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Dexmethylphenidate hydrochlorideis the generic ingredient in three branded drugs marketed by Adare Pharms Inc, Impax Labs Inc, Intellipharmaceutics, Mylan, Par Pharm Inc, Teva Pharms Usa, Novartis, Abhai Inc, Alkem Labs Ltd, Bionpharma Inc, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.
There are six drug master file entries for dexmethylphenidate hydrochloride. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dexmethylphenidate hydrochloride
|Drug Master File Entries:||6|
|Suppliers / Packagers:||14|
|Bulk Api Vendors:||12|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for dexmethylphenidate hydrochloride|
|DailyMed Link:||dexmethylphenidate hydrochloride at DailyMed|
Recent Clinical Trials for dexmethylphenidate hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Cingulate Therapeutics||Phase 1|
|Cingulate Therapeutics||Phase 1/Phase 2|
|Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)||N/A|
Generic filers with tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for dexmethylphenidate hydrochloride
|Drug Class||Central Nervous System Stimulant |
|Physiological Effect||Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for dexmethylphenidate hydrochloride
Paragraph IV (Patent) Challenges for DEXMETHYLPHENIDATE HYDROCHLORIDE
|FOCALIN XR||CAPSULE, EXTENDED RELEASE;ORAL||dexmethylphenidate hydrochloride||021802||2011-09-30|
|FOCALIN XR||CAPSULE, EXTENDED RELEASE;ORAL||dexmethylphenidate hydrochloride||021802||2011-09-29|
|FOCALIN XR||CAPSULE, EXTENDED RELEASE;ORAL||dexmethylphenidate hydrochloride||021802||2010-12-20|
|FOCALIN XR||CAPSULE, EXTENDED RELEASE;ORAL||dexmethylphenidate hydrochloride||021802||2010-12-15|
|FOCALIN XR||CAPSULE, EXTENDED RELEASE;ORAL||dexmethylphenidate hydrochloride||021802||2007-05-14|
|FOCALIN XR||CAPSULE, EXTENDED RELEASE;ORAL||dexmethylphenidate hydrochloride||021802||2007-03-30|
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