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DAYTRANA Drug Profile
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See Plans and PricingWhich 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 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 2017 were $56mm indicating the motivation for generic entry (peak sales were $185mm in 2016).
There have been two patent litigation cases 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.
There is one tentative approval for the generic drug (methylphenidate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for DAYTRANA
| International Patents: | 1 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 19 |
| 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 |
Recent Litigation for DAYTRANA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NOVEN PHARMACEUTICALS v. WATSON LABORATORIES, INC. | 2011-10-13 |
| NOVEN PHARMACEUTICALS v. WATSON LABORATORIES, INC. |
Pharmacology for DAYTRANA
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
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 |
| AKOS022506757 |
| alpha-Phenyl-2-piperidineacetic acid methyl ester |
| alpha-Phenyl-alpha-(2-piperidyl)acetic acid methyl ester |
| API0008866 |
| BCP18286 |
| BDBM50062912 |
| BRD-A19585813-003-01-7 |
| C 4311 |
| C07196 |
| Calocain |
| Centedein |
| Centedein (Salt/Mix) |
| Centedrin (Salt/Mix) |
| Centedrine (Salt/Mix) |
| Centredin |
| CHEBI:84276 |
| CHEMBL796 |
| Concerta |
| Concerta, Methylin, Ritalin |
| Cotempla XR-ODT |
| CS-4657 |
| d-methylphenidate HCl |
| D04999 |
| Daytrana (TN) |
| DB00422 |
| DEA No. 1724 |
| DTXSID5023299 |
| DUGOZIWVEXMGBE-UHFFFAOYSA-N |
| EINECS 204-028-6 |
| FT-0700534 |
| GTPL7236 |
| HSDB 3126 |
| HY-B1091 |
| Jornay PM (a.k.a. HLD200) |
| L001307 |
| LS-565 |
| Meridil |
| Metadate |
| Metadate ER |
| 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 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] |
| NCGC00248587-01 |
| NCI-C56280 |
| Phenidylate |
| phenyl-piperidin-2-yl-acetic acid methyl ester |
| Plimasine |
| PMS-Methylphenidate |
| Riphenidate |
| Ritalin |
| Ritalin (Salt/Mix) |
| Ritalin LA |
| Ritaline |
| Ritaline (Salt/Mix) |
| Ritcher works |
| Rubifen |
| SBI-0206868.P001 |
| SCHEMBL37178 |
| Tsentedrin |
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 | Start Trial | ||||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | Apr 6, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-002 | Apr 6, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-004 | Apr 6, 2006 | RX | Yes | Yes | 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 | 021514-001 | Apr 6, 2006 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-001 | 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 | 021514-001 | Apr 6, 2006 | Start Trial | Start Trial |
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-003 | 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 | 021514-004 | 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 |
| Noven Pharms Inc | DAYTRANA | methylphenidate | FILM, EXTENDED RELEASE;TRANSDERMAL | 021514-001 | 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2006041911 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
