FDA Orange Book · active-ingredient family
Methylphenidate
Methylphenidate is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COTEMPLA XR-ODT · NDA 205489
2
Brand (NDA)
2
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, extended release, tablet, orally disintegrating, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COTEMPLA XR-ODTRLD×4 | NEOS THERAPS INC | NDA 205489 | AB | Jun 19, 2017 | |
| DAYTRANARLD×4 | NOVEN PHARMS INC | NDA 021514 | AB | Apr 06, 2006 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLPHENIDATE×4 | MYLAN TECH VIATRIS | ANDA 206497 | AB | Mar 14, 2022 | |
| METHYLPHENIDATE×3 | ACTAVIS ELIZABETH | ANDA 210924 | AB | Jun 19, 2020 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8840924 | Jun 05, 2026 | 14 d ago | Product |
| 9089496 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 9072680 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 11166947 | Jan 25, 2038 | in 11 yr 9 mo | U-3299 |
Methylphenidate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
