Generic Combogesic IV Availability
Last updated on Dec 12, 2024.
See also: Generic Combogesic
Combogesic IV is a brand name of acetaminophen/ibuprofen, approved by the FDA in the following formulation(s):
COMBOGESIC IV (acetaminophen; ibuprofen sodium - solution;intravenous)
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Manufacturer: HIKMA
Approval date: October 17, 2023
Strength(s): 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) [RLD]
Has a generic version of Combogesic IV been approved?
No. There is currently no therapeutically equivalent version of Combogesic IV available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Combogesic IV. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Aqueous formulation comprising paracetamol and ibuprofen
Patent 11,213,498
Issued: January 4, 2022
Inventor(s): Jacobsen Thomas
Assignee(s): Hyloris Pharmaceuticals S.A.An aqueous ibuprofen and paracetamol composition has a pH 6.3-7.3. The composition can be used as a medicament, especially for the treatment of pain and/or inflammation. The composition can be formulated for intravenous injection.
Patent expiration dates:
- January 14, 2036✓
- January 14, 2036
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Patent 11,389,416
Patent expiration dates:
- July 17, 2035✓
- July 17, 2035
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Combination composition
Patent 11,446,266
Issued: September 20, 2022
Inventor(s): Atkinson Hartley C.
Assignee(s): AFT Pharmaceuticals LimitedAn intravenous composition for providing relief for pain and/or inflammation, the composition having ibuprofen and paracetamol in combination for delivering to a human at each dose: a) approximately 125 mg to approximately 175 mg ibuprofen in combination with approximately 475 mg to approximately 525 mg paracetamol; or b) approximately 275 mg to approximately 325 mg ibuprofen in combination with approximately 975 mg to approximately 1,025 mg paracetamol.
Patent expiration dates:
- October 26, 2031✓
- October 26, 2031✓
- October 26, 2031
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Patent 11,896,567
Patent expiration dates:
- October 26, 2031✓
- October 26, 2031✓
- October 26, 2031
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Patent 12,083,087
Patent expiration dates:
- July 17, 2035✓
- July 17, 2035✓
- July 17, 2035
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- October 17, 2026 - NEW PRODUCT
More about Combogesic IV (acetaminophen / ibuprofen)
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- Side effects
- Dosage information
- FDA approval history
- Drug class: analgesic combinations
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.