Rozerem

Rozerem is a brand name of ramelteon, approved by the FDA in the following formulation(s):

ROZEREM (ramelteon - tablet; oral)

• 
  Manufacturer: TAKEDA GLOBAL
  
  Approval date: July 22, 2005
  
  Strength(s): 8MG ^[RLD]

Has a generic version of Rozerem been approved?

No. There is currently no therapeutically equivalent version of Rozerem available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rozerem. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Tricyclic compounds, their production and use
  Patent 6,034,239
  Issued: March 7, 2000
  Inventor(s): Ohkawa; Shigenori & Uchikawa; Osamu & Fukatsu; Kohji & Miyamoto; Masaomi
  Assignee(s): Takeda Chemical Industries, Ltd.
  A compound of the formula: ##STR1## wherein R.sup.1 is an optionally substituted hydrocarbon, amino or heterocyclic group; R.sup.2 is H or an optionally substituted hydrocarbon group; R.sup.3 is H or an optionally substituted hydrocarbon or heterocyclic group; X is CHR.sup.4, NR.sup.4, O or S in which R.sup.4 is H or an optionally substituted hydrocarbon group; Y is C, CH or N; ring A is optionally substituted 5- to 7-membered ring; ring B is an optionally substituted benzene ring; and m is 1 to 4, or a salt thereof, a process for producing it, an intermediate for the production and a pharmaceutical composition comprising it are provided.
  
  Patent expiration dates:
  
  
  • July 22, 2019
    
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    Patent use: METHOD OF TREATING INSOMNIA CHARACHTERIZED BY DIFFICULTY WITH SLEEP ONSET
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • July 22, 2010 - NEW CHEMICAL ENTITY
  
  
  • October 20, 2011 - LABELING REVISIONS RELATED TO CLINICAL STUDIES
  
  

See also...

• Rozerem Consumer Information (Drugs.com)
• Rozerem Consumer Information (Wolters Kluwer)
• Rozerem Consumer Information (Cerner Multum)
• Rozerem Advanced Consumer Information (Micromedex)
• Rozerem AHFS DI Monographs (ASHP)
• Ramelteon Consumer Information (Wolters Kluwer)
• Ramelteon Consumer Information (Cerner Multum)
• Ramelteon Advanced Consumer Information (Micromedex)
• Ramelteon AHFS DI Monographs (ASHP)