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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7749532 | Once daily formulations of tetracyclines |
Dec, 2027
(3 years from now) | Active |
| US8206740 | Once daily formulations of tetracyclines |
Dec, 2025
(1 year, 1 month from now) | Active |
| US8470364 | Once daily formulations of tetracyclines |
Apr, 2024
(6 months ago) |
Expired
|
| US8394406 | Once daily formulations of tetracyclines |
Apr, 2024
(6 months ago) |
Expired
|
| US8394405 | Once daily formulations of tetracyclines |
Apr, 2024
(6 months ago) |
Expired
|
| US8709478 | Once daily formulations of tetracyclines |
Apr, 2024
(6 months ago) |
Expired
|
| US10058564 | Methods of treating acne |
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
|
| US7232572 | Methods of treating rosacea |
Apr, 2022
(2 years ago) |
Expired
|
| US5789395 | Method of using tetracycline compounds for inhibition of endogenous nitric oxide production |
Aug, 2016
(8 years ago) |
Expired
|
| US5919775 | Method for inhibiting expression of inducible nitric oxide synthase with tetracycline |
Aug, 2016
(8 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 Oracea's patents.
Latest Legal Activities on Oracea's Patents
Given below is the list of recent legal activities going on the following patents of Oracea.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jun, 2023 | US8206740 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Feb, 2022 | US10058564 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Dec, 2021 | US7749532 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 May, 2021 | US8603506 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Sep, 2020 | US8470364 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Aug, 2020 | US8394406 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Dec, 2019 | US8206740 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Dec, 2018 | US7232572 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Oct, 2018 | US7211267 |
| Recordation of Patent Grant Mailed Critical | 28 Aug, 2018 | US10058564 |
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 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 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 |
|---|---|---|---|---|
 | ||||
| US8603506 | August, 2015 |
Terminated-Denied
(16 Feb, 2016) | GALDERMA LABORATORIES, INC. | Dr. Reddy’s Laboratories, Ltd. |
| US8206740 | June, 2013 |
FWD Entered
(09 Dec, 2014) | ||
| US8394405 | June, 2013 |
FWD Entered
(09 Dec, 2014) | Supernus Pharmaceuticals, Inc. | Amneal Pharamceuticals, LLC |
| US8394406 | June, 2013 |
FWD Entered
(09 Dec, 2014) | ||
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Doxycycline is the generic name for the brand Oracea. 21 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 |
Alternative Brands for Oracea
Oracea which is used for treating inflammatory lesions of rosacea., has several other brand drugs using the same active ingredient (Doxycycline). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Doxycycline, Oracea's active ingredient. Check the complete list of approved generic manufacturers for Oracea
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.
Approval 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 |