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Last Updated: November 29, 2020

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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. One supplier is listed for this compound.

Summary for omacetaxine mepesuccinate
International Patents:21
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Suppliers / Packagers: 1
Bulk Api Vendors: 43
Clinical Trials: 14
Patent Applications: 1,549
DailyMed Link:omacetaxine mepesuccinate at DailyMed
Recent Clinical Trials for omacetaxine mepesuccinate

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

SponsorPhase
University of Colorado, DenverPhase 1/Phase 2
The University of Hong KongPhase 2
Teva Pharmaceutical Industries, Ltd.Phase 2

See all omacetaxine mepesuccinate clinical trials

Paragraph IV (Patent) Challenges for OMACETAXINE MEPESUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
SYNRIBO POWDER;SUBCUTANEOUS omacetaxine mepesuccinate 203585 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 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Moodys
McKesson
Harvard Business School
Boehringer Ingelheim

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