Twyneo is a drug owned by Galderma Laboratories Lp. It is protected by 7 US drug patents filed from 2021 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 12, 2038. Details of Twyneo'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). | |||
| US10420743 | Methods and compositions for the treatment of acne |
Jul, 2038
(13 years from now) | Active |
| US12053546 | Stabilized topical formulations containing core-shell microcapsules |
Jun, 2032
(7 years from now) | Active |
| US12070629 | Core stabilized microcapsules, method of their preparation and uses thereof |
Dec, 2030
(6 years from now) | Active |
| US10653899 | Core stabilized microcapsules, method of their preparation and uses thereof |
Dec, 2030
(6 years from now) | Active |
| US11071878 | Core stabilized microcapsules, method of their preparation and uses thereof |
Dec, 2030
(6 years from now) | Active |
| US9868103 | Metal oxide coating of water insoluble ingredients |
Aug, 2028
(3 years from now) | Active |
| US8617580 | Compositions for topical application comprising a peroxide and retinoid |
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 Twyneo's patents.
Latest Legal Activities on Twyneo's Patents
Given below is the list of recent legal activities going on the following patents of Twyneo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Nov, 2023 | US10653899 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Mar, 2023 | US10420743 |
| Mail O.P. Petition Decision | 23 Mar, 2023 | US8617580 |
| Email Notification Critical | 23 Mar, 2023 | US8617580 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 21 Mar, 2023 | US8617580 |
| Record Petition Decision of Granted to Make Entity Status large | 20 Mar, 2023 | US8617580 |
| O.P. Petition Decision | 16 Mar, 2023 | US8617580 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 03 Jan, 2023 | US10420743 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 28 Dec, 2022 | US11071878 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 28 Dec, 2022 | US10653899 |
FDA has granted several exclusivities to Twyneo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Twyneo, 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 Twyneo.
Exclusivity Information
Twyneo holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Twyneo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Jul 26, 2024 |
US patents provide insights into the exclusivity only within the United States, but Twyneo 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 Twyneo's family patents as well as insights into ongoing legal events on those patents.
Twyneo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Twyneo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 12, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Twyneo Generics:
There are no approved generic versions for Twyneo as of now.
About Twyneo
Twyneo is a drug owned by Galderma Laboratories Lp. It is used for treating acne vulgaris in adults and pediatric patients 9 years of age and older. Twyneo uses Benzoyl Peroxide; Tretinoin as an active ingredient. Twyneo was launched by Galderma Labs Lp in 2021.
Can you believe Twyneo received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Twyneo was approved by FDA for market use on 26 July, 2021.
Active Ingredient:
Twyneo uses Benzoyl Peroxide; Tretinoin as the active ingredient. Check out other Drugs and Companies using Benzoyl Peroxide; Tretinoin ingredient
Treatment:
Twyneo is used for treating acne vulgaris in adults and pediatric patients 9 years of age and older.
Dosage:
Twyneo is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3%;0.1% | CREAM | Prescription | TOPICAL |