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Last Updated: November 16, 2019

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EMFLAZA Drug Profile

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When do Emflaza patents expire, and when can generic versions of Emflaza launch?

Emflaza is a drug marketed by Ptc Therap and is included in two NDAs.

The generic ingredient in EMFLAZA is deflazacort. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the deflazacort profile page.

Drug patent expirations by year for EMFLAZA
Drug Prices for EMFLAZA

See drug prices for EMFLAZA

Generic Entry Opportunity Date for EMFLAZA
Generic Entry Dates for EMFLAZA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
NDA:
Dosage:
SUSPENSION;ORAL
Generic Entry Dates for EMFLAZA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EMFLAZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PTC TherapeuticsPhase 3

See all EMFLAZA clinical trials

Pharmacology for EMFLAZA
Synonyms for EMFLAZA
(11beta,16beta)-21-(Acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione
(11beta,16beta)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione
11b,21-Dihydroxy-2'-methyl-5'bH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 21-acetate
11beta,21-Dihydroxy-2'-methyl-5'betaH-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione 21-acetate
11beta,21-dihydroxy-2'-methyl-5'betaH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 2'-acetate
14484-47-0
2-((6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bH-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl acetate
2-((6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-2,4,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-1H-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl acetate
2-[(4aR,4bS,5S,6aS,6bS,9aR,10aS,10bS)-5-hydroxy-4a,6a,8-trimethyl-2-oxo-2,4a,4b,5,6,6a,9a,10,10a,10b,11,12-dodecahydro-6bH-naphtho[2',1':4,5]indeno[1,2-d][1,3]oxazol-6b-yl]-2-oxoethyl acetate
4'H-Pregna-1,4-dieno(16,17-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11beta,16beta)-
484D470
5'-beta-H-Pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 11-beta,21-dihydroxy-2'-methyl-, 21-acetate
5'H-Pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11beta,16beta)-
AB01274724_02
AB01274724-01
AB2000350
AC1L4PC6
ACN-043364
AKOS015895199
Azacort
BCP08474
C-22370
C25H31NO6
Calcort
CAS-14484-47-0
CC-26308
CCG-220817
CHEBI:135720
CHEMBL1201891
Cortax
Cortax;Decortil;Deflanil;Calcort
CS-2349
D03671
D4523
DB11921
Decortil
Deflan
Deflanil
DEFLAZACORT
Deflazacort (Calcort)
Deflazacort (USAN/INN)
Deflazacort [USAN:INN:BAN]
Deflazacort, >=98% (HPLC)
Deflazacort, United States Pharmacopeia (USP) Reference Standard
Deflazacortum
Deflazacortum [INN-Latin]
Dezacor
DL-458-IT
DL-458IT
DSSTox_CID_378
DSSTox_GSID_20378
DSSTox_RID_75552
DTXSID9020378
EINECS 238-483-7
Enzocort
Flantadin
GTPL9477
H894
HMS3714D15
HY-13609
KR5YZ6AE4B
KS-1158
L-5458
Lantadin
MDL 458
MDL-458
MFCD00866106
MolPort-003-846-170
NCGC00255189-01
NCGC00263521-01
Oxazacort
Pregna-1,4-diene-11,21-diol(17alpha,16alpha-d)2'-methyloxazoline-3,20-dione-21-acetate
pregna-1,4-diene-11beta,21-diol-3,20-dione[17alpha,16alpha-d]-2'-methyloxazoline 21-acetate
Q-101371
RL01810
s1888
SCHEMBL4018
Tox21_112506
Tox21_112506_1
Tox21_301415
UNII-KR5YZ6AE4B
Zamene
ZINC4212809

US Patents and Regulatory Information for EMFLAZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ptc Therap EMFLAZA deflazacort SUSPENSION;ORAL 208685-001 Feb 9, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-002 Feb 9, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-001 Feb 9, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-003 Feb 9, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-002 Feb 9, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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