Generic Filsuvez Availability
Last updated on Jan 8, 2025.
Filsuvez is a brand name of birch triterpenes topical, approved by the FDA in the following formulation(s):
FILSUVEZ (birch triterpenes - gel;topical)
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Manufacturer: CHIESI
Approval date: December 18, 2023
Strength(s): 10% [RLD]
Has a generic version of Filsuvez been approved?
No. There is currently no therapeutically equivalent version of Filsuvez available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Filsuvez. 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.
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Betulin-containing birch bark extracts and their formulation
Patent 11,083,733
Issued: August 10, 2021
Inventor(s): Watson John Ashleigh & Jäger Sebastian & Zahn Tobias
Assignee(s): Amryt Research LimitedThe present disclosure relates to birch bark extracts, methods of producing such extracts, stable pharmaceutical compositions containing such extracts and methods of using of such extracts. The birch bark extracts of the present disclosure contain triterpenes, which are known to improve wound healing.
Patent expiration dates:
- January 4, 2039✓
- January 4, 2039
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Betulin-containing birch bark extracts and their formulation
Patent 11,266,660
Issued: March 8, 2022
Inventor(s): Watson John Ashleigh & Jäger Sebastian & Zahn Tobias
Assignee(s): Amryt Research LimitedThe present disclosure relates to birch bark extracts, methods of producing such extracts, stable pharmaceutical compositions containing such extracts and methods of using of such extracts. The birch bark extracts of the present disclosure contain triterpenes, which are known to improve wound healing.
Patent expiration dates:
- January 4, 2039✓
- January 4, 2039
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Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel
Patent 8,828,444
Issued: September 9, 2014
Inventor(s): Scheffler Armin
Assignee(s): Birken AGThe invention relates to an oleogel-forming agent which comprises at least one highly dispersed triterpene. The invention also relates to an oleogel which comprises a nonpolar liquid in an amount ranging from 80% by weight to 99% by weight based on the total weight of the oleogel and an oleogel-forming agent comprising a highly dispersed triterpene in an amount ranging from 1% by weight to 20% by weight based on the total weight of the oleogel. The invention also relates to a method for producing an oleogel.
Patent expiration dates:
- June 21, 2025✓
- June 21, 2025
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Use of an oleogel containing triterpene for healing wounds
Patent 9,352,041
Issued: May 31, 2016
Inventor(s): Scheffler Armin
Assignee(s): BIRKEN AGAn oleogel comprising a non-polar liquid and a powder containing triterpene is provided as an oleogel that may be used for healing wounds.
Patent expiration dates:
- November 24, 2030✓
- November 24, 2030
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Use of an oleogel containing triterpene for healing wounds
Patent 9,827,214
Issued: November 28, 2017
Inventor(s): Scheffler Armin
Assignee(s): AMRYT RESEARCH LIMITEDAn oleogel comprising a non-polar liquid and a powder containing triterpene is provided as an oleogel that may be used for healing wounds.
Patent expiration dates:
- November 24, 2030✓
- November 24, 2030
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:
- December 18, 2028 - NEW CHEMICAL ENTITY
- December 18, 2030 - TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
More about Filsuvez (birch triterpenes topical)
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Glossary
Term | Definition |
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.