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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ROZEREM | ramelteon | TABLET;ORAL | 021782-001 | Jul 22, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Sa | RAMELTEON | ramelteon | TABLET;ORAL | 091693-001 | Jul 26, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Xiromed | RAMELTEON | ramelteon | TABLET;ORAL | 216209-001 | Nov 25, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
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 | |||
Zydus Pharms | RAMELTEON | ramelteon | TABLET;ORAL | 211567-001 | Jul 22, 2019 | AB | RX | No | No | ⤷ 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 |
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