COMBOGESIC Drug Patent Profile
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When do Combogesic patents expire, and what generic alternatives are available?
Combogesic is a drug marketed by Aft Pharms Us and Hikma and is included in two NDAs. There are eight patents protecting this drug.
The generic ingredient in COMBOGESIC is acetaminophen; ibuprofen sodium. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Combogesic
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for COMBOGESIC?
- What are the global sales for COMBOGESIC?
- What is Average Wholesale Price for COMBOGESIC?
Summary for COMBOGESIC
| US Patents: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Clinical Trials: | 2 |
| What excipients (inactive ingredients) are in COMBOGESIC? | COMBOGESIC excipients list |
| DailyMed Link: | COMBOGESIC at DailyMed |
Recent Clinical Trials for COMBOGESIC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AFT Pharmaceuticals, Ltd. | PHASE3 |
Pharmacology for COMBOGESIC
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for COMBOGESIC
COMBOGESIC is protected by two US patents and one FDA Regulatory Exclusivity.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aft Pharms Us | COMBOGESIC | acetaminophen; ibuprofen | TABLET;ORAL | 209471-001 | Mar 1, 2023 | RX | Yes | Yes | 11,534,407 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Hikma | COMBOGESIC IV | acetaminophen; ibuprofen sodium | SOLUTION;INTRAVENOUS | 215320-001 | Oct 17, 2023 | RX | Yes | Yes | 12,220,392 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | COMBOGESIC IV | acetaminophen; ibuprofen sodium | SOLUTION;INTRAVENOUS | 215320-001 | Oct 17, 2023 | RX | Yes | Yes | 11,213,498 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Hikma | COMBOGESIC IV | acetaminophen; ibuprofen sodium | SOLUTION;INTRAVENOUS | 215320-001 | Oct 17, 2023 | RX | Yes | Yes | 11,446,266 | ⤷ 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 COMBOGESIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aft Pharms Us | COMBOGESIC | acetaminophen; ibuprofen | TABLET;ORAL | 209471-001 | Mar 1, 2023 | 10,532,036 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for COMBOGESIC
See the table below for patents covering COMBOGESIC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | E543491 | ⤷ Start Trial | |
| Australia | 2005260243 | A combination composition | ⤷ Start Trial |
| Australia | 2008202029 | A Combinatin Composition | ⤷ Start Trial |
| Brazil | PI0512756 | composição farmacêutica de combinação para o tratamento de dor, método de controle de dor, uso de uma composição e embalagem farmacêutica incluindo comprimidos ou cápsulas | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for COMBOGESIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1781277 | PA2024501 | Lithuania | ⤷ Start Trial | PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726 |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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