Generic Ultram Availability

See also: Generic Ultram ER

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

ULTRAM (tramadol hydrochloride - tablet; oral)

Has a generic version of Ultram been approved?

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

tramadol hydrochloride tablet; oral

  • Manufacturer: ALVOGEN
    Approval date: November 28, 2011
    Strength(s): 50MG [AB]
  • Manufacturer: AMNEAL PHARMS
    Approval date: June 20, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: APOTEX
    Approval date: July 10, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: CARACO
    Approval date: June 19, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: CSPC OUYI PHARM CO
    Approval date: March 29, 2013
    Strength(s): 50MG [AB]
  • Manufacturer: IPCA LABS LTD
    Approval date: November 16, 2012
    Strength(s): 50MG [AB]
  • Manufacturer: MALLINCKRODT
    Approval date: June 25, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: MUTUAL PHARM
    Approval date: June 20, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: MYLAN
    Approval date: June 21, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: November 21, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: NORTHSTAR HLTHCARE
    Approval date: May 26, 2010
    Strength(s): 50MG [AB]
  • Manufacturer: PLIVA
    Approval date: July 1, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: TEVA
    Approval date: June 19, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: WATSON LABS
    Approval date: June 24, 2002
    Strength(s): 50MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: January 31, 2011
    Strength(s): 50MG [AB]

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

  • Analgesic regimen
    Patent 6,339,105
    Issued: January 15, 2002
    Inventor(s): Marc; Kamin & William; Olson
    Assignee(s): Ortho-McNeil Pharmaceutical, Inc.
    A regimen for the administration of tramadol for the treatment of analgesia is described. The regimen involves a slower initial titration rate of tramadol which results in a significantly lower percentage of discontinuations of therapy due to a lower incidence and severity of side effects.
    Patent expiration dates:
    • October 12, 2019
      ✓ 
      Patent use: A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF ABOUT 25MG
    • April 12, 2020
      ✓ 
      Patent use: A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF ABOUT 25MG
      ✓ 
      Pediatric exclusivity

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.
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.

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