Famotidine; ibuprofen - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for famotidine; ibuprofen and what is the scope of patent protection?
Famotidine; ibuprofen
is the generic ingredient in four branded drugs marketed by Horizon, Torrent, Endo Operations, Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in six NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Famotidine; ibuprofen has twenty-five patent family members in fifteen countries.
Eleven suppliers are listed for this compound.
Summary for famotidine; ibuprofen
| International Patents: | 25 |
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 11 |
| Clinical Trials: | 6 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for famotidine; ibuprofen |
| DailyMed Link: | famotidine; ibuprofen at DailyMed |
Recent Clinical Trials for famotidine; ibuprofen
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 4 |
| Horizon Pharma Ireland, Ltd., Dublin Ireland | Phase 4 |
| Pediatric Rheumatology Collaborative Study Group | Phase 4 |
Pharmacology for famotidine; ibuprofen
| Drug Class | Histamine-2 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for famotidine; ibuprofen
Paragraph IV (Patent) Challenges for FAMOTIDINE; IBUPROFEN
| 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 famotidine; ibuprofen
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ascent Pharms Inc | IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 216814-001 | Mar 15, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 211890-001 | Aug 3, 2021 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519-001 | Apr 23, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Torrent | FAMOTIDINE AND IBUPROFEN | famotidine; ibuprofen | TABLET;ORAL | 215925-001 | Mar 18, 2024 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | FAMOTIDINE; IBUPROFEN | famotidine; ibuprofen | TABLET;ORAL | 203658-001 | Mar 22, 2024 | AB | RX | No | 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 famotidine; ibuprofen
| 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 | |
| New Zealand | 574200 | METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN AND FAMOTIDINE | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
