OMACETAXINE MEPESUCCINATE - Generic Drug Details
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What are the generic sources for omacetaxine mepesuccinate and what is the scope of freedom to operate?
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 |
| Finished Product Suppliers / Packagers: | 1 |
| 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
| 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 |
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 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Teva Pharms Intl | SYNRIBO | omacetaxine mepesuccinate | POWDER;SUBCUTANEOUS | 203585-001 | Oct 26, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OMACETAXINE MEPESUCCINATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 60234708 | ⤷ Try a Trial | |
| Portugal | 2177223 | ⤷ Try a Trial | |
| Austria | 451106 | ⤷ Try a Trial | |
| Japan | 2005508896 | ⤷ Try a Trial | |
| Cyprus | 1112817 | ⤷ Try a Trial | |
| Denmark | 1443933 | ⤷ Try a Trial | |
| Denmark | 2177223 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
