Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
Cipla
Medtronic
Cantor Fitzgerald
McKinsey
Chubb
Harvard Business School
Mallinckrodt

Generated: May 24, 2018

DrugPatentWatch Database Preview

FOCALIN XR Drug Profile

or, see our see our flat-rate plans

« Back to Dashboard

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 five drug master file entries for this compound. Seventeen 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

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 021802-005 Oct 23, 2009 ➤ Sign Up ➤ Sign Up
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011 ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for FOCALIN XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release capsules 25 mg ➤ Subscribe 2011-09-30
➤ Subscribe Extended-release capsules 35 mg ➤ Subscribe 2011-09-29
➤ Subscribe Extended-release Capsule 40 mg ➤ Subscribe 2010-12-20
➤ Subscribe Extended-release Capsule 30 mg ➤ Subscribe 2010-12-15
➤ Subscribe Extended-release Capsules 15 mg ➤ Subscribe 2007-05-14
➤ Subscribe Extended-release Capsules 5mg, 10mg and 20 mg ➤ Subscribe 2007-03-30

Non-Orange Book US Patents for FOCALIN XR

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

or, see our see our flat-rate plans

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

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Moodys
Daiichi Sankyo
Cantor Fitzgerald
Fish and Richardson
Deloitte
Express Scripts
McKinsey
Harvard Business School

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.