FDA Orange Book · active-ingredient family
Amphetamine sulfate
Amphetamine sulfate is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EVEKEO ODT · NDA 209905
1
Brand (NDA)
17
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EVEKEO ODTRLD×5 | AZURITY | NDA 209905 | — | Apr 16, 2021 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMPHETAMINE SULFATE×2 | RHODES PHARMS | ANDA 213852 | — | Sep 07, 2021 | |
| AMPHETAMINE SULFATE×2 | GLENMARK PHARMS LTD | ANDA 212186 | — | Jan 27, 2021 | |
| AMPHETAMINE SULFATE×2 | SUN PHARM INDS INC | ANDA 214574 | — | Jan 27, 2021 | |
| AMPHETAMINE SULFATE×2 | SPECGX LLC | ANDA 213583 | AA | Jan 22, 2021 | |
| AMPHETAMINE SULFATE×2 | ALKEM LABS LTD | ANDA 213720 | AA | Oct 27, 2020 | |
| AMPHETAMINE SULFATE×2 | EPIC PHARMA LLC | ANDA 213980 | AA | Oct 27, 2020 | |
| AMPHETAMINE SULFATE×2 | INGENUS PHARMS LLC | ANDA 213763 | — | Aug 24, 2020 | |
| AMPHETAMINE SULFATE×2 | DR REDDYS LABS SA | ANDA 213898 | — | Jul 14, 2020 | |
| AMPHETAMINE SULFATE×2 | SENORES PHARMS | ANDA 212901 | AA | May 22, 2020 | |
| AMPHETAMINE SULFATE×2 | PRINSTON INC | ANDA 211861 | AA | Mar 11, 2020 | |
| AMPHETAMINE SULFATE×2 | SANALUZ | ANDA 212582 | AA | Feb 04, 2020 | |
| AMPHETAMINE SULFATE×2 | BIONPHARMA | ANDA 212919 | AA | Nov 22, 2019 | |
| AMPHETAMINE SULFATE×2 | GRANULES | ANDA 212619 | AA | Aug 05, 2019 | |
| AMPHETAMINE SULFATE×2 | AUROLIFE PHARMA LLC | ANDA 211639 | AA | Apr 17, 2019 | |
| AMPHETAMINE SULFATE×2 | AMNEAL PHARMS | ANDA 211139 | AA | Sep 26, 2018 | |
| EVEKEO×2 | AZURITY | ANDA 200166 | AA | Aug 09, 2012 | |
| AMPHETAMINE SULFATERLD×2 | LANNETT | ANDA 083901 | — | Aug 31, 1984 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10441554 | Mar 10, 2037 | in 10 yr 11 mo | Product |
| 11160772 | Mar 10, 2037 | in 10 yr 11 mo | Product |
| 11896562 | Mar 10, 2037 | in 10 yr 11 mo | U-3299 |
Amphetamine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
