NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as ALCON LABS INC, WATSON LABS INC, BAUSCH AND LOMB and others. It is marketed under 2 brand names, including SIMBRINZA, BRINZOLAMIDE. Available in 2 different strengths, such as 0.2%;1%, 1%, and administered through 1 route including SUSPENSION/DROPS;OPHTHALMIC.
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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 | |
|---|---|---|---|---|---|
| {"application_id":"82477","ingredient":"BRIMONIDINE TARTRATE; BRINZOLAMIDE","trade_name":"SIMBRINZA","family_id":"52a44241f2634eab83ec","publication_number":"US9421265B2","cleaned_patent_number":"9421265","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-17","publication_date":"2016-08-23","legal_status":"Granted"} | US9421265B2 Formulation | 23 Aug, 2016 | Granted | 17 Jun, 2030 | |
| {"application_id":"82520","ingredient":"BRIMONIDINE TARTRATE; BRINZOLAMIDE","trade_name":"SIMBRINZA","family_id":"52a44241f2634eab83ec","publication_number":"US9044484B2","cleaned_patent_number":"9044484","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-10-30","publication_date":"2015-06-02","legal_status":"Granted"} | US9044484B2 Formulation | 02 Jun, 2015 | Granted | 30 Oct, 2030 |
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.