FDA Orange Book · active-ingredient family
Apixaban
Apixaban is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ELIQUIS SPRINKLE · NDA 220073
2
Brand (NDA)
13
Generics (ANDA)
6
Listed patents
8
Exclusivity periods
Brand (NDA) products · for suspension, tablet, tablet, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELIQUIS SPRINKLERLD | BRISTOL | NDA 220073 | — | Apr 17, 2025 | |
| ELIQUISRLD×3 | BRISTOL MYERS SQUIBB | NDA 202155 | — | Apr 17, 2025 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| APIXABAN×2 | MACLEODS PHARMS LTD | ANDA 210067 | — | Feb 27, 2025 | |
| APIXABAN×2 | IMPAX | ANDA 209810 | — | Feb 14, 2025 | |
| APIXABAN×2 | TORRENT | ANDA 210156 | — | Dec 17, 2024 | |
| APIXABAN×2 | APOTEX | ANDA 210091 | — | Feb 16, 2024 | |
| APIXABAN×2 | HETERO LABS LTD V | ANDA 210066 | — | Nov 21, 2023 | |
| APIXABAN×2 | AUROBINDO PHARMA LTD | ANDA 210026 | — | May 26, 2023 | |
| APIXABAN×2 | ZYDUS PHARMS | ANDA 210185 | — | Feb 27, 2023 | |
| APIXABAN×2 | BRECKENRIDGE | ANDA 209845 | — | Jul 26, 2021 | |
| APIXABAN×2 | REGCON HOLDINGS | ANDA 209898 | AB | Sep 11, 2020 | |
| APIXABAN×2 | ACCORD HLTHCARE | ANDA 210180 | AB | Jul 28, 2020 | |
| APIXABAN×2 | BIONPHARMA | ANDA 210152 | — | Apr 08, 2020 | |
| APIXABAN×2 | MICRO LABS | ANDA 210013 | — | Dec 23, 2019 | |
| APIXABAN×2 | MYLAN | ANDA 210128 | — | Dec 23, 2019 |
Marketing exclusivity (8)
- NPNew product exclusivity (3 years)
Apr 17, 2028
in 1 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 4 mo
- NSNew strength exclusivity (3 years)
Apr 17, 2028
in 1 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 4 mo
- NPPNew patient population exclusivity (3 years)
Apr 17, 2028
in 1 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 4 mo
- NPPNew patient population exclusivity (3 years)
Apr 17, 2028
in 1 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 4 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6967208 | Nov 21, 2026 | in 5 mo | SubstanceProductU-4180 |
| 6967208*PED | May 21, 2027 | in 11 mo | |
| 9326945 | Feb 24, 2031 | in 4 yr 9 mo | Product |
| 9326945*PED | Aug 24, 2031 | in 5 yr 3 mo | |
| 11896586 | Nov 22, 2040 | in 14 yr 8 mo | ProductU-4180 |
| 11896586*PED | May 22, 2041 | in 15 yr 2 mo |
Apixaban — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
