FDA Orange Book
Is there a generic for Seysara?
Seysara contains sarecycline. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Seysara (sarecycline). The Orange Book shows its last listed patent expires February 9, 2033.
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Seysara products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 60MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209521, held by ALMIRALL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Seysara patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9481639 | August 10, 2028 | Method of use | U-2409 | 209521 |
| 8513223 | December 7, 2029 | Method of use | U-2406 | 209521 |
| 8318706 | January 3, 2032 | Drug substance, Drug product | U-2405 | 209521 |
| 9255068 | February 9, 2033 | Drug substance, Drug product | U-2407 | 209521 |
| 9255068 | February 9, 2033 | Drug substance, Drug product | U-2408 | 209521 |
Seysara NDC codes
Questions
Is there a generic for Seysara?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Seysara (sarecycline). The Orange Book shows its last listed patent expires February 9, 2033.
What is the generic name for Seysara?
The active ingredient in Seysara is sarecycline, per the FDA Orange Book.
When does the Seysara patent expire?
The last patent listed for Seysara in the Orange Book expires February 9, 2033. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.