AZELASTINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Azelastine Hydrochloride, and when can generic versions of Azelastine Hydrochloride launch?
Azelastine Hydrochloride is a drug marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Sciegen Pharms Inc, Upsher Smith Labs, Zydus Pharms, and Apotex. and is included in twenty-eight NDAs.
The generic ingredient in AZELASTINE HYDROCHLORIDE 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 Azelastine Hydrochloride
A generic version of AZELASTINE HYDROCHLORIDE was approved as azelastine hydrochloride; fluticasone propionate by APOTEX on April 28th, 2017.
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Summary for AZELASTINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 28 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 46 |
| Patent Applications: | 1,692 |
| 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 |
|---|---|
| MEDA Pharma GmbH & Co. KG | Phase 2 |
| Sandoz | Phase 1 |
| Nanjing University of Chinese Medicine | N/A |
Pharmacology for AZELASTINE HYDROCHLORIDE
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for AZELASTINE HYDROCHLORIDE
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 208111-001 | Feb 18, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 216421-002 | May 29, 2024 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alembic | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209620-001 | Mar 20, 2019 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 091444-001 | Oct 24, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 202609-001 | Mar 17, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 078738-001 | Jun 21, 2010 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 210092-001 | Feb 25, 2020 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
