FDA Orange Book · active-ingredient family
Perflutren
Perflutren is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DEFINITY · NDA 021064
1
Brand (NDA)
0
Generics (ANDA)
11
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEFINITYRLD×2 | LANTHEUS MEDCL | NDA 021064 | — | Jul 31, 2001 |
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10583207 | Dec 28, 2035 | in 9 yr 8 mo | U-665 |
| 11395856 | Dec 28, 2035 | in 9 yr 8 mo | SubstanceProductU-665 |
| 10022460 | Dec 28, 2035 | in 9 yr 8 mo | SubstanceProduct |
| 9789210 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 10583208 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11925695 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11529431 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11857646 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11266750 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 12161730 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 10588988 | May 04, 2037 | in 11 yr | U-665 |
Perflutren — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
