Generic Fortical Availability

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

FORTICAL (calcitonin salmon recombinant - spray, metered;nasal)

  • Manufacturer: UPSHER SMITH
    Approval date: August 12, 2005
    Strength(s): 200 IU/SPRAY [RLD]

Has a generic version of Fortical been approved?

No. There is currently no therapeutically equivalent version of Fortical available in the United States.

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

  • Nasal calcitonin formulations
    Patent 6,440,392
    Issued: August 27, 2002
    Inventor(s): William; Stern
    Assignee(s): Unigene Laboratories, Inc.
    A liquid pharmaceutical composition is disclosed comprising calcitonin or an acid addition salt thereof and citric acid or salt thereof in a concentration from about to about 50 mM, said composition being in a form table for nasal administration.
    Patent expiration dates:
    • February 2, 2021
      ✓ 
      Patent use: NASAL ADMINISTRATION
      ✓ 
      Drug product
  • Nasal calcitonin formulation
    Patent RE40812
    Issued: June 30, 2009
    Inventor(s): Stern; William
    Assignee(s): Unigene Laboratories Inc.
    A liquid pharmaceutical composition is disclosed comprising calcitonin or an acid addition salt thereof and citric acid or salt thereof in a concentration from about to about 50 mM, said composition being in a form table for nasal administration. A liquid pharmaceutical composition is provided for nasal administration of calcitonin or an acid addition salt thereof. The nasal pharmaceutical formulations contain a component selected from the group consisting of citric acid, citric acid salt and a combination thereof.
    Patent expiration dates:
    • February 2, 2021
      ✓ 
      Drug product
  • Nasal calcitonin formulations
    Patent RE43580
    Issued: August 14, 2012
    Inventor(s): Stern; William
    Assignee(s): Unigene Laboratories, Inc.
    A liquid pharmaceutical composition is disclosed comprising calcitonin or an acid addition salt thereof and citric acid or salt thereof in a concentration from about to about 50 mM, said composition being in a form table for nasal administration. A liquid pharmaceutical composition is provided for nasal administration of calcitonin or an acid addition salt thereof. The nasal pharmaceutical formulations contain a component selected from the group consisting of citric acid, citric acid salt and a combination thereof.
    Patent expiration dates:
    • February 2, 2021
      ✓ 
      Patent use: NASAL ADMINISTRATION
      ✓ 
      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.

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