Generic Robinul Availability

See also: Generic Robinul Forte

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

ROBINUL (glycopyrrolate - injectable; injection)

ROBINUL (glycopyrrolate - tablet; oral)

  • Manufacturer: SHIONOGI INC
    Approved Prior to Jan 1, 1982
    Strength(s): 1MG [RLD] [AA]

Has a generic version of Robinul been approved?

A generic version of Robinul 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 Robinul and have been approved by the FDA:

glycopyrrolate injectable; injection

  • Manufacturer: HIKMA FARMACEUTICA
    Approval date: September 21, 2011
    Strength(s): 0.2MG/ML [AP]
  • Manufacturer: LUITPOLD
    Approval date: July 23, 1986
    Strength(s): 0.2MG/ML [AP]

glycopyrrolate tablet; oral

  • Manufacturer: BOCA PHARMA
    Approval date: October 19, 2011
    Strength(s): 1MG [AA]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: March 21, 2008
    Strength(s): 1MG [AA]
  • Manufacturer: EXCELLIUM
    Approval date: September 21, 2012
    Strength(s): 1MG [AA]
  • Manufacturer: PAR PHARM
    Approval date: August 31, 2006
    Strength(s): 1MG [AA]
  • Manufacturer: RANBAXY
    Approval date: August 18, 2009
    Strength(s): 1MG [AA]
  • Manufacturer: VINTAGE
    Approval date: December 29, 2008
    Strength(s): 1MG [AA]
  • Manufacturer: WEST WARD
    Approval date: March 5, 2009
    Strength(s): 1MG [AA]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Robinul. 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.

  • Method for increasing the bioavailability of glycopyrrolate
    Patent 7,091,236
    Issued: August 15, 2006
    Inventor(s): Roberts; Alan & Venkataraman; Bala
    Assignee(s): Sciele Pharma, Inc.
    The invention relates to a method of increasing the bioavailability of glycopyrrolate by administration of a therapeutically effective amount of glycopyrrolate without food.
    Patent expiration dates:
    • April 24, 2024
      ✓ 
      Patent use: FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCER

See also...

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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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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