Blujepa Generic: When Will Generic Gepotidacin 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
Blujepa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2038 to 2039 A wide window 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? December 2042 4 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 gepotidacin mesylate is expected to be available between 2038 and 2039. None is for sale yet.
Why 2038 to 2039?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Blujepa’s last patent runs to December 2042, how can a generic come sooner?
The patent that runs to December 2042 (12,528,809) covers the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, the companies are expected to settle on a date. 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 Blujepa 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.
Blujepa by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- 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 2025 March 2025 FDA Orange Book
- Patents listed 4 last runs to December 2042 A generic is expected sooner, between 2038 and 2039. See why FDA Orange Book
- Pharmacies pay $91.40 per tablet NADAC, October 2026
- Medicare Part D spent $45.8K in 2025, for 24 people CMS Part D Spending by Drug
Blujepa’s Road to a Generic
Blujepa has had the market to itself since the FDA approved it in March 2025 (Glaxosmithkline LLC). Its FDA protection (antibiotic incentive (gain)) runs to March 2035. Its 4 listed patents run to December 2042.
The first generic of Blujepa is expected between 2038 and 2039.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before December 2042
The last listed patent runs to December 2042; a court ruling or a settlement can bring a generic sooner. 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.
Blujepa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Blujepa’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 |
|---|---|---|---|
| 8,389,524 | The active ingredient; the product’s formulation; a way of using it (U-4166) | February 2029 | Active |
| 10,702,521 | A way of using it (U-4361) | August 2035 | Active |
| 11,229,646 | A way of using it (U-4361) | August 2035 | Active |
| 12,528,809 | The active ingredient; the product’s formulation; a way of using it (U-4361, U-4408) | December 2042 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-978 | Three years of protection for a newly approved use (indication). | December 2028 | Active |
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | March 2030 | Active |
| Antibiotic incentive (GAIN) GAIN | Five more years for a medicine that treats a serious or life-threatening infection. | March 2035 | Active |
Source: FDA Orange Book, application 218230. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Gepotidacin Mesylate
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 Blujepa yet.
Approved by the FDA
Not yet. The FDA has not approved a generic gepotidacin mesylate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic gepotidacin mesylate 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).
Blujepa Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Blujepa 750 mg tablet
$91.40 per tablet in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $91.40 |
| September 2026 | $91.40 |
| August 2026 | $91.33 |
| July 2026 | $91.37 |
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 Blujepa today: $91.40 per tablet for Blujepa 750 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 $91.40 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 Blujepa
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 Blujepa, before manufacturer rebates.
- $343.4K
- January to March 2026, the latest CMS has posted
For 170 people, about $1,876 per prescription fill - $45.8K
- 2025, the whole year
For 24 people, about $1,761 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $343,395 | 170 | $1,876.47 |
| 2025 | $45,785 | 24 | $1,760.98 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Blujepa only, so no generic is counted in it. What CMS says it is used for: Gepotidacin is used to treat bladder infections (urinary tract infections) and certain genital infections (gonorrhea). This medication is an antibiotic.
Blujepa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 750MG BASE | Tablet | Oral | March 2025 | Prescription reference product |
Source: FDA Orange Book, Glaxosmithkline LLC. Listed for sale today by GlaxoSmithKline LLC (FDA NDC Directory).
Blujepa NDC Codes and Packages
Each Blujepa 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 |
|---|---|---|---|
| 00173-0922-38 | GEPOTIDACIN MESYLATE 750 mg/1 tablet, film coated | bottle of 8 tablets | GlaxoSmithKline LLC |
| 00173-0922-45 | GEPOTIDACIN MESYLATE 750 mg/1 tablet, film coated | bottle of 20 tablets | GlaxoSmithKline LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Blujepa’s own FDA approval (NDA 218230) are listed, never a generic. Some codes belong to companies that repackage Blujepa: it is the same medicine in a different package.
What a Generic Blujepa Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Blujepa 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 Blujepa”. 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 Blujepa
Is there a generic for Blujepa right now?
No. As of October 9, 2026 no generic gepotidacin mesylate is listed for sale in the FDA NDC Directory.
When will Blujepa go generic?
2038 to 2039 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to December 2042; a court ruling or a settlement can bring a generic sooner.
Will generic gepotidacin mesylate be the same as Blujepa?
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 Blujepa?
Not yet. The FDA Orange Book lists no approved generic version of Blujepa.
When does the Blujepa patent expire?
The FDA Orange Book lists 4 patents for Blujepa; the last runs to December 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 window on this page (2038 to 2039) weighs all of that.
How much does Blujepa cost now?
Pharmacies paid about $91.40 per tablet for Blujepa 750 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 2038 to 2039 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
- SalonpasMenthol and Methyl SalicylateJanuary 2030
- AkynzeoNetupitant and Palonosetron HydrochlorideSeptember 2031
- VerquvoVericiguatJanuary 2035
- NouressCysteine HydrochlorideMarch 2039
- DhivyCarbidopa and LevodopaMarch 2039
- Invega HafyeraPaliperidone PalmitateMay 2041
About Blujepa
- Generic name gepotidacin mesylate
- How it is taken By mouth
- Company Glaxosmithkline LLC
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Blujepa
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.