Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 18, 2019

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, 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

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SponsorPhase
University of East AngliaN/A
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)N/A
Federal University of São PauloPhase 4

See all dexmethylphenidate hydrochloride clinical trials

Recent Litigation for dexmethylphenidate hydrochloride

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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 Trial40MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial35MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial25MGCAPSULE, 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

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 206931-002 Dec 4, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202731-004 Jul 5, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride TABLET;ORAL 212631-001 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079108-002 Aug 5, 2015 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 021802-004 Aug 1, 2006   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010   Start Trial   Start Trial
>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 verifification 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.