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Generic Absorica Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

See also: Generic Absorica LD

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

ABSORICA (isotretinoin - capsule;oral)

  • Manufacturer: SUN PHARM INDS INC
    Approval date: May 25, 2012
    Strength(s): 10MG [RLD] [AB2], 20MG [RLD] [AB2], 30MG [RLD] [AB2], 40MG [RLD] [AB2]
  • Manufacturer: SUN PHARM INDS INC
    Approval date: August 15, 2014
    Strength(s): 25MG [RLD] [AB2], 35MG [RLD] [AB2]

Has a generic version of Absorica been approved?

A generic version of Absorica has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Absorica and have been approved by the FDA:

isotretinoin capsule;oral

  • Manufacturer: ACTAVIS LABS FL
    Approval date: March 31, 2021
    Strength(s): 10MG [AB2], 20MG [AB2], 25MG [AB2], 30MG [AB2], 35MG [AB2], 40MG [AB2]
  • Manufacturer: UPSHER SMITH LABS
    Approval date: April 12, 2021
    Strength(s): 40MG [AB2]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Absorica. 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: Generic Drug FAQ.

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.

  • Pharmaceutical semi-solid composition of isotretinoin
    Patent 7,435,427
    Issued: October 14, 2008
    Inventor(s): Vanderbist; Francis & Servais; Cecile & Baudier; Philippe
    Assignee(s): Galephar M/F

    An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle.

    Patent expiration dates:

    • September 21, 2021
      ✓ 
      Drug product
  • Pharmaceutical semi-solid composition of isotretinoin
    Patent 8,367,102
    Issued: February 5, 2013
    Assignee(s): Galephar Pharmaceutical Research, Inc.

    An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle.

    Patent expiration dates:

    • September 21, 2021
      ✓ 
      Patent use: TREATMENT OF A SKIN DISORDER
  • Pharmaceutical semi-solid composition of isotretinoin
    Patent 8,952,064
    Issued: February 10, 2015
    Assignee(s): Galephar Pharmaceutical Research, Inc.

    An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle

    Patent expiration dates:

    • September 21, 2021
      ✓ 
      Drug product
  • Pharmaceutical semi-solid composition of isotretinoin
    Patent 9,078,925
    Issued: July 14, 2015
    Assignee(s): GALEPHAR PHARMACEUTICAL RESEARCH, INC.

    The invention relates to an oral pharmaceutical composition of isotretinoin at least two excipients, one of the excipients being a hydrophilic excipient having an HLB value greater than or equal to 10 and the other excipient being an oily vehicle. The oral pharmaceutical composition is substantially devoid of food effect as characterized by a dissolution profile wherein at least 70% of the oral pharmaceutical composition is dissolved after about four hours in a USP2 dissolution apparatus at a paddle speed of 100 rpm, and a dissolution media composed of 900 mL of pH 7.5 buffer containing 0.11% pancreatin, 4.7% cholic acid, 0.14% sodium dihydroxide phosphate and 0.5% sodium hydroxide at 37° C.

    Patent expiration dates:

    • September 21, 2021
      ✓ 
      Drug product
  • Pharmaceutical semi-solid composition of isotretinoin
    Patent 9,089,534
    Issued: July 28, 2015
    Assignee(s): Galephar Pharmaceutical Research, Inc.

    An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle.

    Patent expiration dates:

    • September 21, 2021
      ✓ 
      Drug product

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.