NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 12 pharmaceutical companies such as HIKMA INTL PHARMS, EUGIA PHARMA, GLENMARK PHARMS LTD and others. It is marketed under 4 brand names, including NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE and others. Available in 5 different strengths, such as 40MG/200ML (0.2MG/ML), 20MG/200ML (0.1MG/ML), 25MG/10ML (2.5MG/ML) and others, and administered through 3 routes including INJECTABLE;INTRAVENOUS, INJECTABLE;INJECTION, CAPSULE;ORAL.
API availability: Loading API feasibility...
Licensing: 12 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":"61616","ingredient":"NICARDIPINE HYDROCHLORIDE","trade_name":"CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER","family_id":"f707322712f344b596f2","publication_number":"US10758616B2","cleaned_patent_number":"10758616","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-18","publication_date":"2020-09-01","legal_status":"Granted"} | US10758616B2 Formulation | 01 Sep, 2020 | Granted | 18 Apr, 2027 | |
| {"application_id":"61621","ingredient":"NICARDIPINE HYDROCHLORIDE","trade_name":"CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER","family_id":"f707322712f344b596f2","publication_number":"US11547758B2","cleaned_patent_number":"11547758","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-18","publication_date":"2023-01-10","legal_status":"Granted"} | US11547758B2 | 10 Jan, 2023 | Granted | 18 Apr, 2027 | |
| {"application_id":"61612","ingredient":"NICARDIPINE HYDROCHLORIDE","trade_name":"CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER","family_id":"f707322712f344b596f2","publication_number":"US7659291B2","cleaned_patent_number":"7659291","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-18","publication_date":"2010-02-09","legal_status":"Granted"} | US7659291B2 | 09 Feb, 2010 | Granted | 18 Apr, 2027 | |
| {"application_id":"61588","ingredient":"NICARDIPINE HYDROCHLORIDE","trade_name":"CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER","family_id":"f707322712f344b596f2","publication_number":"US8455524B2","cleaned_patent_number":"8455524","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-18","publication_date":"2013-06-04","legal_status":"Granted"} | US8455524B2 | 04 Jun, 2013 | Granted | 18 Apr, 2027 | |
| {"application_id":"61610","ingredient":"NICARDIPINE HYDROCHLORIDE","trade_name":"CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER","family_id":"f707322712f344b596f2","publication_number":"US7612102B2","cleaned_patent_number":"7612102","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-26","publication_date":"2009-11-03","legal_status":"Patented case"} | US7612102B2 Formulation | 03 Nov, 2009 | Patented case | 26 Dec, 2027 | |
| {"application_id":"61613","ingredient":"NICARDIPINE HYDROCHLORIDE","trade_name":"CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER","family_id":"f707322712f344b596f2","publication_number":"US9364564B2","cleaned_patent_number":"9364564","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-26","publication_date":"2016-06-14","legal_status":"Patented case"} | US9364564B2 Formulation | 14 Jun, 2016 | Patented case | 26 Dec, 2027 |
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 Nicardipine Hydrochloride
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.