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UBS
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Fish and Richardson
Accenture
McKesson
Boehringer Ingelheim

Generated: April 23, 2018

DrugPatentWatch Database Preview

Methylphenidate - Generic Drug Details

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What are the generic sources for methylphenidate and what is the scope of methylphenidate freedom to operate?

Methylphenidate
is the generic ingredient in fourteen branded drugs marketed by Noven Pharms Inc, Neos Theraps Inc, Rhodes Pharms, Lannett Co Inc, Barr Labs Inc, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, Nextwave Pharms, Abhai Llc, Breckenridge Pharm, Novel Labs Inc, Tris Pharma Inc, Ascent Pharms Inc, Tedor Pharma Inc, Pfizer Inc, Janssen Pharms, Able, Actavis Elizabeth, Actavis Labs Fl, Amneal Pharms, Cnty Line Pharms, Kremers Urban Pharms, Mountain, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Bionpharma Inc, Sun Pharm Inds Inc, and Vintage Pharms, and is included in fifty-eight NDAs. There are thirty-five 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-one drug master file entries for methylphenidate. Two suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for methylphenidate
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
➤ Try a Free Trial➤ Try a Free Trial10MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Try a Free Trial➤ Try a Free Trial60MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Try a Free Trial➤ Try a Free Trial50MGCAPSULE, 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
Amneal Pharms METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 207515-001 Feb 1, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis RITALIN-SR methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 018029-001 Mar 30, 1982 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-003 Jun 5, 2002 AB1 RX Yes No ➤ 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 methylphenidate

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

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Non-Orange Book US Patents for methylphenidate

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
8,709,491 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles ➤ Try a Free Trial
9,265,737 Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles ➤ Try a Free Trial
8,916,191 Device for transdermal administration of drugs including acrylic polymers ➤ Try a Free Trial
9,017,731 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Cipla
Chubb
Queensland Health
Colorcon
Medtronic
US Department of Justice
Citi
Baxter

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