ROZEREM Drug Patent Profile
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When do Rozerem patents expire, and what generic alternatives are available?
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-four 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ROZEREM?
- What are the global sales for ROZEREM?
- What is Average Wholesale Price for ROZEREM?
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: | 2,026 |
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 |
The VA Western New York Healthcare System | Phase 4 |
Pharmacology for ROZEREM
Drug Class | Melatonin Receptor Agonist |
Mechanism of Action | Melatonin Receptor Agonists |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Slovakia | 283970 | ⤷ Sign Up | |
Japan | H10287665 | TRICYCLIC COMPOUND, ITS PRODUCTION, AND MEDICINE | ⤷ Sign Up |
China | 1212691 | ⤷ Sign Up | |
Japan | 2004300160 | MEDICAL PREPARATION CONTAINING COPOLYBIDONE | ⤷ Sign Up |
Poland | 328726 | ⤷ Sign Up | |
Japan | 3633895 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |