Tyzavan Generic: When Will Generic Vancomycin 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
Tyzavan Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2035 About 9 years away Why then?
- Has the FDA approved a generic? January 2016 5 companies approved
- When does the last patent end? November 2035 6 patents listed with the FDA
- Can you buy a generic today? Yes 27 companies list one
It already is. A generic vancomycin hydrochloride is listed for sale by 27 companies, so ask your pharmacy whether it can fill your prescription with one.
Why November 2035?
It is when Tyzavan’s patents 10,039,804, 10,188,697, 10,849,956, 11,517,609 and 2 more end. They cover the product’s formulation and a way of using it, and once they end, 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.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Tyzavan, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Tyzavan 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
- $59M a yearSmaller seller
- FDA approved 2019 February 2019 FDA Orange Book
- Patents listed 6 last runs to November 2035 FDA Orange Book
- Generics FDA-approved 5 companies, the first approved January 2016 FDA Orange Book
- Medicare Part D spent $78.7K in January to March 2026, for 390 people CMS Part D Spending by Drug
- Medicaid prescriptions 17 in the last four reported quarters, $3,037 CMS Medicaid drug utilization, to Q1 2026
Tyzavan’s Road to a Generic
Tyzavan has had the market to itself since the FDA approved it in February 2019 (Hikma Pharmaceuticals USA Inc). Its 6 listed patents run to November 2035.
The first generic of Tyzavan is expected in November 2035.
Why that month: patents 10,039,804, 10,188,697, 10,849,956, 11,517,609 and 2 more, on the product’s formulation and a way of using it, end 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.
Tyzavan Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Tyzavan’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: patents 10,039,804, 10,188,697, 10,849,956, 11,517,609 and 2 more, which end in November 2035, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,039,804 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-282) | November 2035 | Active |
| 10,188,697 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-282) | November 2035 | Active |
| 10,849,956 Sets the expected month of generic availability | The product’s formulation | November 2035 | Active |
| 11,517,609 Sets the expected month of generic availability | A way of using it (U-282) | November 2035 | Active |
| 11,628,200 Sets the expected month of generic availability | The product’s formulation | November 2035 | Active |
| 12,161,690 Sets the expected month of generic availability | The product’s formulation | November 2035 | Active |
Source: FDA Orange Book, application 211962. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Vancomycin Hydrochloride
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 application count is on record for Tyzavan, but the FDA has already approved 5 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 5 companies, the first in January 2016. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic vancomycin hydrochloride is listed for sale by 27 companies. Ask your pharmacy whether it can fill your prescription with it.
Almaject, Inc., Athenex Pharmaceutical Division, LLC., AuroMedics Pharma LLC, BluePoint Laboratories, Camber Pharmaceuticals, Inc., Civica, Inc and 21 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Samson Medical Technologies LLC | January 2016 | EQ 100GM BASE | – |
| Hikma Pharmaceuticals USA Inc | June 2023 | EQ 1.5GM BASE/VIAL, EQ 1.25GM BASE/VIAL | AP |
| Eugia Pharma Specialities Ltd | August 2023 | EQ 1.5GM BASE/VIAL, EQ 1.25GM BASE/VIAL | AP |
| Gland Pharma Ltd | March 2025 | EQ 1.5GM BASE/VIAL, EQ 1.25GM BASE/VIAL, EQ 750MG BASE/VIAL | AP |
| Steriscience Pte Ltd | October 2025 | EQ 1.5GM BASE/VIAL, EQ 1.25GM BASE/VIAL, EQ 750MG BASE/VIAL | AP |
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).
Tyzavan 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 Tyzavan, 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 Tyzavan
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 Tyzavan, before manufacturer rebates.
- $78.7K
- January to March 2026, the latest CMS has posted
For 390 people, about $92 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $78,715 | 390 | $91.64 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Tyzavan only, so no generic is counted in it. What CMS says it is used for: Vancomycin is used to treat serious bacterial infections. It is an antibiotic that works by stopping the growth of bacteria.
