Dificid Generic: When Will Generic Fidaxomicin 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
Dificid Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2034 About 8 years 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? November 2034 5 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic fidaxomicin is expected to be available in November 2034, about 8 years away. None is for sale yet.
Why November 2034?
It is when Dificid’s patent 9,808,530 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
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 Dificid 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.
Dificid by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $4M a yearSmaller seller
- FDA approved 2011 May 2011 FDA Orange Book
- Patents listed 5 last runs to November 2034 FDA Orange Book
- Pharmacies pay $248.38 per tablet, up 4% in a year NADAC, October 2026
- Medicare Part D spent $130.6M in 2025, for 21.3K people CMS Part D Spending by Drug
- Medicaid prescriptions 2,328 in the last four reported quarters, $10.4M CMS Medicaid drug utilization, to Q1 2026
Dificid’s Road to a Generic
Dificid has had the market to itself since the FDA approved it in May 2011 (Cubist Pharmaceuticals LLC). Its FDA protection (orphan drug) runs to January 2027. Its 5 listed patents run to November 2034. Generic companies have challenged its patents with the FDA since May 2015.
The first generic of Dificid is expected in November 2034.
Why that month: patent 9,808,530, on the product’s formulation, 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.
Dificid Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Dificid’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.
The one that matters for a generic launch: patent 9,808,530, which ends in November 2034, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,906,489 | A way of using it (U-319, U-2741) | September 2027 with the pediatric extension | Active |
| 7,378,508 | The active ingredient; the product’s formulation | January 2028 with the pediatric extension | Active |
| 7,863,249 | The active ingredient; the product’s formulation | January 2028 with the pediatric extension | Active |
| 8,859,510 | A way of using it (U-319, U-2741) | January 2028 with the pediatric extension | Active |
| 9,808,530 Sets the expected month of generic availability | The product’s formulation | November 2034 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-367 | Seven years of protection for a use in a rare disease. | January 2027 | Active |
Source: FDA Orange Book, application 213138, 201699. Patent numbers open the patent on Google Patents.
Patent Challenges to Dificid
The first patent challenge to Dificid reached the FDA in May 2015, from one company on that first day. A first challenger began selling its generic in July 2025.
What Is a Patent Challenge?
A generic company that wants to sell its version before Dificid’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 200 mg | May 2015 | 1 company | Decision deferred decided January 2024 | January 2024 | July 2025 | July 2027 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Fidaxomicin
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 Dificid yet.
Generic companies have challenged Dificid’s patents with the FDA since May 2015: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic fidaxomicin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic fidaxomicin 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).
Dificid Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Dificid 200 mg tablet
$248.38 per tablet in October 2026, up 4% 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 tablet |
|---|---|
| October 2026 | $248.38 |
| September 2026 | $248.38 |
| August 2026 | $248.47 |
| July 2026 | $248.58 |
| June 2026 | $248.65 |
| May 2026 | $248.71 |
| April 2026 | $248.69 |
| March 2026 | $248.69 |
| February 2026 | $248.67 |
| January 2026 | $248.70 |
| February 2024 | $238.76 |
| January 2024 | $238.76 |
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 Dificid today: $248.38 per tablet for Dificid 200 mg tablet 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 $248.38 pharmacies pay per tablet 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 Dificid
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 Dificid, before manufacturer rebates.
- $5.9M
- January to March 2026, the latest CMS has posted
For 1,203 people, about $4,262 per prescription fill - $130.6M
- 2025, the whole year
For 21,318 people, about $4,647 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $5,940,533 | 1,203 | $4,261.50 |
| 2025 | $130,589,932 | 21,318 | $4,646.50 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Dificid only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a severe intestinal condition (C. difficile-associated diarrhea) due to a certain type of bacteria. This condition may rarely occur after taking antibiotics.
Medicaid Prescriptions by Quarter
2,328 prescriptions in the four quarters to Q1 2026, $10.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 223 | $993,229 |
| Q4 2025 | 267 | $1,132,414 |
| Q3 2025 | 604 | $2,675,349 |
| Q2 2025 | 1,234 | $5,581,428 |
| Q1 2025 | 1,140 | $4,965,437 |
Source: CMS Medicaid State Drug Utilization Data, over Dificid’s own package codes.
Dificid Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 200MG | Tablet | Oral | May 2011 | Prescription reference product |
| 40MG/ML | For suspension | Oral | January 2020 | Prescription reference product |
Source: FDA Orange Book, Cubist Pharmaceuticals LLC. Listed for sale today by Merck Sharp & Dohme LLC (FDA NDC Directory).
Dificid NDC Codes and Packages
Each Dificid 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 |
|---|---|---|---|
| 52015-0080-01 | FIDAXOMICIN 200 mg/1 tablet, film coated | bottle of 20 tablets | Merck Sharp & Dohme LLC |
| 52015-0080-01 | FIDAXOMICIN 200 mg/1 tablet, film coated | bottle of 20 tablets | Merck Sharp & Dohme LLC |
| 52015-0700-22 | FIDAXOMICIN 200 mg/5mL granule, for suspension | bottle of 150 mL | Merck Sharp & Dohme LLC |
| 52015-0700-22 | FIDAXOMICIN 200 mg/5mL granule, for suspension | bottle of 150 mL | Merck Sharp & Dohme LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Dificid’s own FDA approval (NDA 213138, NDA 201699) are listed, never a generic. Some codes belong to companies that repackage Dificid: it is the same medicine in a different package.
What a Generic Dificid Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Dificid 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 Dificid”. 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 Dificid
Is there a generic for Dificid right now?
No. As of October 9, 2026 no generic fidaxomicin is listed for sale in the FDA NDC Directory.
When will Dificid go generic?
November 2034 is the expected month, and that is probable but not certain. It is when Dificid’s patent 9,808,530 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic fidaxomicin be the same as Dificid?
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 Dificid?
Not yet. The FDA Orange Book lists no approved generic version of Dificid.
When does the Dificid patent expire?
The FDA Orange Book lists 5 patents for Dificid; the last runs to November 2034, counting a six-month pediatric extension. The one behind the expected month is patent 9,808,530, which ends in November 2034. 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 2034) weighs all of that.
Has anyone challenged the Dificid patents?
Yes. The first patent challenge to Dificid reached the FDA in May 2015, from one company on that first day. A first challenger began selling its generic in July 2025. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Dificid cost now?
Pharmacies paid about $248.38 per tablet for Dificid 200 mg tablet 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 2034 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
- YonsaAbiraterone AcetateDuring 2026
- FlolipidSimvastatinFebruary 2030
- BrinsupriBrensocatibJuly 2039
- PosimirBupivacaineJanuary 2041
- LivtencityMaribavirNovember 2042
- TiglutikRiluzoleTBD no date yet
About Dificid
- Generic name fidaxomicin
- How it is taken By mouth
- Company Cubist Pharmaceuticals LLC
- Patent challenges Since May 2015 (FDA)
- More drugs Brand-name drugs starting with D
- Have a question? A pharmacist answers, free. Ask about Dificid
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 Paragraph IV Patent Certifications list, 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.