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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

See all OMACETAXINE MEPESUCCINATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OMACETAXINE MEPESUCCINATE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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

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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

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Country	Patent Number	Title	Estimated Expiration
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
Spain	2334774		⤷ Sign Up
Spain	2383771		⤷ Sign Up
Canada	2459822	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
Denmark	1443933		⤷ Sign Up
Japan	4794816		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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