Orange Book product · Brand (NDA)
SPRITAM
LEVETIRACETAM
At a glance
Jul 31, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2015
11 yr 1 mo ago
Today
Patent 11160786 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9339489 expires
Listed drug product patent expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9669009 expires
Listed method-of-use patent (U-1850) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9669009 expires
Listed method-of-use patent (U-2021) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 9669009 expires
Listed method-of-use patent (U-2022) expiration.
Mar 14, 2034
in 7 yr 10 mo
Pharmaceutical detail
Active ingredient
LEVETIRACETAM
Strength
1GM
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 207958
Product number
004
Marketing status
DISCN
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.
- 2018ELEPSIA XRBrand (NDA)
NDA 204417 · TRIPOINT
- 2011LEVETIRACETAM IN SODIUM CHLORIDEBrand (NDA)
NDA 202543 · HQ SPCLT PHARMA
- 2006KEPPRABrand (NDA)
NDA 021872 · UCB INC
- 2003KEPPRABrand (NDA)
NDA 021505 · UCB INC
- 2026LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 218364 · MYLAN LABS LTD
- 2025LEVETIRACETAMGeneric (ANDA)
ANDA 215465 · KNACK
- 2025LEVETIRACETAMGeneric (ANDA)
ANDA 218080 · ANDA REPOSITORY
- 2025LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 219562 · CAPLIN
- 2024LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 209705 · B BRAUN MEDICAL
- 2024LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 211356 · HIKMA
- 2023LEVETIRACETAMGeneric (ANDA)
ANDA 214673 · STRIDES PHARMA
- 2023LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 217059 · BAXTER HLTHCARE CORP
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11160786 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 9339489 | Mar 14, 2034 | in 7 yr 10 mo | ProductU-1850 |
| 9669009 | Mar 14, 2034 | in 7 yr 10 mo | U-1850 |
| 9669009 | Mar 14, 2034 | in 7 yr 10 mo | U-2021 |
| 9669009 | Mar 14, 2034 | in 7 yr 10 mo | U-2022 |
