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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 75 |
| Clinical Trials: | 2 |
| Patent Applications: | 6,337 |
| Drug Prices: | Drug price information for EMFLAZA |
| What excipients (inactive ingredients) are in EMFLAZA? | EMFLAZA excipients list |
| DailyMed Link: | EMFLAZA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| PTC Therapeutics | Phase 3 |
Pharmacology for EMFLAZA
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for EMFLAZA
US Patents and Regulatory Information for EMFLAZA
EMFLAZA is protected by zero US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EMFLAZA is ⤷ Try a Trial.
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: ⤷ Try a Trial
TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ptc Therap | EMFLAZA | deflazacort | TABLET;ORAL | 208684-003 | Feb 9, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ptc Therap | EMFLAZA | deflazacort | TABLET;ORAL | 208684-001 | Feb 9, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ptc Therap | EMFLAZA | deflazacort | TABLET;ORAL | 208684-003 | Feb 9, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ptc Therap | EMFLAZA | deflazacort | SUSPENSION;ORAL | 208685-001 | Feb 9, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
