMOHARRINGTONINE ALONE OR COMBINED WITH OTHER AGENTS) ⤷  Sign Up
European Patent Office 2177223 Homoharringtonine seule ou en combinaison avec d'autres agents pour une utilisation dans le traitement des leucémies myélogènes chroniques résistantes ou intolérantes aux inhibiteurs de protéine kinase à l'exception du STI 571 (Homoharringtonine alone or combined with other agents for use in treating chronic myelogenous leukemia resistant or intolerant to protein kinase inhibitors other than STI 571) ⤷  Sign Up
Germany 60234708 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.