Generic Oravig Availability

Last updated on Jan 11, 2023.

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

ORAVIG (miconazole - tablet;buccal)

Manufacturer: GALT PHARMS
Approval date: April 16, 2010
Strength(s): 50MG ^[RLD]

Has a generic version of Oravig been approved?

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

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

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.

Prolonged release bioadhesive therapeutic systems
Patent 6,916,485
Issued: July 12, 2005
Inventor(s): Aiache; Jean-Marc & Costantini; Dominique & Chaumont; Christine
Assignee(s): Bioalliance Pharma
The present invention concerns a prolonged release bioadhesive mucosal therapeutic system containing at least one active principle, with an active dissolution test of more than 70% over 8 hours and to a method for its preparation. The bioadhesive therapeutic system may be in tablet form and may contain quantities of natural proteins representing at least 50% by weight of active principle and at least 20% by weight of the tablet, between 10% and 20% of a hydrophilic polymer, and compression excipients, and may contain between 4% and 10% of an alkali metal alkylsulphate to reinforce the local availability of active principle and between 0.1% and 1% of a monohydrate sugar.
Patent expiration dates:
- September 11, 2022
  ✓
  Patent use: TREATMENT OF OROPHARYNGEAL CANDIDIASIS
  ✓
  Drug product
Prolonged release bioadhesive therapeutic systems
Patent 7,651,698
Issued: January 26, 2010
Inventor(s): Aiache; Jean-Marc & Costantini; Dominique & Chaumont; Christine
Assignee(s): Bioalliance Pharma
The present invention concerns a prolonged release bioadhesive mucosal therapeutic system containing at least one active principle, with an active principle dissolution test of more than 70% over 8 hours and to a method for its preparation. This bioadhesive therapeutic system comprises quantities of natural proteins representing 50% by weight of active principle and at least 20% by weight of said tablet, between 10% and 20% of a hydrophilic polymer, and compression excipients, and comprising between 4% and 10% of an alkali metal alkylsulphate to reinforce the local availability of active principle and between 0.1% and 1% of a monohydrate sugar.
Patent expiration dates:
- September 11, 2022
  ✓
  Patent use: TREATMENT OF OROPHARYNGEAL CANDIDIASIS
Prolonged release bioadhesive therapeutic systems
Patent 8,518,442
Issued: August 27, 2013
Assignee(s): BioAlliance Pharma, S.A.
The present invention concerns a prolonged release bioadhesive mucosal therapeutic system containing at least one active principle, with an active principle dissolution test of more than 70% over 8 hours and to a method for its preparation. Said bioadhesive therapeutic system comprises quantities of natural proteins representing at least 50% by weight of active principle and at least 20% by weight of said tablet, between 10% and 20% of a hydrophilic polymer, and compression excipients, and comprising between 4% and 10% of an alkali metal alkylsulphate to reinforce the local availability of active principle and between 0.1% and 1% of a monohydrate sugar.
Patent expiration dates:
- September 11, 2022
  ✓
  Drug product

More about Oravig (miconazole)

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.