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-eight 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.
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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: | 76 |
| Clinical Trials: | 47 |
| Patent Applications: | 2,482 |
| 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 |
|---|---|
| Overseas Pharmaceuticals, Ltd. | PHASE1 |
| Beijing CTSmed Co. Ltd | PHASE1 |
| Brigham and Women's Hospital | 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ 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 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 | ⤷ Start Trial | ⤷ Start Trial |
| Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | ⤷ Start Trial | ⤷ Start 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 |
|---|---|---|---|
| Austria | 469644 | ⤷ Start Trial | |
| Australia | 1430502 | ⤷ Start Trial | |
| Canada | 2428817 | PREPARATION PHARMACEUTIQUE CONTENANT DE LA COPOLYVIDONE (COPOLYVIDONE-CONTAINING PREPARATION) | ⤷ Start Trial |
| Canada | 2650698 | PREPARATION PHARMACEUTIQUE CONTENANT DE LA COPOLYVIDONE (COPOLYVIDONE-CONTAINING PREPARATION) | ⤷ Start Trial |
| Germany | 60142305 | ⤷ Start 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) | ⤷ Start 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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