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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	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	022580-001	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	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	022580-002	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	022580-004	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
Portugal	2317997		⤷ Sign Up
Mexico	342684	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
Canada	2727313	PROTOCOLE D'ADMINISTRATION DE DOSES CROISSANTES VISANT A UNE PERTE DE POIDS ET A UN TRAITEMENT DE L'OBESITE (ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY)	⤷ 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	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
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	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.