FDA Orange Book · active-ingredient family
Dexmethylphenidate hydrochloride
Dexmethylphenidate hydrochloride is approved as 2 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FOCALIN XR · NDA 021802
2
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOCALIN XRRLD×8 | SANDOZ | NDA 021802 | AB | May 26, 2005 | |
| FOCALINRLD×3 | SANDOZ | NDA 021278 | AB | Nov 13, 2001 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE×8 | ASCENT PHARMS INC | ANDA 215523 | AB | Dec 08, 2021 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×6 | PLATINUM | ANDA 078992 | AB | Nov 23, 2021 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×8 | SUN PHARM INDS INC | ANDA 206734 | — | Nov 05, 2021 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×8 | GRANULES | ANDA 213813 | AB | Sep 09, 2020 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×2 | BIONPHARMA | ANDA 209754 | — | Mar 24, 2020 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | ALKEM LABS LTD | ANDA 212631 | AB | Jul 19, 2019 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×8 | ADARE PHARMS INC | ANDA 210279 | AB | Oct 09, 2018 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×2 | CEDIPROF INC | ANDA 209211 | AB | Sep 19, 2018 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | RHODES PHARMS | ANDA 208756 | — | Nov 20, 2017 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | LANNETT CO INC | ANDA 209468 | — | Sep 25, 2017 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×2 | IMPAX LABS INC | ANDA 203614 | AB | Jul 05, 2017 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×4 | TEVA PHARMS USA | ANDA 202731 | AB | Jul 05, 2017 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×8 | PH HEALTH | ANDA 202842 | AB | Nov 30, 2016 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | TRIS PHARMA INC | ANDA 207901 | AB | Aug 26, 2016 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | ABHAI LLC | ANDA 206931 | AB | Dec 04, 2015 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | NOVEL LABS INC | ANDA 204534 | AB | Dec 04, 2015 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | SUN PHARM INDUSTRIES | ANDA 201231 | AB | Sep 24, 2015 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×8 | AUROLIFE PHARMA LLC | ANDA 202580 | — | Aug 25, 2015 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×5 | IMPAX LABS INC | ANDA 079108 | AB | Aug 05, 2015 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×4 | TEVA PHARMS USA | ANDA 078908 | AB | Nov 19, 2013 | |
| DEXMETHYLPHENIDATE HYDROCHLORIDE×3 | TEVA PHARMS | ANDA 077107 | — | Jan 29, 2007 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Dexmethylphenidate hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
