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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 twelve branded drugs marketed by Rhodes Pharms, Lannett Co Inc, Barr Labs Inc, Impax Labs Inc, Mayne Pharma, Specgx Llc, Teva Pharms, Novartis, 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, Cnty Line Pharms, Kremers Urban Pharms, Mountain, Mylan Pharms Inc, Osmotica, Watson Labs, Abhai Inc, Actavis Labs Fl Inc, Bionpharma Inc, Sun Pharm Inds Inc, and Vintage Pharms, and is included in fifty-six 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-one drug master file entries for methylphenidate hydrochloride. Thirty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for methylphenidate hydrochloride

International Patents:	310
US Patents:	27
Tradenames:	12
Applicants:	32
NDAs:	56
Drug Master File Entries:	31
Suppliers / Packagers:	37
Bulk Api Vendors:	39
Clinical Trials:	344
Patent Applications:	3,814
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	methylphenidate hydrochloride at DailyMed

Pharmacology for methylphenidate hydrochloride

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

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
		10MG	CAPSULE, EXTENDED RELEASE; ORAL
		60MG	CAPSULE, EXTENDED RELEASE;ORAL
		50MG	CAPSULE, 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
Kremers Urban Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091695-004	Sep 23, 2013	BX	RX	No	No
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	AB	RX	Yes	No
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-001	Apr 17, 2015		RX	Yes	No
Rhodes Pharms	APTENSIO XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	205831-005	Apr 17, 2015		RX	Yes	No			Y

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	021284-004	Apr 10, 2004
Novartis	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-001	Jun 5, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000

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
9,675,704	Modified release formulations containing drug-ion exchange resin complexes
8,597,684	Modified release formulations containing drug-ion exchange resin complexes
6,673,367	Controlled/modified release oral methylphenidate formulations
8,119,163	Nanoparticulate and controlled release compositions comprising cefditoren

International Patents for methylphenidate hydrochloride

Country	Document Number	Estimated Expiration
Portugal	1140088
World Intellectual Property Organization (WIPO)	2007027273
Australia	2006285349
Canada	2660649