Generic Karbinal ER Availability
Last updated on Oct 9, 2024.
Karbinal ER is a brand name of carbinoxamine, approved by the FDA in the following formulation(s):
KARBINAL ER (carbinoxamine maleate - suspension, extended release;oral)
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Manufacturer: AYTU
Approval date: March 28, 2013
Strength(s): 4MG/5ML [RLD]
Has a generic version of Karbinal ER been approved?
An Authorized Generic version of Karbinal ER has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- Carbinoxamine Maleate ORAL SUSPENSION, EXTENDED RELEASE 4 mg/5mL
Neos Therapeutics LP
NDC Code: 625420101
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Karbinal ER. 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 FAQ.
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.
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Patent 8,062,667
Patent expiration dates:
- March 29, 2029✓
- March 29, 2029
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Modified release formulations containing drug—ion exchange resin complexes
Patent 9,522,191
Issued: December 20, 2016
Inventor(s): Mehta Ketan & Tu Yu-Hsing
Assignee(s): Tris Pharma, Inc.An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. Methods of making the coated complex and the liquid suspension are described.
Patent expiration dates:
- June 15, 2027✓
- June 15, 2027
More about Karbinal ER (carbinoxamine)
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.