DEXMETHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for dexmethylphenidate hydrochloride and what is the scope of patent protection?
Dexmethylphenidate hydrochloride
is the generic ingredient in four branded drugs 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, Sandoz, Abhai Inc, Alkem Labs Ltd, Bionpharma, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, Tris Pharma Inc, and Commave Therap, and is included in twenty-five NDAs. There are six patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for dexmethylphenidate hydrochloride. Nineteen suppliers are listed for this compound.
Summary for DEXMETHYLPHENIDATE HYDROCHLORIDE
US Patents: | 6 |
Tradenames: | 4 |
Applicants: | 21 |
NDAs: | 25 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 19 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 18 |
Patent Applications: | 64 |
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 |
Corium, Inc. | Phase 4 |
Almac | 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 |
US Patents and Regulatory Information for DEXMETHYLPHENIDATE HYDROCHLORIDE
Expired US Patents for DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-008 | Apr 21, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-001 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-003 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-006 | Aug 11, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | FOCALIN XR | dexmethylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021802-003 | May 26, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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