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Generated: December 16, 2018

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Methylphenidate - Generic Drug Details

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What are the generic drug sources for methylphenidate and what is the scope of methylphenidate patent protection?

Methylphenidate is the generic ingredient in fifteen branded drugs marketed by Noven Pharms Inc, Neos Theraps Inc, Rhodes Pharms, Ironshore Pharms, Lannett Co Inc, Barr Labs Inc, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Actavis Labs Fl Inc, Nextwave Pharms, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Wes Pharma Inc, Ascent Pharms Inc, Rising Pharms, Janssen Pharms, Able, Actavis Elizabeth, Actavis Labs Fl, Amneal Pharms, Ani Pharms Inc, Cnty Line Pharms, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Aurolife Pharma Llc, Bionpharma Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in sixty-two NDAs. There are forty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has forty-nine patent family members in twenty-nine countries.

There are thirty-two drug master file entries for methylphenidate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for methylphenidate
Medical Subject Heading (MeSH) Categories for methylphenidate
Synonyms for methylphenidate
.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
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 (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
Tentative approvals for METHYLPHENIDATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up60MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up50MGCAPSULE, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-001 Dec 4, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actavis Elizabeth METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 040321-003 Feb 5, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mountain METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 091159-003 Mar 12, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-004 Aug 8, 2018 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Ani Pharms Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 208607-003 Jul 14, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 090710-002 Mar 15, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583-002 Sep 29, 2015 AB2 RX No 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 methylphenidate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Accenture
Mallinckrodt
Fuji
US Army
Boehringer Ingelheim
Merck
Harvard Business School
Healthtrust

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.