FDA Orange Book
Generic for Kengreal
Kengreal contains cangrelor. 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
Yes. The generic name for Kengreal is cangrelor. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Kengreal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 50MG/VIAL | Marketed (Rx) | AP | 2 | AP |
NDA 204958, held by CHIESI USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cangrelor
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLAND PHARMA LTD | 213551 | AP (A-rated, therapeutically equivalent) | August 11, 2025 | 50MG/VIAL |
| MSN LABORATORIES PRIVATE LTD | 213703 | AP (A-rated, therapeutically equivalent) | June 4, 2026 | 50MG/VIAL |
Kengreal patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9925265 | May 13, 2029 | Method of use | U-2260 | 204958 |
| 9427448 | November 10, 2030 | Method of use | U-1926 | 204958 |
| 8680052 | March 9, 2033 | Method of use | U-2979 | 204958 |
| 10039780 | July 10, 2035 | Method of use | U-2260 | 204958 |
| 9439921 | July 10, 2035 | Drug product | None | 204958 |
| 9700575 | July 10, 2035 | Drug product | None | 204958 |
| 9295687 | July 10, 2035 | Drug product | None | 204958 |
Kengreal NDC codes
Questions
Is there a generic for Kengreal?
Yes. The generic name for Kengreal is cangrelor. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Kengreal?
The active ingredient in Kengreal is cangrelor, per the FDA Orange Book.
When does the Kengreal patent expire?
The last patent listed for Kengreal in the Orange Book expires July 10, 2035. 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.