FDA Orange Book
Is there a generic for Cosela?
Cosela contains trilaciclib. 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 Cosela (trilaciclib). The Orange Book shows its last listed patent expires November 13, 2040 and its last listed exclusivity ends February 12, 2026.
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Cosela products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 300MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 214200, held by PHARMACOSMOS AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cosela patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11040042 | October 25, 2031 | Drug product | None | 214200 |
| 10189850 | October 25, 2031 | Drug product | None | 214200 |
| 10189849 | October 25, 2031 | Drug substance | None | 214200 |
| 10927120 | October 25, 2031 | Drug product | None | 214200 |
| 9957276 | October 25, 2031 | Drug substance | None | 214200 |
| 8598197 | October 25, 2031 | Drug substance, Drug product | None | 214200 |
| 9487530 | March 14, 2034 | Method of use | U-3079 | 214200 |
| 9487530 | March 14, 2034 | Method of use | U-3080 | 214200 |
| 10085992 | March 14, 2034 | Method of use | U-3081 | 214200 |
| 11717523 | March 14, 2034 | Method of use | U-3678 | 214200 |
| 11717523 | March 14, 2034 | Method of use | U-3679 | 214200 |
| 10966984 | March 14, 2034 | Method of use | U-3079 | 214200 |
| 10966984 | March 14, 2034 | Method of use | U-3080 | 214200 |
| 8598186 | December 30, 2034 | Drug substance, Drug product | None | 214200 |
| 12527798 | December 5, 2037 | Method of use | U-3504 | 214200 |
| 11529352 | July 23, 2039 | Method of use | U-3504 | 214200 |
| 12168666 | November 13, 2040 | Drug substance, Drug product | None | 214200 |
Cosela exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 12, 2026 | 214200 |
Cosela NDC codes
Questions
Is there a generic for Cosela?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cosela (trilaciclib). The Orange Book shows its last listed patent expires November 13, 2040 and its last listed exclusivity ends February 12, 2026.
What is the generic name for Cosela?
The active ingredient in Cosela is trilaciclib, per the FDA Orange Book.
When does the Cosela patent expire?
The last patent listed for Cosela in the Orange Book expires November 13, 2040. 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.