ROZEREM Drug Patent Profile

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-three 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 26^th, 2013.

Summary for ROZEREM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	46
Patent Applications:	2,201
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ROZEREM
What excipients (inactive ingredients) are in ROZEREM?	ROZEREM excipients list
DailyMed Link:	ROZEREM at DailyMed

See drug prices for ROZEREM

Recent Clinical Trials for ROZEREM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Rhode Island Hospital	Phase 4
The VA Western New York Healthcare System	Phase 4

See all ROZEREM clinical trials

Pharmacology for ROZEREM

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ROZEREM

N05CH	Melatonin receptor agonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ROZEREM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ROZEREM	Tablets	ramelteon	8 mg	021782	2	2009-07-22

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

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
Takeda Pharms Usa	ROZEREM	ramelteon	TABLET;ORAL	021782-001	Jul 22, 2005

International Patents for ROZEREM

See the table below for patents covering ROZEREM around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2884153
Poland	188093
European Patent Office	1550655