NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 26 pharmaceutical companies such as HOSPIRA INC, TEVA PHARMS, FRESENIUS KABI USA and others. It is marketed under 3 brand names, including GEMCITABINE HYDROCHLORIDE, INFUGEM, AVGEMSI. Available in 23 different strengths, such as EQ 2GM BASE/VIAL, EQ 1GM BASE/VIAL, EQ 200MG BASE/VIAL and others, and administered through 2 routes including INJECTABLE;INJECTION, SOLUTION;INTRAVENOUS.
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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 | |
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| {"application_id":"73859","ingredient":"GEMCITABINE HYDROCHLORIDE","trade_name":"INFUGEM","family_id":"c47be9d2fa5246f5bb0e","publication_number":"US9241948B2","cleaned_patent_number":"9241948","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-01","publication_date":"2016-01-26","legal_status":"Granted"} | US9241948B2 Formulation | 26 Jan, 2016 | Granted | 01 Jul, 2033 |
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.