Generic Evrysdi Availability
Last updated on Apr 10, 2025.
Evrysdi is a brand name of risdiplam, approved by the FDA in the following formulation(s):
EVRYSDI (risdiplam - for solution;oral)
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Manufacturer: GENENTECH INC
Approval date: August 7, 2020
Strength(s): 0.75MG/ML [RLD]
EVRYSDI (risdiplam - tablet;oral)
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Manufacturer: GENENTECH INC
Approval date: February 11, 2025
Strength(s): 5MG [RLD]
Is there a generic version of Evrysdi available?
No. There is currently no therapeutically equivalent version of Evrysdi available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Evrysdi. 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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Treatment of SMA
Patent 11,534,444
Issued: December 27, 2022
Inventor(s): Pfefen; Jean-Paul et al.
Assignee(s): Hoffmann-La Roche Inc. (Little Falls, NJ)The present invention relates to 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido[1,2-a]pyrimidin-4-one for use in the treatment of spinal muscular atrophy (SMA), its pharmaceutical composition to be used in the treatment of SMA, its methods of treatment thereof.
Patent expiration dates:
- October 4, 2038✓
- October 4, 2038
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Compounds for treating spinal muscular atrophy
Patent 11,827,646
Issued: November 28, 2023
Inventor(s): Ratni; Hasane et al.
Assignee(s): Hoffmann-La Roche Inc. (Little Falls, NJ); PTC Therapeutics, Inc. (South Plainfield, NJ)The present invention provides compounds of formula (I) ##STR00001## wherein A, R.sup.1, R.sup.2 and R.sup.3 are as described herein, as well as pharmaceutically acceptable salts thereof. Further the present invention is concerned with the manufacture of the compounds of formula (I), pharmaceutical compositions comprising them and their use as medicaments.
Patent expiration dates:
- January 25, 2036✓
- January 25, 2036
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Compositions for treating spinal muscular atrophy
Patent 11,938,136
Issued: March 26, 2024
Inventor(s): Alsenz; Jochem et al.
Assignee(s): Hoffmann-La Roche Inc. (Little Falls, NJ)The present invention provides pharmaceutical compositions comprising a compound of formula (I) ##STR00001## wherein A, R.sup.1, R.sup.2 and R.sup.3 are as described herein, as well as pharmaceutically acceptable salts thereof. Further the present invention is concerned with the manufacture of the pharmaceutical compositions comprising a compound of formula (I) and their use as medicaments.
Patent expiration dates:
- November 8, 2036✓
- November 8, 2036
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Forms of pyrido[1,2-a]pyrimidin-4-one derivatives, its formulation and its process of making
Patent 12,122,789
Issued: October 22, 2024
Inventor(s): Meier; Roland et al.
Assignee(s): Hoffmann-La Roche Inc. (Little Falls, NJ)The present invention relates to a process for the preparation of 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido[1,2-a]pyrimidin-4-one useful as pharmaceutically active compounds.
Patent expiration dates:
- April 15, 2041✓✓
- April 15, 2041
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Compounds for treating spinal muscular atrophy
Patent 9,586,955
Issued: March 7, 2017
Inventor(s): Qi; Hongyan et al.
Assignee(s): PTC Therapeutics, Inc. (South Plainfield, NJ); F. Hoffmann-La Roche AG (Basel, CH)Provided herein are compounds of Formula (I): ##STR00001##
and forms thereof, including compositions thereof and uses therewith for treating spinal muscular atrophy.Patent expiration dates:
- February 8, 2033✓✓
- February 8, 2033
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Compounds for treating spinal muscular atrophy
Patent 9,969,754
Issued: May 15, 2018
Inventor(s): Ratni; Hasane et al.
Assignee(s): HOFFMANN-LA ROCHE INC. (Little Falls, NJ); PTC THERAPEUTICS, INC. (South Plainfield, NJ)The present invention provides compounds of formula (I) ##STR00001## wherein A, R.sup.1, R.sup.2 and R.sup.3 are as described herein, as well as pharmaceutically acceptable salts thereof. Further the present invention is concerned with the manufacture of the compounds of formula (I), pharmaceutical compositions comprising them and their use as medicaments.
Patent expiration dates:
- May 11, 2035✓✓✓
- May 11, 2035
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:
- May 27, 2025 - NEW PATIENT POPULATION
- August 7, 2025 - NEW CHEMICAL ENTITY
- October 3, 2026 - INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
- August 7, 2027 - TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PATIENTS 2 MONTHS OF AGE AND OLDER
- May 27, 2029 - TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PEDIATRIC PATIENTS BETWEEN BIRTH AND 2 MONTHS OF AGE
More about Evrysdi (risdiplam)
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- During pregnancy
- FDA approval history
- Drug class: miscellaneous uncategorized agents
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
