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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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Colorcon
Mallinckrodt
Boehringer Ingelheim
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Generated: July 19, 2018

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 methylphenidate hydrochloride patent protection?

Methylphenidate hydrochloride
is the generic ingredient in twelve branded drugs marketed by 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-seven NDAs. There are twenty-seven patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylphenidate hydrochloride has three hundred and ten patent family members in thirty-six countries.

There are thirty-two drug master file entries for methylphenidate hydrochloride. Thirty-six suppliers are listed for this compound. There are two tentative approvals for this compound.
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
AK116471
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
D-erythro-Methylphenidate Hydrochloride
D01296
DSSTox_CID_886
DSSTox_GSID_20886
DSSTox_RID_75843
DTXSID8020886
EINECS 206-065-3
FT-0603372
FT-0672046
FT-0672047
H-Tic-OtBu.HCl
HE332528
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 HCL
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 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(SEE ALSO: METHYLPHENIDATE, CAS 113-45-1, NTPNO M20344)
Methylphenidate.HCl
Methylphenidate(Ritalin)
Methylphenidylacetate hydrochloride
Metilfenidat hydrochloride
MFCD00058191
MLS003922100
NCGC00091942-01
NCGC00257863-01
NSC 169868
NSC-169868
NSC-759278
NSC169868
NSC759278
Pharmakon1600-01505907
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
Tentative approvals for METHYLPHENIDATE HYDROCHLORIDE
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 HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 079031-001 Jul 13, 2012 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583-001 Sep 29, 2015 AB2 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Osmotica METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 205327-002 Jul 28, 2017 AB RX No 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 HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-003 Jun 5, 2002 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-002 Aug 1, 2000 ➤ Sign Up ➤ Sign Up
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002 ➤ 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 HYDROCHLORIDE

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
6,673,367 Controlled/modified release oral methylphenidate formulations ➤ Sign Up
6,730,325 Multiparticulate modified release composition ➤ Sign Up
6,793,936 Multiparticulate modified release composition ➤ Sign Up
6,902,742 Multiparticulate modified release composition ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Argus Health
Baxter
Queensland Health
Daiichi Sankyo
Accenture
Healthtrust
Julphar
UBS

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