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Last Updated: June 29, 2022

EMFLAZA Drug Patent Profile


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Which patents cover Emflaza, 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. One supplier is listed for this compound. Additional details are available on the deflazacort profile page.

Summary for EMFLAZA
Drug patent expirations by year for EMFLAZA
Drug Prices for EMFLAZA

See drug prices for EMFLAZA

DrugPatentWatch® Estimated 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

US Patents and Regulatory Information for EMFLAZA

EMFLAZA is protected by zero US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EMFLAZA is See Plans and Pricing.

This potential generic entry date is based on TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting EMFLAZA

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-002 Feb 9, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-001 Feb 9, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-003 Feb 9, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ptc Therap EMFLAZA deflazacort TABLET;ORAL 208684-002 Feb 9, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Boehringer Ingelheim
Express Scripts
Medtronic
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.