Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Methylphenidate hydrochloride - Generic Drug Details

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

Methylphenidate hydrochloride is the generic ingredient in fourteen branded drugs marketed by 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, Novelgenix Theraps, Tris 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, Alkem Labs Ltd, Aurolife Pharma Llc, Bionpharma Inc, Cediprof Inc, Mountain, Oxford Pharms, and Sun Pharm Inds Inc, and is included in seventy-one NDAs. There are thirty-seven patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylphenidate hydrochloride has two hundred and ninety-three patent family members in thirty-seven countries.

There are thirty-two drug master file entries for methylphenidate hydrochloride. Forty-two suppliers are listed for this compound.

Drug Prices for methylphenidate hydrochloride

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Recent Clinical Trials for methylphenidate hydrochloride

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

SponsorPhase
Purdue Pharma, CanadaPhase 4
National Taiwan University HospitalN/A
National Cancer Institute (NCI)Phase 2/Phase 3

See all methylphenidate hydrochloride clinical trials

Recent Litigation for methylphenidate hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
Recro Gainesville LLC v. Actavis Laboratories FL, Inc.2017-10-30
Alza Corporation v. Amneal Pharmaceuticals of New York, LLC2016-10-07

See all methylphenidate hydrochloride litigation

Pharmacology for methylphenidate hydrochloride
Synonyms for methylphenidate hydrochloride
113-45-1 (Parent)
2-Piperidineacetic acid, .alpha.-phenyl-, methyl ester, hydrochloride
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride
2-Piperidineacetic acid, alpha-phenyl-, methyl ester, hydrochloride, (R*,R*)-(+-)-
298-59-9
298M599
AC1L1SQ4
AC1Q5YRN
AKOS016010356
alpha-phenyl-2-piperidineacetic acid methyl ester hydrochloride
AN-23356
API0003340
CAS-298-59-9
CC-30903
CCG-213572
CCRIS 6258
Centedrin
Centedrine
CHEBI:31836
CHEMBL1722
ciba 4311b
Concerta (TN)
CS-4658
D01296
Daytrana
DSSTox_CID_886
DSSTox_GSID_20886
DSSTox_RID_75843
DTXSID8020886
EINECS 206-065-3
FT-0603372
FT-0672046
FT-0672047
H-Tic-OtBu.HCl
HY-B1091A
JUMYIBMBTDDLNG-UHFFFAOYSA-N
LS-42
Medikinet
Meridil hydrochloride
Metadate
Metadate (TN)
Metadate CD
Metadate ER
Methyl .alpha.-phenyl-2-piperidineacetate hydrochloride
methyl 2-phenyl-2-(2-piperidyl)acetate hydrochloride
Methyl 2-phenyl-2-(piperidin-2-yl)acetate hydrochloride
methyl 2-phenyl-2-piperidin-2-ylacetate hydrochloride
methyl alpha-phenyl-2-piperidine-acetate hydrochloride
Methyl alpha-phenyl-2-piperidineacetate hydrochloride
Methyl Phenidylacetate Hydrochloride
methyl phenyl(piperidin-2-yl)acetate hydrochloride
Methylin
Methylin ER
Methylphenidan Hydrochloride
Methylphenidate (hydrochloride)
Methylphenidate HCl
Methylphenidate hydrochloride (JAN/USP)
Methylphenidate hydrochloride [USAN:JAN]
Methylphenidate hydrochloride [USP:JAN]
Methylphenidate Hydrochloride ER
Methylphenidate hydrochloride solution, (Racemic mixture), ampule of 1 mL, 1.0 mg/mL in methanol (as free base), certified reference material
Methylphenidate hydrochloride, European Pharmacopoeia (EP) Reference Standard
Methylphenidate Hydrochloride(Ritalin hydrochloride)
METHYLPHENIDATE HYDROCHLORIDE(SEE ALSO: METHYLPHENIDATE, CAS 113-45-1, NTPNO M20344)
Methylphenidate.HCl
Methylphenidate(Ritalin)
Methylphenidylacetate hydrochloride
Metilfenidat hydrochloride
MLS003922100
NCGC00091942-01
NCGC00257863-01
NSC 169868
NSC-169868
NSC-759278
NSC169868
NSC759278
Pharmakon1600-01505907
PMS-Methylphenidate
QuilliChew ER
Quillivant XR
Quillivant xr (TN)
Rilaline
Rilatine
Ritalin
Ritalin (TN)
Ritalin hy drochloride
Ritalin hydrochloride
Ritalin LA
Ritalin SR
Ritalin-SR
SC-83308
SCHEMBL41067
SMR000058998
threo-Methyl |A-phenyl-|A-(2-piperidyl)acetate hydrochloride
Tox21_111186
Tox21_200309
TRANSGENIC MODEL EVALUATION (METHYLPHENIDATE HYDROCHLORIDE) (SEE ALSO: METHYLPHENIDATE HYDROCHLORIDE)
WLN: T6MTJ BYR & VO1 & GH
Paragraph IV (Patent) Challenges for METHYLPHENIDATE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
QUILLICHEW ER TABLET, EXTENDED RELEASE, CHEWABLE;ORAL methylphenidate hydrochloride 207960 2016-04-25
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-24
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-23
QUILLIVANT XR FOR SUSPENSION, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 202100 2013-08-02
METHYLIN SOLUTION;ORAL methylphenidate hydrochloride 021419 2010-04-13
RITALIN LA CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021284 2007-05-21
METADATE CD CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021259 2007-03-15
RITALIN LA CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021284 2006-08-21
CONCERTA TABLET, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021121 2005-07-19
METADATE CD CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 021259 2005-05-13

US Patents and Regulatory Information for methylphenidate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078458-003 Dec 1, 2011 AB1 RX No No   Start Trial   Start Trial   Start Trial
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583-002 Sep 29, 2015 AB2 RX No No   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-006 Feb 27, 2019 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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002   Start Trial   Start Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000   Start Trial   Start Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Colorcon

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