Generic Kloxxado Availability
Last updated on Apr 10, 2025.
Kloxxado is a brand name of naloxone, approved by the FDA in the following formulation(s):
KLOXXADO (naloxone hydrochloride - spray;nasal)
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Manufacturer: HIKMA
Approval date: April 29, 2021
Strength(s): 8MG/SPRAY [RLD]
Is there a generic version of Kloxxado available?
No. There is currently no therapeutically equivalent version of Kloxxado available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kloxxado. 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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Liquid naloxone spray
Patent 10,722,510
Issued: July 28, 2020
Inventor(s): Amancha Kiran & Chilampalli Shivani & Potta Thrimoorthy & Yan Ningxin & Goskonda Venkat R.
Assignee(s): HIKMA PHARMACEUTICALS USA INC.The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention both intranasally and sublingually to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally and sublingually the naloxone formulations of the present invention.
Patent expiration dates:
- August 26, 2034✓✓
- August 26, 2034
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Liquid naloxone spray
Patent 10,973,814
Issued: April 13, 2021
Inventor(s): Amancha; Kiran et al.
Assignee(s): HIKMA PHARMACEUTICALS USA INC. (Eatontown, NJ)The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Patent expiration dates:
- August 26, 2034✓✓
- August 26, 2034
-
Liquid naloxone spray
Patent 11,135,155
Issued: October 5, 2021
Inventor(s): Amancha Kiran & Chilampalli Chandeshwari & Potta Thrimoorthy & Yan Ningxin & Goskonda Venkat R.
Assignee(s): Hikma Pharmaceuticals USA Inc.The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Patent expiration dates:
- August 26, 2034✓
- August 26, 2034
-
Liquid naloxone spray
Patent 11,617,713
Issued: April 4, 2023
Inventor(s): Amancha; Kiran et al.
Assignee(s): Hikma Pharmaceuticals USA Inc. (Eatontown, NJ)The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Patent expiration dates:
- August 26, 2034✓✓
- August 26, 2034
-
Liquid naloxone spray
Patent 11,628,139
Issued: April 18, 2023
Inventor(s): Amancha; Kiran et al.
Assignee(s): Hikma Pharmaceuticals USA Inc. (Eatontown, NJ)The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Patent expiration dates:
- August 26, 2034✓✓
- August 26, 2034
-
Liquid naloxone spray
Patent 11,975,096
Issued: May 7, 2024
Inventor(s): Amancha; Kiran et al.
Assignee(s): Hikma Pharmaceuticals USA Inc. (Berkeley Heights, NJ)The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Patent expiration dates:
- August 26, 2034✓
- August 26, 2034
More about Kloxxado (naloxone)
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- Latest FDA alerts (2)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: antidotes
- Breastfeeding
- En español
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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.