NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 37 pharmaceutical companies such as VIATRIS, WATSON LABS INC, CHARTWELL RX and others. It is marketed under 3 brand names, including REVATIO, SILDENAFIL CITRATE, LIQREV. Available in 6 different strengths, such as EQ 10MG BASE/ML, EQ 20MG BASE, EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML) and others, and administered through 4 routes including FOR SUSPENSION;ORAL, TABLET;ORAL, SOLUTION;INTRAVENOUS and others.
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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":"83200","ingredient":"SILDENAFIL CITRATE","trade_name":"LIQREV","family_id":"79f502b554734a40bd75","publication_number":"US11337979B2","cleaned_patent_number":"11337979","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2022-05-24","legal_status":"Granted"} | US11337979B2 Formulation | 24 May, 2022 | Granted | 24 Dec, 2038 | |
| {"application_id":"83201","ingredient":"SILDENAFIL CITRATE","trade_name":"LIQREV","family_id":"79f502b554734a40bd75","publication_number":"US11464778B2","cleaned_patent_number":"11464778","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2022-10-11","legal_status":"Granted"} | US11464778B2 Formulation | 11 Oct, 2022 | Granted | 24 Dec, 2038 | |
| {"application_id":"116357","ingredient":"SILDENAFIL CITRATE","trade_name":"LIQREV","family_id":"79f502b554734a40bd75","publication_number":"US11759468B2","cleaned_patent_number":"11759468","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2023-09-19","legal_status":"Patented case"} | US11759468B2 Formulation | 19 Sep, 2023 | Patented case | 24 Dec, 2038 | |
| {"application_id":"124064","ingredient":"SILDENAFIL CITRATE","trade_name":"LIQREV","family_id":"79f502b554734a40bd75","publication_number":"US12005062B2","cleaned_patent_number":"12005062","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2024-06-11","legal_status":"Granted"} | US12005062B2 Formulation | 11 Jun, 2024 | Granted | 24 Dec, 2038 | |
| {"application_id":"139404","ingredient":"SILDENAFIL CITRATE","trade_name":"LIQREV","family_id":"79f502b554734a40bd75","publication_number":"US12186321B2","cleaned_patent_number":"12186321","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-12-24","publication_date":"2025-01-07","legal_status":"Granted"} | US12186321B2 Formulation | 07 Jan, 2025 | Granted | 24 Dec, 2038 |
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.