Generic Isturisa Availability
Last updated on Oct 9, 2024.
Isturisa is a brand name of osilodrostat, approved by the FDA in the following formulation(s):
ISTURISA (osilodrostat phosphate - tablet;oral)
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Manufacturer: RECORDATI RARE
Approval date: March 6, 2020
Strength(s): EQ 1MG BASE [RLD], EQ 5MG BASE [RLD], EQ 10MG BASE (discontinued) [RLD]
Has a generic version of Isturisa been approved?
No. There is currently no therapeutically equivalent version of Isturisa available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Isturisa. 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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Pharmaceutical dosage forms
Patent 10,143,680
Issued: December 4, 2018
Inventor(s): Beato Stefania & Quinton Peggy
Assignee(s): Novartis AGThe present invention relates to pharmaceutical dosage forms for oral administration comprising the drug substance 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile or any pharmaceutically acceptable salt thereof and to processes of making said solid pharmaceutical dosage forms.
Patent expiration dates:
- July 6, 2035✓
- July 6, 2035
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Pharmaceutical dosage forms
Patent 10,709,691
Issued: July 14, 2020
Inventor(s): Beato Stefania & Quinton Peggy
Assignee(s): RECORDATI AGThe present invention relates to pharmaceutical dosage forms for oral administration comprising the drug substance 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile or any pharmaceutically acceptable salt thereof and to processes of making said solid pharmaceutical dosage forms.
Patent expiration dates:
- October 12, 2035✓
- October 12, 2035
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Organic compounds
Patent 8,314,097
Issued: November 20, 2012
Inventor(s): Ksander Gary Michael & Meredith Erik & Monovich Lauren G. & Papillon Julien & Firooznia Fariborz & Hu Qi-Ying
Assignee(s): Novartis AGThe present invention provides a compound of formula I:
Patent expiration dates:
- March 27, 2029✓✓
- March 27, 2029
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Use of an adrenal hormone-modifying agent
Patent 8,609,862
Issued: December 17, 2013
Inventor(s): Hu Qi-Ying & Ksander Gary Michael & Meredith Erik & Monovich Lauren G. & Papillon Julien & Schumacher Christoph
Assignee(s): Novartis AGThe present invention relates to a method of treating a disease or disorder characterised by increased stress hormone levels and/or decreased androgen hormone levels in a subject, comprising administering to the subject a therapeutically effective amount of a compound represented by formula (I):
Patent expiration dates:
- January 13, 2031✓
- January 13, 2031
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Organic compounds
Patent 8,835,646
Issued: September 16, 2014
Inventor(s): Ksander Gary Michael & Meredith Erik & Monovich Lauren & Papillon Julien & Firooznia Fariborz & Hu Qi-Ying
Assignee(s): Novartis AGThe present invention provides a compound of formula I:
Patent expiration dates:
- August 23, 2026✓✓
- August 23, 2026
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Use of an adrenal hormone-modifying agent
Patent 9,434,754
Issued: September 6, 2016
Inventor(s): Hu Qi-Ying & Ksander Gary Michael & Meredith Erik & Monovich Lauren G & Papillon Julien & Schumacher Christoph
Assignee(s): Novartis AGThe present invention relates to a method of treating a disease or disorder characterized by increased stress hormone levels and/or decreased androgen hormone levels in a subject, comprising administering to the subject a therapeutically effective amount of a compound represented by formula (I):
Patent expiration dates:
- January 13, 2031✓
- January 13, 2031
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:
- March 6, 2025 - NEW CHEMICAL ENTITY
- March 6, 2027 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
More about Isturisa (osilodrostat)
- Check interactions
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- Imprints, shape & color data
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: adrenal corticosteroid inhibitors
- Breastfeeding
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Patient resources
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Related treatment guides
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.