FDA Orange Book
Is there a generic for Definity?
Definity contains perflutren. 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 Definity (perflutren). The Orange Book shows its last listed patent expires May 4, 2037.
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Definity products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 13.04MG/2ML (6.52MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 021064, held by LANTHEUS MEDICAL IMAGING INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Definity patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10583207 | December 28, 2035 | Method of use | U-665 | 021064 |
| 9789210 | March 16, 2037 | Method of use | U-665 | 021064 |
| 10583208 | March 16, 2037 | Method of use | U-665 | 021064 |
| 11925695 | March 16, 2037 | Method of use | U-665 | 021064 |
| 11529431 | March 16, 2037 | Method of use | U-665 | 021064 |
| 11857646 | March 16, 2037 | Method of use | U-665 | 021064 |
| 11266750 | March 16, 2037 | Method of use | U-665 | 021064 |
| 12161730 | March 16, 2037 | Method of use | U-665 | 021064 |
| 10588988 | May 4, 2037 | Method of use | U-665 | 021064 |
Definity NDC codes
Questions
Is there a generic for Definity?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Definity (perflutren). The Orange Book shows its last listed patent expires May 4, 2037.
What is the generic name for Definity?
The active ingredient in Definity is perflutren, per the FDA Orange Book.
When does the Definity patent expire?
The last patent listed for Definity in the Orange Book expires May 4, 2037. 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.