DUEXIS Drug Patent Profile
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Which patents cover Duexis, and when can generic versions of Duexis launch?
Duexis is a drug marketed by Horizon and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-five patent family members in fifteen countries.
The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Duexis
A generic version of DUEXIS was approved as famotidine; ibuprofen by ENDO OPERATIONS on March 22nd, 2024.
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Summary for DUEXIS
| International Patents: | 25 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 1 |
| Patent Applications: | 42 |
| Drug Prices: | Drug price information for DUEXIS |
| Drug Sales Revenues: | Drug sales revenues for DUEXIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DUEXIS |
| What excipients (inactive ingredients) are in DUEXIS? | DUEXIS excipients list |
| DailyMed Link: | DUEXIS at DailyMed |
Recent Clinical Trials for DUEXIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Horizon Pharma Ireland, Ltd., Dublin Ireland | Phase 4 |
| Pediatric Rheumatology Collaborative Study Group | Phase 4 |
Pharmacology for DUEXIS
| Drug Class | Histamine-2 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists |
Paragraph IV (Patent) Challenges for DUEXIS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| DUEXIS | Tablets | famotidine; ibuprofen | 800 mg/26.6 mg | 022519 | 1 | 2011-12-06 |
US Patents and Regulatory Information for DUEXIS
DUEXIS is protected by five US patents.
Patents protecting DUEXIS
Methods and medicaments for administration of ibuprofen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
Stable compositions of famotidine and ibuprofen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable compositions of famotidine and ibuprofen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable compositions of famotidine and ibuprofen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable compositions of famotidine and ibuprofen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519-001 | Apr 23, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519-001 | Apr 23, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519-001 | Apr 23, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519-001 | Apr 23, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519-001 | Apr 23, 2011 | DISCN | 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 |
International Patents for DUEXIS
When does loss-of-exclusivity occur for DUEXIS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 06269894
Patent: Medicaments containing famotidine and ibuprofen and administration of same
Estimated Expiration: ⤷ Sign Up
Patent: 07275360
Patent: Methods and medicaments for administration of ibuprofen
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 39747
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0714937
Patent: forma de dosagem unitÁria oral, e, uso de uma forma de dosagem unitÁria
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 15496
Patent: MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 57928
Patent: PROCEDES ET MEDICAMENTS DESTINES A L'ADMINISTRATION D'IBUPROFENE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1257800
Patent: Medicaments containing famotidine and ibuprofen and administration of same
Estimated Expiration: ⤷ Sign Up
Patent: 1516368
Patent: Methods and medicaments for administration of ibuprofen
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 43637
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19288
Patent: MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 43637
Patent: PROCÉDÉS ET MÉDICAMENTS DESTINÉS À L'ADMINISTRATION D'IBUPROFÈNE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN)
Estimated Expiration: ⤷ Sign Up
Patent: 38919
Patent: Compositions contenant de l'ibuprofene et de la famotidine ainsi que des compositions contenant de 25 mg a 28 mg de la famotidine (Compositions comprising famotidine and ibuprofen as well as compositions comprising 25 mg to 28 mg famotidine)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8732
Patent: שימוש באיבופרופין ופאמוטידין להכנת תרופות (Use of ibuprofen and famotidine in the preparation of medicaments)
Estimated Expiration: ⤷ Sign Up
Patent: 6425
Patent: יחידת מינון למתן פומי המכילה איבופרופן ופאמוטידין (Oral unit dose form containing ibuprofen and famotidine)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 09501801
Estimated Expiration: ⤷ Sign Up
Patent: 09543885
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5846
Patent: Medicaments containing famotidine and ibuprofen and administration of same
Estimated Expiration: ⤷ Sign Up
Patent: 4200
Patent: METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN AND FAMOTIDINE
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 43637
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 43637
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0900423
Patent: Methods and medicaments for administration of ibuprofen
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 80747
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 DUEXIS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 2043637 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2007012022 | ⤷ Sign Up | |
| South Africa | 200900423 | Methods and medicaments for administration of ibuprofen | ⤷ Sign Up |
| Israel | 188732 | שימוש באיבופרופין ופאמוטידין להכנת תרופות (Use of ibuprofen and famotidine in the preparation of medicaments) | ⤷ Sign Up |
| Japan | 2009543885 | ⤷ Sign Up | |
| Poland | 2043637 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >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 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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