Generic Doryx Availability

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

DORYX (doxycycline hyclate - tablet, delayed release;oral)

  • Manufacturer: MAYNE PHARMA
    Approval date: May 6, 2005
    Strength(s): EQ 75MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: MAYNE PHARMA
    Approval date: June 20, 2008
    Strength(s): EQ 150MG BASE [AB]
  • Manufacturer: MAYNE PHARMA
    Approval date: April 11, 2013
    Strength(s): EQ 80MG BASE, EQ 200MG BASE [RLD]

Has a generic version of Doryx been approved?

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

doxycycline hyclate tablet, delayed release;oral

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: December 14, 2011
    Strength(s): EQ 75MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: HERITAGE PHARMS INC
    Approval date: April 30, 2013
    Strength(s): EQ 75MG BASE [AB], EQ 100MG BASE [AB], EQ 150MG BASE [AB]
  • Manufacturer: IMPAX LABS INC
    Approval date: December 28, 2010
    Strength(s): EQ 75MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: December 28, 2010
    Strength(s): EQ 75MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: February 8, 2012
    Strength(s): EQ 150MG BASE [AB]

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

  • Modified release coated drug preparation
    Patent 6,958,161
    Issued: October 25, 2005
    Inventor(s): Hayes; David & LoPore; Angelo & Lukas; Stefan & Quinn; Eugene
    Assignee(s): F H Faulding & Co Limited
    A modified release preparation having one or more coated core elements, each core element including an active ingredient and having a modified release coating, wherein a stabilising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile.
    Patent expiration dates:
    • December 15, 2022
      ✓ 
      Patent use: TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • April 11, 2016 - ALTERNATE DOSING REGIMEN FOR UNCOMPLICATED URETHRAL OR ENDOCERVICAL INFECTION CAUSED BY CHLAMYDIA TRACHOMATIS, ADMINISTER 200 MG BY MOUTH ONCE-A-DAY FOR 7 DAYS
    • April 11, 2016 - NEW STRENGTH

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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