Doryx is a drug owned by Mayne Pharma International Pty Ltd. It is protected by 2 US drug patents filed from 2013 to 2015. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 03, 2028. Details of Doryx'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6958161 | Modified release coated drug preparation |
Dec, 2022
(1 year, 7 months ago) |
Expired
|
| US8715724 | Tabletting process |
Feb, 2028
(3 years from now) | Active |
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 Doryx's patents.
Latest Legal Activities on Doryx's Patents
Given below is the list of recent legal activities going on the following patents of Doryx.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 20 Jan, 2006 | US6958161 (Litigated) |
| Recordation of Patent Grant Mailed | 25 Oct, 2005 | US6958161 (Litigated) |
| Patent Issue Date Used in PTA Calculation | 25 Oct, 2005 | US6958161 (Litigated) |
| Issue Notification Mailed | 05 Oct, 2005 | US6958161 (Litigated) |
| Receipt into Pubs | 22 Sep, 2005 | US6958161 (Litigated) |
| Dispatch to FDC | 21 Sep, 2005 | US6958161 (Litigated) |
| Application Is Considered Ready for Issue | 21 Sep, 2005 | US6958161 (Litigated) |
| Receipt into Pubs | 20 Sep, 2005 | US6958161 (Litigated) |
| Workflow - File Sent to Contractor | 04 May, 2005 | US6958161 (Litigated) |
| Issue Fee Payment Received | 29 Apr, 2005 | US6958161 (Litigated) |
FDA has granted several exclusivities to Doryx. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Doryx, 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 Doryx.
Exclusivity Information
Doryx holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Doryx's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | Apr 11, 2016 |
| New Dosing Schedule(D-136) | Apr 11, 2016 |
US patents provide insights into the exclusivity only within the United States, but Doryx 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 Doryx's family patents as well as insights into ongoing legal events on those patents.
Doryx's family patents
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Generic Launch
Generic Release Date:
Doryx's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 03, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Doryx Generics:
Doxycycline Hyclate is the generic name for the brand Doryx. 59 different companies have already filed for the generic of Doryx, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Doryx's generic
How can I launch a generic of Doryx before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Doryx's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Doryx'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 Doryx -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg and 100 mg | 1 | 28 Dec, 2010 | 15 Dec, 2022 | Eligible | |
| 150 mg | 19 Dec, 2008 | 1 | 15 Dec, 2022 | Extinguished | |
| 200 mg | 19 May, 2014 | 1 | 19 May, 2016 | 15 Dec, 2022 | Eligible |
| 80 mg | 01 Jul, 2015 | 1 | 29 Apr, 2016 | 15 Dec, 2022 | Extinguished Eligible |
| 50 mg | 05 Nov, 2015 | 1 | 23 May, 2016 | 03 Feb, 2028 | Eligible |
| 60 mg and 120 mg | 28 Sep, 2017 | 1 | 23 Dec, 2034 | Extinguished |
About Doryx
Doryx is a drug owned by Mayne Pharma International Pty Ltd. It is used for treating or preventing infections caused by susceptible bacteria. Doryx uses Doxycycline Hyclate as an active ingredient. Doryx was launched by Mayne Pharma in 2014.
Market Authorisation Date:
Doryx was approved by FDA for market use on 19 December, 2014.
Active Ingredient:
Doryx uses Doxycycline Hyclate as the active ingredient. Check out other Drugs and Companies using Doxycycline Hyclate ingredient
Treatment:
Doryx is used for treating or preventing infections caused by susceptible bacteria.
Dosage:
Doryx is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE | Discontinued | ORAL |
| EQ 80MG BASE | TABLET, DELAYED RELEASE | Prescription | ORAL |
| EQ 75MG BASE | TABLET, DELAYED RELEASE | Discontinued | ORAL |
| EQ 200MG BASE | TABLET, DELAYED RELEASE | Prescription | ORAL |
| EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE | Discontinued | ORAL |
| EQ 150MG BASE | TABLET, DELAYED RELEASE | Discontinued | ORAL |