FDA Orange Book · active-ingredient family
Ramelteon
Ramelteon is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ROZEREM · NDA 021782
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROZEREMRLD | TAKEDA PHARMS USA | NDA 021782 | AB | Jul 22, 2005 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RAMELTEON | HIBROW HLTHCARE | ANDA 215485 | AB | Jun 04, 2026 | |
| RAMELTEON | AUROBINDO PHARMA LTD | ANDA 215972 | AB | Jul 10, 2023 | |
| RAMELTEON | MICRO LABS | ANDA 215243 | AB | Feb 09, 2023 | |
| RAMELTEON | XIROMED | ANDA 216209 | AB | Nov 25, 2022 | |
| RAMELTEON | ANDAS 5 HOLDING | ANDA 215435 | AB | Aug 24, 2022 | |
| RAMELTEON | APPCO | ANDA 213815 | AB | Oct 26, 2020 | |
| RAMELTEON | GRANULES | ANDA 213186 | — | Aug 21, 2020 | |
| RAMELTEON | I3 PHARMS | ANDA 212650 | AB | Apr 10, 2020 | |
| RAMELTEON | ZYDUS PHARMS | ANDA 211567 | AB | Jul 22, 2019 | |
| RAMELTEON | ACTAVIS LABS FL INC | ANDA 091610 | AB | Aug 19, 2015 | |
| RAMELTEON | DR REDDYS LABS SA | ANDA 091693 | AB | Jul 26, 2013 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ramelteon — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
