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-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 |
|---|---|---|---|
| Spain | 2175350 | ⤷ Try a Trial | |
| Japan | H10287665 | TRICYCLIC COMPOUND, ITS PRODUCTION, AND MEDICINE | ⤷ Try a Trial |
| Japan | 2002212063 | COPOLYVIDONE-CONTAINING PHARMACEUTICAL PREPARATION | ⤷ Try a Trial |
| China | 100443480 | ⤷ Try a Trial | |
| >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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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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