AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE Drug Patent Profile
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Which patents cover Azelastine Hydrochloride And Fluticasone Propionate, and what generic alternatives are available?
Azelastine Hydrochloride And Fluticasone Propionate is a drug marketed by Apotex and Padagis Israel and is included in two NDAs.
The generic ingredient in AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE 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 And Fluticasone Propionate
A generic version of AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE was approved as azelastine hydrochloride; fluticasone propionate by APOTEX on April 28th, 2017.
Summary for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 15 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE? | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE excipients list |
| DailyMed Link: | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE at DailyMed |
Recent Clinical Trials for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zhongnan Hospital | Phase 4 |
| Wuhan Union Hospital, China | Phase 4 |
| Zheng Liu ENT | Phase 4 |
See all AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE clinical trials
Pharmacology for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
| Drug Class | Corticosteroid Histamine-1 Receptor Antagonist |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
US Patents and Regulatory Information for AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 207712-001 | Apr 28, 2017 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Padagis Israel | AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 208111-001 | Feb 18, 2021 | AB | RX | 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 |
