DAYTRANA Drug Patent Profile

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When do Daytrana patents expire, and when can generic versions of Daytrana launch?

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

This drug has one patent family member in one country.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Daytrana

A generic version of DAYTRANA was approved as methylphenidate by MYLAN TECH VIATRIS on March 14^th, 2022.

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Summary for DAYTRANA

International Patents:	1
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	15
Patent Applications:	5,427
Drug Prices:	Drug price information for DAYTRANA
Drug Sales Revenues:	Drug sales revenues for DAYTRANA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAYTRANA
What excipients (inactive ingredients) are in DAYTRANA?	DAYTRANA excipients list
DailyMed Link:	DAYTRANA at DailyMed

Drug patent expirations by year for DAYTRANA

Recent Clinical Trials for DAYTRANA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3
Matthew J O'Brien, PhD, BCBA-D	Phase 4

See all DAYTRANA clinical trials

Pharmacology for DAYTRANA

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

Paragraph IV (Patent) Challenges for DAYTRANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DAYTRANA	Transdermal System	methylphenidate	10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs	021514	1	2011-04-13

US Patents and Regulatory Information for DAYTRANA

DAYTRANA is protected by three US patents.

Patents protecting DAYTRANA

Device for transdermal administration of drugs including acrylic polymers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Device for transdermal administration of drugs including acrylic based polymers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF

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Glossary

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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	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	AB	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

Expired US Patents for DAYTRANA

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

International Patents for DAYTRANA

See the table below for patents covering DAYTRANA around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	0379045	Système pour délivrer une drogue transdermique, à base d'un multipolymère acrylique. (Transdermal acrylic multipolymer drug delivery system.)	⤷ Sign Up
European Patent Office	0453505		⤷ Sign Up
World Intellectual Property Organization (WIPO)	9640086		⤷ Sign Up
South Korea	100363052		⤷ Sign Up
Canada	2315237	COMPOSITIONS ET PROCEDES DE TRAITEMENT DU TROUBLE DEFICITAIRE DE L'ATTENTION ET DE L'HYPERACTIVITE AVEC DEFICIT DE L'ATTENTION AU MOYEN DU METHYLPHENIDATE (COMPOSITIONS AND METHODS FOR TREATMENT OF ATTENTION DEFICIT DISORDER AND ATTENTION DEFICIT/HYPERACTIVITY DISORDER WITH METHYLPHENIDATE)	⤷ Sign Up
Australia	2004092		⤷ Sign Up
Finland	924313		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration