Talicia Generic: When Will It 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
Talicia Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2027 About 13 months away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? May 2042 7 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic amoxicillin, omeprazole magnesium, and rifabutin is expected to be available in November 2027, about 13 months away. None is for sale yet.
Why November 2027?
It is when Talicia’s FDA protection for antibiotic incentive (gain) ends. Five more years for a medicine that treats a serious or life-threatening infection. We rate it probable: more likely than not, but it can still move.
If Talicia’s last patent runs to May 2042, how can a generic come sooner?
The 7 patents that run past the expected month, to May 2042 (9,050,263, 9,498,445, 9,603,806, 10,238,606 and 3 more), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Talicia as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Talicia by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2019 November 2019 FDA Orange Book
- Patents listed 7 last runs to May 2042 A generic is expected sooner, in November 2027. See why FDA Orange Book
- Pharmacies pay $4.88 per capsule, up 6.3% in a year NADAC, October 2026
- Medicare Part D spent $3.1M in 2025, for 3,782 people CMS Part D Spending by Drug
- Medicaid prescriptions 6,073 in the last four reported quarters, $4.9M CMS Medicaid drug utilization, to Q4 2025
Talicia’s Road to a Generic
Talicia has had the market to itself since the FDA approved it in November 2019 (Talicia Holdings Inc). Its FDA protection (antibiotic incentive (gain)) runs to November 2027. Its 7 listed patents run to May 2042.
The first generic of Talicia is expected in November 2027.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then. That is about 14.5 years before the last listed patent runs out, in May 2042.
Why a Generic Can Come Before May 2042
The last listed patent runs to May 2042, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Talicia Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Talicia’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 |
|---|---|---|---|
| 9,050,263 | The product’s formulation; a way of using it (U-2660) | February 2034 | Active |
| 9,498,445 | The product’s formulation; a way of using it (U-2660) | February 2034 | Active |
| 9,603,806 | The product’s formulation; a way of using it (U-2660) | February 2034 | Active |
| 10,238,606 | The product’s formulation | February 2034 | Active |
| 11,135,172 | The product’s formulation; a way of using it (U-2660) | February 2034 | Active |
| 11,931,463 | The product’s formulation; a way of using it (U-3866) | February 2034 | Active |
| 11,878,011 | A way of using it (U-3816) | May 2042 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | November 2022 | Ended |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | November 2027 | Active |
Source: FDA Orange Book, application 213004. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Amoxicillin, Omeprazole Magnesium, and Rifabutin
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 company is recorded as having applied to the FDA to make a generic Talicia yet.
Approved by the FDA
Not yet. The FDA has not approved a generic amoxicillin, omeprazole magnesium, and rifabutin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic amoxicillin, omeprazole magnesium, and rifabutin for sale with the FDA.
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).
Talicia Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Talicia DR 10-250-12.5 mg cap
$4.88 per capsule in October 2026, up 6.3% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| October 2026 | $4.88 |
| September 2026 | $4.88 |
| August 2026 | $4.89 |
| July 2026 | $4.89 |
| June 2026 | $4.88 |
| May 2026 | $4.88 |
| April 2026 | $4.86 |
| March 2026 | $4.86 |
| February 2026 | $4.86 |
| January 2026 | $4.86 |
| February 2024 | $4.59 |
| January 2024 | $4.33 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Talicia today: $4.88 per capsule for Talicia DR 10-250-12.5 mg cap in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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).
Dollar figures apply FDA’s median drops to the $4.88 pharmacies pay per capsule today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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.
What Medicare and Medicaid Spend on Talicia
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Talicia, before manufacturer rebates.
- $760.4K
- January to March 2026, the latest CMS has posted
For 897 people, about $833 per prescription fill - $3.1M
- 2025, the whole year
For 3,782 people, about $802 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $760,376 | 897 | $832.83 |
| 2025 | $3,105,974 | 3,782 | $802.16 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Talicia only, so no generic is counted in it. What CMS says it is used for: This product is used to treat H. pylori infection in the stomach. H. pylori can cause stomach problems such as ulcers.
