NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 22 pharmaceutical companies such as ZYLA, SAGENT PHARMS INC, EPIC PHARMA LLC and others. It is marketed under 4 brand names, including SPRIX, KETOROLAC TROMETHAMINE, OMIDRIA and others. Available in 8 different strengths, such as 15.75MG/SPRAY, 15MG/ML, 30MG/ML and others, and administered through 5 routes including SPRAY, METERED;NASAL, INJECTABLE;INJECTION, SOLUTION/DROPS;OPHTHALMIC and others.
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Licensing: 22 potential partnersUS Launch window: Loading launch window...
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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":"70378","ingredient":"KETOROLAC TROMETHAMINE","trade_name":"ACULAR LS","family_id":"4b0d63c3ff864879ad20","publication_number":"US8008338B2","cleaned_patent_number":"8008338","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-24","publication_date":"2011-08-30","legal_status":"Patented case"} | US8008338B2 | 30 Aug, 2011 | Patented case | 24 Nov, 2027 | |
| {"application_id":"70458","ingredient":"KETOROLAC TROMETHAMINE","trade_name":"ACUVAIL","family_id":"e3dda2af0e4c46e7869c","publication_number":"US8512717B2","cleaned_patent_number":"8512717","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-03-07","publication_date":"2013-08-20","legal_status":"Granted"} | US8512717B2 Formulation | 20 Aug, 2013 | Granted | 07 Mar, 2028 | |
| {"application_id":"70435","ingredient":"KETOROLAC TROMETHAMINE","trade_name":"ACUVAIL","family_id":"37d35b0676d140d49590","publication_number":"US9192571B2","cleaned_patent_number":"9192571","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-03-07","publication_date":"2015-11-24","legal_status":"Granted"} | US9192571B2 Formulation | 24 Nov, 2015 | Granted | 07 Mar, 2028 | |
| {"application_id":"70393","ingredient":"KETOROLAC TROMETHAMINE","trade_name":"ACUVAIL","family_id":"37d35b0676d140d49590","publication_number":"US7842714B2","cleaned_patent_number":"7842714","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-15","publication_date":"2010-11-30","legal_status":"Granted"} | US7842714B2 Molecular Formulation | 30 Nov, 2010 | Granted | 15 Aug, 2029 | |
| {"application_id":"2437","ingredient":"KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE","trade_name":"OMIDRIA","family_id":"278e3acd62c14517a5fc","publication_number":"US9855246B2","cleaned_patent_number":"9855246","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-10-23","publication_date":"2018-01-02","legal_status":"Granted"} | US9855246B2 Formulation | 02 Jan, 2018 | Granted | 23 Oct, 2033 | |
| {"application_id":"2441","ingredient":"KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE","trade_name":"OMIDRIA","family_id":"278e3acd62c14517a5fc","publication_number":"US9066856B2","cleaned_patent_number":"9066856","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-23","publication_date":"2015-06-30","legal_status":"Granted"} | US9066856B2 | 30 Jun, 2015 | Granted | 23 Apr, 2034 | |
| {"application_id":"2444","ingredient":"KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE","trade_name":"OMIDRIA","family_id":"278e3acd62c14517a5fc","publication_number":"US9486406B2","cleaned_patent_number":"9486406","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-23","publication_date":"2016-11-08","legal_status":"Granted"} | US9486406B2 | 08 Nov, 2016 | Granted | 23 Apr, 2034 |
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.