Ramelteon - Generic Drug Details
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What are the generic sources for ramelteon and what is the scope of freedom to operate?
Ramelteon
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Andas 5 Holding, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Micro Labs, Upsher Smith Labs, Xiromed, Zydus Pharms, and Takeda Pharms Usa, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for ramelteon. Twenty-four suppliers are listed for this compound.
Summary for ramelteon
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 11 |
| NDAs: | 11 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 80 |
| Patent Applications: | 3,229 |
| Drug Prices: | Drug price trends for ramelteon |
| What excipients (inactive ingredients) are in ramelteon? | ramelteon excipients list |
| DailyMed Link: | ramelteon at DailyMed |
Recent Clinical Trials for ramelteon
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Hong Kong | Phase 3 |
| University of Sao Paulo | Phase 4 |
| Centennial Medical Center | Phase 4 |
Pharmacology for ramelteon
| Drug Class | Melatonin Receptor Agonist |
| Mechanism of Action | Melatonin Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ramelteon
US Patents and Regulatory Information for ramelteon
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| I3 Pharms | RAMELTEON | ramelteon | TABLET;ORAL | 212650-001 | Apr 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Andas 5 Holding | RAMELTEON | ramelteon | TABLET;ORAL | 215435-001 | Aug 24, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Ltd | RAMELTEON | ramelteon | TABLET;ORAL | 215972-001 | Jul 10, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | RAMELTEON | ramelteon | TABLET;ORAL | 211567-001 | Jul 22, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| 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 ramelteon
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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