Sarecycline Hydrochloride | ||||
CAS NO.: | 1035979-44-2 | |||
Chemical Formula: | C24H30ClN3O8 | |||
Molecular Weight: | 524.0000 | |||
DMF&GMP status: | Please contact us for more details. | Description: |
Sarecycline is an oral, once daily, narrow spectrum tetracycline used to treat moderate-to-severe acne. Oral sarecycline use has been rarely linked to serum enzyme elevations during therapy and, although suspected of causing liver injury, it has yet to be linked to clinically apparent acute hepatic injury.
Sarecycline is a semi-synthetic derivative of tetracycline that was initially discovered by Paratek Pharmaceuticals from Boston, MA but then licensed to Warner Chilcott of Rockaway, NJ in July of 2007. After completing various phase-II and phase-III trials demonstrating its effectiveness in treating moderate to severe facial acne vulgaris the US Food and Drug Administration approved Barcelona based Almirall, S.A.'s Seysara (sarecylcine) as a new first in class narrow spectrum tetracycline derived oral antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older. Seysara (sarecycline) was originally part of Allergan's US Medical Dermatology portfolio, before Almirall acquired the portfolio in the second half of 2018 as a means of consolidating and reinforcing the dermatology-focused pharmaceutical company's presence in the United States. Acne vulgaris itself is a common chronic skin condition associated with the blockage and/or inflammation of hair follicles and their accompanying sebaceous glands. The acne often presents physically as a mixture of non-inflammatory and inflammatory lesions mainly on the face but on the back and chest as well. Based upon data from Global Burden of Disease studies, the acne vulgaris condition affects up to 85% of young adults aged 12 to 25 years globally - with the possibility of permanent physical and mental scarring resulting from cases of severe acne. Subsequently, while a number of first line tetracycline therapies like doxycycline and minocycline do exist for treating acne vulgaris, sarecycline presents a new and innovative therapy choice because it exhibits the necessary antibacterial activity against relevant pathogens that cause acne vulgaris but also possesses a low propensity for resistance development in such pathogens and a narrower, more specific spectrum of antibacterial activity, resulting in fewer off-target antibacterial effects on endogenous intestinal flora and consequently fewer resultant adverse effects associated with diarrhea, fungal overgrowth, etc. **The products protected by patents in this product catalog are used for laboratory analysis, research and development, and cannot be sold to any country or region with patent protection and for commercial purpose. If the resulting patent infringement risks and responsibilities will be borne by the buyer. |
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Approvals | ||||
Active Ingredient | Dosage Form; Route | Strength | Proprietary Name | Applicant |
SARECYCLINE HYDROCHLORIDE | TABLET;ORAL | EQ 60MG BASE | SEYSARA | ALMIRALL LLC |
SARECYCLINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | SEYSARA | ALMIRALL LLC |
SARECYCLINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | SEYSARA | ALMIRALL LLC |
Patent Data | ||||
Patent No. | Patent Expiration | Drug Substance Claim | Drug Product Claim | Patent Use Code |
8318706 | 05/01/2031 | DS | DP | U-2405 |
8513223 | 12/07/2029 | U-2406 | ||
9255068 | 02/09/2033 | DS | DP | U-2407 U-2408 |
9481639 | 08/10/2028 | U-2409 | ||
Exclusive Data | ||||
Exclusivity Code | Exclusivity Expiration | |||
NCE | 10/01/2023 | |||