RAMELTEON Drug Patent Profile
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When do Ramelteon patents expire, and what generic alternatives are available?
Ramelteon is a drug marketed by Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Granules, I3 Pharms, Innogenix, Micro Labs, Upsher Smith Labs, Xiromed, and Zydus Pharms. and is included in ten NDAs.
The generic ingredient in RAMELTEON 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 Ramelteon
A generic version of RAMELTEON was approved as ramelteon by DR REDDYS LABS SA on July 26th, 2013.
Summary for RAMELTEON
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 80 |
| Patent Applications: | 2,201 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RAMELTEON |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | RAMELTEON | ramelteon | TABLET;ORAL | 091610-001 | Aug 19, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Micro Labs | RAMELTEON | ramelteon | TABLET;ORAL | 215243-001 | Feb 9, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Granules | RAMELTEON | ramelteon | TABLET;ORAL | 213186-001 | Aug 21, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Upsher Smith Labs | RAMELTEON | ramelteon | TABLET;ORAL | 213815-001 | Oct 26, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma Ltd | RAMELTEON | ramelteon | TABLET;ORAL | 215972-001 | Jul 10, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys Labs Sa | RAMELTEON | ramelteon | TABLET;ORAL | 091693-001 | Jul 26, 2013 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Innogenix | RAMELTEON | ramelteon | TABLET;ORAL | 215435-001 | Aug 24, 2022 | AB | RX | No | No | ⤷ 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 |
