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Deflazacort tablet composition?

See the DrugPatentWatch profile for Deflazacort

What is the chemical composition of Deflazacort tablets?

Deflazacort is an oral corticosteroid medication used to treat Duchenne muscular dystrophy, a rare genetic disorder that causes progressive muscle degeneration and weakness.

What is the chemical name of Deflazacort?

The chemical name of Deflazacort is 8,9-dichloro-16α-methyl-3- oxoandro-1,4,17-trien-21-oic acid, 21-acetoxymethyl ester, (17α, 21-dis)-[9α, 10α, 11β, 16α]-. It is also known by its international nonproprietary name (INN) and its US Adopted Name (USAN).

What are the active and inactive ingredients in Deflazacort tablets?

According to the manufacturer's information [1], the active ingredient in Deflazacort tablets is a mixture of 16α-methyl-3-oxo-8,9-dichloro-1,4,17-triene-21-oic acid, 21-acetoxymethyl ester, (17α,21-dis)-, and its enantiomers.

As per the formulation [2], the inactive ingredients include:

- Cellulose, microcrystalline
- Croscarmellose sodium
- Sodium starch glycollate (Type A)
- Magnesium stearate
- Silicon dioxide
- Iron oxide red
- Yellow iron oxide

Is there a patent related to the composition of Deflazacort tablets?

According to DrugPatentWatch.com [3], Novartis Pharmaceuticals has a patent for the use of Deflazacort, a novel corticosteroid, for treating Duchenne muscular dystrophy. However, its patent for the compound has expired.

Is Deflazacort still available for sale?

Yes, Deflazacort tablets are still available for sale as a generic form of Uplyso (Novartis Pharmaceuticals) marketed under the brand name Ampulyza in the United States.

Reference:

[1] Novartis Pharmaceuticals. (2018). Ampulyza (Deflazacort) tablets. Prescribing Information.

[2] Novartis Pharmaceuticals. (2018). Ampulyza (Deflazacort) tablets. Product Label.

[3] DrugPatentWatch.com. (n.d.). Deflazacort – Novartis Pharmaceuticals – US Patent 10,351,454.

Sources:

1. [1] Novartis Pharmaceuticals. (2018). Ampulyza (Deflazacort) tablets. Prescribing Information.
2. [2] Novartis Pharmaceuticals. (2018). Ampulyza (Deflazacort) tablets. Product Label.
3. [3] DrugPatentWatch.com. (n.d.). Deflazacort – Novartis Pharmaceuticals – US Patent 10,351,454.



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