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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 19, 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 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, 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 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-one suppliers are listed for this compound. There are two tentative approvals 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
National Taiwan University HospitalN/A
National Cancer Institute (NCI)Phase 2/Phase 3
M.D. Anderson Cancer CenterPhase 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

Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial60MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial50MGCAPSULE, 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 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

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
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583-003 Sep 29, 2015 AB2 RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205105-001 Jul 28, 2016 AB2 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
Breckenridge METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 207587-003 Mar 3, 2017 AB RX No No   Start Trial   Start Trial   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 021121-003 Dec 8, 2000   Start Trial   Start Trial
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002   Start Trial   Start Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Baxter
Medtronic
McKesson
Merck

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