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Last Updated: November 12, 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 freedom to operate?

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

Methylphenidate has three patent family members in two countries.

There are thirty-two drug master file entries for methylphenidate. One supplier is listed for this compound. There is one tentative approval for this compound.

Drug Prices for methylphenidate

See drug prices for methylphenidate

Drug Sales Revenue Trends for methylphenidate

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Recent Clinical Trials for methylphenidate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Taiwan University HospitalN/A
National Cancer Institute (NCI)Phase 2/Phase 3
M.D. Anderson Cancer CenterPhase 2/Phase 3

See all methylphenidate clinical trials

Recent Litigation for methylphenidate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Neos Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.2017-12-13
NOVEN PHARMACEUTICALS v. WATSON LABORATORIES, INC.2011-10-13
NOVEN PHARMACEUTICALS v. WATSON LABORATORIES, INC.

See all methylphenidate litigation

Generic filers with tentative approvals for METHYLPHENIDATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial25.9MGTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial17.3MGTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial8.6MGTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Paragraph IV (Patent) Challenges for METHYLPHENIDATE
Tradename Dosage Ingredient NDA Submissiondate
COTEMPLA XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL methylphenidate 205489 2017-09-01
DAYTRANA FILM, EXTENDED RELEASE;TRANSDERMAL methylphenidate 021514 2011-04-13

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
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 040300-003 Nov 27, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-004 Feb 27, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-002 Dec 4, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Aurolife Pharma Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 209276-001 Oct 25, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 AB3 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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