Sirturo Generic: When Will Generic Bedaquiline 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
Sirturo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? March 2029 About 2.5 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? March 2029 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic bedaquiline fumarate is expected to be available in March 2029, about 2.5 years away. None is for sale yet.
Why March 2029?
It is when Sirturo’s patent 7,498,343 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, 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 Sirturo 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.
Sirturo 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
- $14M a yearSmaller seller
- FDA approved 2012 December 2012 FDA Orange Book
- Patents listed 2 last runs to March 2029 FDA Orange Book
- Medicare Part D spent $4.3M in 2025, for 155 people CMS Part D Spending by Drug
- Medicaid prescriptions 184 in the last four reported quarters, $1.1M CMS Medicaid drug utilization, to Q1 2026
Sirturo’s Road to a Generic
Sirturo has had the market to itself since the FDA approved it in December 2012 (Janssen Therapeutics Div Janssen Products LP). Its FDA protection (new patient population) runs to July 2028. Its 2 listed patents run to March 2029.
The first generic of Sirturo is expected in March 2029.
Why that month: patent 7,498,343, on the active ingredient, the product’s formulation and a way of using it, 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.
Sirturo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Sirturo’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 7,498,343, which ends in December 2026; the first generic is expected after it, in March 2029, about 2.5 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,498,343 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-1321) | December 2026 | Active |
| 8,546,428 | The active ingredient; the product’s formulation; a way of using it (U-1321) | March 2029 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | August 2026 | Ended |
| Orphan drug ODE-251 | Seven years of protection for a use in a rare disease. | August 2026 | Ended |
| Orphan drug ODE-307 | Seven years of protection for a use in a rare disease. | May 2027 | Active |
| New clinical information M-306 | Three years of protection for a change backed by new clinical studies. | June 2027 | Active |
| New patient population NPP | Three years of protection for a newly approved group of patients. | July 2028 | Active |
Source: FDA Orange Book, application 204384. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Bedaquiline Fumarate
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 Sirturo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic bedaquiline fumarate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic bedaquiline fumarate 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).
Sirturo 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 Sirturo, 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.
What Medicare and Medicaid Spend on Sirturo
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 Sirturo, before manufacturer rebates.
- $943.4K
- January to March 2026, the latest CMS has posted
For 89 people, about $4,717 per prescription fill - $4.3M
- 2025, the whole year
For 155 people, about $4,692 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $943,377 | 89 | $4,716.89 |
| 2025 | $4,279,387 | 155 | $4,692.31 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Sirturo only, so no generic is counted in it. What CMS says it is used for: This medication must be used with other medications to treat active multi-drug-resistant tuberculosis (TB) of the lungs in people with limited treatment options. Bedaquiline belongs to a class of drugs known as antibiotics.
Medicaid Prescriptions by Quarter
184 prescriptions in the four quarters to Q1 2026, $1.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 42 | $187,443 |
| Q4 2025 | 39 | $178,477 |
| Q3 2025 | 90 | $649,280 |
| Q2 2025 | 13 | $62,087 |
| Q1 2025 | 15 | $78,709 |
Source: CMS Medicaid State Drug Utilization Data, over Sirturo’s own package codes.
Sirturo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 100MG BASE | Tablet | Oral | December 2012 | Prescription reference product |
| EQ 20MG BASE | Tablet | Oral | May 2020 | Prescription reference product |
Source: FDA Orange Book, Janssen Therapeutics Div Janssen Products LP. Listed for sale today by Janssen Products, LP (FDA NDC Directory).
Sirturo NDC Codes and Packages
Each Sirturo 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 |
|---|---|---|---|
| 59676-0701-01 | BEDAQUILINE FUMARATE 100 mg/1 tablet | bottle of 188 tablets | Janssen Products, LP |
| 59676-0701-01 | BEDAQUILINE FUMARATE 100 mg/1 tablet | bottle of 188 tablets | Janssen Products, LP |
| 59676-0702-60 | BEDAQUILINE FUMARATE 20 mg/1 tablet | bottle of 60 tablets | Janssen Products, LP |
| 59676-0702-60 | BEDAQUILINE FUMARATE 20 mg/1 tablet | bottle of 60 tablets | Janssen Products, LP |
Source: the FDA NDC Directory, current listings only. Only packages sold under Sirturo’s own FDA approval (NDA 204384) are listed, never a generic. Some codes belong to companies that repackage Sirturo: it is the same medicine in a different package.
What a Generic Sirturo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Sirturo 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 Sirturo”. 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 Sirturo
Is there a generic for Sirturo right now?
No. As of October 9, 2026 no generic bedaquiline fumarate is listed for sale in the FDA NDC Directory.
When will Sirturo go generic?
March 2029 is the expected month, and that is probable but not certain. It is when Sirturo’s patent 7,498,343 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic bedaquiline fumarate be the same as Sirturo?
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 Sirturo?
Not yet. The FDA Orange Book lists no approved generic version of Sirturo.
When does the Sirturo patent expire?
The FDA Orange Book lists 2 patents for Sirturo; the last runs to March 2029. The one behind the expected month is patent 7,498,343, which ends in December 2026. 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 (March 2029) weighs all of that.
Changes to This Projection
- First generic expected March 2029 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
- Trijardy XREmpagliflozin, Linagliptin, and Metformin Hydrochloride2032 to 2033
- LupkynisVoclosporin2033 to 2034
- Pylarify TruvuPiflufolastat F 18June 2034
- GemtesaVibegron2038 to 2039
- CamceviLeuprolide MesylateJanuary 2039
- ZepboundTirzepatideJanuary 2040
About Sirturo
- Generic name bedaquiline fumarate
- How it is taken By mouth
- Company Janssen Therapeutics Div Janssen Products LP
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Sirturo
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, 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.