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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: | 23 |
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 3 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 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 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
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 | 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 | Y | Start Trial | |||
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | 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 | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | Start Trial | Start Trial | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | 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 | 022580-003 | 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 | 022580-004 | 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
Country | Patent Number | Estimated Expiration |
---|---|---|
Mexico | 2010013503 | Start Trial |
Spain | 2606041 | Start Trial |
European Patent Office | 2305226 | Start Trial |
Japan | 5752595 | Start Trial |
European Patent Office | 2317997 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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