Orange Book product · Brand (NDA)
OTEZLA XR
APREMILAST
At a glance
Aug 29, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2025
10 mo ago
Today
Exclusivity ends · ODE*
FDA marketing exclusivity
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
Patent 7427638 expires
Listed drug substance patent expiration.
Feb 16, 2028
in 1 yr 8 mo
Patent 10092541 expires
Listed method-of-use patent (U-2659) expiration.
May 29, 2034
in 8 yr 1 mo
Patent 11752129 expires
Listed drug product patent expiration.
May 27, 2042
in 16 yr 2 mo
Patent 11752129 expires
Listed drug product patent expiration.
May 27, 2042
in 16 yr 2 mo
Patent 11752129 expires
Listed drug product patent expiration.
May 27, 2042
in 16 yr 2 mo
Patent 11969409 expires
Listed drug product patent expiration.
May 27, 2042
in 16 yr 2 mo
Patent 12427136 expires
Listed method-of-use patent (U-1858) expiration.
May 27, 2042
in 16 yr 2 mo
Patent 12427136 expires
Listed method-of-use patent (U-4290) expiration.
May 27, 2042
in 16 yr 2 mo
Patent 12427136 expires
Listed method-of-use patent (U-4291) expiration.
May 27, 2042
in 16 yr 2 mo
Pharmaceutical detail
Active ingredient
APREMILAST
Strength
75MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 210745
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2014OTEZLABrand (NDA)
NDA 205437 · 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 (4)
- ODE*FDA marketing exclusivity
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
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7427638 | Feb 16, 2028 | in 1 yr 8 mo | SubstanceProduct |
| 10092541 | May 29, 2034 | in 8 yr 1 mo | U-2659 |
| 11752129 | May 27, 2042 | in 16 yr 2 mo | ProductU-4264 |
| 11752129 | May 27, 2042 | in 16 yr 2 mo | ProductU-4265 |
| 11752129 | May 27, 2042 | in 16 yr 2 mo | ProductU-4266 |
| 11969409 | May 27, 2042 | in 16 yr 2 mo | Product |
| 12427136 | May 27, 2042 | in 16 yr 2 mo | U-1858 |
| 12427136 | May 27, 2042 | in 16 yr 2 mo | U-4290 |
| 12427136 | May 27, 2042 | in 16 yr 2 mo | U-4291 |
