Seysara is a drug owned by Almirall Llc. It is protected by 4 US drug patents filed in 2018 out of which none have expired yet. Seysara's patents have been open to challenges since 01 October, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 09, 2033. Details of Seysara's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9255068 | Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(methyl)amino)-methyl] acid amide and methods of using the same |
Feb, 2033
(8 years from now) | Active |
| US8318706 | Substituted tetracycline compounds |
May, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8513223 | Substituted tetracycline compounds for treatment of inflammatory skin disorders |
Dec, 2029
(5 years from now) | Active |
| US9481639 | Substituted tetracycline compounds for treatment of inflammatory skin disorders |
Aug, 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 Seysara's patents.
Latest Legal Activities on Seysara's Patents
Given below is the list of recent legal activities going on the following patents of Seysara.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 May, 2024 | US8318706 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 May, 2024 | US9481639 |
| Requirement for information sent under 37 CFR 1.750 | 23 Jan, 2024 | US8318706 |
| transaction for FDA Determination of Regulatory Review Period | 28 Dec, 2023 | US8318706 |
| transaction for FDA Determination of Regulatory Review Period | 08 Dec, 2023 | US8318706 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jul, 2023 | US9255068 |
| Terminal Disclaimer Filed Critical | 06 Dec, 2022 | US8318706 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 06 Dec, 2022 | US8318706 |
| Second letter to regulating agency to determine regulatory review period | 27 May, 2021 | US8318706 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2021 | US8513223 |
FDA has granted several exclusivities to Seysara. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Seysara, 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 Seysara.
Exclusivity Information
Seysara holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Seysara's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 01, 2023 |
US patents provide insights into the exclusivity only within the United States, but Seysara 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 Seysara's family patents as well as insights into ongoing legal events on those patents.
Seysara's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Seysara's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 09, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Seysara Generics:
There are no approved generic versions for Seysara as of now.
About Seysara
Seysara is a drug owned by Almirall Llc. It is used for treating acne vulgaris in patients 9 years of age and older. Seysara uses Sarecycline Hydrochloride as an active ingredient. Seysara was launched by Almirall in 2018.
Can you believe Seysara 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:
Seysara was approved by FDA for market use on 01 October, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Seysara is 01 October, 2018, its NCE-1 date is estimated to be 01 October, 2022.
Active Ingredient:
Seysara uses Sarecycline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Sarecycline Hydrochloride ingredient
Treatment:
Seysara is used for treating acne vulgaris in patients 9 years of age and older.
Dosage:
Seysara is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 60MG BASE | TABLET | Prescription | ORAL |