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Last Updated: April 18, 2024

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 patent protection?

Phentermine hydrochloride; topiramate is the generic ingredient in one branded drug marketed by Vivus and is included in one NDA. 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:	1
Applicants:	1
NDAs:	1
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for phentermine hydrochloride; topiramate

Generic Entry Date for phentermine hydrochloride; topiramate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: NEW PATIENT POPULATION Dosage: CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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	022580-004	Jul 17, 2012	⤷ Try a Trial	⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	⤷ Try a Trial	⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	⤷ Try a Trial	⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	⤷ Try a Trial	⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	⤷ Try a Trial	⤷ Try a Trial
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	⤷ Try a Trial	⤷ Try a 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	Title	Estimated Expiration
Brazil	PI0914991	regime de doses crescentes para conseguir a perda de peso e tratar obesidade	⤷ Try a Trial
South Korea	20140121491	ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY	⤷ Try a Trial
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.)	⤷ Try a Trial
South Africa	201008839	LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSITION AND METHODS OF USE THEREOF	⤷ Try a Trial
Hong Kong	1213489	低劑量的托吡酯/苯丁胺組合物及其使用方法 (LOW DOSE TOPIRAMATE PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF)	⤷ Try a Trial
Japan	5752595		⤷ Try a Trial
>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	⤷ Try a Trial	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	CR 2021 00049	Denmark	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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