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Last Updated: January 17, 2021

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DAYTRANA Drug 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. Two suppliers are listed for this compound. Additional details are available on the methylphenidate profile page.

US ANDA Litigation and Generic Entry Outlook for Daytrana

Annual sales in 2018 were $142mm indicating the motivation for generic entry (peak sales were $185mm in 2016).

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DAYTRANA
Drug Prices for DAYTRANA

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Drug Sales Revenue Trends for DAYTRANA

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Recent Clinical Trials for DAYTRANA

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

SponsorPhase
Matthew O'BrienPhase 4
Nicoleta StoiceaPhase 1
St. Louis UniversityPhase 4

See all DAYTRANA clinical trials

Pharmacology for DAYTRANA
Paragraph IV (Patent) Challenges for DAYTRANA
Tradename Dosage Ingredient NDA Submissiondate
DAYTRANA FILM, EXTENDED RELEASE;TRANSDERMAL methylphenidate 021514 2011-04-13

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   Start Trial   Start Trial Y   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006 RX Yes No   Start Trial   Start Trial Y   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 DAYTRANA

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

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