PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - Generic Drug Details

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What are the generic sources for phentermine hydrochloride; topiramate and what is the scope of freedom to operate?

Phentermine hydrochloride; topiramate is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc and Vivus Llc, and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride; topiramate has forty patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

International Patents:	40
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	25
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	Early Phase 1
University of Minnesota	Phase 3
University of Florida	Phase 3

See all PHENTERMINE HYDROCHLORIDE; TOPIRAMATE clinical trials

Pharmacology for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

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

Anatomical Therapeutic Chemical (ATC) Classes for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QSYMIA	Extended-release Capsules	phentermine hydrochloride; topiramate	3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg	022580	1	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 Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982-001	Jun 25, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	⤷ Sign Up	⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	⤷ Sign Up	⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	⤷ Sign Up	⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	⤷ Sign Up	⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	⤷ Sign Up	⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	⤷ Sign Up	⤷ Sign Up
>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	Title	Estimated Expiration
South Korea	20110042280	LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSITION AND METHODS OF USE THEREOF	⤷ Sign Up
South Africa	201008840	ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY	⤷ Sign Up
Spain	2606041		⤷ Sign Up
Mexico	2010013505	REGIMEN DE DOSIFICACION ESCALANTE PARA EFECTUAR LA PERDIDA DE PESO Y EL TRATAMIENTO DE OBESIDAD. (ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY.)	⤷ Sign Up
Chile	2010001365	Uso de fentermina en combinacion con topiramato para tratar la obesidad mediante una reduccion de peso en una persona.	⤷ Sign Up
Chile	2010001366	Composicion farmaceutica de liberacion controlada que comprende topiramato, celulosa microcristalina y metilcelulosa; preparado farmaceutico que la comprende, util para tratar la obesidad, diabetes o una afeccion relacionada.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	CA 2021 00049	Denmark	⤷ Sign Up	PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
2317997	2190050-1	Sweden	⤷ Sign Up	PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
2317997	CR 2021 00049	Denmark	⤷ Sign Up	PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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