Asacol HD

See also: Generic Asacol

Asacol HD is a brand name of mesalamine, approved by the FDA in the following formulation(s):

ASACOL HD (mesalamine - tablet, delayed release; oral)

• 
  Manufacturer: WARNER CHILCOTT LLC
  
  Approval date: May 29, 2008
  
  Strength(s): 800MG ^[RLD]

Has a generic version of Asacol HD been approved?

No. There is currently no therapeutically equivalent version of Asacol HD available.

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

• 
  Orally administrable pharmaceutical compositions
  Patent 5,541,170
  Issued: July 30, 1996
  Inventor(s): Rhodes; John & Evans; Brian K.
  Assignee(s): Tillotts Pharma AG
  A solid dosage form, such as a capsule or tablet, containing a pharmacologically active agent is coated with an anionic polymer, which is insoluble in gastric juice and in intestinal juice below pH7 but soluble in colonic intestinal juice, in a sufficient amount that the oral dosage form remains intact until it reaches the colon. The preferred anionic polymer is a partly methyl esterified methacrylic acid polymer in which the ratio of free carboxylic groups to ester groups is about 1:2. The invention has particular application to dosage forms of prednisolone and salts thereof, indomethacin, ibuprofen, and, especially, 5-amino-salicylic acid.
  
  Patent expiration dates:
  
  
  • July 30, 2013
    
    ✓ 
    Patent use: TREATMENT OF ULCERATIVE COLITIS
    ✓ 
    Drug product
  
  



• 
  Orally administrable pharmaceutical composition
  Patent 5,541,171
  Issued: July 30, 1996
  Inventor(s): Rhodes; John & Evans; Brian K.
  Assignee(s): Tillotts Pharma AG
  A solid dosage form, such as a capsule or tablet, containing a pharmacologically active agent is coated with an anionic polymer, which is insoluble in gastric juice and in intestinal juice below pH7 but soluble in colonic intestinal juice, in a sufficient amount that the oral dosage form remains intact until it reaches the colon. The preferred anionic polymer is a partly methyl esterified methacrylic acid polymer in which the ratio of free carboxylic groups to ester groups is about 1:2. The invention has particular application to dosage forms of prednisolone and salts thereof, indomethacin, ibuprofen, and, especially, 5-amino-salicylic acid.
  
  Patent expiration dates:
  
  
  • July 30, 2013
    
    ✓ 
    Patent use: TREATMENT OF ULCERATIVE COLITIS
    ✓ 
    Drug product
  
  



• 
  Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
  Patent 6,893,662
  Issued: May 17, 2005
  Inventor(s): Dittmar; Gregory Paul & Amante; Joseph Michael & Cronk; Tony Ryan & Newby; Daniel Gary
  Assignee(s): The Procter & Gamble Company
  The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent. This invention further relates to a method of maintaining the desired site of delivery of a therapeutic agent in the gastrointestinal tract by administering the above compositions to a human or lower animal.
  
  Patent expiration dates:
  
  
  • November 15, 2021
    
    ✓ 
    Patent use: TREATMENT OF ULCERATIVE COLITIS
    ✓ 
    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:
  • May 29, 2011 - NEW PRODUCT
  
  

See also...

• Asacol HD Delayed-Release Tablets Consumer Information (Wolters Kluwer)
• Asacol HD Consumer Information (Cerner Multum)
• Asacol HD Advanced Consumer Information (Micromedex)
• Mesalamine Controlled-Release Capsules Consumer Information (Wolters Kluwer)
• Mesalamine Delayed-Release Tablets Consumer Information (Wolters Kluwer)
• Mesalamine Enema Consumer Information (Wolters Kluwer)
• Mesalamine Extended-Release Capsules Consumer Information (Wolters Kluwer)
• Mesalamine Suppositories Consumer Information (Wolters Kluwer)
• Mesalamine Consumer Information (Cerner Multum)
• Mesalamine rectal Consumer Information (Cerner Multum)
• Mesalamine Advanced Consumer Information (Micromedex)
• Mesalamine Rectal Advanced Consumer Information (Micromedex)
• SfRowasa Advanced Consumer Information (Micromedex)
• Mesalamine AHFS DI Monographs (ASHP)