Generic Solaraze Availability

Solaraze is a brand name of diclofenac topical, approved by the FDA in the following formulation(s):

SOLARAZE (diclofenac sodium - gel;topical)

  • Manufacturer: FOUGERA PHARMS
    Approval date: October 16, 2000
    Strength(s): 3% [RLD] [AB]

Has a generic version of Solaraze been approved?

A generic version of Solaraze 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 Solaraze and have been approved by the FDA:

DICLOFENAC SODIUM (diclofenac sodium gel;topical)

  • Manufacturer: TOLMAR
    Approval date: October 28, 2013
    Strength(s): 3% [AB]

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

  • Treatment of basal cell carcinoma and actinic keratosis employing hyaluronic acid and NSAIDs
    Patent 5,639,738
    Issued: June 17, 1997
    Inventor(s): Falk; Rudolf Edgar & Asculai; Samuel Simon
    Assignee(s): Hyal Pharmaceutical Corporation
    A method of treating a mammal for a condition of the skin or exposed tissue selected from the group consisting of basal cell carcinoma and actinic keratosis is provided. The method consists essentially of topically administering to the site of the condition, more than once per day over a period of days sufficient to treat the condition, a non-toxic effective dosage amount of a composition consisting essentially of (a) a non-steroidal anti-inflammatory drug (NSAID) in an amount sufficient to block prostaglandin synthesis, (b) hyaluronic acid or a pharmaceutically acceptable salt thereof in an amount effective to transport said NSAID into the skin or exposed tissue at the site of the condition. The concentration of the hyaluronic add or salt thereof is between 1-3% by weight of the composition. The molecular weight of the hyaluronic acid or salt thereof is between 150,000 and 750,000 Daltons. A pharmaceutical excipient suitable for topical application is included. The NSAID in the composition may be diclofenac sodium.
    Patent expiration dates:
    • June 17, 2014
      ✓ 
      Patent use: TREATMENT OF ACTINIC KERATOSES
  • Compositions comprising hyaluronic acid and prostaglandin-synthesis-inhibiting drugs
    Patent 5,792,753
    Issued: August 11, 1998
    Inventor(s): Falk; Rudolf Edgar & Asculai; Samuel Simon
    Assignee(s): Hyal Pharmaceutical Corporation
    A topically administrable pharmaceutical composition is disclosed which comprises a therapeutically effective amount of a drug which inhibits prostaglandin synthesis, and an amount of a form of hyaluronic acid sufficient to transport the composition through the skin into the epidermis or dermis where the composition remains until discharged via the lymphatic system, wherein (a) the drug is 1-5% by weight of the composition, and (b) the form of hyaluronic acid is 1-3% by weight of the composition, has a molecular weight greater than about 150,000 daltons and less than 750,000 daltons, and is selected from the group consisting of hyaluronic acid and salts thereof.
    Patent expiration dates:
    • August 11, 2015
  • Treatment of conditions and disease
    Patent 5,852,002
    Issued: December 22, 1998
    Inventor(s): Falk; Rudolf Edgar & Asculai; Samuel S.
    Assignee(s): Hyal Pharmaceutical Corporation
    A combination for administration to a mammal which combination employs a therapeutically effective amount of a medicinal and/or therapeutic agent to treat a disease or condition and an amount of hyaluronic acid and/or salts thereof and/or homologues, analogues, derivatives, complexes, esters, fragments and subunits of hyaluronic acid sufficient to facilitate the agent's penetration through the tissue (including scar tissue) at the site to be treated, through the cell membranes into the individual cells to be treated.
    Patent expiration dates:
    • June 17, 2014
      ✓ 
      Patent use: TREATMENT OF ACTINIC KERATOSES
  • Treatment of disease and conditions
    Patent 5,914,322
    Issued: June 22, 1999
    Inventor(s): Falk; Rudolf Edgar & Asculai; Samuel Simon
    Assignee(s): Hyal Pharmaceutical Corporation
    A topically applied transdermally penetrating systemic independent acting pharmaceutical combination and formulation for the treatment of a disease or condition of the skin and exposed tissue for example, basal cell carcinoma, the precancerous, often recurrent, actinic keratoses lesions, fungal lesions, "liver" spots and like lesions (found for the most part in the epidermis), squamous cell tumours, metastatic cancer of the breast to the skin, primary and metastatic melanoma in the skin, genital warts (condyloma acuminata) cervical cancer, and HPV (Human Papilloma Virus) including HPV of the cervix, psoriasis (both plaque-type psoriasis and nail bed psoriasis), corns on the feet and hair loss on the head of pregnant women, comprising, together with pharmaceutical excipients suitable for topical application, a therapeutically effective non-toxic amount of a drug which inhibits prostaglandin synthesis administered with, or carried in, an amount of hyaluronic acid and/or salts thereof and/or homologues, analogues, derivatives, complexes, esters, fragments, and/or sub-units of hyaluronic acid (preferably hyaluronic acid and salts thereof) sufficient to facilitate the drug's penetration through the skin and tissue (including any scar tissue) at the site requiring treatment, to block prostaglandin synthesis.
    Patent expiration dates:
    • August 11, 2015
  • Treatment of conditions and disease
    Patent 5,929,048
    Issued: July 27, 1999
    Inventor(s): Falk; Rudolf Edgar & Asculai; Samuel S.
    Assignee(s): Hyal Pharmaceutical Corporation
    A combination for administration to a mammal which combination employs a therapeutically effective amount of a medicinal and/or therapeutic agent to treat a disease or condition and an amount of hyaluronic acid and/or salts thereof and/or homologues, analogues, derivatives, complexes, esters, fragments and subunits of hyaluronic acid sufficient to facilitate the agent's penetration through the tissue (including scar tissue) at the site to be treated, through the cell membranes into the individual cells to be treated.
    Patent expiration dates:
    • June 17, 2014
      ✓ 
      Patent use: TREATMENT OF ACTINIC KERATOSES
  • Compositions comprising hyaluronic acid and drugs
    Patent 5,985,850
    Issued: November 16, 1999
    Inventor(s): Falk; Rudolf Edgar & Asculai; Samuel S.
    Assignee(s): Hyal Pharmaceuticals Corporation
    A dosage amount of a pharmaceutical composition comprising a therapeutically effective amount of an agent to treat a disease or condition involving underperfused tissue and pathological tissue in humans and a form of hyaluronic acid, wherein the form of hyaluronic acid is available to transport the agent from the point of administration to the site to be treated.
    Patent expiration dates:
    • August 11, 2015
      ✓ 
      Drug product

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.
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