Medicaid Prescriptions by Quarter
6,073 prescriptions in the four quarters to Q4 2025, $4.9M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 1,628 | $1,309,696 |
| Q3 2025 | 1,806 | $1,449,067 |
| Q2 2025 | 1,321 | $1,062,160 |
| Q1 2025 | 1,318 | $1,062,341 |
Source: CMS Medicaid State Drug Utilization Data, over Talicia’s own package codes.
Talicia Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 250MG;EQ 10MG BASE;12.5MG | Capsule, delayed release | Oral | November 2019 | Prescription reference product |
Source: FDA Orange Book, Talicia Holdings Inc. Listed for sale today by RedHill Biopharma Ltd (FDA NDC Directory).
Talicia NDC Codes and Packages
Each Talicia 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 |
|---|---|---|---|
| 57841-1150-02 | OMEPRAZOLE MAGNESIUM 10 mg/1 / AMOXICILLIN 250 mg/1 / RIFABUTIN 12.5 mg/1 capsule, delayed release | carton of 2 bottles of 84 capsules | RedHill Biopharma Ltd |
| 57841-1150-02 | OMEPRAZOLE MAGNESIUM 10 mg/1 / AMOXICILLIN 250 mg/1 / RIFABUTIN 12.5 mg/1 capsule, delayed release | carton of 2 bottles of 84 capsules | RedHill Biopharma Ltd |
| 57841-1150-04 | OMEPRAZOLE MAGNESIUM 10 mg/1 / AMOXICILLIN 250 mg/1 / RIFABUTIN 12.5 mg/1 capsule, delayed release | carton of 2 bottles of 84 capsules | RedHill Biopharma Ltd |
| 57841-1150-04 | OMEPRAZOLE MAGNESIUM 10 mg/1 / AMOXICILLIN 250 mg/1 / RIFABUTIN 12.5 mg/1 capsule, delayed release | carton of 2 bottles of 84 capsules | RedHill Biopharma Ltd |
Source: the FDA NDC Directory, current listings only. Only packages sold under Talicia’s own FDA approval (NDA 213004) are listed, never a generic. Some codes belong to companies that repackage Talicia: it is the same medicine in a different package.
What a Generic Talicia Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Talicia as usual. When one arrives, there is nothing you need to sign up for.
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.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Talicia”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Talicia
Is there a generic for Talicia right now?
No. As of October 9, 2026 no generic amoxicillin, omeprazole magnesium, and rifabutin is listed for sale in the FDA NDC Directory.
When will Talicia go generic?
November 2027 is the expected month, and that is probable but not certain. It is when Talicia’s FDA protection for antibiotic incentive (gain) ends. Five more years for a medicine that treats a serious or life-threatening infection. The last listed patent runs to May 2042, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic amoxicillin, omeprazole magnesium, and rifabutin be the same as Talicia?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Talicia?
Not yet. The FDA Orange Book lists no approved generic version of Talicia.
When does the Talicia patent expire?
The FDA Orange Book lists 7 patents for Talicia; the last runs to May 2042. 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 month on this page (November 2027) weighs all of that.
How much does Talicia cost now?
Pharmacies paid about $4.88 per capsule for Talicia DR 10-250-12.5 mg cap in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected November 2027 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
- NexplanonEtonogestrel2028 to 2029
- IncivekTelaprevirMay 2028
- VeltassaPatiromer Sorbitex Calcium2030 to 2031
- DefitelioDefibrotide SodiumJune 2032
- AgamreeVamoroloneApril 2034
- RomvimzaVimseltinibFebruary 2040
About Talicia
- Generic name amoxicillin, omeprazole magnesium, and rifabutin
- How it is taken By mouth
- Company Talicia Holdings Inc
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Talicia
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, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.