NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 11 pharmaceutical companies such as JANSSEN PRODS, TEVA PHARMS USA, LUPIN LTD and others. It is marketed under 4 brand names, including PREZISTA, PREZCOBIX, DARUNAVIR and others. Available in 7 different strengths, such as 100MG/ML, 800MG, 150MG;EQ 800MG BASE and others, and administered through 2 routes including SUSPENSION;ORAL, TABLET;ORAL.
API availability: Loading API feasibility...
Licensing: 11 potential partnersUS Launch window: Loading launch window...
Stay ahead with worldwide patent expiry and latest updates.
FDA approval history for this ingredient
Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.
Key expiration dates for US patents covering this ingredient
Stay ahead with worldwide patent expiry insights, market data, and research updates.
Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
|
|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"37519","ingredient":"COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"SYMTUZA","family_id":"0602d214c76a4d1d9d0b","publication_number":"US7390791B2","cleaned_patent_number":"7390791","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-04-17","publication_date":"2008-06-24","legal_status":"Expired"} | US7390791B2 Molecular Formulation | 24 Jun, 2008 | Expired | 17 Apr, 2025 | |
| {"application_id":"83141","ingredient":"COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"PREZCOBIX","family_id":"0509b810d9e84987b041","publication_number":"US7700645B2","cleaned_patent_number":"7700645","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-26","publication_date":"2010-04-20","legal_status":"Granted"} | US7700645B2 | 20 Apr, 2010 | Granted | 26 Jun, 2027 | |
| {"application_id":"93342","ingredient":"COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"PREZCOBIX","family_id":"d62e2198e4184de59f06","publication_number":"US8148374B2","cleaned_patent_number":"8148374","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-03","publication_date":"2012-04-03","legal_status":"Court proceedings terminated"} | US8148374B2 Molecular Formulation | 03 Apr, 2012 | Court proceedings terminated | 03 Sep, 2029 | |
| {"application_id":"91044","ingredient":"COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"SYMTUZA","family_id":"edf7e71302324e0ea5cb","publication_number":"US8754065B2","cleaned_patent_number":"8754065","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-15","publication_date":"2014-06-17","legal_status":"Granted"} | US8754065B2 Molecular Formulation | 17 Jun, 2014 | Granted | 15 Aug, 2032 | |
| {"application_id":"90997","ingredient":"COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"SYMTUZA","family_id":"edf7e71302324e0ea5cb","publication_number":"US9296769B2","cleaned_patent_number":"9296769","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-15","publication_date":"2016-03-29","legal_status":"Granted"} | US9296769B2 Molecular Formulation | 29 Mar, 2016 | Granted | 15 Aug, 2032 | |
| {"application_id":"93538","ingredient":"COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"PREZCOBIX","family_id":"373fcc6058714641968b","publication_number":"US10039718B2","cleaned_patent_number":"10039718","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-10-06","publication_date":"2018-08-07","legal_status":"Granted"} | US10039718B2 Formulation | 07 Aug, 2018 | Granted | 06 Oct, 2032 | |
| {"application_id":"100029","ingredient":"COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"SYMTUZA","family_id":"a3189cee52ba4702bef7","publication_number":"US10786518B2","cleaned_patent_number":"10786518","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-19","publication_date":"2020-09-29","legal_status":"Granted"} | US10786518B2 | 29 Sep, 2020 | Granted | 19 Jul, 2038 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Darunavir
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.