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DAYTRANA Drug Profile

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Which patents cover Daytrana, and what generic alternatives are available?

Daytrana is a drug marketed by Noven Pharms Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in twenty-nine countries.

The generic ingredient in DAYTRANA is methylphenidate. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.

Summary for DAYTRANA

International Patents:	47
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	22
Clinical Trials:	12
Patent Applications:	4,372
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DAYTRANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAYTRANA
DailyMed Link:	DAYTRANA at DailyMed

Generic Entry Opportunity Date for DAYTRANA

NDA:

021514

Dosage:

FILM, EXTENDED RELEASE;TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for DAYTRANA

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

Medical Subject Heading (MeSH) Categories for DAYTRANA

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

Synonyms for DAYTRANA

.alpha.-Phenyl-2-piperidineacetic acid methyl ester

113-45-1

2-Piperidineacetic acid, .alpha.-phenyl-, methyl ester

2-Piperidineacetic acid, alpha-phenyl-, methyl ester

298-59-9 (hydrochloride)

4311/B Ciba

AB01563134_01

AC1L1HJM

AK112570

AKOS022506757

alpha-Phenyl-2-piperidineacetic acid methyl ester

alpha-Phenyl-alpha-(2-piperidyl)acetic acid methyl ester

API0008866

Attenta (TN)

BDBM50062912

Biphentin (TN)

C 4311

C07196

Calocain

Centedein

Centedein (Salt/Mix)

Centedrin

Centedrin (Salt/Mix)

Centedrine (Salt/Mix)

Centredin

CHEBI:84276

CHEMBL796

Concerta

Concerta (TN)

Concerta, Methylin, Ritalin

Cotempla XR-ODT

CS-4657

d-methylphenidate HCl

D02PPN

D04999

Daytrana (TN)

DB00422

DEA No. 1724

DR000523

DTXSID5023299

DUGOZIWVEXMGBE-UHFFFAOYSA-N

EINECS 204-028-6

Equasym (TN)

FT-0700534

GTPL7236

HE297259

HSDB 3126

HY-B1091

L001307

LS-565

Meridil

Metadate

Metadate CD

Metadate ER

Metadate ER (TN)

Methyl .alpha.-phenyl-.alpha.-(2-piperidyl)acetate

Methyl .alpha.-phenyl-.alpha.-2-piperidinylacetate

Methyl .alpha.-phenyl-2-piperidine-acetate

Methyl .alpha.-phenyl-2-piperidineacetate

Methyl (2-phenyl-2-(2-piperidyl)acetate)

Methyl 2-phenyl-2-(piperidin-2-yl)acetate

methyl 2-phenyl-2-piperidin-2-ylacetate

Methyl alpha-phenyl-alpha-(2-piperidyl)acetate

Methyl alpha-phenyl-alpha-2-piperidinylacetate

methyl alpha-piperid-2-ylphenylacetate

Methyl phenidate

Methyl phenidyl acetate

Methyl phenidylacetate

Methyl phenyl(2-piperidinyl)acetate #

methyl phenyl(piperidin-2-yl)acetate

Methylfenidan

Methylin

Methylin (Salt/Mix)

Methylin (TN)

Methylin ER

Methylofenidan

Methylphen

Methylphenidan

methylphenidate

METHYLPHENIDATE (SEE ALSO: METHYLPHENIDATE HYDROCHLORIDE, CAS 298-59-9, NTPNO 10266-R)

Methylphenidate (USAN/INN)

Methylphenidate [INN:BAN]

Methylphenidate [USAN:INN:BAN]

Methylphenidate HCl

Methylphenidatum

Methylphenidatum [INN-Latin]

Methylphenidylacetate hydrochloride

MethyPatch

Metilfenidato

Metilfenidato [INN-Spanish]

Metilfenidato [Italian]

Motiron (TN)

NCGC00248587-01

NCI-C56280

Phenidylate

Plimasine

PMS-Methylphenidate

Riphenidate

Ritalin

Ritalin (Salt/Mix)

Ritalin (TN)

Ritalin LA

Ritalin LA (TN)

Ritalin SR

Ritalin-SR

Ritaline

Ritaline (Salt/Mix)

Ritcher works

Rubifen

Rubifen (TN)

SBI-0206868.P001

SCHEMBL37178

Tsentedrin

US Patents and Regulatory Information for DAYTRANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006		RX	Yes	No			Y
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006		RX	Yes	Yes
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006		RX	Yes	No			Y
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006		RX	Yes	No			Y
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006		RX	Yes	No			Y
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006		RX	Yes	Yes			Y

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Expired US Patents for DAYTRANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006

Paragraph IV (Patent) Challenges for DAYTRANA

Drugname	Dosage	Strength	RLD	Date
	Transdermal System	10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrs

Non-Orange Book US Patents for DAYTRANA

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
8,916,191	Device for transdermal administration of drugs including acrylic polymers
9,333,263	Device for transdermal administration of drugs including acrylic based polymers

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International Patents for DAYTRANA

Country	Document Number	Estimated Expiration
Portugal	1037615
World Intellectual Property Organization (WIPO)	9930694
Hungary	226615
Taiwan	I244396
Czech Republic	20002209
Czech Republic	300535