Azelastine hydrochloride - Generic Drug Details
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What are the generic sources for azelastine hydrochloride and what is the scope of patent protection?
Azelastine hydrochloride
is the generic ingredient in eight branded drugs marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, Mylan Speciality Lp, Mylan Spclt Viatris, Bayer Hlthcare, Akorn, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in thirty NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Azelastine hydrochloride has fifty patent family members in twenty-four countries.
There are nine drug master file entries for azelastine hydrochloride. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for azelastine hydrochloride
International Patents: | 50 |
US Patents: | 5 |
Tradenames: | 8 |
Applicants: | 20 |
NDAs: | 30 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Clinical Trials: | 43 |
Patent Applications: | 3,210 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for azelastine hydrochloride |
What excipients (inactive ingredients) are in azelastine hydrochloride? | azelastine hydrochloride excipients list |
DailyMed Link: | azelastine hydrochloride at DailyMed |
Recent Clinical Trials for azelastine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sandoz | Phase 1 |
Johanna Maria Vermeulen | N/A |
Nanjing University of Chinese Medicine | N/A |
Generic filers with tentative approvals for AZELASTINE HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 205.5MCG | SPRAY;NASAL |
⤷ Try a Trial | ⤷ Try a Trial | 205.5MCG | SPRAY;NASAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for azelastine hydrochloride
Drug Class | Histamine-1 Receptor Antagonist |
Mechanism of Action | Histamine H1 Receptor Antagonists |
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CHILDREN'S ASTEPRO ALLERGY | Nasal Spray | azelastine hydrochloride | 205.5 mcg/spray | 213872 | 1 | 2021-07-12 |
ASTEPRO | Nasal Spray | azelastine hydrochloride | 205.5 mcg/spray | 022203 | 2011-12-15 | |
OPTIVAR | Ophthalmic Solution | azelastine hydrochloride | 0.05% | 021127 | 1 | 2006-12-13 |
ASTELIN | Nasal Spray | azelastine hydrochloride | 0.125 mg base/spray | 020114 | 1 | 2005-11-14 |
US Patents and Regulatory Information for azelastine hydrochloride
Expired US Patents for azelastine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Spclt Viatris | ASTELIN | azelastine hydrochloride | SPRAY, METERED;NASAL | 020114-001 | Nov 1, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for azelastine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006058022 | ⤷ Try a Trial | |
South Korea | 20070104884 | COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF | ⤷ Try a Trial |
Hungary | E030388 | ⤷ Try a Trial | |
European Patent Office | 2522365 | Compositions comprenant de l'azélastine et leurs procédés d'utilisation (Compositions comprising azelastine and methods of use thereof) | ⤷ Try a Trial |
Turkey | 201820559 | ⤷ Try a Trial | |
Hungary | E031470 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for azelastine hydrochloride
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 | C300740 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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