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Last Updated: March 18, 2024

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, Granules, Impax Labs Inc, Intellipharmaceutics, Par Pharm Inc, 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. Seventeen 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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Drug patent expirations by year for DEXMETHYLPHENIDATE HYDROCHLORIDE
Recent Clinical Trials for DEXMETHYLPHENIDATE HYDROCHLORIDE

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

SponsorPhase
Corium, Inc.Phase 4
AlmacPhase 4
Prometrika, LLCPhase 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
Abhai Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 206931-003 Dec 4, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intellipharmaceutics DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078992-002 Nov 23, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Granules DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 213813-008 Sep 9, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rhodes Pharms DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 208756-001 Nov 20, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202842-004 Nov 30, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206734-007 Nov 5, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.