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. Three suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Emflaza
A generic version of EMFLAZA was approved as deflazacort by AUROBINDO PHARMA LTD on February 9th, 2024.
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Questions you can ask:
- What is the 5 year forecast for EMFLAZA?
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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: | 5,782 |
| Drug Prices: | Drug price information for EMFLAZA |
| What excipients (inactive ingredients) are in EMFLAZA? | EMFLAZA excipients list |
| DailyMed Link: | EMFLAZA at DailyMed |
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 |
US Patents and Regulatory Information for EMFLAZA
EMFLAZA is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting EMFLAZA
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
Exclusivity Expiration: ⤷ Sign Up
| 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 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ptc Therap | EMFLAZA | deflazacort | TABLET;ORAL | 208684-003 | Feb 9, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ptc Therap | EMFLAZA | deflazacort | TABLET;ORAL | 208684-001 | Feb 9, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
