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Last Updated: December 13, 2024

Dexmethylphenidate hydrochloride - Generic Drug Details


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What are the generic 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.

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

SponsorPhase
NYU Langone HealthPhase 4
AlmacPhase 4
Prometrika, LLCPhase 4

See all dexmethylphenidate hydrochloride clinical trials

Pharmacology for dexmethylphenidate hydrochloride
Drug ClassCentral Nervous System Stimulant
Physiological EffectCentral Nervous System Stimulation
Medical Subject Heading (MeSH) Categories for dexmethylphenidate hydrochloride
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for dexmethylphenidate hydrochloride
N06BA Centrally acting sympathomimetics
N06B PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06 PSYCHOANALEPTICS
N Nervous system
N06BA Centrally acting sympathomimetics
N06B PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06 PSYCHOANALEPTICS
N Nervous system
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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ascent Pharms Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 215523-004 Dec 8, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cediprof Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 209211-001 Sep 19, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cediprof Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 209211-002 Sep 19, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202731-003 May 19, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurolife Pharma Llc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204266-001 Aug 25, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurolife Pharma Llc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204266-002 Aug 25, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lannett Co Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 209468-001 Sep 25, 2017 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

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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 021802-004 Aug 1, 2006 ⤷  Sign Up ⤷  Sign Up
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 ⤷  Sign Up ⤷  Sign Up
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 ⤷  Sign Up ⤷  Sign Up
Sandoz FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001 ⤷  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 021802-004 Aug 1, 2006 ⤷  Sign Up ⤷  Sign Up
Sandoz FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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