Is there a generic for Deflazacort?

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.

What is the reference-listed drug for Deflazacort?

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

Does Deflazacort have FDA marketing exclusivity?

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.

What dosage forms of Deflazacort are approved?

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

FDA Orange Book · active-ingredient family

Deflazacort

Deflazacort: 2 brands, 11 generics; first approved Feb 09, 2017; generic available.

Generic available5 exclusivity periods

Generic status & protection

Generic available — 11 ANDA applications approved.

Latest exclusivity ends Jun 07, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

EMFLAZARLDRS

PTC THERAPNDA 2086852017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.75MG/ML	SUSPENSION	ORAL	Rx	AB

EMFLAZARLD

PTC THERAPNDA 20868420174 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6MG	TABLET	ORAL	Rx	AB
18MG	TABLET	ORAL	Rx	AB
30MG	TABLET	ORAL	Rx	AB
36MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (11)

DEFLAZACORT

CARNEGIEANDA 2207092026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.75MG/ML	SUSPENSION	ORAL	Rx	AB

DEFLAZACORT

SUN PHARM INDS INCANDA 2199302026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.75MG/ML	SUSPENSION	ORAL	Rx	AB

DEFLAZACORT

AMNEALANDA 21717320254 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6MG	TABLET	ORAL	Rx	AB
18MG	TABLET	ORAL	Rx	AB
30MG	TABLET	ORAL	Rx	AB
36MG	TABLET	ORAL	Rx	AB

DEFLAZACORT

ZYDUS LIFESCIENCESANDA 2200422025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.75MG/ML	SUSPENSION	ORAL	Rx	AB

DEFLAZACORT

UPSHER SMITH LABSANDA 2169922025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.75MG/ML	SUSPENSION	ORAL	Rx	AB

PYQUVI

AUCTAANDA 2194172025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.75MG/ML	SUSPENSION	ORAL	Rx	AB

JAYTHARI

ZYDUS LIFESCIENCESANDA 21925420254 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6MG	TABLET	ORAL	Rx	AB
18MG	TABLET	ORAL	Rx	AB
30MG	TABLET	ORAL	Rx	AB
36MG	TABLET	ORAL	Rx	AB

DEFLAZACORT

SUN PHARMANDA 21774120254 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6MG	TABLET	ORAL	Rx	AB
18MG	TABLET	ORAL	Rx	AB
30MG	TABLET	ORAL	Rx	AB
36MG	TABLET	ORAL	Rx	AB

DEFLAZACORT

UPSHER SMITH LABSANDA 21672020244 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6MG	TABLET	ORAL	Rx	AB
18MG	TABLET	ORAL	Rx	AB
30MG	TABLET	ORAL	Rx	AB
36MG	TABLET	ORAL	Rx	AB

DEFLAZACORT

TRIS PHARMA INCANDA 2178132024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
22.75MG/ML	SUSPENSION	ORAL	Rx	AB

DEFLAZACORT

AUROBINDO PHARMA LTDANDA 21712320244 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6MG	TABLET	ORAL	Rx	AB
18MG	TABLET	ORAL	Rx	AB
30MG	TABLET	ORAL	Rx	AB
36MG	TABLET	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (5)

ODE-252Orphan-drug exclusivity (7 years)
Jun 07, 2026
1 mo ago
ODE-252Orphan-drug exclusivity (7 years)
Jun 07, 2026
1 mo ago
ODE-252Orphan-drug exclusivity (7 years)
Jun 07, 2026
1 mo ago
ODE-252Orphan-drug exclusivity (7 years)
Jun 07, 2026
1 mo ago
ODE-252Orphan-drug exclusivity (7 years)
Jun 07, 2026
1 mo ago

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Feb 09, 2017

9 yr 7 mo ago

Most recent approval

May 28, 2026

1 mo ago

Approvals span 2017–2026 across 13 FDA applications.

Brand (NDA) 215%

Generic (ANDA) 1185%

Deflazacort — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo