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DAYTRANA Drug Profile
» See Plans and Pricing
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
Summary for DAYTRANA
| International Patents: | 1 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 14 |
| Clinical Trials: | 13 |
| Patent Applications: | 6 |
| Formulation / Manufacturing: | see details |
| 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 |
| DailyMed Link: | DAYTRANA at DailyMed |
Recent Clinical Trials for DAYTRANA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Matthew O'Brien | Phase 4 |
| Nicoleta Stoicea | Phase 1 |
| St. Louis University | Phase 4 |
Pharmacology for DAYTRANA
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
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 |
International Patents for DAYTRANA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 9602656 | Start Trial |
| Denmark | 174994 | Start Trial |
| Canada | 2126366 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9518603 | Start Trial |
| Finland | 933761 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
