MedPath

Regadenoson

Generic Name
Regadenoson
Brand Names
Lexiscan, Rapiscan
Drug Type
Small Molecule
Chemical Formula
C15H18N8O5
CAS Number
313348-27-5
Unique Ingredient Identifier
7AXV542LZ4
Background

Regadenoson is an A2A adenosine receptor agonist that causes coronary vasodilation and used for myocardial perfusion imagining. Manufactured by Astellas and FDA approved April 10, 2008.

Indication

Diagnostic agent for radionuclide myocardial perfusion imaging (MPI)

Indies Pharma Secures FDA Approval for Generic Regadenoson, Targeting $400M Market

• Indies Pharma Jamaica has received FDA approval for its generic drug, Regadenoson, marking a historic milestone as the first Jamaican company to achieve this feat. • The approval unlocks access to a substantial US$400 million market, positioning Indies Pharma among the top players in the United States for this medication. • Generic Regadenoson is bioequivalent to Astellas Pharma's Lexiscan, offering a cost-effective alternative for patients undergoing cardiac stress tests. • Indies Pharma anticipates significant revenue growth, projecting a potential doubling of sales and aiming for $2-3 billion in revenue by FY2025.

Astellas Faces Setback as US Court Invalidates Key Myrbetriq Patent

• A Delaware district court has invalidated Astellas' key patent for Myrbetriq (mirabegron), their blockbuster overactive bladder medication that generated $1.35 billion in revenue last fiscal year. • Multiple generic versions of mirabegron have received approval, including from Zydus Cadila and Lupin Labs, though immediate launches are unlikely due to Astellas' planned appeal. • The patent invalidation adds to Astellas' upcoming revenue challenges, including recent Lexiscan generic competition and the anticipated 2027 US patent expiration of their top-selling drug Xtandi.
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