Dymista Drug Patent Profile
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Which patents cover Dymista, and what generic alternatives are available?
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 | PI0312128 | formulação farmacêutica compreendendo azelastina e éster de fluticasona | ⤷ Try a Trial |
European Patent Office | 2072051 | Combinaison d'azélastine et de mométasone (Combination of azelastine and mometasone) | ⤷ Try a Trial |
Germany | 60327203 | ⤷ Try a Trial | |
Israel | 216932 | הרכב רוקחות המכיל אזלסטין וציקלזוניד ושיטה לייצור תרופה לטיפול באלרגיה תקופתית המכילה הרכב זה (Pharmaceutical formulation that comprises azelastine and ciclesonide and a method for manufacturing a medicanment for treating seasonal allergy comprising said formulation) | ⤷ Try a Trial |
United Kingdom | 0213739 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 03105856 | ⤷ Try a Trial | |
South Africa | 200500331 | 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 | 122013000059 | Germany | ⤷ Try a Trial | PRODUCT NAME: AZELASTIN ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON UND EIN PHARMAZEUTISCH UNBEDENKLICHER ESTER VON FLUTICASON; NAT. REGISTRATION NO/DATE: 85237.00.00 20130318; FIRST REGISTRATION: SLOWAKEI 24/0055/13-S 20130215 |
1519731 | C01519731/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013 |
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 |
1519731 | C300740 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215 |
1519731 | C20130025 00090 | Estonia | ⤷ Try a Trial | PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013 |
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 |
1519731 | PA2013023 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |