Orange Book product · Brand (NDA)
COTEMPLA XR-ODT
METHYLPHENIDATE
At a glance
Jun 19, 2017
Approved
Brand (NDA)
Application
AB
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 19, 2017
9 yr 2 mo ago
Patent 8840924 expires
Listed drug product patent expiration.
Jun 05, 2026
14 d ago
Today
Patent 9072680 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9089496 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 11166947 expires
Listed method-of-use patent (U-3299) expiration.
Jan 25, 2038
in 11 yr 9 mo
Pharmaceutical detail
Active ingredient
METHYLPHENIDATE
Strength
8.6MG
Dosage form
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 205489
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.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8840924 | Jun 05, 2026 | 14 d ago | Product |
| 9072680 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 9089496 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 11166947 | Jan 25, 2038 | in 11 yr 9 mo | U-3299 |
