NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as ALNYLAM PHARMS INC. It is marketed under 1 brand name, including GIVLAARI. Available in 1 different strength, such as EQ 189MG BASE/ML (EQ 189MG BASE/ML), and administered through 1 route including SOLUTION;SUBCUTANEOUS.
API availability: Loading API feasibility...
Licensing: 1 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":"74496","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"5514892e6c74497cb0e7","publication_number":"US9150605B2","cleaned_patent_number":"9150605","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-08-28","publication_date":"2015-10-06","legal_status":"Granted"} | US9150605B2 Molecular Formulation | 06 Oct, 2015 | Granted | 28 Aug, 2025 | |
| {"application_id":"77231","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"5b7c622bdfe347008dc9","publication_number":"US10131907B2","cleaned_patent_number":"10131907","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-24","publication_date":"2018-11-20","legal_status":"Granted"} | US10131907B2 Molecular Formulation | 20 Nov, 2018 | Granted | 24 Aug, 2028 | |
| {"application_id":"77210","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"b5231ff2f0c14a999e1d","publication_number":"US8828956B2","cleaned_patent_number":"8828956","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-04","publication_date":"2014-09-09","legal_status":"Granted"} | US8828956B2 Molecular Formulation | 09 Sep, 2014 | Granted | 04 Dec, 2028 | |
| {"application_id":"77207","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"b5231ff2f0c14a999e1d","publication_number":"US8106022B2","cleaned_patent_number":"8106022","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-12","publication_date":"2012-01-31","legal_status":"Granted"} | US8106022B2 Molecular Formulation | 31 Jan, 2012 | Granted | 12 Dec, 2029 | |
| {"application_id":"77549","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"e3199e36a2ef4fdc9661","publication_number":"US9631193B2","cleaned_patent_number":"9631193","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2017-04-25","legal_status":"Granted"} | US9631193B2 | 25 Apr, 2017 | Granted | 15 Mar, 2033 | |
| {"application_id":"77592","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"e3199e36a2ef4fdc9661","publication_number":"US10125364B2","cleaned_patent_number":"10125364","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-15","publication_date":"2018-11-13","legal_status":"Granted"} | US10125364B2 Molecular Formulation | 13 Nov, 2018 | Granted | 15 Mar, 2033 | |
| {"application_id":"77591","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"e3199e36a2ef4fdc9661","publication_number":"US9133461B2","cleaned_patent_number":"9133461","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-11-30","publication_date":"2015-09-15","legal_status":"Granted"} | US9133461B2 Molecular Formulation | 15 Sep, 2015 | Granted | 30 Nov, 2033 | |
| {"application_id":"77648","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"121fb80c58c34fdd89cb","publication_number":"US11028392B2","cleaned_patent_number":"11028392","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-03","publication_date":"2021-06-08","legal_status":"Granted"} | US11028392B2 Molecular Formulation | 08 Jun, 2021 | Granted | 03 Oct, 2034 | |
| {"application_id":"77601","ingredient":"GIVOSIRAN SODIUM","trade_name":"GIVLAARI","family_id":"121fb80c58c34fdd89cb","publication_number":"US10119143B2","cleaned_patent_number":"10119143","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-03","publication_date":"2018-11-06","legal_status":"Granted"} | US10119143B2 Molecular Formulation | 06 Nov, 2018 | Granted | 03 Oct, 2034 |
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 Givosiran Sodium
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.