DEXMETHYLPHENIDATE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Dexmethylphenidate Hydrochloride, and when can generic versions of Dexmethylphenidate Hydrochloride launch?
Dexmethylphenidate Hydrochloride is a drug marketed by Adare Pharms Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Endo Operations, Granules, Impax Labs Inc, Intellipharmaceutics, Sun Pharm Inds Inc, Teva Pharms Usa, Abhai Inc, Alkem Labs Ltd, Bionpharma, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc. and is included in twenty-two NDAs.
The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dexmethylphenidate Hydrochloride
A generic version of DEXMETHYLPHENIDATE HYDROCHLORIDE was approved as dexmethylphenidate hydrochloride by INTELLIPHARMACEUTICS on November 18th, 2013.
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Questions you can ask:
- What is the 5 year forecast for DEXMETHYLPHENIDATE HYDROCHLORIDE?
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Summary for DEXMETHYLPHENIDATE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 19 |
| NDAs: | 22 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 18 |
| Patent Applications: | 36 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEXMETHYLPHENIDATE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in DEXMETHYLPHENIDATE HYDROCHLORIDE? | DEXMETHYLPHENIDATE HYDROCHLORIDE excipients list |
| DailyMed Link: | DEXMETHYLPHENIDATE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DEXMETHYLPHENIDATE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NYU Langone Health | Phase 4 |
| Premier Research Group plc | Phase 4 |
| Corium, Inc. | Phase 4 |
Pharmacology for DEXMETHYLPHENIDATE HYDROCHLORIDE
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for DEXMETHYLPHENIDATE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DEXMETHYLPHENIDATE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DEXMETHYLPHENIDATE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 25 mg | 021802 | 1 | 2011-09-30 |
| FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 35 mg | 021802 | 1 | 2011-09-29 |
| FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 40 mg | 021802 | 1 | 2010-12-20 |
| FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 30 mg | 021802 | 1 | 2010-12-15 |
| FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 15 mg | 021802 | 1 | 2007-05-14 |
| FOCALIN XR | Extended-release Capsules | dexmethylphenidate hydrochloride | 5 mg, 10 mg and 20 mg | 021802 | 1 | 2007-03-30 |
| FOCALIN | Tablets | dexmethylphenidate hydrochloride | 2.5 mg | 021278 | 1 | 2004-07-27 |
| FOCALIN | Tablets | dexmethylphenidate hydrochloride | 5 mg and 10 mg | 021278 | 1 | 2004-05-27 |
