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Last Updated: December 2, 2022

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, Granules, Impax Labs Inc, Intellipharmaceutics, Par Pharm Inc, Sun Pharm Inds Inc, Teva Pharms Usa, Novartis, Abhai Inc, Alkem Labs Ltd, Bionpharma Inc, 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. Eighteen suppliers are listed for this compound.

Recent Clinical Trials for dexmethylphenidate hydrochloride

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

SponsorPhase
Cingulate TherapeuticsPhase 3
Premier Research Group plcPhase 3
Cingulate TherapeuticsPhase 1

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
Sun Pharm Inds Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206734-008 Nov 5, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ascent Pharms Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 215523-004 Dec 8, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abhai Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 206931-001 Dec 4, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-002 May 7, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ascent Pharms Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 215523-007 Dec 8, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 See Plans and Pricing See Plans and Pricing
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 See Plans and Pricing See Plans and Pricing
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 See Plans and Pricing See Plans and Pricing
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 See Plans and Pricing See Plans and Pricing
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Merck

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.