Durezol is a drug owned by Sandoz Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Durezol's patents have been open to challenges since 23 September, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 18, 2019. Details of Durezol's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6114319 (Pediatric) | Compositions containing difluprednate |
Nov, 2019
(5 years ago) |
Expired
|
| US6114319 | Compositions containing difluprednate |
May, 2019
(5 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Durezol and ongoing litigations to help you estimate the early arrival of Durezol generic.
Durezol's Litigations
Durezol been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 15, 2015, against patent number US6114319. The petitioner Akorn, Inc., challenged the validity of this patent, with SENJU PHARMACEUTICAL CO., LTD as the respondent. Click below to track the latest information on how companies are challenging Durezol's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6114319 | May, 2015 |
FWD Entered
(22 Nov, 2016) | SENJU PHARMACEUTICAL CO., LTD | Akorn, Inc. |
FDA has granted some exclusivities to Durezol. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Durezol, 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 Durezol.
Exclusivity Information
Durezol holds 6 exclusivities. All of its exclusivities have expired in 2019. Details of Durezol's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 23, 2013 |
| New Indication(I-653) | Jun 13, 2015 |
| M(M-127) | Mar 22, 2016 |
| Pediatric Exclusivity(PED) | Sep 22, 2016 |
| Orphan Drug Exclusivity(ODE) | Jun 13, 2019 |
| Orphan Drug Exclusivity(ODE-26) | Jun 13, 2019 |
US patents provide insights into the exclusivity only within the United States, but Durezol 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 Durezol's family patents as well as insights into ongoing legal events on those patents.
Durezol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Durezol's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 18, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Durezol Generic API suppliers:
Difluprednate is the generic name for the brand Durezol. 4 different companies have already filed for the generic of Durezol, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Durezol's generic
How can I launch a generic of Durezol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Durezol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Durezol'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 Durezol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 01 May, 2014 | 1 | 18 May, 2019 | Extinguished |
About Durezol
Durezol is a drug owned by Sandoz Inc. Durezol uses Difluprednate as an active ingredient. Durezol was launched by Sandoz in 2008.
Approval Date:
Durezol was approved by FDA for market use on 23 June, 2008.
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 Durezol is 23 June, 2008, its NCE-1 date is estimated to be 23 September, 2015.
Active Ingredient:
Durezol uses Difluprednate as the active ingredient. Check out other Drugs and Companies using Difluprednate ingredient
Dosage:
Durezol is available in emulsion form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05% | EMULSION | Prescription | OPHTHALMIC |