Tyzavan Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | Solution | Intravenous | February 2019 | Prescription reference product |
| EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | Solution | Intravenous | February 2019 | Prescription reference product |
| EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | Solution | Intravenous | February 2019 | Prescription reference product |
| EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | Solution | Intravenous | February 2019 | Prescription reference product |
| EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | Solution | Intravenous | May 2020 | Prescription reference product |
| EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | Solution | Intravenous | May 2020 | Prescription reference product |
| EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | Solution | Intravenous | May 2020 | Prescription reference product |
Source: FDA Orange Book, Hikma Pharmaceuticals USA Inc. Listed for sale today by Hikma Pharmaceuticals USA Inc. (FDA NDC Directory).
Tyzavan NDC Codes and Packages
Each Tyzavan 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 |
|---|---|---|---|
| 00143-9472-06 | VANCOMYCIN 1 g/200mL injection, solution | carton of 6 bags of 200 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9472-12 | VANCOMYCIN 1 g/200mL injection, solution | carton of 12 bags of 200 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9466-06 | VANCOMYCIN 1.25 g/250mL injection, solution | carton of 6 bags of 250 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9469-06 | VANCOMYCIN 1.5 g/300mL injection, solution | carton of 6 bags of 300 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9467-06 | VANCOMYCIN 1.75 g/350mL injection, solution | carton of 6 bags of 350 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9470-06 | VANCOMYCIN 2 g/400mL injection, solution | carton of 6 bags of 400 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9471-06 | VANCOMYCIN 500 mg/100mL injection, solution | carton of 6 bags of 100 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9471-12 | VANCOMYCIN 500 mg/100mL injection, solution | carton of 12 bags of 100 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9468-06 | VANCOMYCIN 750 mg/150mL injection, solution | carton of 6 bags of 150 mL | Hikma Pharmaceuticals USA Inc. |
| 00143-9468-12 | VANCOMYCIN 750 mg/150mL injection, solution | carton of 12 bags of 150 mL | Hikma Pharmaceuticals USA Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Tyzavan’s own FDA approval (NDA 211962) are listed, never a generic. Some codes belong to companies that repackage Tyzavan: it is the same medicine in a different package.
What a Generic Tyzavan Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Tyzavan
Is there a generic for Tyzavan right now?
Yes. The FDA NDC Directory lists a generic vancomycin hydrochloride from 27 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Tyzavan go generic?
It already has. The FDA NDC Directory lists a generic vancomycin hydrochloride from 27 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic vancomycin hydrochloride be the same as Tyzavan?
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. The FDA has already approved 5 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Tyzavan?
Yes. The FDA Orange Book lists approved generic versions from 5 companies, the first approved in January 2016: Samson Medical Technologies LLC, Hikma Pharmaceuticals USA Inc, Eugia Pharma Specialities Ltd, Gland Pharma Ltd and 1 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Tyzavan patent expire?
The FDA Orange Book lists 6 patents for Tyzavan; the last runs to November 2035. The one behind the expected month is patents 10,039,804, 10,188,697, 10,849,956, 11,517,609 and 2 more, which end in November 2035. 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 2035) weighs all of that.
Changes to This Projection
- First generic expected November 2035 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
- ErivedgeVismodegibNovember to December 2028
- XaciatoClindamycin PhosphateDecember 2029
- KisqaliRibociclib SuccinateJuly to September 2031
- OrserduElacestrant Hydrochloride2035 to 2037
- AzstarysDexmethylphenidate Hydrochloride and Serdexmethylphenidate ChlorideDecember 2037
- SunosiSolriamfetol HydrochlorideDuring 2040
About Tyzavan
- Generic name vancomycin hydrochloride
- How it is taken Into a vein (IV)
- Company Hikma Pharmaceuticals USA Inc
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Tyzavan
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.