ASTEPRO Drug Patent Profile
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When do Astepro patents expire, and what generic alternatives are available?
Astepro is a drug marketed by Mylan Speciality Lp and Bayer Hlthcare and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has fifty patent family members in twenty-four countries.
The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Astepro
A generic version of ASTEPRO was approved as azelastine hydrochloride by APOTEX INC on April 30th, 2009.
Summary for ASTEPRO
International Patents: | 50 |
US Patents: | 3 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Clinical Trials: | 4 |
Patent Applications: | 1,793 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ASTEPRO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ASTEPRO |
DailyMed Link: | ASTEPRO at DailyMed |
Recent Clinical Trials for ASTEPRO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Meda Pharmaceuticals | Phase 4 |
Novella Clinical | Phase 4 |
Meda Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ASTEPRO
Paragraph IV (Patent) Challenges for ASTEPRO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ASTEPRO | Nasal Spray | azelastine hydrochloride | 205.5 mcg/spray | 022203 | 2011-12-15 |
US Patents and Regulatory Information for ASTEPRO
ASTEPRO is protected by three US patents.
Patents protecting ASTEPRO
Compositions comprising azelastine and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions comprising azelastine and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
Compositions comprising azelastine
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 | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-001 | Oct 15, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-001 | Jun 17, 2021 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-002 | Aug 31, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-001 | Jun 17, 2021 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-001 | Oct 15, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-002 | Aug 31, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
International Patents for ASTEPRO
See the table below for patents covering ASTEPRO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2486942 | ⤷ Try a Trial | |
Israel | 238308 | תכשירי רוקחות המכילים אזלאסטין (Pharmaceutical compositions containing azelastine) | ⤷ Try a Trial |
Spain | 2704482 | ⤷ Try a Trial | |
Portugal | 2377557 | ⤷ Try a Trial | |
South Korea | 20180030953 | 아젤라스틴을 포함하는 조성물 및 이의 사용 방법 (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF) | ⤷ Try a Trial |
Poland | 2522365 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ASTEPRO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 | 92269 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
1519731 | C300740 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |