Tembexa Generic: When Will Generic Brincidofovir 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
Tembexa 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? Not yet None in the FDA’s records yet
- When does the last patent end? October 2034 5 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic brincidofovir. None is for sale yet.
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 Tembexa 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.
Tembexa by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- How sure
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2021 June 2021 FDA Orange Book
- Patents listed 5 last runs to October 2034 FDA Orange Book
Tembexa’s Road to a Generic
Tembexa has had the market to itself since the FDA approved it in June 2021 (Emergent Biodefense Operations Lansing LLC). Its FDA protection (orphan drug) runs to June 2028. Its 5 listed patents run to October 2034.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
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.
Tembexa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Tembexa’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 |
|---|---|---|---|
| 9,303,051 | The active ingredient; the product’s formulation; a way of using it (U-3165) | July 2034 | Active |
| 8,962,829 | The active ingredient; the product’s formulation | October 2034 | Active |
| 9,371,344 | The product’s formulation | October 2034 | Active |
| 10,112,909 | A way of using it (U-3165) | October 2034 | Active |
| 10,487,061 | The product’s formulation; a way of using it (U-3165) | October 2034 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-354 | Seven years of protection for a use in a rare disease. | June 2028 | Active |
Source: FDA Orange Book, application 214460, 214461. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Brincidofovir
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 Tembexa yet.
Approved by the FDA
Not yet. The FDA has not approved a generic brincidofovir. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic brincidofovir 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).
Tembexa 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 Tembexa, 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.
Tembexa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | June 2021 | Prescription reference product |
| 10MG/ML | Suspension | Oral | June 2021 | Prescription reference product |
Source: FDA Orange Book, Emergent Biodefense Operations Lansing LLC. Listed for sale today by Chimerix, Inc. and Emergent BioDefense Operations Lansing LLC (FDA NDC Directory).
Tembexa NDC Codes and Packages
Each Tembexa 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 |
|---|---|---|---|
| 79622-0012-65 | 10 mg/mL suspension | bottle of 65 mL | Chimerix, Inc. |
| 79622-0012-70 | 10 mg/mL suspension | bottle of 65 mL | Chimerix, Inc. |
| 79622-0010-04 | 100 mg tablet, film coated | blister pack of 4 tablets | Chimerix, Inc. |
| 79622-0010-10 | 100 mg tablet, film coated | blister pack of 4 tablets | Chimerix, Inc. |
| 64678-0012-01 | BRINCIDOFOVIR 10 mg/mL suspension | bottle of 65 mL | Emergent BioDefense Operations Lansing LLC |
| 64678-0012-01 | BRINCIDOFOVIR 10 mg/mL suspension | bottle of 65 mL | Emergent BioDefense Operations Lansing LLC |
| 64678-0012-02 | BRINCIDOFOVIR 10 mg/mL suspension | bottle of 65 mL | Emergent BioDefense Operations Lansing LLC |
| 64678-0012-02 | BRINCIDOFOVIR 10 mg/mL suspension | bottle of 65 mL | Emergent BioDefense Operations Lansing LLC |
Show the other 6 Tembexa packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 64678-0012-03 | BRINCIDOFOVIR 10 mg/mL suspension | bottle of 45 mL | Emergent BioDefense Operations Lansing LLC |
| 64678-0012-04 | BRINCIDOFOVIR 10 mg/mL suspension | bottle of 45 mL | Emergent BioDefense Operations Lansing LLC |
| 64678-0010-01 | BRINCIDOFOVIR 100 mg/1 tablet, film coated | blister pack of 4 tablets | Emergent BioDefense Operations Lansing LLC |
| 64678-0010-01 | BRINCIDOFOVIR 100 mg/1 tablet, film coated | blister pack of 4 tablets | Emergent BioDefense Operations Lansing LLC |
| 64678-0010-02 | BRINCIDOFOVIR 100 mg/1 tablet, film coated | blister pack of 4 tablets | Emergent BioDefense Operations Lansing LLC |
| 64678-0010-02 | BRINCIDOFOVIR 100 mg/1 tablet, film coated | blister pack of 4 tablets | Emergent BioDefense Operations Lansing LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Tembexa’s own FDA approval (NDA 214460, NDA 214461) are listed, never a generic. Some codes belong to companies that repackage Tembexa: it is the same medicine in a different package.
What a Generic Tembexa Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Tembexa 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 Tembexa”. 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 Tembexa
Is there a generic for Tembexa right now?
No. As of October 9, 2026 no generic brincidofovir is listed for sale in the FDA NDC Directory.
When will Tembexa go generic?
There is no expected month yet. No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
Will generic brincidofovir be the same as Tembexa?
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 Tembexa?
Not yet. The FDA Orange Book lists no approved generic version of Tembexa.
When does the Tembexa patent expire?
The FDA Orange Book lists 5 patents for Tembexa; the last runs to October 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 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
- SalonpasMenthol and Methyl SalicylateJanuary 2030
- VerzenioAbemaciclibJanuary to March 2032
- DocivyxDocetaxelMarch 2036
- AltrenoTretinoinAugust 2038
- NouressCysteine HydrochlorideMarch 2039
- Invega HafyeraPaliperidone PalmitateMay 2041
About Tembexa
- Generic name brincidofovir
- How it is taken By mouth
- Company Emergent Biodefense Operations Lansing LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Tembexa
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.