Generic Bynfezia Pen Availability
Bynfezia Pen is a brand name of octreotide, approved by the FDA in the following formulation(s):
BYNFEZIA PEN (octreotide acetate - solution;subcutaneous)
Manufacturer: SUN PHARM
Approval date: January 28, 2020
Strength(s): EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) [RLD]
Has a generic version of Bynfezia Pen been approved?
No. There is currently no therapeutically equivalent version of Bynfezia Pen available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bynfezia Pen. 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: Generic Drug FAQs.
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.
Issued: July 9, 2019
Assignee(s): SUN PHARMACEUTICAL INDUSTRIES LIMITED
The present invention relates to a sterile solution comprising: octreotide in the form of a pharmaceutically acceptable salt, present at a concentration equivalent to 2.0 mg/ml to 2.5 mg/ml of octreotide base, and at least one preservative in a pharmaceutically acceptable vehicle, wherein the sterile solution is present in an injection device.
Patent expiration dates:
- May 15, 2038✓
- May 15, 2038
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about Bynfezia Pen (octreotide)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- Drug class: somatostatin and somatostatin analogs
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|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.|