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Last Updated: March 3, 2021

DrugPatentWatch Database Preview

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 three branded drugs marketed by Adare Pharms Inc, Granules Pharms, Impax Labs Inc, Intellipharmaceutics, Mylan, Par Pharm Inc, Teva Pharms Usa, Novartis, Abhai Inc, Alkem Labs Ltd, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, Tris Pharma Inc, and Uspharma, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for dexmethylphenidate hydrochloride. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary 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
University of East AngliaN/A

See all dexmethylphenidate hydrochloride clinical trials

Generic filers with tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial15MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial10MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial5MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Cediprof Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 209211-002 Sep 19, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908-003 Nov 19, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 077107-001 Jan 29, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203614-001 Jul 5, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes 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

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 021802-004 Aug 1, 2006   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Dow
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Merck

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