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. Synribo's patents have been open to challenges since 26 October, 2016. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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 |
| US7842687 | Cephalotaxane derivatives and their processes of preparation and purification |
Mar, 2019
(5 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Synribo's patents.
Latest Legal Activities on Synribo's Patents
Given below is the list of recent legal activities going on the following patents of Synribo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 04 Apr, 2017 | US6987103 |
| Notice of Final Determination -Eligible | 21 Sep, 2016 | US6987103 |
| PTE Interim Patent Extension filed Critical | 15 Aug, 2016 | US6987103 |
| FDA Final Eligibility Letter Critical | 07 Dec, 2015 | US6987103 |
| transaction for FDA Determination of Regulatory Review Period | 07 May, 2015 | US6987103 |
| transaction for FDA Determination of Regulatory Review Period | 21 Apr, 2015 | US6987103 |
| Second letter to regulating agency to determine regulatory review period | 24 Feb, 2015 | US6987103 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2014 | US6987103 |
| Initial letter Re: PTE Application to regulating agency | 26 Nov, 2013 | US6987103 |
| Patent Term Extension Application under 35 USC 156 Filed | 20 Dec, 2012 | US6987103 |
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) | Oct 26, 2019 |
| Orphan Drug Exclusivity(ODE-32) | Oct 26, 2019 |
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
Explore Our Curated Drug Screens
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.
Approval Date:
Synribo was approved by FDA for market use on 26 October, 2012.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 | Discontinued | SUBCUTANEOUS |