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 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® Generic Entry Outlook for Qsymia
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 24, 2025. This may change due to patent challenges or generic licensing.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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 |
| Formulation / Manufacturing: | see details |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION NDA:
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 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 |
Anatomical Therapeutic Chemical (ATC) Classes for QSYMIA
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of QSYMIA is ⤷ Try a Trial.
This potential generic entry date is based on NEW PATIENT POPULATION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting QSYMIA
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | ⤷ 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 | ||||
| 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 | ⤷ 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 | 022580-001 | 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 | 022580-002 | Jul 17, 2012 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 QSYMIA
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
Estimated Expiration: ⤷ Try a Trial
Patent: 09257573
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0914985
Estimated Expiration: ⤷ Try a Trial
Patent: 0914991
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 27313
Estimated Expiration: ⤷ Try a Trial
Patent: 27319
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 10001365
Estimated Expiration: ⤷ Try a Trial
Patent: 10001366
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2112126
Estimated Expiration: ⤷ Try a Trial
Patent: 2112127
Estimated Expiration: ⤷ Try a Trial
Patent: 4825477
Estimated Expiration: ⤷ Try a Trial
Patent: 5534921
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 18103
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 17997
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 00002
Estimated Expiration: ⤷ Try a Trial
Patent: 17997
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 13489
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9874
Estimated Expiration: ⤷ Try a Trial
Patent: 9875
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 52595
Estimated Expiration: ⤷ Try a Trial
Patent: 77053
Estimated Expiration: ⤷ Try a Trial
Patent: 14750
Estimated Expiration: ⤷ Try a Trial
Patent: 11522896
Estimated Expiration: ⤷ Try a Trial
Patent: 11522897
Estimated Expiration: ⤷ Try a Trial
Patent: 15166380
Estimated Expiration: ⤷ Try a Trial
Patent: 16006085
Estimated Expiration: ⤷ Try a Trial
Patent: 17078083
Estimated Expiration: ⤷ Try a Trial
Patent: 17105788
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 2684
Estimated Expiration: ⤷ Try a Trial
Patent: 10013503
Estimated Expiration: ⤷ Try a Trial
Patent: 10013505
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 17997
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1008839
Estimated Expiration: ⤷ Try a Trial
Patent: 1008840
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 110042280
Estimated Expiration: ⤷ Try a Trial
Patent: 110044847
Estimated Expiration: ⤷ Try a Trial
Patent: 140121491
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 06041
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Australia | 2009257573 | Escalating dosing regimen for effecting weight loss and treating obesity | ⤷ Try a Trial |
| Austria | 369126 | ⤷ Try a Trial | |
| South Korea | 20140121491 | ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY | ⤷ Try a Trial |
| Japan | 6077053 | ⤷ Try a Trial | |
| Denmark | 2317997 | ⤷ Try a Trial | |
| China | 104825477 | Low dose Phentermine Composition And Methods Of Use Thereof | ⤷ Try a Trial |
| Australia | 5489600 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QSYMIA
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
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