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. Two 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 14th, 2022.
Summary for DAYTRANA
| International Patents: | 1 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 15 |
| Patent Applications: | 71 |
| 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 |
| What excipients (inactive ingredients) are in DAYTRANA? | DAYTRANA excipients list |
| DailyMed Link: | DAYTRANA at DailyMed |
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 O'Brien | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for DAYTRANA
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Device for transdermal administration of drugs including acrylic polymers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Device for transdermal administration of drugs including acrylic based polymers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | Apr 6, 2006 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-002 | Apr 6, 2006 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-004 | Apr 6, 2006 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | Apr 6, 2006 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-001 | Apr 6, 2006 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| >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
International Patents for DAYTRANA
See the table below for patents covering DAYTRANA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Finland | 110994 | See Plans and Pricing | |
| Denmark | 549489 | See Plans and Pricing | |
| Portugal | 1037615 | See Plans and Pricing | |
| Brazil | 9008012 | See Plans and Pricing | |
| Finland | 121527 | See Plans and Pricing | |
| World Intellectual Property Organization (WIPO) | 9930694 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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