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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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
| 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 |
|---|---|---|---|
| Brazil | 122014030154 | ⤷ Sign Up | |
| Georgia, Republic of | P20115143 | COMBINATION OF AZELASTINE AND FLUTICASONE | ⤷ Sign Up |
| South Korea | 101301558 | ⤷ Sign Up | |
| Brazil | 0312128 | Formulação, produto farmacêutico, embalagem de pressão. mdi, pulverizador nasal, processos para preparar um produto farmacêutico e uma formulação e métodos para profilaxia ou tratamento em um mamìfero tal como um humano, de condições para as quais a administração de um ou mais anti-histamìnico e/ou um ou mais esteróides é indicada e para tratamento de irritação do distúrbios do nariz ou do olho e de distúrbios das vias aéreas | ⤷ Sign Up |
| Israel | 216931 | הרכב רוקחות המכיל אזלסטין ואסטר של מומטסון (Pharmaceutical formulation comprising azelastine and a mometasone ester) | ⤷ Sign Up |
| Portugal | 2075000 | ⤷ 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 | 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 |
| 1519731 | C01519731/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013 |
| 1519731 | C20130025 00090 | Estonia | ⤷ Sign Up | PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013 |
| 1519731 | C300740 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215 |
| 1519731 | CA 2013 00023 | Denmark | ⤷ Sign Up | PRODUCT NAME: AZELASTIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG EN FARMACEUTISK ACCEPTABEL ESTER AF FLUTICASON, HERUNDER AZELASTIN HYDROCHLORID OG FLUTICASON PROPIONAT; NAT. REG. NO/DATE: MT49785 20130219; FIRST REG. NO/DATE: SK 24/0055/13-S 20130215 |
| 1519731 | 92269 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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