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Generated: March 21, 2019

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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 thirteen branded drugs marketed by 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-two NDAs. There are thirty-six 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 thirty-four patent family members in thirty-six countries.

There are thirty-two drug master file entries for methylphenidate hydrochloride. Forty-two 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
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
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
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-003 Dec 4, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ascent Pharms Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 207416-003 Sep 22, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 206726-004 Oct 21, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-003 Apr 17, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ 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
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 021284-002 Jun 5, 2002 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
Covington
Julphar
Chinese Patent Office
Johnson and Johnson

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