FDA Orange Book · active-ingredient family
Aspirin
Aspirin is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VAZALORE · NDA 203697
4
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VAZALORERLD×2 | PLX PHARMA | NDA 203697 | — | Feb 26, 2021 | |
| DURLAZARLD | HESP | NDA 200671 | — | Sep 04, 2015 | |
| BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN | BAYER | NDA 021317 | — | Oct 18, 2001 | |
| 8-HOUR BAYER×2 | BAYER | NDA 016030 | — | Approved Prior to Jan 1, 1982 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10786444 | Sep 29, 2032 | in 6 yr 4 mo | U-3559 |
| 10646431 | Sep 29, 2032 | in 6 yr 4 mo | Product |
| 9226892 | Sep 29, 2032 | in 6 yr 4 mo | U-1733 |
| 9216150 | Sep 29, 2032 | in 6 yr 4 mo | Product |
Aspirin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
