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SEYSARA Drug Profile
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See Plans and PricingWhen do Seysara patents expire, and what generic alternatives are available?
Seysara is a drug marketed by Almirall and is included in one NDA. There are four patents protecting this drug.
This drug has sixty-one patent family members in twenty countries.
The generic ingredient in SEYSARA is sarecycline hydrochloride. One supplier is listed for this compound. Additional details are available on the sarecycline hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Seysara
Seysara will be eligible for patent challenges on October 1, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 9, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SEYSARA
| International Patents: | 61 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for SEYSARA |
| DailyMed Link: | SEYSARA at DailyMed |
Generic Entry Opportunity Date for SEYSARA
Generic Entry Date for SEYSARA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for SEYSARA
| Drug Class | Tetracycline-class Drug |
| Mechanism of Action | P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for SEYSARA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-001 | Oct 1, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-003 | Oct 1, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-002 | Oct 1, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Almirall | SEYSARA | sarecycline hydrochloride | TABLET;ORAL | 209521-002 | Oct 1, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SEYSARA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2707003 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2008079363 | Start Trial |
| Canada | 2835876 | Start Trial |
| Canada | 2925939 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
