NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 19 pharmaceutical companies such as EXTROVIS, RISING, WATSON LABS INC and others. It is marketed under 5 brand names, including LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE, GLYDO and others. Available in 5 different strengths, such as 2%, 0.5%, 1% and others, and administered through 4 routes including INJECTABLE;INJECTION, JELLY;TOPICAL, SOLUTION;TOPICAL and others.
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Licensing: 19 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":"59233","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"AKTEN","family_id":"eddcba920fe94c16a162","publication_number":"US8759401B2","cleaned_patent_number":"8759401","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-24","publication_date":"2014-06-24","legal_status":"Granted"} | US8759401B2 Formulation | 24 Jun, 2014 | Granted | 24 Jul, 2026 | |
| {"application_id":"83372","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"ZINGO","family_id":"40f9db0f3eab41449845","publication_number":"US8540665B2","cleaned_patent_number":"8540665","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-22","publication_date":"2013-09-24","legal_status":"Granted"} | US8540665B2 | 24 Sep, 2013 | Granted | 22 Oct, 2029 | |
| {"application_id":"83368","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"ZINGO","family_id":"40f9db0f3eab41449845","publication_number":"US9358338B2","cleaned_patent_number":"9358338","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-27","publication_date":"2016-06-07","legal_status":"Granted"} | US9358338B2 | 07 Jun, 2016 | Granted | 27 Apr, 2035 | |
| {"application_id":"83352","ingredient":"LIDOCAINE HYDROCHLORIDE","trade_name":"ZINGO","family_id":"7e5dfad5562f4813ba3c","publication_number":"US9370622B2","cleaned_patent_number":"9370622","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-09-28","publication_date":"2016-06-21","legal_status":"Expired"} | US9370622B2 | 21 Jun, 2016 | Expired | 28 Sep, 2035 |
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.