NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 24 pharmaceutical companies such as CHIESI, VIATRIS, TEVA PHARMS USA and others. It is marketed under 7 brand names, including BETHKIS, TOBI PODHALER, TOBRAMYCIN and others. Available in 8 different strengths, such as 300MG/4ML, 28MG, 300MG/5ML and others, and administered through 5 routes including SOLUTION;INHALATION, POWDER;INHALATION, INJECTABLE;INJECTION and others.
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Licensing: 24 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":"66018","ingredient":"TOBRAMYCIN","trade_name":"TOBI PODHALER","family_id":"0497397bc27c40db93f7","publication_number":"US8664187B2","cleaned_patent_number":"8664187","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-20","publication_date":"2014-03-04","legal_status":"Granted"} | US8664187B2 | 04 Mar, 2014 | Granted | 20 Jun, 2025 | |
| {"application_id":"66090","ingredient":"TOBRAMYCIN","trade_name":"TOBI PODHALER","family_id":"22d2ed20a2a748578508","publication_number":"US7559325B2","cleaned_patent_number":"7559325","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-27","publication_date":"2009-07-14","legal_status":"Granted"} | US7559325B2 Formulation | 14 Jul, 2009 | Granted | 27 Oct, 2025 | |
| {"application_id":"82526","ingredient":"DEXAMETHASONE; TOBRAMYCIN","trade_name":"TOBRADEX ST","family_id":"5bf41f458b694641848e","publication_number":"US8101582B2","cleaned_patent_number":"8101582","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-19","publication_date":"2012-01-24","legal_status":"Granted"} | US8101582B2 Formulation | 24 Jan, 2012 | Granted | 19 Dec, 2027 | |
| {"application_id":"82528","ingredient":"DEXAMETHASONE; TOBRAMYCIN","trade_name":"TOBRADEX ST","family_id":"5bf41f458b694641848e","publication_number":"US8450287B2","cleaned_patent_number":"8450287","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-19","publication_date":"2013-05-28","legal_status":"Granted"} | US8450287B2 Formulation | 28 May, 2013 | Granted | 19 Dec, 2027 | |
| {"application_id":"82527","ingredient":"DEXAMETHASONE; TOBRAMYCIN","trade_name":"TOBRADEX ST","family_id":"5bf41f458b694641848e","publication_number":"US7795316B1","cleaned_patent_number":"7795316","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-03","publication_date":"2010-09-14","legal_status":"Patented case"} | US7795316B2 Formulation | 14 Sep, 2010 | Patented case | 03 Aug, 2028 | |
| {"application_id":"66052","ingredient":"TOBRAMYCIN","trade_name":"TOBI PODHALER","family_id":"ad7fb35481704515ac3a","publication_number":"US8869794B1","cleaned_patent_number":"8869794","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-12","publication_date":"2014-10-28","legal_status":"Granted"} | US8869794B2 Formulation | 28 Oct, 2014 | Granted | 12 Sep, 2028 | |
| {"application_id":"66073","ingredient":"TOBRAMYCIN","trade_name":"TOBI PODHALER","family_id":"e07c97bf04a940e6bf2c","publication_number":"US10207066B2","cleaned_patent_number":"10207066","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-04","publication_date":"2019-02-19","legal_status":"Granted"} | US10207066B2 Formulation | 19 Feb, 2019 | Granted | 04 Nov, 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.