QSYMIA Drug Patent Profile
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When do Qsymia patents expire, and what generic alternatives are available?
Qsymia is a drug marketed by Vivus Llc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has forty patent family members in seventeen countries.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Qsymia
A generic version of QSYMIA was approved as phentermine hydrochloride; topiramate by ACTAVIS LABS FL INC on June 25th, 2024.
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Summary for QSYMIA
| International Patents: | 40 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 17 |
| Patent Applications: | 1 |
| Drug Prices: | Drug price information for QSYMIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QSYMIA |
| What excipients (inactive ingredients) are in QSYMIA? | QSYMIA excipients list |
| DailyMed Link: | QSYMIA at DailyMed |
Recent Clinical Trials for QSYMIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novo Nordisk A/S | Phase 4 |
| VIVUS LLC | Phase 4 |
| Alvogen Korea | Phase 4 |
Pharmacology for QSYMIA
| 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 QSYMIA
| 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 QSYMIA
QSYMIA is protected by six US patents and one FDA Regulatory Exclusivity.
Patents protecting QSYMIA
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
FDA Regulatory Exclusivity protecting QSYMIA
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| 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 | 022580-004 | Jul 17, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |||
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |||
| 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 | ||
| >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 QSYMIA
| 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 |
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | 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 QSYMIA
When does loss-of-exclusivity occur for QSYMIA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09257572
Patent: Low dose topiramate/phentermine composition and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Patent: 09257573
Patent: Escalating dosing regimen for effecting weight loss and treating obesity
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0914985
Patent: composição de baixa dose de topiramato/fentermina e métodos de utilização dessa
Estimated Expiration: ⤷ Sign Up
Patent: 0914991
Patent: regime de doses crescentes para conseguir a perda de peso e tratar obesidade
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 27313
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 27319
Patent: COMPOSITION DE TOPIRAMATE/PHENTERMINE A FAIBLE DOSE ET SES PROCEDES D'UTILISATION (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 10001365
Patent: Uso de fentermina en combinacion con topiramato para tratar la obesidad mediante una reduccion de peso en una persona.
Estimated Expiration: ⤷ Sign Up
Patent: 10001366
Patent: Composicion farmaceutica de liberacion controlada que comprende topiramato, celulosa microcristalina y metilcelulosa; preparado farmaceutico que la comprende, util para tratar la obesidad, diabetes o una afeccion relacionada.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2112126
Patent: Low dose topiramate/phentermine compostion and methods of use thereof
Estimated Expiration: ⤷ Sign Up
Patent: 2112127
Patent: Escalating dosing regimen for effecting weight loss and treating obesity
Estimated Expiration: ⤷ Sign Up
Patent: 4825477
Patent: Low dose Phentermine Composition And Methods Of Use Thereof
Estimated Expiration: ⤷ Sign Up
Patent: 5534921
Patent: Novel topiramate compositions and an escalating dosing strategy for treating obesity and related disorders
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 18103
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 17997
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 00002
Patent: PROTOCOLE D ADMINISTRATION DE DOSES CROISSANTES VISANT À UNE PERTE DE POIDS ET À UN TRAITEMENT DE L OBÉSITÉ (ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY)
Estimated Expiration: ⤷ Sign Up
Patent: 17997
Patent: COMPOSITION DE TOPIRAMATE/PHENTERMINE À FAIBLE DOSE ET SES PROCÉDÉS D UTILISATION (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 13489
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9874
Patent: תכשיר טופירמאט/פנטרמין בעל מינון נמוך ושיטות לשימוש בו (Low dose topiramate/phentermine composition and methods of use thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 9875
Patent: Topiramate ו- phentermine לצורך ירידה במשקל במשטר מינון עולה (Topiramate and phentermine for effecting weight loss in an escalating dosing regimen)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 52595
Estimated Expiration: ⤷ Sign Up
Patent: 77053
Estimated Expiration: ⤷ Sign Up
Patent: 14750
Estimated Expiration: ⤷ Sign Up
Patent: 11522896
Estimated Expiration: ⤷ Sign Up
Patent: 11522897
Estimated Expiration: ⤷ Sign Up
Patent: 15166380
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 16006085
Patent: 低用量トピラメート／フェンテルミン組成物およびその使用方法 (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSITION AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 17078083
Patent: 低用量トピラメート／フェンテルミン組成物およびその使用方法 (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSITION AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 17105788
Patent: 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（ＥＳＣＡＬＡＴＩＮＧ ＤＯＳＩＮＧ ＲＥＧＩＭＥＮ） (ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2684
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
Patent: 10013503
Patent: COMPOSICION DE TOPIRAMATO/FENTERMINA DE BAJA DOSIS Y METODOS DE USO DE LA MISMA. (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 10013505
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 17997
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1008839
Patent: LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSITION AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 1008840
Patent: ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 110042280
Patent: LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSITION AND METHODS OF USE THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 110044847
Estimated Expiration: ⤷ Sign Up
Patent: 140121491
Patent: ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 06041
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering QSYMIA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 201008839 | LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSITION AND METHODS OF USE THEREOF | ⤷ Sign Up |
| Brazil | PI0914991 | regime de doses crescentes para conseguir a perda de peso e tratar obesidade | ⤷ Sign Up |
| Cyprus | 1118103 | ⤷ Sign Up | |
| China | 1224352 | ⤷ Sign Up | |
| South Korea | 20110044847 | ⤷ Sign Up | |
| Canada | 2377330 | THERAPIE COMBINEE PERMETTANT DE PERDRE DU POIDS ET DE TRAITER L'OBESITE (COMBINATION THERAPY FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QSYMIA
| 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.
ISSN: 2162-2639
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