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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Chinese Patent Office
Teva
Queensland Health
Johnson and Johnson
Chubb
Healthtrust
Cantor Fitzgerald
Cerilliant

Generated: July 21, 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, Actavis Labs Fl Inc, 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, Ani Pharms Inc, Cnty Line Pharms, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Bionpharma Inc, Mountain, Sun Pharm Inds Inc, and Vintage Pharms, and is included in fifty-nine 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-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
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-001 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Breckenridge Pharm METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 207587-002 Mar 3, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Specgx Llc METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 021475-002 Apr 15, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novel Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, CHEWABLE;ORAL 204115-002 Feb 25, 2015 AB 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 021514-001 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 021514-004 Apr 6, 2006 ➤ Sign Up ➤ Sign Up
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
8,916,191 Device for transdermal administration of drugs including acrylic polymers ➤ Sign Up
9,333,263 Device for transdermal administration of drugs including acrylic based polymers ➤ Sign Up
8,709,491 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles ➤ Sign Up
9,017,731 Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Teva
Harvard Business School
Deloitte
Medtronic
Citi
Accenture
Johnson and Johnson
Healthtrust

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