Orange Book product · Brand (NDA)
OTEZLA
APREMILAST
At a glance
Mar 21, 2014
Approved
Brand (NDA)
Application
AB
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 21, 2014
12 yr 5 mo ago
Today
Exclusivity ends · ODE-248
Orphan-drug exclusivity (7 years)
Jul 19, 2026
in 1 mo
Exclusivity ends · M-299
New use / labeling-change exclusivity (3 years)
Jul 20, 2026
in 1 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jan 19, 2027
in 7 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jan 20, 2027
in 7 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Apr 25, 2027
in 10 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 25, 2027
in 1 yr 4 mo
Patent 7427638 expires
Listed drug substance patent expiration.
Feb 16, 2028
in 1 yr 8 mo
Patent 7427638*PED expires
Listed listed patent expiration.
Aug 16, 2028
in 2 yr 2 mo
Patent 12576034 expires
Listed drug product patent expiration.
Nov 30, 2033
in 7 yr 7 mo
Patent 12576034 expires
Listed drug product patent expiration.
Nov 30, 2033
in 7 yr 7 mo
Patent 12576034 expires
Listed drug product patent expiration.
Nov 30, 2033
in 7 yr 7 mo
Patent 10092541 expires
Listed method-of-use patent (U-2403) expiration.
May 29, 2034
in 8 yr 1 mo
Patent 10092541 expires
Listed method-of-use patent (U-2659) expiration.
May 29, 2034
in 8 yr 1 mo
Patent 9872854 expires
Listed method-of-use patent (U-2232) expiration.
May 29, 2034
in 8 yr 1 mo
Patent 9872854 expires
Listed method-of-use patent (U-2233) expiration.
May 29, 2034
in 8 yr 1 mo
Patent 12576034*PED expires
Listed listed patent expiration.
May 30, 2034
in 8 yr 1 mo
Patent 10092541*PED expires
Listed listed patent expiration.
Nov 29, 2034
in 8 yr 7 mo
Patent 9872854*PED expires
Listed listed patent expiration.
Nov 29, 2034
in 8 yr 7 mo
Pharmaceutical detail
Active ingredient
APREMILAST
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 205437
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025OTEZLA XRBrand (NDA)
NDA 210745 · AMGEN INC
- 2025APREMILASTGeneric (ANDA)
ANDA 211834 · TORRENT
- 2024APREMILASTGeneric (ANDA)
ANDA 211887 · MSN
- 2024APREMILASTGeneric (ANDA)
ANDA 211788 · MACLEODS PHARMS LTD
- 2024APREMILASTGeneric (ANDA)
ANDA 211734 · MANKIND PHARMA
- 2023APREMILASTGeneric (ANDA)
ANDA 211674 · GLENMARK PHARMS LTD
- 2023APREMILASTGeneric (ANDA)
ANDA 211878 · ANNORA
- 2023APREMILASTGeneric (ANDA)
ANDA 211716 · AUROBINDO PHARMA LTD
- 2023APREMILASTGeneric (ANDA)
ANDA 211756 · DR REDDYS
- 2023APREMILASTGeneric (ANDA)
ANDA 211774 · SHILPA
- 2022APREMILASTGeneric (ANDA)
ANDA 211897 · TEVA PHARMS USA INC
- 2021APREMILASTGeneric (ANDA)
ANDA 211761 · ALKEM LABS LTD
Marketing exclusivity (6)
- ODE-248Orphan-drug exclusivity (7 years)
Jul 19, 2026
in 1 mo
- M-299New use / labeling-change exclusivity (3 years)
Jul 20, 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
- NPPNew patient population exclusivity (3 years)
Apr 25, 2027
in 10 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 25, 2027
in 1 yr 4 mo
Listed patents (12)
| 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 |
| 12576034 | Nov 30, 2033 | in 7 yr 7 mo | ProductU-1858 |
| 12576034 | Nov 30, 2033 | in 7 yr 7 mo | ProductU-4290 |
| 10092541 | May 29, 2034 | in 8 yr 1 mo | U-2403 |
| 10092541 | May 29, 2034 | in 8 yr 1 mo | U-2659 |
| 9872854 | May 29, 2034 | in 8 yr 1 mo | U-2232 |
| 9872854 | May 29, 2034 | in 8 yr 1 mo | U-2233 |
| 12576034*PED | May 30, 2034 | in 8 yr 1 mo | |
| 10092541*PED | Nov 29, 2034 | in 8 yr 7 mo | |
| 9872854*PED | Nov 29, 2034 | in 8 yr 7 mo |
