Question 1

Is there a generic for Deflazacort?

Accepted Answer

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Deflazacort, referencing the brand EMFLAZA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Deflazacort?

Accepted Answer

EMFLAZA (NDA 208685, PTC THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Deflazacort have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 5 marketing-exclusivity periods for Deflazacort. 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 4

What dosage forms of Deflazacort are approved?

Accepted Answer

Deflazacort is approved in the following dosage forms: suspension, tablet.

Product	Applicant	Application	TE	Approved
EMFLAZARLD	PTC THERAP	NDA 208685	AB	Feb 09, 2017
EMFLAZARLD×4	PTC THERAP	NDA 208684	AB	Feb 09, 2017

Product	Applicant	Application	TE	Approved
DEFLAZACORT	CARNEGIE	ANDA 220709	AB	May 28, 2026
DEFLAZACORT	SUN PHARM INDS INC	ANDA 219930	AB	Jan 27, 2026
DEFLAZACORT×4	AMNEAL	ANDA 217173	AB	Dec 12, 2025
DEFLAZACORT	ZYDUS LIFESCIENCES	ANDA 220042	AB	Oct 03, 2025
DEFLAZACORT	UPSHER SMITH LABS	ANDA 216992	AB	Aug 11, 2025
PYQUVI	AUCTA	ANDA 219417	AB	Jun 30, 2025
JAYTHARI×4	ZYDUS LIFESCIENCES	ANDA 219254	AB	Apr 08, 2025
DEFLAZACORT×4	SUN PHARM	ANDA 217741	AB	Mar 18, 2025
DEFLAZACORT×4	UPSHER SMITH LABS	ANDA 216720	AB	Nov 05, 2024
DEFLAZACORT	TRIS PHARMA INC	ANDA 217813	AB	Apr 25, 2024
DEFLAZACORT×4	AUROBINDO PHARMA LTD	ANDA 217123	AB	Feb 09, 2024

Deflazacort

Brand (NDA) products · suspension, tablet

Generic (ANDA) products (11)

Marketing exclusivity (5)

Listed patents

Deflazacort — frequently asked questions

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