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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Chubb
QuintilesIMS
McKesson
Healthtrust
Harvard Business School
Fuji
Fish and Richardson
Teva

Generated: July 15, 2018

DrugPatentWatch Database Preview

CONCERTA Drug Profile

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

Concerta is a drug marketed by Janssen Pharms and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has seventy-two patent family members in seventeen countries.

The generic ingredient in CONCERTA is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Drug patent expirations by year for CONCERTA
Pharmacology for CONCERTA
Synonyms for CONCERTA
.alpha.-Phenyl-2-piperidineacetic acid methyl ester
113-45-1
2-Piperidineacetic acid, .alpha.-phenyl-, methyl ester
2-Piperidineacetic acid, alpha-phenyl-, methyl ester
298-59-9 (hydrochloride)
4311/B Ciba
AB01563134_01
AC1L1HJM
AK112570
AKOS022506757
alpha-Phenyl-2-piperidineacetic acid methyl ester
alpha-Phenyl-alpha-(2-piperidyl)acetic acid methyl ester
API0008866
Attenta (TN)
BDBM50062912
Biphentin (TN)
C 4311
C07196
Calocain
Centedein
Centedein (Salt/Mix)
Centedrin
Centedrin (Salt/Mix)
Centedrine (Salt/Mix)
Centredin
CHEBI:84276
CHEMBL796
Concerta (TN)
Concerta, Methylin, Ritalin
Cotempla XR-ODT
CS-4657
d-methylphenidate HCl
D02PPN
D04999
Daytrana
Daytrana (TN)
DB00422
DEA No. 1724
DR000523
DTXSID5023299
DUGOZIWVEXMGBE-UHFFFAOYSA-N
EINECS 204-028-6
Equasym (TN)
FT-0700534
GTPL7236
HE297259
HSDB 3126
HY-B1091
L001307
LS-565
Meridil
Metadate
Metadate CD
Metadate ER
Metadate ER (TN)
Methyl .alpha.-phenyl-.alpha.-(2-piperidyl)acetate
Methyl .alpha.-phenyl-.alpha.-2-piperidinylacetate
Methyl .alpha.-phenyl-2-piperidine-acetate
Methyl .alpha.-phenyl-2-piperidineacetate
Methyl (2-phenyl-2-(2-piperidyl)acetate)
Methyl 2-phenyl-2-(piperidin-2-yl)acetate
methyl 2-phenyl-2-piperidin-2-ylacetate
Methyl alpha-phenyl-alpha-(2-piperidyl)acetate
Methyl alpha-phenyl-alpha-2-piperidinylacetate
methyl alpha-piperid-2-ylphenylacetate
Methyl phenidate
Methyl phenidyl acetate
Methyl phenidylacetate
Methyl phenyl(2-piperidinyl)acetate #
methyl phenyl(piperidin-2-yl)acetate
Methylfenidan
Methylin
Methylin (Salt/Mix)
Methylin (TN)
Methylin ER
Methylofenidan
Methylphen
Methylphenidan
methylphenidate
METHYLPHENIDATE (SEE ALSO: METHYLPHENIDATE HYDROCHLORIDE, CAS 298-59-9, NTPNO 10266-R)
Methylphenidate (USAN/INN)
Methylphenidate [INN:BAN]
Methylphenidate [USAN:INN:BAN]
Methylphenidate HCl
Methylphenidatum
Methylphenidatum [INN-Latin]
Methylphenidylacetate hydrochloride
MethyPatch
Metilfenidato
Metilfenidato [INN-Spanish]
Metilfenidato [Italian]
Motiron (TN)
NCGC00248587-01
NCI-C56280
Phenidylate
Plimasine
PMS-Methylphenidate
Riphenidate
Ritalin
Ritalin (Salt/Mix)
Ritalin (TN)
Ritalin LA
Ritalin LA (TN)
Ritalin SR
Ritalin-SR
Ritaline
Ritaline (Salt/Mix)
Ritcher works
Rubifen
Rubifen (TN)
SBI-0206868.P001
SCHEMBL37178
Tsentedrin

US Patents and Regulatory Information for CONCERTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 AB RX Yes 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 CONCERTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ 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 CONCERTA
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 18 mg*, 27 mg, 36 mg and 54 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 18 mg, 27 mg, 36 mg and 54 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for CONCERTA

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
8,323,691 Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms ➤ Sign Up
2,015,125,493 ➤ Sign Up
9,144,549 Methods and devices for providing prolonged drug therapy ➤ Sign Up
9,029,416 Methods and devices for providing prolonged drug therapy ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Mallinckrodt
Daiichi Sankyo
Argus Health
Baxter
Johnson and Johnson
Express Scripts
Colorcon

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.