Generic Dilaudid Availability

See also: Generic Dilaudid-HP

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

DILAUDID (hydromorphone hydrochloride - injectable; injection)

DILAUDID (hydromorphone hydrochloride - solution; oral)

DILAUDID (hydromorphone hydrochloride - tablet; oral)

Has a generic version of Dilaudid been approved?

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

hydromorphone hydrochloride injectable; injection

  • Manufacturer: HOSPIRA INC
    Approval date: December 1, 2011
    Strength(s): 1MG/ML [AP], 2MG/ML [AP], 4MG/ML [AP]

hydromorphone hydrochloride solution; oral

  • Manufacturer: ROXANE
    Approval date: July 29, 1998
    Strength(s): 5MG/5ML [AA]

hydromorphone hydrochloride tablet; oral

  • Manufacturer: ELITE LABS
    Approval date: October 18, 2005
    Strength(s): 8MG [AB]
  • Manufacturer: LANNETT
    Approval date: December 9, 2009
    Strength(s): 2MG [AB], 4MG [AB], 8MG [AB]
  • Manufacturer: MALLINCKRODT
    Approval date: December 23, 2004
    Strength(s): 8MG [AB]
  • Manufacturer: MALLINCKRODT INC
    Approval date: September 19, 2007
    Strength(s): 2MG [AB], 4MG [AB]
  • Manufacturer: ROXANE
    Approval date: July 29, 1998
    Strength(s): 8MG [AB]
  • Manufacturer: ROXANE
    Approval date: May 29, 2009
    Strength(s): 4MG [AB]

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

  • Hydromorphone and hydrocodone compositions and methods for their synthesis
    Patent 6,589,960
    Issued: July 8, 2003
    Inventor(s): William H.; Harclerode & Robert; Gault & Mark D.; Sandison
    Assignee(s): Abbott Laboratories
    A method for the preparation of a ketone from a narcotic alkaloid having an allyl alcohol moiety is disclosed. The method includes mixing the narcotic alkaloid with an acid in the presence of a catalyst wherein the method is carried out in the substantial absence of hydrogen gas. The method is useful for preparing hydromorphone and hydrocodone compositions having novel impurity profiles. Compositions comprising hydromorphone and hydrocodone are also disclosed.
    Patent expiration dates:
    • November 9, 2020
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      Drug product

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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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