NDA (New Drug Application)
ANDA (Generic Application)
It is formulated by 21 pharmaceutical companies such as SYNTHON BV, GLENMARK PHARMS LTD, DR REDDYS LABS LTD and others. It is marketed under 3 brand names, including LEVOCETIRIZINE DIHYDROCHLORIDE, XYZAL ALLERGY 24HR, LEVOCETIRIZINE HYDROCHLORIDE. Available in 2 different strengths, such as 5MG, 2.5MG/5ML, and administered through 2 routes including TABLET;ORAL, SOLUTION;ORAL.
Track protection status across key markets to assess launch feasibility.
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Licensing: 21 potential partnersUS Launch window: Loading launch window...
FDA approval history for this ingredient
Key expiration dates for US patents covering this ingredient
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":"77116","ingredient":"LEVOCETIRIZINE DIHYDROCHLORIDE","trade_name":"XYZAL ALLERGY 24HR","family_id":"880943cf7d164d19b463","publication_number":"US8633194B2","cleaned_patent_number":"8633194","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-16","publication_date":"2014-01-21","legal_status":"Granted"} | US8633194B2 Formulation | 21 Jan, 2014 | Granted | 16 Oct, 2027 |
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
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.