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

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Last Updated: December 9, 2019

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FOCALIN Drug Profile

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Which patents cover Focalin, and what generic alternatives are available?

Focalin is a drug marketed by Novartis and is included in two NDAs. There are two patents protecting this drug and eight Paragraph IV challenges.

The generic ingredient in FOCALIN is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Drug patent expirations by year for FOCALIN
Drug Prices for FOCALIN

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Drug Sales Revenue Trends for FOCALIN

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Recent Clinical Trials for FOCALIN

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

SponsorPhase
Matthew O'BrienPhase 4
Massachusetts General HospitalPhase 4
University Hospital, Basel, SwitzerlandPhase 0

See all FOCALIN clinical trials

Recent Litigation for FOCALIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.2013-05-17
CELGENE CORPORATION v. MYLAN PHARAMACEUTICALS, INC.2012-12-07
CELGENE CORPORATION v. KV PHARMACEUTICAL COMPANY2008-12-05

See all FOCALIN litigation

Pharmacology for FOCALIN
Synonyms for FOCALIN
(+)-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, .alpha.-phenyl-, methyl ester, (.alpha.S,2S)-
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
40572-71-2
56502-30-8
AC1L4BP0
AC1L4BP3
AJ-24248
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
D03721
D07806
DB06701
Dex methylphenidate
dex-methylphenidate
dex-methylphenidate hydrochloride
Dexmethylphenidate
Dexmethylphenidate (INN)
Dexmethylphenidate [INN]
Dexmethylphenidate HCl
Dexmethylphenidate hydrochloride
Dexmethylphenidate hydrochloride (USAN)
Dexmethylphenidate hydrochloride [USAN]
dexmethylphenidatum
dexmetilfenidato
dl-threo-Methylphenidate HCl
dl-threo-Methylphenidate Hydrochloride
DUGOZIWVEXMGBE-CHWSQXEVSA-N
Equasym IR
Equasym XL
Focalin (TN)
Focalin XR
GTPL7554
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 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)
MethyPatch
NWP-06
PDSP1_000871
PDSP1_000903
PDSP2_000857
PDSP2_000889
Ritalin QD
SB13180
SCHEMBL34326
threo-(+)-Methylphenidate
threo-Methylphenydate
UNII-1678OK0E08
UNII-207ZZ9QZ49 component DUGOZIWVEXMGBE-CHWSQXEVSA-N
UNII-4B3SC438HI component JUMYIBMBTDDLNG-OJERSXHUSA-N
UNII-M32RH9MFGP
ZINC896711
Paragraph IV (Patent) Challenges for FOCALIN
Tradename Dosage Ingredient NDA Submissiondate
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 2004-07-27
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 2004-05-27

US Patents and Regulatory Information for FOCALIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 AB RX Yes No   Start Trial   Start Trial Y   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 FOCALIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-002 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-002 Nov 13, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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