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Generic Naropin Availability

Naropin is a brand name of ropivacaine, approved by the FDA in the following formulation(s):

NAROPIN (ropivacaine hydrochloride - injectable;injection)

  • Manufacturer: FRESENIUS KABI USA
    Approval date: September 24, 1996
    Strength(s): 2MG/ML [AP], 5MG/ML [AP], 7.5MG/ML [AP], 10MG/ML [RLD] [AP]

Has a generic version of Naropin been approved?

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 injectable;injection

  • Manufacturer: HOSPIRA
    Approval date: September 23, 2014
    Strength(s): 2MG/ML [AP], 5MG/ML [AP], 7.5MG/ML [AP], 10MG/ML [AP]
  • Manufacturer: NAVINTA LLC
    Approval date: July 17, 2014
    Strength(s): 5MG/ML [AP], 10MG/ML [AP]
  • Manufacturer: SAGENT STRIDES
    Approval date: September 23, 2014
    Strength(s): 2MG/ML [AP], 5MG/ML [AP], 7.5MG/ML [AP], 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: About generic drugs.

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.

  • Methods and compositions for the treatment of pain utilizing ropivacaine
    Patent 5,670,524
    Issued: September 23, 1997
    Inventor(s): Eek; Arne Torsten
    Assignee(s): Astra AB
    Use of a pharmaceutically acceptable salt of ropivacaine for the manufacture of a pharmaceutical preparation with sensoric block and minimal motor blockade.
    Patent expiration dates:
    • September 23, 2014
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      Patent use: METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.25% BY WEIGHT OF ROPIVACAINE
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      Drug substance
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      Drug product
  • Connector for packaging containing medical fluids and packaging for medical fluids
    Patent 7,828,787
    Issued: November 9, 2010
    Inventor(s): Brandenburger; Torsten & Rahimy; Ismael
    Assignee(s): Fresenius Kabi Deutschland GmbH
    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
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      Drug product
  • Connector for medical liquid-containing packages and medical liquid-containing packages
    Patent 7,857,802
    Issued: December 28, 2010
    Inventor(s): Brandenburger; Torsten & Rahimy; Ismael
    Assignee(s): Fresenius Kabi Deutschland GmbH
    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
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      Drug product
  • Connector for packaging containing medical fluids and packaging for medical fluids
    Patent 8,118,802
    Issued: February 21, 2012
    Inventor(s): Brandenburger; Torsten & Rahimy; Ismael
    Assignee(s): Fresenius Kabi Deutschland GmbH
    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:
    • May 18, 2023
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      Drug product
  • Connector for packings containing medical liquids, and corresponding packing for medical liquids
    Patent 8,162,915
    Issued: April 24, 2012
    Inventor(s): Brandenburger; Torsten & Heilmann; Klaus & Knierbein; Bernd
    Assignee(s): Fresenius Kabi Deutschland GmbH
    A connector for packings containing medical liquids, particularly infusion, transfusion or enteral bags, comprises a connecting part (1) for accommodating a spike for drawing out the liquid and comprises a closure part (3) that closes the passage (2) inside the connecting part (1). The connecting part (1) has an elastically deformable pinching off part (4) provided in the form of a tubular section with a non-circular cross-section. A base part (5), which widens on both sides is adjoined to said pinching off part (4) and can be integrated in the packing. During manufacturing, the packing is filled with liquid via the connecting part. After filling, the pinching off part is pressed together whereby preventing liquid from escaping. Afterwards, the closure part is placed onto the connecting part. The manufacturing of the packing is simplified by virtue of the fact that an additional tube for connecting the connector and packing is rendered unnecessary.
    Patent expiration dates:
    • May 23, 2024
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      Drug product

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
APInjectable 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.
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