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Last Updated: December 6, 2019

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Dexmethylphenidate hydrochloride - Generic Drug Details

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What are the generic drug 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, 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, and Tris Pharma Inc, and is included in twenty NDAs. There are two patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmethylphenidate hydrochloride has one hundred and forty-two patent family members in thirty-three countries.

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

Recent Clinical Trials for dexmethylphenidate hydrochloride

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

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

See all dexmethylphenidate hydrochloride clinical trials

Recent Litigation for dexmethylphenidate hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Recro Gainesville LLC v. Actavis Laboratories FL, Inc.2017-10-30
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Recro Gainesville LLC v. Alvogen Malta Operations Ltd.2014-11-03

See all dexmethylphenidate hydrochloride litigation

Generic filers with tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial5MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial40MGCAPSULE, 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
Synonyms for dexmethylphenidate hydrochloride
(+/-)-threo-Methylphenidate hydrochloride
(|AR,2R)-|A-Phenyl-2-piperidineacetic Acid Methyl Ester Hydrochloride
(2R,2 inverted exclamation mark R)-(+)-threo-Methyl |A-Phenyl-|A-(2-piperidyl)acetate Hydrochloride
1678OK0E08
19262-68-1
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (alphaR,2R)-
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (R-(R*,R*))-
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (R*,R*)- (+-)-
23655-65-4
35652-13-2
56502-30-8
AC1L4BP0
AKOS027321667
Biphentin
CHEMBL904
d-Ritalin Hydrochloride
d-threo methylphenidate hydrochloride
D-threo-Methylphenidate hydrochloride
D03721
dex-methylphenidate hydrochloride
Dexmethylphenidate HCl
Dexmethylphenidate hydrochloride (USAN)
Dexmethylphenidate hydrochloride [USAN]
dl-threo-Methylphenidate HCl
dl-threo-Methylphenidate Hydrochloride
Equasym IR
Equasym XL
Focalin
Focalin (TN)
Focalin XR
JUMYIBMBTDDLNG-OJERSXHUSA-N
LS-114148
LS-194106
Metadate MR
methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate hydrochloride
methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate;hydrochloride
Methyl (2R)-phenyl((2R)-piperidin-2-yl)acetate hydrochloride
Methylphenidate Hydrochloride 1.0 mg/ml in Methanol (as free base)
MethyPatch
NWP-06
Ritalin QD
SB13180
UNII-1678OK0E08
UNII-4B3SC438HI component JUMYIBMBTDDLNG-OJERSXHUSA-N
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
Mylan DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204266-002 Aug 25, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Intellipharmaceutics DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078992-004 Nov 18, 2013 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
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908-004 May 19, 2014 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

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 021802-008 Apr 21, 2011   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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