Oracea Patent Expiration

Oracea is a drug owned by Galderma Laboratories Lp. It is protected by 13 US drug patents filed from 2013 to 2018. Out of these, 2 drug patents are active and 11 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 19, 2027. Details of Oracea'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).
US5789395 Method of using tetracycline compounds for inhibition of endogenous nitric oxide production
Aug, 2016

(7 years ago)

Expired
US5919775 Method for inhibiting expression of inducible nitric oxide synthase with tetracycline
Aug, 2016

(7 years ago)

Expired
US10058564 Methods of treating acne
Apr, 2022

(2 years ago)

Expired
US7232572 Methods of treating rosacea
Apr, 2022

(2 years ago)

Expired
US9241946 Methods of treating acne
Apr, 2022

(2 years ago)

Expired
US8603506 Methods of treating acne
Apr, 2022

(2 years ago)

Expired
US7211267 Methods of treating acne
Apr, 2022

(2 years ago)

Expired
US8394406 Once daily formulations of tetracyclines
Apr, 2024

(3 months ago)

Expired
US8394405 Once daily formulations of tetracyclines
Apr, 2024

(3 months ago)

Expired
US8470364 Once daily formulations of tetracyclines
Apr, 2024

(3 months ago)

Expired
US8709478 Once daily formulations of tetracyclines
Apr, 2024

(3 months ago)

Expired
US8206740 Once daily formulations of tetracyclines
Dec, 2025

(1 year, 5 months from now)

Active
US7749532 Once daily formulations of tetracyclines
Dec, 2027

(3 years from now)

Active


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 Oracea and ongoing litigations to help you estimate the early arrival of Oracea generic.

Oracea's Litigations

Oracea has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 20, 2013, against patent number US8394406. The petitioner , challenged the validity or infringement of this patent, with None as the respondent. Click below to track the latest information on how companies are challenging Oracea's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8603506 August, 2015 Terminated-Denied GALDERMA LABORATORIES, INC. Dr. Reddy’s Laboratories, Ltd.
US8206740 June, 2013 FWD Entered
US8394405 June, 2013 FWD Entered Supernus Pharmaceuticals, Inc. Amneal Pharamceuticals, LLC
US8394406 June, 2013 FWD Entered

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US patents provide insights into the exclusivity only within the United States, but Oracea 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 Oracea's family patents as well as insights into ongoing legal events on those patents.

Oracea's family patents

Oracea has patent protection in a total of 13 countries. It's US patent count contributes only to 45.8% of its total global patent coverage. 5 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 Oracea.

Family Patents

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Generic Launch

Generic Release Date:

Oracea's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 19, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Oracea Generics:

Doxycycline is the generic name for the brand Oracea. 20 different companies have already filed for the generic of Oracea, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Oracea's generic

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

You can seek FDA approval to launch a generic drug before the expiration of Oracea's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Oracea'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 Oracea -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
40 mg 12 Dec, 2008 1 05 Apr, 2022 Extinguished




About Oracea

Oracea is a drug owned by Galderma Laboratories Lp. It is used for treating inflammatory lesions of rosacea. Oracea uses Doxycycline as an active ingredient. Oracea was launched by Galderma Labs Lp in 2006.

Market Authorisation Date:

Oracea was approved by FDA for market use on 26 May, 2006.

Active Ingredient:

Oracea uses Doxycycline as the active ingredient. Check out other Drugs and Companies using Doxycycline ingredient

Treatment:

Oracea is used for treating inflammatory lesions of rosacea.

Dosage:

Oracea is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
40MG CAPSULE Prescription ORAL