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
*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
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| University of Colorado, Denver | Phase 1/Phase 2 |
| The University of Hong Kong | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for OMACETAXINE MEPESUCCINATE
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 |
| >Country | >Patent Number | >Title | >Estimated Expiration |
