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Generated: March 25, 2019

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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 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, Alvogen Pine Brook, Janssen Pharms, Able, Actavis Elizabeth, Actavis Labs Fl, Amneal Pharms, Ani Pharms Inc, Cnty Line Pharms, Granules 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-four 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
AKOS022506757
alpha-Phenyl-2-piperidineacetic acid methyl ester
alpha-Phenyl-alpha-(2-piperidyl)acetic acid methyl ester
API0008866
BCP18286
BDBM50062912
BRD-A19585813-003-01-7
C 4311
C07196
Calocain
Centedein
Centedein (Salt/Mix)
Centedrin (Salt/Mix)
Centedrine (Salt/Mix)
Centredin
CHEBI:84276
CHEMBL796
Concerta
Concerta, Methylin, Ritalin
Cotempla XR-ODT
CS-4657
d-methylphenidate HCl
D04999
Daytrana
Daytrana (TN)
DB00422
DEA No. 1724
DTXSID5023299
DUGOZIWVEXMGBE-UHFFFAOYSA-N
EINECS 204-028-6
FT-0700534
GTPL7236
HSDB 3126
HY-B1091
Jornay PM (a.k.a. HLD200)
L001307
LS-565
Meridil
Metadate
Metadate ER
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 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]
NCGC00248587-01
NCI-C56280
Phenidylate
phenyl-piperidin-2-yl-acetic acid methyl ester
Plimasine
PMS-Methylphenidate
Riphenidate
Ritalin
Ritalin (Salt/Mix)
Ritalin LA
Ritaline
Ritaline (Salt/Mix)
Ritcher works
Rubifen
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 Up40MGCAPSULE, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up30MGCAPSULE, 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
Novartis RITALIN methylphenidate hydrochloride TABLET;ORAL 010187-006 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079031-002 Jul 13, 2012 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-001 Apr 17, 2015 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 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 021514-001 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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