Doryx Patent Expiration

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


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

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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

Doryx has patent protection in a total of 2 countries. It has a significant patent presence in the US with 62.5% of its patents being US patents. Click below to unlock the full patent family tree for Doryx.

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. 58 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