Solodyn is a drug owned by Bausch Health Us Llc. It is protected by 9 US drug patents filed from 2013 to 2015. Out of these, 8 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 17, 2031. Details of Solodyn'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). | |||
| US5908838 | Method for the treatment of acne |
Feb, 2018
(6 years ago) |
Expired
|
| US8722650 | Extended-release minocycline dosage forms |
Jun, 2025
(10 months from now) | Active |
| US7790705 | Minocycline oral dosage forms for the treatment of acne |
Jun, 2025
(10 months from now) | Active |
| US8252776 | Minocycline oral dosage forms for the treatment of acne |
Jun, 2025
(10 months from now) | Active |
| US8268804 | Minocycline oral dosage forms for the treatment of acne |
Jun, 2025
(10 months from now) | Active |
| US7919483 | Method for the treatment of acne |
Mar, 2027
(2 years from now) | Active |
| US7541347 | Minocycline oral dosage forms for the treatment of acne |
Apr, 2027
(2 years from now) | Active |
| US7544373 | Minocycline oral dosage forms for the treatment of acne |
Apr, 2027
(2 years from now) | Active |
| US9192615 | Method for the treatment of acne and certain dosage forms thereof |
Nov, 2031
(7 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 Solodyn's patents.
Latest Legal Activities on Solodyn's Patents
Given below is the list of recent legal activities going on the following patents of Solodyn.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Feb, 2024 | US8268804 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Jan, 2024 | US8252776 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9192615 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2022 | US7919483 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Feb, 2022 | US7790705 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Dec, 2020 | US7541347 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Dec, 2020 | US7544373 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Mar, 2020 | US8268804 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jan, 2020 | US8252776 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 May, 2019 | US9192615 |
US patents provide insights into the exclusivity only within the United States, but Solodyn 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 Solodyn's family patents as well as insights into ongoing legal events on those patents.
Solodyn's family patents
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Generic Launch
Generic Release Date:
Solodyn's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 17, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Solodyn Generics:
Minocycline Hydrochloride is the generic name for the brand Solodyn. 26 different companies have already filed for the generic of Solodyn, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Solodyn's generic
How can I launch a generic of Solodyn before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Solodyn's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Solodyn'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 Solodyn -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 45 mg, 90 mg and 135 mg | |||||
| 55 mg | 02 Dec, 2010 | 1 | 30 Nov, 2011 | 20 Nov, 2025 | Eligible |
| 65 mg and 115 mg | 19 Nov, 2009 | 1 | 18 May, 2012 | 19 Feb, 2018 | Extinguished Eligible |
| 80 mg | 27 Oct, 2010 | 1 | 25 Sep, 2014 | 19 Feb, 2018 | Non-Forfeiture |
| 105 mg | 13 Dec, 2010 | 1 | 19 Feb, 2018 | Non-Forfeiture |
About Solodyn
Solodyn is a drug owned by Bausch Health Us Llc. It is used for managing moderate to severe acne vulgaris by treating inflammatory lesions. Solodyn uses Minocycline Hydrochloride as an active ingredient. Solodyn was launched by Bausch in 2006.
Market Authorisation Date:
Solodyn was approved by FDA for market use on 08 May, 2006.
Active Ingredient:
Solodyn uses Minocycline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Minocycline Hydrochloride ingredient
Treatment:
Solodyn is used for managing moderate to severe acne vulgaris by treating inflammatory lesions.
Dosage:
Solodyn is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 80MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 105MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 55MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 65MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 115MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |