NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as ST RENATUS. It is marketed under 1 brand name, including KOVANAZE. Available in 1 different strength, such as 0.1MG/SPRAY;6MG/SPRAY, and administered through 1 route including SPRAY, METERED;NASAL.
API availability: Loading API feasibility...
Licensing: 1 potential partnersUS Launch window: Loading launch window...
Stay ahead with worldwide patent expiry and latest updates.
FDA approval history for this ingredient
Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.
Key expiration dates for US patents covering this ingredient
Stay ahead with worldwide patent expiry insights, market data, and research updates.
Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
|
|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"81076","ingredient":"OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE","trade_name":"KOVANAZE","family_id":"38e6ddb3590646e38cc1","publication_number":"US8580282B2","cleaned_patent_number":"8580282","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-02","publication_date":"2013-11-12","legal_status":"Granted"} | US8580282B2 Formulation | 12 Nov, 2013 | Granted | 02 Apr, 2030 | |
| {"application_id":"81054","ingredient":"OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE","trade_name":"KOVANAZE","family_id":"38e6ddb3590646e38cc1","publication_number":"US9308191B2","cleaned_patent_number":"9308191","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-02","publication_date":"2016-04-12","legal_status":"Granted"} | US9308191B2 Formulation | 12 Apr, 2016 | Granted | 02 Apr, 2030 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Oxymetazoline Hydrochloride; Tetracaine Hydrochloride
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.