NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 6 pharmaceutical companies such as AMNEAL, TEVA PHARMS USA INC, DR REDDYS and others. It is marketed under 1 brand name, including LUBIPROSTONE. Available in 2 different strengths, such as 8MCG, 24MCG, and administered through 1 route including CAPSULE;ORAL.
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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":"45807","ingredient":"LUBIPROSTONE","trade_name":"AMITIZA","family_id":"f4ecc2e0d71f41f9afee","publication_number":"US8748481B2","cleaned_patent_number":"8748481","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-09-01","publication_date":"2014-06-10","legal_status":"Granted"} | US8748481B2 | 10 Jun, 2014 | Granted | 01 Sep, 2025 | |
| {"application_id":"45854","ingredient":"LUBIPROSTONE","trade_name":"AMITIZA","family_id":"2aeccfbbcabf484992dd","publication_number":"US8338639B2","cleaned_patent_number":"8338639","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-23","publication_date":"2012-12-25","legal_status":"Granted"} | US8338639B2 Formulation | 25 Dec, 2012 | Granted | 23 Jan, 2027 | |
| {"application_id":"45855","ingredient":"LUBIPROSTONE","trade_name":"AMITIZA","family_id":"2aeccfbbcabf484992dd","publication_number":"US8779187B2","cleaned_patent_number":"8779187","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-23","publication_date":"2014-07-15","legal_status":"Granted"} | US8779187B2 Formulation | 15 Jul, 2014 | Granted | 23 Jan, 2027 | |
| {"application_id":"45837","ingredient":"LUBIPROSTONE","trade_name":"AMITIZA","family_id":"2aeccfbbcabf484992dd","publication_number":"US8026393B2","cleaned_patent_number":"8026393","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-25","publication_date":"2011-09-27","legal_status":"Granted"} | US8026393B2 Formulation | 27 Sep, 2011 | Granted | 25 Oct, 2027 |
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.