Combogesic Generic: When Will Generic Acetaminophen and Ibuprofen Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Combogesic Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? February 2023 9 companies approved
- When does the last patent end? February 2039 2 patents listed with the FDA
- Can you buy a generic today? Yes 19 companies list one
It already is. A generic acetaminophen and ibuprofen is listed for sale by 19 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Combogesic, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Combogesic by the Numbers
- Reason
- Court hold endsWhen a generic maker challenges a patent, FDA must wait up to 30 months before approving it. That wait ends then.
- How sure
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2023 March 2023 FDA Orange Book
- Patents listed 2 last runs to February 2039 FDA Orange Book
- Generics FDA-approved 9 companies, the first approved February 2023 FDA Orange Book
Combogesic’s Road to a Generic
Combogesic has had the market to itself since the FDA approved it in March 2023 (Aft Pharmaceuticals US Inc). Its FDA protections on record ended by March 2026. Its 2 listed patents run to February 2039.
When a generic maker challenges a patent, FDA must wait up to 30 months before approving it. That wait ends then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Combogesic Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Combogesic’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,197,830 | The product’s formulation; a way of using it (U-3553) | February 2039 | Active |
| 11,534,407 | The product’s formulation; a way of using it (U-3553) | February 2039 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | March 2026 | Ended |
Source: FDA Orange Book, application 209471. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Acetaminophen and Ibuprofen
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No application count is on record for Combogesic, but the FDA has already approved 9 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 9 companies, the first in February 2023. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic acetaminophen and ibuprofen is listed for sale by 19 companies. Ask your pharmacy whether it can fill your prescription with it.
AMERISOURCE BERGEN, Aurohealth LLC, Bionpharma Inc., CHAIN DRUG MARKETING ASSOCIATION INC., CVS, CVS Pharmacy and 13 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| L Perrigo Co | February 2023 | 250MG;125MG | – |
| Marksans Pharma Ltd | July 2023 | 250MG;125MG | – |
| Granules Pharmaceuticals Inc | July 2023 | 250MG;125MG | – |
| Bionpharma Inc | August 2023 | 250MG;125MG | – |
| Aurobindo Pharma Ltd | March 2024 | 250MG;125MG | – |
| Glenmark Pharmaceuticals Ltd | April 2024 | 250MG;125MG | – |
| Dr Reddys Laboratories Ltd | August 2024 | 250MG;125MG | – |
| Lnk International Inc | December 2025 | 250MG;125MG | – |
| Taro Pharmaceutical Industries Ltd | January 2026 | 250MG;125MG | – |
| Strides Pharma Global Pte Ltd discontinued | January 2025 | 250MG;125MG | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Combogesic Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Combogesic, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
Combogesic Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 325MG;97.5MG | Tablet | Oral | March 2023 | Prescription reference product |
Source: FDA Orange Book, Aft Pharmaceuticals US Inc. Listed for sale today by Hikma Pharmaceuticals USA Inc, Preferred Pharmaceuticals Inc., AFT Pharmaceuticals US, Inc. and Bryant Ranch Prepack (FDA NDC Directory).
Combogesic NDC Codes and Packages
Each Combogesic package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00143-9432-27 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 250 tablets | Hikma Pharmaceuticals USA Inc |
| 68788-4009-01 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 120 tablets | Preferred Pharmaceuticals Inc. |
| 68788-4181-01 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 120 tablets | Preferred Pharmaceuticals Inc. |
| 71335-3161-01 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 30 tablets | Bryant Ranch Prepack |
| 71335-3161-02 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 60 tablets | Bryant Ranch Prepack |
| 71335-3161-03 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 90 tablets | Bryant Ranch Prepack |
| 71335-3161-04 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 120 tablets | Bryant Ranch Prepack |
| 72260-0129-01 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 250 tablets | AFT Pharmaceuticals US, Inc. |
| 72260-0129-02 | ACETAMINOPHEN 325 mg/1 / IBUPROFEN 97.5 mg/1 tablet, film coated | bottle of 60 tablets | AFT Pharmaceuticals US, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Combogesic’s own FDA approval (NDA 209471) are listed, never a generic. Some codes belong to companies that repackage Combogesic: it is the same medicine in a different package.
What a Generic Combogesic Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Combogesic
Is there a generic for Combogesic right now?
Yes. The FDA NDC Directory lists a generic acetaminophen and ibuprofen from 19 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Combogesic go generic?
It already has. The FDA NDC Directory lists a generic acetaminophen and ibuprofen from 19 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic acetaminophen and ibuprofen be the same as Combogesic?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. The FDA has already approved 9 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Combogesic?
Yes. The FDA Orange Book lists approved generic versions from 9 companies, the first approved in February 2023: L Perrigo Co, Marksans Pharma Ltd, Granules Pharmaceuticals Inc, Bionpharma Inc and 5 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Combogesic patent expire?
The FDA Orange Book lists 2 patents for Combogesic; the last runs to February 2039. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (a date that is not known yet) weighs all of that.
Changes to This Projection
- First generic expected a date that is not known yet on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- EohiliaBudesonideFebruary 2031
- OrkambiIvacaftor and LumacaftorJune 2031
- WidaplikAmlodipine, Indapamide, and TelmisartanJanuary 2038
- AuvelityBupropion Hydrochloride and Dextromethorphan HydrobromideSeptember 2038
- KhapzoryLevoleucovorinMarch 2039
- SubveniteLamotrigineMay 2040
About Combogesic
- Generic name acetaminophen and ibuprofen
- How it is taken By mouth
- Company Aft Pharmaceuticals US Inc
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Combogesic
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.