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Generic Pradaxa Availability

Last updated on Mar 9, 2023.

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

PRADAXA (dabigatran etexilate mesylate - capsule;oral)

PRADAXA (dabigatran etexilate mesylate - pellets;oral)

  • Manufacturer: BOEHRINGER INGELHEIM
    Approval date: June 21, 2021
    Strength(s): EQ 20MG BASE/PACKET [RLD], EQ 30MG BASE/PACKET [RLD], EQ 40MG BASE/PACKET [RLD], EQ 50MG BASE/PACKET [RLD], EQ 110MG BASE/PACKET [RLD], EQ 150MG BASE/PACKET [RLD]

Has a generic version of Pradaxa been approved?

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

dabigatran etexilate mesylate capsule;oral

  • Manufacturer: ALKEM LABS LTD
    Approval date: March 11, 2020
    Strength(s): EQ 75MG BASE [AB], EQ 150MG BASE [AB]
  • Manufacturer: HETERO LABS LTD III
    Approval date: May 6, 2020
    Strength(s): EQ 75MG BASE [AB], EQ 150MG BASE [AB]

Note: No generic formulation of the following product is available.

  • dabigatran etexilate mesylate - pellets;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pradaxa. 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: Generic Drug FAQ.

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.

  • Film container
    Patent 7,866,474
    Issued: January 11, 2011
    Inventor(s): Geser; Johannes & Beyer; Sebastian
    Assignee(s): Boehringer Ingelheim International GmbH

    A film container (FIG. 4) comprises two rectangular films (5) joined together at their periphery to form a receiving chamber (6) for a filling (7), particularly a pharmaceutical formulation of an active substance, at least one of said films (5) being provided, for the purpose of tearing it open, with a marking (13) formed within the connecting region, which is exposed after the films (5) have been bent. The marking (13) extends centrally between two opposing outer edges (11) of the film container (1).

    Patent expiration dates:

    • August 31, 2027
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • March 2, 2028
      ✓ 
      Pediatric exclusivity
  • 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament
    Patent 7,932,273
    Issued: April 26, 2011
    Inventor(s): Schmid; Rolf & Sieger; Peter & Sobotta; Rainer
    Assignee(s): Boehringer Ingelheim International GmbH

    Ethyl 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl)phenylamino]methyl}-1-methyl-1H-benzimidazole-5-carbonyl)pyridin-2-ylamino]propionate methanesulfonate in the crystalline modifications I and II and as the hemihydrate and the use thereof as a pharmaceutical composition.

    Patent expiration dates:

    • September 7, 2025
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • March 7, 2026
      ✓ 
      Pediatric exclusivity
  • Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
    Patent 9,034,822
    Issued: May 19, 2015
    Assignee(s): Boehringer Igelheim International GmbH

    The present invention relates to antibody molecules against anticoagulants, in particular dabigatran, and their use as antidotes of such anticoagulants.

    Patent expiration dates:

    • January 20, 2031
      ✓ 
      Patent use: METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB
    • July 20, 2031
      ✓ 
      Pediatric exclusivity
  • Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof
    Patent 9,925,174
    Issued: March 27, 2018
    Assignee(s): Boehringer Ingelheim International GmbH

    The invention relates to a new administration form for the oral application of the active substance ethyl 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazole-5-carbonyl)-pyridin-2-yl-amino]-propionate and the pharmacologically acceptable salts thereof.

    Patent expiration dates:

    • June 14, 2023
      ✓ 
      Drug product
    • December 14, 2023
      ✓ 
      Pediatric exclusivity

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:

    • June 21, 2024 - TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN
    • June 21, 2024 - NEW PRODUCT
    • December 21, 2024 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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