Generic Opfolda Availability
Last updated on Dec 12, 2024.
Opfolda is a brand name of miglustat, approved by the FDA in the following formulation(s):
OPFOLDA (miglustat - capsule;oral)
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Manufacturer: AMICUS THERAP US
Approval date: September 28, 2023
Strength(s): 65MG [RLD]
Has a generic version of Opfolda been approved?
No. There is currently no therapeutically equivalent version of Opfolda available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Opfolda. 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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Highly potent acid alpha-glucosidase with enhanced carbohydrates
Patent 10,208,299
Issued: February 19, 2019
Inventor(s): Gotschall Russell & Do Hung V.
Assignee(s): Amicus Therapeutics, Inc.Recombinant human alpha glucosidase (rhGAA) composition derived from CHO cells that contains a more optimized glycan composition consisting of a higher amount of rhGAA containing N-glycans carrying mannose-6-phosphate (M6P) or bis-M6P than conventional rhGAAs, along with low amount of non-phosphorylated high mannose glycans, and low amount of terminal galactose on complex oligosaccharides. Compositions containing the rhGAA, and methods of use are described.
Patent expiration dates:
- September 30, 2035✓✓✓
- September 30, 2035
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High concentration alpha-glucosidase compositions for the treatment of pompe disease
Patent 10,512,677
Issued: December 24, 2019
Inventor(s): Valenzano Kenneth & Crowley John & Khanna Richie & Flanagan John
Assignee(s): Amicus Therapeutics, Inc.The present application provides for compositions comprising high concentrations of acid a-glucosidase in combination with an active site-specific chaperone for the acid α-glucosidase, and methods for treating Pompe disease in a subject in need thereof, that includes a method of administering to the subject such compositions. The present application also provides methods for increasing the in vitro and in vivo stability of an acid α-glucosidase enzyme formulation.
Patent expiration dates:
- March 7, 2033✓
- March 7, 2033
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Augmented acid alpha-glucosidase for the treatment of Pompe disease
Patent 10,857,212
Issued: December 8, 2020
Inventor(s): Do Hung V. & Khanna Richie & Gotschall Russell
Assignee(s): Amicus Therapeutics, Inc.A method for treating Pompe disease including administration of recombinant human acid α-glucosidase having optimal glycosylation with mannose-6-phosphate residues in combination with an amount of miglustat effective to maximize tissue uptake of recombinant human acid α-glucosidase while minimizing inhibition of the enzymatic activity of the recombinant human acid α-glucosidase is provided.
Patent expiration dates:
- August 12, 2037✓
- August 12, 2037
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Highly potent acid alpha-glucosidase with enhanced carbohydrates
Patent 10,961,522
Issued: March 30, 2021
Inventor(s): Gotschall Russell & Do Hung V.
Assignee(s): Amicus Therapeutics, Inc.Recombinant human alpha glucosidase (rhGAA) composition derived from CHO cells that contains a more optimized glycan composition consisting of a higher amount of rhGAA containing N-glycans carrying mannose-6-phosphate (M6P) or bis-M6P than conventional rhGAAs, along with low amount of non-phosphorylated high mannose glycans, and low amount of terminal galactose on complex oligosaccharides. Compositions containing the rhGAA, and methods of use are described.
Patent expiration dates:
- September 30, 2035✓
- September 30, 2035
-
High concentration alpha-glucosidase compositions for the treatment of Pompe disease
Patent 11,278,599
Issued: March 22, 2022
Inventor(s): Valenzano Kenneth & Crowley John & Khanna Richie & Flanagan John
Assignee(s): Amicus Therapeutics, Inc.The present application provides for compositions comprising high concentrations of acid a-glucosidase in combination with an active site-specific chaperone for the acid α-glucosidase, and methods for treating Pompe disease in a subject in need thereof, that includes a method of administering to the subject such compositions. The present application also provides methods for increasing the in vitro and in vivo stability of an acid α-glucosidase enzyme formulation.
Patent expiration dates:
- March 7, 2033✓
- March 7, 2033
-
Augmented acid alpha-glucosidase for the treatment of Pompe disease
Patent 11,278,601
Issued: March 22, 2022
Inventor(s): Do Hung V. & Khanna Richie & Gotschall Russell
Assignee(s): Amicus Therapeutics, Inc.A method for treating Pompe disease including administration of recombinant human acid α-glucosidase having optimal glycosylation with mannose-6-phosphate residues in combination with an amount of miglustat effective to maximize tissue uptake of recombinant human acid α-glucosidase while minimizing inhibition of the enzymatic activity of the recombinant human acid α-glucosidase is provided.
Patent expiration dates:
- December 29, 2036✓✓
- December 29, 2036
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Patent 11,753,632
Patent expiration dates:
- September 30, 2035✓
- September 30, 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:
- September 28, 2026 - NEW PRODUCT
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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.
