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Phentermine hydrochloride; topiramate - Generic Drug Details
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 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: | 17 |
| 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 Colorado- Clinical and Translational Sciences Institute | Phase 2 |
| University of Colorado- Nutrition Obesity Research Center | Phase 2 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
See all phentermine hydrochloride; topiramate clinical trials
Recent Litigation for phentermine hydrochloride; topiramate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| VIVUS, INC. v. TEVA PHARMACEUTICALS USA, INC. | 2015-04-15 |
| VIVUS, INC. v. ACTAVIS LABORATORIES FL, INC. | 2014-06-12 |
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 | 022580-002 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | 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 | Start Trial | ||||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| 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 | 022580-003 | 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 | ||||
| >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 | 022580-002 | 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 | 022580-004 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for phentermine hydrochloride; topiramate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0076493 | Start Trial |
| European Patent Office | 2305226 | Start Trial |
| Spain | 2291215 | Start Trial |
| Australia | 770068 | Start Trial |
| Mexico | 342684 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009152189 | Start Trial |
| China | 102112127 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 verifification 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.
ISSN: 2162-2639
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