Generic Pylera Availability
Pylera is a brand name of bismuth subcitrate potassium/metronidazole/tetracycline, approved by the FDA in the following formulation(s):
PYLERA (bismuth subcitrate potassium; metronidazole; tetracycline - capsule;oral)
Manufacturer: APTALIS PHARMA US
Approval date: September 28, 2006
Strength(s): 140MG;125MG;125MG [RLD]
Has a generic version of Pylera been approved?
No. There is currently no therapeutically equivalent version of Pylera available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pylera. 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.
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.
Double capsule for the administration of active principles in multiple therapies
Issued: February 26, 2002
Inventor(s): Giovanni; Sanso
Assignee(s): Axcan Pharma Inc.
A pharmaceutical dosage form particularly suitable for the administration of active principles in multiple therapies is disclosed. The pharmaceutical dosage form is a double capsule where in an internal capsule is placed inside an external one. Each internal and external capsule includes one or more active principles. A double capsule according to the invention is preferably used in triple or quadruple therapies against the microorganisms Helicobacter Pylori. Advantages of this pharmaceutical dosage form consist in providing a simple posology for administration of two and more active principles, allowing the active principles to activate at the right intervals of time and in the preestablished quantities, and preventing interactions between active principles. In a preferred embodiment of the invention, the pharmaceutical dosage form has an external capsule containing bismuth subcitrate and metronidazole, and an internal capsule containing tetracycline and optionally omeprazole, which is used in therapy for eradication of Helicobacter pylori.Patent expiration dates:
- December 14, 2018✓
- December 14, 2018✓
- December 14, 2018
- Pylera Consumer Information (Drugs.com)
- Pylera Consumer Information (Wolters Kluwer)
- Pylera Consumer Information (Cerner Multum)
- Pylera Advanced Consumer Information (Micromedex)
- Bismuth subcitrate/metronidazole/tetracycline Consumer Information (Wolters Kluwer)
- Bismuth subcitrate potassium, metronidazole, and tetracycline Consumer Information (Cerner Multum)
- Bismuth subcitrate, metronidazole, and tetracycline Advanced Consumer Information (Micromedex)
|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.|