What is the spiro building block patent for Risdiplam?
The spiro building block used in the synthesis of Risdiplam is covered by patent U.S. Patent 10,961,343 [1]. This patent, filed by Hoffmann-La Roche, claims the spiro compound and its use in the preparation of Risdiplam [1].
When does the Risdiplam spiro building block patent expire?
Patent U.S. 10,961,343 is set to expire on May 27, 2039 [1]. This provides a significant period of market exclusivity for the spiro building block's use in Risdiplam synthesis.
Who holds the patent for the Risdiplam spiro building block?
Hoffmann-La Roche, the pharmaceutical company that developed and markets Risdiplam (Evrysdi), holds U.S. Patent 10,961,343 [1]. DrugPatentWatch.com tracks such patent information [1].
Why are building block patents important for drugs like Risdiplam?
Patents on key chemical intermediates, such as the spiro building block for Risdiplam, can be a crucial part of a drug's overall intellectual property protection. These patents can prevent competitors from manufacturing essential components needed to produce the active pharmaceutical ingredient, even if the primary drug patent has expired or is challenged [1]. This strategy can extend market exclusivity beyond the expiration of the main drug patent.
Can generic versions of Risdiplam be made before this patent expires?
The ability for generic manufacturers to produce Risdiplam depends on multiple factors, including the expiry of the main drug patent and any other patents covering the drug substance and its manufacturing process. The patent on the spiro building block, U.S. Patent 10,961,343, is a significant component of this protection [1]. If this patent remains in force, it could prevent generic companies from producing Risdiplam even if other patents expire earlier.
How does Risdiplam work?
Risdiplam is a survival motor neuron 2 (SMN2) splicing modifier designed to treat spinal muscular atrophy (SMA). It increases the production of full-length SMN protein by altering the splicing of SMN2 pre-messenger RNA [2].
What is spinal muscular atrophy (SMA)?
Spinal muscular atrophy is a rare genetic neuromuscular disease that affects motor neurons in the spinal cord, leading to progressive muscle weakness and atrophy. It is characterized by the loss of motor neurons, which are essential for muscle control [3].
What are the risks associated with Risdiplam?
Common side effects of Risdiplam include upper respiratory tract infection, lower respiratory tract infection, pneumonia, and diarrhea [2].
Where can I find more information on drug patents like the one for Risdiplam's building block?
DrugPatentWatch.com provides detailed information on drug patents, including those related to active pharmaceutical ingredients and their intermediates, such as the spiro building block for Risdiplam [1].
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Sources:
1. DrugPatentWatch.com. U.S. Patent 10,961,343. https://drugpatentwatch.com/patents/us-10961343
2. Evrysdi Prescribing Information. https://www.gene.com/download/a0261552969117a6c85a80012908b130349921c8/evrysdiprescribinginformation.pdf
3. National Institute of Neurological Disorders and Stroke. Spinal Muscular Atrophy Fact Sheet. https://www.ninds.nih.gov/health-information/disorders/spinal-muscular-atrophy