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Generated: December 16, 2018

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FOCALIN XR Drug Profile

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When do Focalin Xr patents expire, and what generic alternatives are available?

Focalin Xr is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and six Paragraph IV challenges.

This drug has one hundred and forty-two patent family members in thirty-three countries.

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

Drug patent expirations by year for FOCALIN XR
Pharmacology for FOCALIN XR
Medical Subject Heading (MeSH) Categories for FOCALIN XR
Synonyms for FOCALIN XR
(+)-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
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)
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

US Patents and Regulatory Information for FOCALIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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 FOCALIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-007 Apr 21, 2011 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for FOCALIN XR
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Chubb
Chinese Patent Office
McKesson
Federal Trade Commission
Boehringer Ingelheim
Express Scripts
Fish and Richardson
Deloitte

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