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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Teva
Cipla
Citi
Cerilliant
QuintilesIMS
Moodys

Generated: May 26, 2018

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 dexmethylphenidate hydrochloride freedom to operate?

Dexmethylphenidate hydrochloride
is the generic ingredient in three branded drugs marketed by Impax Labs Inc, Intellipharmaceutics, Mylan Pharms Inc, Par Pharm Inc, Teva Pharms Usa, Novartis, Abhai Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, and Tris Pharma Inc, and is included in seventeen 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 five drug master file entries for dexmethylphenidate hydrochloride. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for dexmethylphenidate hydrochloride
Medical Subject Heading (MeSH) Categories for dexmethylphenidate hydrochloride
Synonyms for dexmethylphenidate hydrochloride
(+)-threo-Methylphenidate
(+/-)-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
(2R)-2-[(R)-1-Phenyl-2-oxo-2-methoxyethyl]piperidinium
(R)-2-((R)-Methoxycarbonyl-phenyl-methyl)-piperidinium; chloride
(R)-methyl 2-phenyl-2-((R)-piperidin-2-yl)acetate hydrochloride
1678OK0E08
19262-68-1
2-PIPERIDINEACETIC ACID A-PHENYL-,METHYL ESTER,STEREOISOMER
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, (alphaR,2R)-
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*)- (+-)-
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, threo-
23655-65-4
35652-13-2
40431-64-9
56502-30-8
AC1L4BP0
AC1L4BP3
AJ-24248
AK311895
AKOS027321667
alpha-Phenyl-2-piperidineacetic acid methyl ester (threo isomer)
Attenade
BDBM50062915
BDBM50142839
Biphentin
CHEBI:51860
CHEMBL827
CHEMBL904
d-Methylphenidate
D-MPH
d-Ritalin Hydrochloride
d-threo methylphenidate
d-threo methylphenidate hydrochloride
d-threo-Methylphenidate
D-threo-Methylphenidate hydrochloride
D-TMP
D02QCD
D03721
D04XQW
D07806
DB06701
Dex methylphenidate
dex-methylphenidate
dex-methylphenidate hydrochloride
Dexmethylphenidate
Dexmethylphenidate (INN)
Dexmethylphenidate [INN]
Dexmethylphenidate HCl
Dexmethylphenidate hydrochloride (USAN)
Dexmethylphenidate hydrochloride [USAN]
dexmethylphenidatum
dexmetilfenidato
dl-threo-Methylphenidate HCl
dl-threo-Methylphenidate Hydrochloride
DUGOZIWVEXMGBE-CHWSQXEVSA-N
Equasym IR
Equasym XL
Focalin
Focalin (TN)
Focalin XR
GTPL7554
HE218450
HE321998
HE327535
HE341507
JUMYIBMBTDDLNG-OJERSXHUSA-N
LS-114147
LS-114148
LS-194106
M32RH9MFGP
Metadate MR
methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate
METHYL (2R)-2-PHENYL-2-[(2R)-PIPERIDIN-2-YL]ACETATE HCL
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
methyl (2R)-phenyl[(2R)-piperidin-2-yl]acetate
methyl (R)-phenyl[(R)-piperidin-2-yl]acetate
Methyl D-phenidate
Methylphenidate Hydrochloride 1.0 mg/ml in Methanol (as free base)
NWP-06
NWP06
PDSP1_000871
PDSP1_000903
PDSP2_000857
PDSP2_000889
Ritalin QD
SCHEMBL1649811
SCHEMBL34326
threo-(+)-Methylphenidate
threo-Methylphenydate
UNII-1678OK0E08
UNII-207ZZ9QZ49 component DUGOZIWVEXMGBE-CHWSQXEVSA-N
UNII-4B3SC438HI component JUMYIBMBTDDLNG-OJERSXHUSA-N
UNII-M32RH9MFGP
ZINC896711
Tentative approvals for DEXMETHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up5MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up40MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up35MGCAPSULE, EXTENDED RELEASE;ORAL

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
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908-003 Nov 19, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 202842-003 Nov 30, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078908-004 May 19, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs Inc DEXMETHYLPHENIDATE HYDROCHLORIDE dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079108-004 Dec 21, 2015 AB RX 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
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for dexmethylphenidate hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,580,712 Wireless high-speed data network planning tool ➤ Sign Up
6,793,936 Multiparticulate modified release composition ➤ Sign Up
8,119,163 Nanoparticulate and controlled release compositions comprising cefditoren ➤ Sign Up
6,902,742 Multiparticulate modified release composition ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Colorcon
Fuji
Harvard Business School
Fish and Richardson
QuintilesIMS
Mallinckrodt
Moodys
Cantor Fitzgerald

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.