Generic Pradaxa Availability

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

PRADAXA (dabigatran etexilate mesylate - capsule;oral)

  • Manufacturer: BOEHRINGER INGELHEIM
    Approval date: October 19, 2010
    Strength(s): EQ 75MG BASE, EQ 150MG BASE [RLD]

Has a generic version of Pradaxa been approved?

No. There is currently no therapeutically equivalent version of Pradaxa available in the United States.

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: 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.

  • Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions
    Patent 6,087,380
    Issued: July 11, 2000
    Inventor(s): Hauel; Norbert & Priepke; Henning & Ries; Uwe & Stassen; Jean Marie & Wienen; Wolfgang
    Assignee(s): Boehringer Ingelheim Pharma KG
    New disubstituted bicyclic heterocycles of general formula EQU R.sub.a --A--Het--B--Ar--E (I) Compounds of the above general formula I, wherein E denotes an R.sub.b NH--C(.dbd.NH)-- group, have valuable pharmacological properties, particularly a thrombin-inhibiting effect and the effect of prolonging thrombin time, and those wherein E denotes a cyano group, are valuable intermediates for preparing the other compounds of general formula I. Exemplary compounds of formula I are: (a) 1-Methyl-2-[N-(4-amidinophenyl)-aminomethyl]-benzimidazol-5-yl-carboxylic acid-N-phenyl-N-(2-hydroxycarbonylethyl)-amide, (b) 1-Methyl-2-[N-(4-amidinophenyl)-aminomethyl]-benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(hydroxycarbonylmethyl)-amide, (c) 1-Methyl-2-[N-(4-amidino-2-methoxy-phenyl)-aminomethyl]-benzimidazol-5-yl- carboxylic acid-N-(2-pyridyl)-N-(hydroxycarbonylmethyl)-amide, and (d) 1-Methyl-2-[N-[4-(N-n-hexyloxycarbonylamidino)phenyl]aminomethyl]-benzimid azol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl) amide.
    Patent expiration dates:
    • February 18, 2018
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      Patent use: INHIBITION OF THROMBIN
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  • 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
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      Drug product
  • 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
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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:
    • October 19, 2015 -
    • April 4, 2017 - TO REDUCE THE RISK OF RECURRENCE OF DVT AND PE IN PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED
    • April 4, 2017 - TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR 5-10 DAYS

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.
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