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.
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Questions you can ask:
- What is the 5 year forecast for DYMISTA?
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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: | 13 |
Patent Applications: | 36 |
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 |
---|---|
Humanis Saglık Anonim Sirketi | Phase 1 |
St. Paul's Sinus Centre | Phase 4 |
MEDA Pharma GmbH & Co. KG | Phase 4 |
Pharmacology for DYMISTA
Drug Class | Corticosteroid Histamine-1 Receptor Antagonist |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Combination of azelastine and steroids
Patent Number: ⤷ Sign Up
Patent 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Canada | 2779633 | ASSOCIATION D'AZELASTINE ET DE STEROIDES (COMBINATION OF AZELASTINE AND STEROIDS) | ⤷ Sign Up |
Hungary | S1300032 | ⤷ Sign Up | |
Denmark | 2075000 | ⤷ Sign Up | |
Portugal | 1519731 | ⤷ Sign Up | |
Russian Federation | 2005100781 | КОМБИНАЦИЯ АЗЕЛАСТИНА И СТЕРОИДОВ | ⤷ Sign Up |
Luxembourg | 92269 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DYMISTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1519731 | 175 5006-2013 | Slovakia | ⤷ Sign Up | PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215 |
0316633 | 99C0012 | Belgium | ⤷ Sign Up | PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218 |
1519731 | C300740 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215 |
1519731 | 1390033-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215 |
1519731 | 132013902182575 | Italy | ⤷ Sign Up | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
1519731 | 13C0067 | France | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |