FDA Orange Book · active-ingredient family
Apremilast
Apremilast is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
2
Brand (NDA)
13
Generics (ANDA)
11
Listed patents
22
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OTEZLA XRRLD | AMGEN INC | NDA 210745 | — | Aug 29, 2025 | |
| OTEZLARLD×3 | AMGEN INC | NDA 205437 | AB | Mar 21, 2014 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| APREMILAST×3 | TORRENT | ANDA 211834 | — | Jun 20, 2025 | |
| APREMILAST×3 | MSN | ANDA 211887 | AB | Dec 16, 2024 | |
| APREMILAST×3 | MACLEODS PHARMS LTD | ANDA 211788 | — | Nov 25, 2024 | |
| APREMILAST×3 | MANKIND PHARMA | ANDA 211734 | AB | Feb 07, 2024 | |
| APREMILAST×3 | GLENMARK PHARMS LTD | ANDA 211674 | — | Oct 16, 2023 | |
| APREMILAST×3 | ANNORA | ANDA 211878 | AB | Jul 26, 2023 | |
| APREMILAST×3 | AUROBINDO PHARMA LTD | ANDA 211716 | — | Jul 19, 2023 | |
| APREMILAST×3 | DR REDDYS | ANDA 211756 | — | Jul 14, 2023 | |
| APREMILAST×3 | SHILPA | ANDA 211774 | AB | Apr 07, 2023 | |
| APREMILAST×3 | TEVA PHARMS USA INC | ANDA 211897 | — | Aug 18, 2022 | |
| APREMILAST×3 | ALKEM LABS LTD | ANDA 211761 | AB | Sep 21, 2021 | |
| APREMILAST×3 | AMNEAL | ANDA 211782 | — | Jun 30, 2021 | |
| APREMILAST×3 | UNICHEM | ANDA 211819 | — | Feb 17, 2021 |
Marketing exclusivity (22)
- M-299New use / labeling-change exclusivity (3 years)
Jul 20, 2026
in 1 mo
- ODE*FDA marketing exclusivity
Jul 19, 2026
in 1 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 19, 2027
in 7 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 20, 2027
in 7 mo
- M-299New use / labeling-change exclusivity (3 years)
Jul 20, 2026
in 1 mo
- NPPNew patient population exclusivity (3 years)
Apr 25, 2027
in 10 mo
- ODE-248Orphan-drug exclusivity (7 years)
Jul 19, 2026
in 1 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 19, 2027
in 7 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 25, 2027
in 1 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 20, 2027
in 7 mo
- M-299New use / labeling-change exclusivity (3 years)
Jul 20, 2026
in 1 mo
- NPPNew patient population exclusivity (3 years)
Apr 25, 2027
in 10 mo
- ODE-248Orphan-drug exclusivity (7 years)
Jul 19, 2026
in 1 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 19, 2027
in 7 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 25, 2027
in 1 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 20, 2027
in 7 mo
- M-299New use / labeling-change exclusivity (3 years)
Jul 20, 2026
in 1 mo
- NPPNew patient population exclusivity (3 years)
Apr 25, 2027
in 10 mo
- ODE-248Orphan-drug exclusivity (7 years)
Jul 19, 2026
in 1 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 19, 2027
in 7 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 25, 2027
in 1 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 20, 2027
in 7 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7427638 | Feb 16, 2028 | in 1 yr 8 mo | SubstanceProduct |
| 7427638*PED | Aug 16, 2028 | in 2 yr 2 mo | |
| 12576034 | Nov 30, 2033 | in 7 yr 7 mo | ProductU-4291 |
| 10092541 | May 29, 2034 | in 8 yr 1 mo | U-2659 |
| 9872854 | May 29, 2034 | in 8 yr 1 mo | U-2232 |
| 12576034*PED | May 30, 2034 | in 8 yr 1 mo | |
| 9872854*PED | Nov 29, 2034 | in 8 yr 7 mo | |
| 10092541*PED | Nov 29, 2034 | in 8 yr 7 mo | |
| 11752129 | May 27, 2042 | in 16 yr 2 mo | ProductU-4264 |
| 12427136 | May 27, 2042 | in 16 yr 2 mo | U-1858 |
| 11969409 | May 27, 2042 | in 16 yr 2 mo | Product |
Apremilast — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
