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Last Updated: July 20, 2024

Dexmethylphenidate hydrochloride - Generic Drug Details


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What are the generic drug sources for dexmethylphenidate hydrochloride and what is the scope of freedom to operate?

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.

Recent Clinical Trials for dexmethylphenidate hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Prometrika, LLCPhase 4
Premier Research Group plcPhase 4
Corium, Inc.Phase 4

See all dexmethylphenidate hydrochloride clinical trials

Pharmacology for dexmethylphenidate hydrochloride
Medical Subject Heading (MeSH) Categories 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Granules DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 213813-002 Sep 9, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Adare Pharms Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210279-002 Oct 9, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 077107-002 Jan 29, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 021802-007 Apr 21, 2011 ⤷  Sign Up ⤷  Sign Up
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 ⤷  Sign Up ⤷  Sign Up
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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