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 |
---|---|---|---|
Japan | H11152281 | TRICYCLIC COMPOUND, ITS PRODUCTION AND AGENT | ⤷ Try a Trial |
Czech Republic | 9802775 | ⤷ Try a Trial | |
Norway | 322205 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |