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Generated: October 20, 2018

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FOCALIN Drug Profile

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Which patents cover Focalin, and when can generic versions of Focalin launch?

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. Fourteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Drug patent expirations by year for FOCALIN
Pharmacology for FOCALIN
Medical Subject Heading (MeSH) Categories 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 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 (TN)
Focalin XR
GTPL7554
HE218450
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
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

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-002 May 26, 2005 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-001 May 26, 2005 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-006 Aug 11, 2010 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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

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

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Paragraph IV (Patent) Challenges for FOCALIN
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 2.5 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe ➤ Try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Colorcon
Julphar
Argus Health
Covington
UBS
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

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.

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