NDA (New Drug Application)
ANDA (Generic Application)
It is formulated by 8 pharmaceutical companies such as MYLAN ASI, TARO, AM REGENT and others. It is marketed under 2 brand names, including GRANISETRON HYDROCHLORIDE, SUSTOL. Available in 6 different strengths, such as EQ 1MG BASE/ML (EQ 1MG BASE/ML), EQ 4MG BASE/4ML (EQ 1MG BASE/ML), EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) and others, and administered through 4 routes including INJECTABLE;INJECTION, TABLET;ORAL, INJECTABLE;SUBCUTANEOUS and others.
Track protection status across key markets to assess launch feasibility.
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Licensing: 8 potential partnersUS Launch window: Loading launch window...
FDA approval history for this ingredient
Key expiration dates for US patents covering this ingredient
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":"56250","ingredient":"GRANISETRON","trade_name":"SANCUSO","family_id":"e4d9410192004356b6d7","publication_number":"US7608282B2","cleaned_patent_number":"7608282","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-01-22","publication_date":"2009-10-27","legal_status":"Granted"} | US7608282B2 Formulation | 27 Oct, 2009 | Granted | 22 Jan, 2025 |
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
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.