FDA Orange Book · active-ingredient family
Regadenoson
Regadenoson is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LEXISCAN · NDA 022161
1
Brand (NDA)
13
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEXISCANRLD | ASTELLAS | NDA 022161 | AP | Apr 10, 2008 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REGADENOSON | INDIES PHARMA | ANDA 218054 | AP | Aug 22, 2024 | |
| REGADENOSON | GE HEALTHCARE | ANDA 215955 | — | Aug 05, 2024 | |
| REGADENOSON | BAXTER HLTHCARE CORP | ANDA 217455 | AP | May 23, 2023 | |
| REGADENOSON | MYLAN | ANDA 213856 | AP | Apr 04, 2023 | |
| REGADENOSON | HIKMA | ANDA 215827 | AP | Feb 02, 2023 | |
| REGADENOSON | EUGIA PHARMA | ANDA 216437 | AP | Oct 26, 2022 | |
| REGADENOSON | HOSPIRA | ANDA 214349 | AP | Aug 31, 2022 | |
| REGADENOSON | GLAND | ANDA 207320 | AP | Jul 12, 2022 | |
| REGADENOSON | IMS LTD | ANDA 214252 | AP | May 23, 2022 | |
| REGADENOSON | ACCORD HLTHCARE | ANDA 213236 | AP | Apr 11, 2022 | |
| REGADENOSON | APOTEX | ANDA 207604 | AP | Apr 11, 2022 | |
| REGADENOSON | DR REDDYS | ANDA 213210 | AP | Apr 11, 2022 | |
| REGADENOSON | MEITHEAL | ANDA 212806 | AP | Apr 11, 2022 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8106183 | Feb 02, 2027 | in 8 mo | Substance |
| RE47301 | Feb 02, 2027 | in 8 mo | Product |
Regadenoson — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
