Phentermine hydrochloride; topiramate - Generic Drug Details

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What are the generic drug sources for phentermine hydrochloride; topiramate and what is the scope of patent protection?

Phentermine hydrochloride; topiramate is the generic ingredient in one branded drug marketed by Vivus and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride; topiramate has sixty-four patent family members in nineteen countries.

There are seventeen drug master file entries for phentermine hydrochloride; topiramate. One supplier is listed for this compound.

Summary for phentermine hydrochloride; topiramate

International Patents:	64
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	17
Suppliers / Packagers:	1
Clinical Trials:	18
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for phentermine hydrochloride; topiramate
DailyMed Link:	phentermine hydrochloride; topiramate at DailyMed

Recent Clinical Trials for phentermine hydrochloride; topiramate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Minnesota	Phase 2
Jaime Moore, MD MPH	Phase 2
University of Colorado- Clinical and Translational Sciences Institute	Phase 2

See all phentermine hydrochloride; topiramate clinical trials

Recent Litigation for phentermine hydrochloride; topiramate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
VIVUS, INC. v. TEVA PHARMACEUTICALS USA, INC.	2015-04-15
VIVUS, INC. v. ACTAVIS LABORATORIES FL, INC.	2014-06-12

See all phentermine hydrochloride; topiramate litigation

Pharmacology for phentermine hydrochloride; topiramate

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors
Physiological Effect	Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
QSYMIA	CAPSULE, EXTENDED RELEASE;ORAL	phentermine hydrochloride; topiramate	022580	2013-07-18

US Patents and Regulatory Information for phentermine hydrochloride; topiramate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012		RX	Yes	No	Start Trial	Start Trial				Start Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012		RX	Yes	No	Start Trial	Start Trial				Start Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012		RX	Yes	No	Start Trial	Start Trial				Start Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for phentermine hydrochloride; topiramate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	Start Trial	Start Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	Start Trial	Start Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	Start Trial	Start Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for phentermine hydrochloride; topiramate

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Country	Patent Number	Estimated Expiration
Portugal	2317997	Start Trial
Japan	2011522897	Start Trial
Denmark	1187603	Start Trial
European Patent Office	1825851	Start Trial
South Korea	20110044847	Start Trial
>Country	>Patent Number	>Estimated Expiration

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