Phentermine Hydrochloride; Topiramate Global Patent Coverage & Expiry Overview

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It is formulated by 3 pharmaceutical companies such as VIVUS LLC, ACTAVIS LABS FL INC, DR REDDYS LABS SA. It is marketed under 2 brand names, including QSYMIA, PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE. Available in 4 different strengths, such as EQ 15MG BASE;92MG, EQ 11.25MG BASE;69MG, EQ 7.5MG BASE;46MG and others, and administered through 1 route including CAPSULE, EXTENDED RELEASE;ORAL.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength	Route of Administration	Companies	Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

	Patent Number	Publication Date	Legal Status	Patent Expiry Date
{"application_id":"44712","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8895057B2","cleaned_patent_number":"8895057","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2014-11-25","legal_status":"Granted"}	US8895057B2	25 Nov, 2014	Granted	09 Jun, 2028
{"application_id":"44747","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8895058B2","cleaned_patent_number":"8895058","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2014-11-25","legal_status":"Granted"}	US8895058B2 Formulation	25 Nov, 2014	Granted	09 Jun, 2028
{"application_id":"44748","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US9011905B2","cleaned_patent_number":"9011905","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2015-04-21","legal_status":"Granted"}	US9011905B2 Formulation	21 Apr, 2015	Granted	09 Jun, 2028
{"application_id":"44749","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US9011906B2","cleaned_patent_number":"9011906","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-09","publication_date":"2015-04-21","legal_status":"Granted"}	US9011906B2	21 Apr, 2015	Granted	09 Jun, 2028
{"application_id":"44745","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8580298B2","cleaned_patent_number":"8580298","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-15","publication_date":"2013-11-12","legal_status":"Granted"}	US8580298B2 Formulation	12 Nov, 2013	Granted	15 May, 2029
{"application_id":"44746","ingredient":"PHENTERMINE HYDROCHLORIDE; TOPIRAMATE","trade_name":"QSYMIA","family_id":"3be4f2e622cd42bcbd3d","publication_number":"US8580299B2","cleaned_patent_number":"8580299","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-14","publication_date":"2013-11-12","legal_status":"Granted"}	US8580299B2	12 Nov, 2013	Granted	14 Jun, 2029

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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.