NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as MYLAN SPECIALITY LP, APOTEX, PADAGIS ISRAEL and others. It is marketed under 2 brand names, including DYMISTA, AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE. Available in 1 different strength, such as 0.137MG/SPRAY;0.05MG/SPRAY, and administered through 1 route including SPRAY, METERED;NASAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
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| {"application_id":"81025","ingredient":"AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE","trade_name":"DYMISTA","family_id":"b54faf89c8904bca8b65","publication_number":"US8168620B2","cleaned_patent_number":"8168620","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-08-24","publication_date":"2012-05-01","legal_status":"Granted"} | US8168620B2 | 01 May, 2012 | Granted | 24 Aug, 2026 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.