Question 1

Is there a generic for Osilodrostat phosphate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Osilodrostat phosphate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Osilodrostat phosphate?

Accepted Answer

ISTURISA (NDA 212801, RECORDATI RARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Osilodrostat phosphate?

Accepted Answer

The Orange Book lists 6 patents against Osilodrostat phosphate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Osilodrostat phosphate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Osilodrostat phosphate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Osilodrostat phosphate are approved?

Accepted Answer

Osilodrostat phosphate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8835646	Aug 23, 2026	in 2 mo	SubstanceProduct
8609862	Jan 13, 2031	in 4 yr 8 mo	U-4177
9434754	Jan 13, 2031	in 4 yr 8 mo	Substance
8314097	May 20, 2033	in 7 yr	SubstanceProduct
10143680	Jul 06, 2035	in 9 yr 2 mo	Product
10709691	Oct 12, 2035	in 9 yr 5 mo	U-4177

Osilodrostat phosphate

Brand (NDA) products · tablet

Marketing exclusivity (6)

Listed patents (6)

Osilodrostat phosphate — frequently asked questions

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