DYMISTA Drug Patent Profile
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Which patents cover Dymista, and when can generic versions of Dymista launch?
Dymista is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-seven patent family members in twenty-seven countries.
The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dymista
A generic version of DYMISTA was approved as azelastine hydrochloride; fluticasone propionate by APOTEX on April 28th, 2017.
Summary for DYMISTA
International Patents: | 57 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 12 |
Patent Applications: | 36 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DYMISTA |
Drug Sales Revenues: | Drug sales revenues for DYMISTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DYMISTA |
What excipients (inactive ingredients) are in DYMISTA? | DYMISTA excipients list |
DailyMed Link: | DYMISTA at DailyMed |
Recent Clinical Trials for DYMISTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
St. Paul's Sinus Centre | Phase 4 |
MEDA Pharma GmbH & Co. KG | Phase 4 |
MEDA Pharma GmbH & Co. KG | Phase 3 |
Pharmacology for DYMISTA
Drug Class | Corticosteroid Histamine-1 Receptor Antagonist |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DYMISTA
Paragraph IV (Patent) Challenges for DYMISTA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DYMISTA | Nasal Spray | azelastine hydrochloride; fluticasone propionate | 137 mcg/50 mcg per spray | 202236 | 1 | 2014-06-13 |
US Patents and Regulatory Information for DYMISTA
DYMISTA is protected by two US patents.
Patents protecting DYMISTA
Combination of azelastine and steroids
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Combination of azelastine and steroids
Patent Number: ⤷ Try a Trial
Patent 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
Expired US Patents for DYMISTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DYMISTA
See the table below for patents covering DYMISTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 122014030158 | formulação farmacêutica | ⤷ Try a Trial |
European Patent Office | 2072051 | Combinaison d'azélastine et de mométasone (Combination of azelastine and mometasone) | ⤷ Try a Trial |
Mexico | PA04012666 | COMBINACION DE AZELASTINA Y ESTEROIDES. (COMBINATION OF AZELASTINE AND STEROIDS.) | ⤷ Try a Trial |
Luxembourg | 92269 | ⤷ Try a Trial | |
China | 1674910 | Combination of azelastine and steroids | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DYMISTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1519731 | 40/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION AUS AZELASTINHYDROCHLORID UND FLUTICASONPROPRIONAT; NAT. REGISTRATION NO/DATE: 1-31812 20130226; FIRST REGISTRATION: SK 24/0055/13-S 20130215 |
1519731 | 175 5006-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215 |
1519731 | C01519731/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013 |
1519731 | 13C0067 | France | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
0316633 | 99C0012 | Belgium | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |