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 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*:
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
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 | 022580-003 | Jul 17, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | ||||
>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
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2015166380 | 体重減少の達成および肥満症の治療のための漸増用量投与計画(ESCALATINGDOSINGREGIMEN) (ESCALATING DOSING REGIMEN (ESCALATINGDOSINGREGIMEN) FOR ACHIEVING WEIGHT REDUCTION AND TREATING OBESITY) | ⤷ Try a Trial |
Denmark | 2317997 | ⤷ Try a Trial | |
Israel | 209874 | תכשיר טופירמאט/פנטרמין בעל מינון נמוך ושיטות לשימוש בו (Low dose topiramate/phentermine composition and methods of use thereof) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
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 | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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