Oforta

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

OFORTA (fludarabine phosphate - tablet; oral)

• 
  Manufacturer: SANOFI AVENTIS US
  
  Approval date: December 18, 2008
  
  Strength(s): 10MG ^[RLD]

Has a generic version of Oforta been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Oforta. 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.

• 
  Oral fludara of high-purity formulation with quick release of active ingredient
  Patent 7,148,207
  Issued: December 12, 2006
  Inventor(s): Heil; Wolfgang & Tistam; Ulf & Lipp; Ralph & Tack; Johannes-Wilhelm
  Assignee(s): Schering Aktiengesellschaft
  This invention relates to a quick-release tablet formulation with >99.19% pure fludara (high-purity fludara) as an active ingredient in a defined composition of residual contaminants.
  
  Patent expiration dates:
  
  
  • December 20, 2022
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
    ✓ 
    Drug product
  
  



• 
  Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5%
  Patent 7,547,776
  Issued: June 16, 2009
  Inventor(s): Tilstam; Ulf & Schmitz; Thomas & Nickisch; Klaus
  Assignee(s): Bayer Schering Pharma Aktiengesellschaft
  The present invention generally relates to a fludarabine-phosphate with a purity of at least 99.5%.
  
  Patent expiration dates:
  
  
  • December 10, 2018
    
    ✓ 
    Drug substance
  
  

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:
  • December 18, 2011 - NEW DOSAGE FORM
  
  
  • December 18, 2015 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Oforta Consumer Information (Drugs.com)
• Oforta Consumer Information (Wolters Kluwer)
• Oforta Consumer Information (Cerner Multum)
• Oforta Advanced Consumer Information (Micromedex)
• Fludarabine Consumer Information (Wolters Kluwer)
• Fludarabine Tablets Consumer Information (Wolters Kluwer)
• Fludarabine Consumer Information (Cerner Multum)
• Fludarabine injection Consumer Information (Cerner Multum)
• Fludarabine Advanced Consumer Information (Micromedex)
• Fludarabine Intravenous Advanced Consumer Information (Micromedex)
• Fludarabine Phosphate AHFS DI Monographs (ASHP)