NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 29 pharmaceutical companies such as AMNEAL PHARMS NY, ACTAVIS MID ATLANTIC, AUROBINDO PHARMA and others. It is marketed under 11 brand names, including CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE and others. Available in 7 different strengths, such as 5MG, 10MG, 5MG/5ML and others, and administered through 8 routes including TABLET;ORAL, SOLUTION;ORAL, TABLET, ORALLY DISINTEGRATING;ORAL and others.
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Licensing: 29 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":"74921","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"QUZYTTIR","family_id":"49f07c823271443ba8fb","publication_number":"US9180090B2","cleaned_patent_number":"9180090","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-11","publication_date":"2015-11-10","legal_status":"Granted"} | US9180090B2 | 10 Nov, 2015 | Granted | 11 Feb, 2030 | |
| {"application_id":"74929","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"QUZYTTIR","family_id":"49f07c823271443ba8fb","publication_number":"US9119771B2","cleaned_patent_number":"9119771","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-11","publication_date":"2015-09-01","legal_status":"Granted"} | US9119771B2 | 01 Sep, 2015 | Granted | 11 Feb, 2030 | |
| {"application_id":"74928","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"QUZYTTIR","family_id":"49f07c823271443ba8fb","publication_number":"US8513259B2","cleaned_patent_number":"8513259","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-11","publication_date":"2013-08-20","legal_status":"Granted"} | US8513259B2 | 20 Aug, 2013 | Granted | 11 Feb, 2030 | |
| {"application_id":"74926","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"QUZYTTIR","family_id":"49f07c823271443ba8fb","publication_number":"US8263581B2","cleaned_patent_number":"8263581","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-28","publication_date":"2012-09-11","legal_status":"Granted"} | US8263581B2 | 11 Sep, 2012 | Granted | 28 Feb, 2030 | |
| {"application_id":"74927","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"QUZYTTIR","family_id":"49f07c823271443ba8fb","publication_number":"US8314083B2","cleaned_patent_number":"8314083","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-28","publication_date":"2012-11-20","legal_status":"Granted"} | US8314083B2 | 20 Nov, 2012 | Granted | 28 Feb, 2030 | |
| {"application_id":"71011","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"ZERVIATE","family_id":"b56ff6b18af54e4a83b0","publication_number":"US9750684B2","cleaned_patent_number":"9750684","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-15","publication_date":"2017-09-05","legal_status":"Granted"} | US9750684B2 Formulation | 05 Sep, 2017 | Granted | 15 Mar, 2030 | |
| {"application_id":"70991","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"ZERVIATE","family_id":"b56ff6b18af54e4a83b0","publication_number":"US9993471B2","cleaned_patent_number":"9993471","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-15","publication_date":"2018-06-12","legal_status":"Granted"} | US9993471B2 | 12 Jun, 2018 | Granted | 15 Mar, 2030 | |
| {"application_id":"71009","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"ZERVIATE","family_id":"b56ff6b18af54e4a83b0","publication_number":"US8829005B2","cleaned_patent_number":"8829005","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-09-15","publication_date":"2014-09-09","legal_status":"Granted"} | US8829005B2 | 09 Sep, 2014 | Granted | 15 Sep, 2030 | |
| {"application_id":"71010","ingredient":"CETIRIZINE HYDROCHLORIDE","trade_name":"ZERVIATE","family_id":"b56ff6b18af54e4a83b0","publication_number":"US9254286B2","cleaned_patent_number":"9254286","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-09","publication_date":"2016-02-09","legal_status":"Granted"} | US9254286B2 | 09 Feb, 2016 | Granted | 09 Jan, 2033 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.