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SYNRIBO Drug Patent Profile

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When do Synribo patents expire, and when can generic versions of Synribo launch?

Synribo is a drug marketed by Teva Pharms Intl and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in twelve countries.

The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There are two drug master file entries for this compound. Additional details are available on the omacetaxine mepesuccinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Synribo

Synribo was eligible for patent challenges on October 26, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for SYNRIBO

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	7
Patent Applications:	1,494
Drug Prices:	Drug price information for SYNRIBO
What excipients (inactive ingredients) are in SYNRIBO?	SYNRIBO excipients list
DailyMed Link:	SYNRIBO at DailyMed

Drug patent expirations by year for SYNRIBO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SYNRIBO

Generic Entry Date for SYNRIBO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 203585 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 SYNRIBO

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
Teva Pharmaceutical Industries, Ltd.	Phase 1/Phase 2
University of Florida	Phase 1/Phase 2

See all SYNRIBO clinical trials

Paragraph IV (Patent) Challenges for SYNRIBO

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 SYNRIBO

SYNRIBO is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYNRIBO is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SYNRIBO

Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)

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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 SYNRIBO

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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 SYNRIBO

See the table below for patents covering SYNRIBO around the world.

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Country	Patent Number	Title	Estimated Expiration
Denmark	2177223		⤷ Sign Up
France	2776292	CEPHALOTAXANES PORTEURS DE CHAINE LATERALE ET LEUR PROCEDE DE SYNTHESE	⤷ Sign Up
South Korea	20010042085		⤷ Sign Up
Denmark	1443933		⤷ Sign Up
Japan	2004523586		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration