Generic Alinia Availability

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

ALINIA (nitazoxanide - for suspension;oral)

  • Manufacturer: ROMARK
    Approval date: November 22, 2002
    Strength(s): 100MG/5ML [RLD]

ALINIA (nitazoxanide - tablet;oral)

  • Manufacturer: ROMARK
    Approval date: July 21, 2004
    Strength(s): 500MG [RLD]

Has a generic version of Alinia been approved?

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

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

  • Benzamide derivatives
    Patent 5,578,621
    Issued: November 26, 1996
    Inventor(s): Rossignol; Jean-Francois
    The present invention relates to a new compound of formula I ##STR1## with one of the symbols R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 representing OH, whereas the remaining symbols represent H; to a pharmaceutical composition containing the said compound, and to the use of said compound as anti-parasital, anti-bacterial, anti-fungal agent. The Prior Art Nitrothiazole compound PH 5776 (2-(acetolyloxy)-N-(5-nitro 2-thiazolyl) benzamide) is a compound of formula II ##STR2## in which R.sub.1 =O--COCH3 R.sub.2 =R.sub.3 =R.sub.4 =R.sub.5 =H The preparation and uses of this compound are disclosed in U.S. Pat. No. 3,950,351, as well as in publication made by Applicant. In U.S. Pat. No. 3,950,351, the compound of formula II is prepared by reacting ##STR3## This reaction is not suitable for the preparation of pure compound of formula I ##STR4## in which one of the symbols R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 represent OH, whereas the remaining symbols represent H. Moreover, contrary to what could be expected from the prior art, i.e. that the presence of an acyloxy group was necessary for rendering the compound active and efficient against bacteria, parasites, . . . , it has now been found that the compound of formula I ##STR5## with one of the symbols R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 representing OH, whereas the remaining symbols represent H; had an excellent efficiency against parasites, bacteria, fungus although it does not contain an acyloxy group. The compound of formula I had a substantially immediate action against parasite, fungus, bacteria.
    Patent expiration dates:
    • November 26, 2013
      ✓ 
      Patent use: METHOD OF TREATING PARASITIC INFECTIONS
      ✓ 
      Drug product
    • September 8, 2014
      ✓ 
      Patent use: METHOD OF TREATING PARASITIC INFECTIONS
  • Method for treatment of opportunistic infections with pharmaceutical compositions of tizoxanide and nitazoxanide
    Patent 5,965,590
    Issued: October 12, 1999
    Inventor(s): Rossignol; Jean-Fran.cedilla.ois
    Methods for treatment of Cryptosporidium parvum, Isospora belli, Enterocytzoon bieneusi, Encephalitozoon intestinalis, Mycobacterium tuberculosis, Mycobacterium avium intracellulare, Pneumocystis carinii, and Toxoplasma gondii, the methods comprising the administration of a pharmaceutical composition containing as active agent at least one compound selected the group consisting of a compound of formula I: ##STR1## and a compound of formula II: ##STR2##
    Patent expiration dates:
    • July 3, 2017
      ✓ 
      Patent use: METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED MAMMAL
  • Pharmaceutical compositions of tizoxanide and nitazoxanide
    Patent 5,968,961
    Issued: October 19, 1999
    Inventor(s): Rossignol; Jean-Fran.cedilla.ois
    Assignee(s): Romark Laboratories, L.C.
    The present invention relates to a pharmaceutical composition containing as active agent, solid particles of a compound selected from the group consisting of: compound of formula I ##STR1## and mixtures thereof, said particles having a particle size smaller than 200 .mu.m, the mean particle size of the said active solid particles being greater than 10 .mu.m. It also relates to a pharmaceutical composition which contains at least one pharmaceutically acceptable acid.
    Patent expiration dates:
    • May 7, 2017
      ✓ 
      Drug product
    • May 7, 2017
  • 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide
    Patent 6,020,353
    Issued: February 1, 2000
    Inventor(s): Rossignol; Jean-Francois
    Assignee(s): Romark Laboratories, L.C.
    The present invention relates to a pharmaceutical composition containing a compound of formula I ##STR1## with one of the symbols R.sub.1, R.sub.2, R.sub.3, R.sub.4 and R.sub.5 representing OH, whereas the remaining symbols represent H as antiviral agent.
    Patent expiration dates:
    • September 18, 2014
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • September 8, 2014
  • Acid stabilized pharmaceutical compositions of tizoxanide and nitazoxanide
    Patent 6,117,894
    Issued: September 12, 2000
    Inventor(s): Rossignol; Jean-Fran.cedilla.ois
    Assignee(s): Romark Laboratories, L.C.
    The present invention relates to a pharmaceutical composition containing as active agent, solid particles of a compound selected from the group consisting of: compound of formula I: ##STR1## compound of formula II: ##STR2## and mixtures thereof. said particles having a particle size smaller than 200 .mu.m, the mean particle size of the said active solid particles being greater than 10 .mu.m. It also relates to a pharmaceutical composition which contains at least one pharmaceutically acceptable acid.
    Patent expiration dates:
    • May 7, 2017

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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