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 18, 2010
Strength(s): 150MG [RLD], 75MG
Has a generic version of Pradaxa been approved?
No. There is currently no therapeutically equivalent version of Pradaxa available.
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:
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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Drug substance
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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.
See also...
- Pradaxa Consumer Information (Drugs.com)
- Pradaxa Consumer Information (Wolters Kluwer)
- Pradaxa Consumer Information (Cerner Multum)
- Pradaxa Advanced Consumer Information (Micromedex)
- Dabigatran Consumer Information (Wolters Kluwer)
- Dabigatran Consumer Information (Cerner Multum)
- Dabigatran Advanced Consumer Information (Micromedex)
