Synribo Patent Expiration

Synribo is a drug owned by Teva Pharmaceuticals International Gmbh. It is protected by 3 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 26, 2026. Details of Synribo's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE45128 Cephalotaxane derivatives and their processes of preparation and purification
Mar, 2019

(5 years ago)

Expired
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7842687 Cephalotaxane derivatives and their processes of preparation and purification
Mar, 2019

(5 years ago)

Expired
US6987103 Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents
Oct, 2026

(2 years from now)

Active


FDA has granted several exclusivities to Synribo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Synribo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Synribo.

Exclusivity Information

Synribo holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Synribo's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 26, 2017
Orphan Drug Exclusivity(ODE-32) Oct 26, 2019
Orphan Drug Exclusivity(ODE) Oct 26, 2019

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US patents provide insights into the exclusivity only within the United States, but Synribo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Synribo's family patents as well as insights into ongoing legal events on those patents.

Synribo's family patents

Synribo has patent protection in a total of 13 countries. It's US patent count contributes only to 9.1% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Synribo.

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Generic Launch

Generic Release Date:

Synribo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 26, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Synribo Generics:

There are no approved generic versions for Synribo as of now.

How can I launch a generic of Synribo before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Synribo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Synribo's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Synribo -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
3.5 mg/vial 26 Oct, 2016 1 28 Jun, 2023 Extinguished




About Synribo

Synribo is a drug owned by Teva Pharmaceuticals International Gmbh. It is used for treating leukemia, specifically chronic myeloid/myelogenous leukemia (CML), including patients resistant to or intolerant of tyrosine kinase inhibitors. Synribo uses Omacetaxine Mepesuccinate as an active ingredient. Synribo was launched by Teva Pharms Intl in 2012.

Market Authorisation Date:

Synribo was approved by FDA for market use on 26 October, 2012.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Synribo is 26 October, 2012, its NCE-1 date is estimated to be 26 October, 2016

Active Ingredient:

Synribo uses Omacetaxine Mepesuccinate as the active ingredient. Check out other Drugs and Companies using Omacetaxine Mepesuccinate ingredient

Treatment:

Synribo is used for treating leukemia, specifically chronic myeloid/myelogenous leukemia (CML), including patients resistant to or intolerant of tyrosine kinase inhibitors.

Dosage:

Synribo is available in powder form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
3.5MG/VIAL POWDER Prescription SUBCUTANEOUS