Generic Naropin Availability
Last updated on Apr 10, 2025.
Naropin is a brand name of ropivacaine, approved by the FDA in the following formulation(s):
NAROPIN (ropivacaine hydrochloride - solution;injection)
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Manufacturer: FRESENIUS KABI USA
Approval date: September 24, 1996
Strength(s): 40MG/20ML (2MG/ML) [RLD] [AP], 75MG/10ML (7.5MG/ML) (discontinued) [RLD], 100MG/10ML (10MG/ML) [RLD] [AP], 150MG/20ML (7.5MG/ML) [RLD] [AP], 150MG/30ML (5MG/ML) [RLD] [AP], 200MG/100ML (2MG/ML) [RLD] [AP], 200MG/20ML (10MG/ML) [RLD] [AP], 400MG/200ML (2MG/ML) [RLD] [AP] -
Manufacturer: FRESENIUS KABI USA
Approval date: May 1, 1998
Strength(s): 50MG/10ML (5MG/ML) (discontinued) [RLD], 20MG/10ML (2MG/ML) [RLD] [AP], 100MG/20ML (5MG/ML) [RLD] [AP] -
Manufacturer: FRESENIUS KABI USA
Approval date: January 4, 2011
Strength(s): 1GM/200ML (5MG/ML) [RLD] [AP], 500MG/100ML (5MG/ML) [RLD] [AP]
Is there a generic version of Naropin available?
A generic version of Naropin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Naropin and have been approved by the FDA:
ropivacaine hydrochloride solution;injection
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Manufacturer: AMNEAL
Approval date: March 7, 2023
Strength(s): 1GM/200ML (5MG/ML) [AP], 500MG/100ML (5MG/ML) [AP] -
Manufacturer: AMNEAL
Approval date: March 8, 2023
Strength(s): 200MG/100ML (2MG/ML) [AP], 400MG/200ML (2MG/ML) [AP] -
Manufacturer: ANTHEA PHARMA
Approval date: March 21, 2025
Strength(s): 40MG/20ML (2MG/ML) [AP], 150MG/30ML (5MG/ML) [AP], 200MG/20ML (10MG/ML) [AP] -
Manufacturer: CAPLIN
Approval date: April 9, 2020
Strength(s): 40MG/20ML (2MG/ML) [AP], 100MG/20ML (5MG/ML) [AP], 150MG/30ML (5MG/ML) [AP], 200MG/20ML (10MG/ML) [AP] -
Manufacturer: CAPLIN
Approval date: May 23, 2024
Strength(s): 200MG/100ML (2MG/ML) [AP], 400MG/200ML (2MG/ML) [AP] -
Manufacturer: EUGIA PHARMA
Approval date: July 13, 2016
Strength(s): 40MG/20ML (2MG/ML) [AP], 100MG/20ML (5MG/ML) [AP], 100MG/10ML (10MG/ML) [AP], 150MG/30ML (5MG/ML) [AP], 150MG/20ML (7.5MG/ML) [AP], 200MG/100ML (2MG/ML) [AP], 200MG/20ML (10MG/ML) [AP] -
Manufacturer: GLAND
Approval date: August 18, 2022
Strength(s): 200MG/100ML (2MG/ML) [AP], 400MG/200ML (2MG/ML) [AP] -
Manufacturer: HIKMA
Approval date: July 20, 2020
Strength(s): 40MG/20ML (2MG/ML) [AP], 150MG/30ML (5MG/ML) [AP], 150MG/20ML (7.5MG/ML) [AP], 200MG/20ML (10MG/ML) [AP] -
Manufacturer: HIKMA
Approval date: August 15, 2024
Strength(s): 200MG/100ML (2MG/ML) [AP], 400MG/200ML (2MG/ML) [AP], 500MG/100ML (5MG/ML) [AP] -
Manufacturer: INFORLIFE
Approval date: June 11, 2018
Strength(s): 1GM/200ML (5MG/ML) [AP], 200MG/100ML (2MG/ML) [AP], 400MG/200ML (2MG/ML) [AP], 500MG/100ML (5MG/ML) [AP] -
Manufacturer: KINDOS
Approval date: July 30, 2024
Strength(s): 20MG/10ML (2MG/ML) [AP], 40MG/20ML (2MG/ML) [AP], 100MG/20ML (5MG/ML) [AP], 100MG/10ML (10MG/ML) [AP], 150MG/30ML (5MG/ML) [AP], 150MG/20ML (7.5MG/ML) [AP], 200MG/20ML (10MG/ML) [AP] -
Manufacturer: MYLAN LABS LTD
Approval date: October 26, 2023
Strength(s): 200MG/100ML (2MG/ML) [AP], 400MG/200ML (2MG/ML) [AP] -
Manufacturer: NAVINTA LLC
Approval date: July 17, 2014
Strength(s): 150MG/30ML (5MG/ML) [AP], 200MG/20ML (10MG/ML) [AP] -
Manufacturer: RISING
Approval date: April 11, 2016
Strength(s): 150MG/30ML (5MG/ML) [AP] -
Manufacturer: RISING
Approval date: March 16, 2018
Strength(s): 200MG/100ML (2MG/ML) [AP], 400MG/200ML (2MG/ML) [AP] -
Manufacturer: SOMERSET THERAPS LLC
Approval date: June 15, 2018
Strength(s): 20MG/10ML (2MG/ML) [AP], 40MG/20ML (2MG/ML) [AP], 100MG/20ML (5MG/ML) [AP], 100MG/10ML (10MG/ML) [AP], 150MG/30ML (5MG/ML) [AP], 150MG/20ML (7.5MG/ML) [AP], 200MG/20ML (10MG/ML) [AP]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Naropin. 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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Connector for packaging containing medical fluids and packaging for medical fluids
Patent 7,828,787
Issued: November 9, 2010
Inventor(s): Brandenburger; Torsten et al.
Assignee(s): Fresenius Kabi Deutschland GmbH (Bad Homburg, DE)The disclosure relates to a connector for packaging containing medical fluids, in particular infusion or transfusion bags, including a tubular connection part for receiving a spike for the withdrawal of fluid, and having a lower opening on the packaging side and an upper opening on the connection side. A self-sealing membrane, which is pierced by the spike, is located in the connection part. The membrane has an upper, annular section leading into a lower, plate-shaped section, said annular section of the membrane surrounding the spike in a sealing manner, when the latter pierces the plate-shaped section. The membrane acts as a guide for the spike and also reseals the connector, once the spike has been removed.
Patent expiration dates:
- October 18, 2025✓
- October 18, 2025
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Connector for medical liquid-containing packages and medical liquid-containing packages
Patent 7,857,802
Issued: December 28, 2010
Inventor(s): Brandenburger; Torsten et al.
Assignee(s): Fresenius Kabi Deutschland GmbH (Bad Homburg V.D.H., DE)The invention relates to a connector for medical liquid-containing packages, in particular to infusion or transfusion bags comprising a connection element (1) provided with a channel-shaped opening (1c) in which a self-sealing membrane (8) is arranged. A breakable part (17) which is connected to the connection piece closes the channel-shaped opening. Above the membrane (8), said connection element is embodied in the form a connection piece (13) comprising an internal cone (14) and external thread (15), the membrane (8) being sealed for receiving a syringe cone shaft. The inventive connector makes it possible to inject an active substance by means of a conventional Luer lock syringe devoid of an injection cannula (needle).
Patent expiration dates:
- November 28, 2026✓
- November 28, 2026
More about Naropin (ropivacaine)
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Glossary
Term | Definition |
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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. |
AP | Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.