rozerem Drug Patent Profile
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Which patents cover Rozerem, and when can generic versions of Rozerem launch?
Rozerem is a drug marketed by Takeda Pharms Usa and is included in one NDA.
The generic ingredient in ROZEREM is ramelteon. There are three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ramelteon profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rozerem
A generic version of rozerem was approved as ramelteon by DR REDDYS LABS SA on July 26th, 2013.
Summary for rozerem
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 110 |
Clinical Trials: | 46 |
Patent Applications: | 2,201 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for rozerem |
What excipients (inactive ingredients) are in rozerem? | rozerem excipients list |
DailyMed Link: | rozerem at DailyMed |
Recent Clinical Trials for rozerem
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Brigham and Women's Hospital | Phase 4 |
Rhode Island Hospital | Phase 4 |
State University of New York at Buffalo | Phase 4 |
Pharmacology for rozerem
Drug Class | Melatonin Receptor Agonist |
Mechanism of Action | Melatonin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for rozerem
US Patents and Regulatory Information for rozerem
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 rozerem
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rozerem
See the table below for patents covering rozerem around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2241666 | COMPOSES TRICYCLIQUES, LEUR PRODUCTION ET LEUR UTILISATION (TRICYCLIC COMPOUNDS, THEIR PRODUCTION AND USE) | ⤷ Try a Trial |
Japan | 3633895 | ⤷ Try a Trial | |
European Patent Office | 1334732 | PREPARATION PHARMACEUTIQUE A BASE DE N-[2-(1,6,7,8-TETRAHYDRO-2H-INDENO[5,4 B]FURAN-8-YL)ETHYL]PROPIONAMIDE REVETUE D'UN ENROBAGE CONTENANT DE LA COPOLYVIDONE EN ABSENCE DE POLYETHYLENE GLYCOL (PHARMACEUTICAL PREPARATION OF N-[2-(1,6,7,8-TETRAHYDRO-2H-INDENO[5,4 B]FURAN-8-YL)ETHYL]PROPIONAMIDE COATED WITH A COPOLYVIDONE-CONTAINING COATING FREE OF POLYETHYLENE GLYCOL) | ⤷ Try a Trial |
Japan | 2004300160 | MEDICAL PREPARATION CONTAINING COPOLYBIDONE | ⤷ Try a Trial |
Japan | H10287665 | TRICYCLIC COMPOUND, ITS PRODUCTION, AND MEDICINE | ⤷ Try a Trial |
Czech Republic | 291626 | Tricyklické sloučeniny, způsob výroby a použití (Tricyclic compounds, process of their preparation and use) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |