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Last Updated: September 27, 2020

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DEXMETHYLPHENIDATE HYDROCHLORIDE Drug 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, Impax Labs Inc, Intellipharmaceutics, Mylan, Par Pharm Inc, Teva Pharms Usa, 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 nineteen NDAs.

The generic ingredient in DEXMETHYLPHENIDATE HYDROCHLORIDE is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Dexmethylphenidate Hydrochloride

A generic version of DEXMETHYLPHENIDATE HYDROCHLORIDE was approved as dexmethylphenidate hydrochloride by MYLAN on August 28th, 2013.

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Drug patent expirations by year for DEXMETHYLPHENIDATE HYDROCHLORIDE
Recent Clinical Trials for DEXMETHYLPHENIDATE HYDROCHLORIDE

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

SponsorPhase
Cingulate TherapeuticsPhase 1
Cingulate TherapeuticsPhase 1/Phase 2
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)N/A

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 NDA Submissiondate
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
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 2004-07-27
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 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
Abhai Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 206931-002 Dec 4, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908-001 Nov 19, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Cediprof Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 209211-002 Sep 19, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 201231-002 Sep 24, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 212631-003 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 209468-001 Sep 25, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 204534-003 Dec 4, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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