Kimyrsa Generic: When Will Generic Oritavancin Diphosphate 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
Kimyrsa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2029 About 3 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? July 2035 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 oritavancin diphosphate is expected to be available in August 2029, about 3 years away. None is for sale yet.
Why August 2029?
It is when Kimyrsa’s patents 8,420,592 and 12,514,899 end. They cover a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Kimyrsa’s last patent runs to July 2035, how can a generic come sooner?
The 2 patents that run past the expected month, to July 2035 (9,682,061 and 9,649,352), cover a way of using it, the active ingredient and the product’s formulation. 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. 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 Kimyrsa 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.
Kimyrsa 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
- $21M a yearSmaller seller
- FDA approved 2021 March 2021 FDA Orange Book
- Patents listed 4 last runs to July 2035 A generic is expected sooner, in August 2029. See why FDA Orange Book
- Medicare Part D spent $437.4K in 2025, for 51 people CMS Part D Spending by Drug
- Medicaid prescriptions 79 in the last four reported quarters, $401.8K CMS Medicaid drug utilization, to Q4 2025
Kimyrsa’s Road to a Generic
Kimyrsa has had the market to itself since the FDA approved it in March 2021 (Melinta Therapeutics LLC). Its 4 listed patents run to July 2035.
The first generic of Kimyrsa is expected in August 2029.
Why that month: patents 8,420,592 and 12,514,899, on a way of using it, end then. That is about 6 years before the last listed patent runs out, in July 2035.
Why a Generic Can Come Before July 2035
The last listed patent runs to July 2035; 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.
Kimyrsa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Kimyrsa’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 8,420,592 and 12,514,899, which end in August 2029, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,420,592 Sets the expected month of generic availability | A way of using it (U-3101) | August 2029 | Active |
| 12,514,899 Sets the expected month of generic availability | A way of using it (U-4398) | August 2029 | Active |
| 9,682,061 | A way of using it (U-3101) | April 2030 | Active |
| 9,649,352 | The active ingredient; the product’s formulation | July 2035 | Active |
Source: FDA Orange Book, application 214155. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Oritavancin Diphosphate
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 Kimyrsa yet.
Approved by the FDA
Not yet. The FDA has not approved a generic oritavancin diphosphate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic oritavancin diphosphate 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).
Kimyrsa 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 Kimyrsa, 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 Kimyrsa
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 Kimyrsa, before manufacturer rebates.
- $437.4K
- 2025, the whole year
For 51 people, about $5,832 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $437,425 | 51 | $5,832.34 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Kimyrsa only, so no generic is counted in it. What CMS says it is used for: This medication is an antibiotic used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria.
Medicaid Prescriptions by Quarter
79 prescriptions in the four quarters to Q4 2025, $401.8K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 22 | $112,018 |
| Q3 2025 | 30 | $150,187 |
| Q2 2025 | 14 | $72,052 |
| Q1 2025 | 13 | $67,579 |
Source: CMS Medicaid State Drug Utilization Data, over Kimyrsa’s own package codes.
Kimyrsa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 1.2GM BASE/VIAL | Powder | Intravenous | March 2021 | Prescription reference product |
Source: FDA Orange Book, Melinta Therapeutics LLC. Listed for sale today by Melinta Therapeutics, LLC (FDA NDC Directory).
Kimyrsa NDC Codes and Packages
Each Kimyrsa 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 |
|---|---|---|---|
| 70842-0225-01 | ORITAVANCIN DIPHOSPHATE 1200 mg/40mL injection, powder, lyophilized, for solution | vial of 40 mL | Melinta Therapeutics, LLC |
| 70842-0225-01 | ORITAVANCIN DIPHOSPHATE 1200 mg/40mL injection, powder, lyophilized, for solution | vial of 40 mL | Melinta Therapeutics, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Kimyrsa’s own FDA approval (NDA 214155) are listed, never a generic. Some codes belong to companies that repackage Kimyrsa: it is the same medicine in a different package.
What a Generic Kimyrsa Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Kimyrsa 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 Kimyrsa”. 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 Kimyrsa
Is there a generic for Kimyrsa right now?
No. As of October 9, 2026 no generic oritavancin diphosphate is listed for sale in the FDA NDC Directory.
When will Kimyrsa go generic?
August 2029 is the expected month, and that is probable but not certain. It is when Kimyrsa’s patents 8,420,592 and 12,514,899 end. They cover a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to July 2035; a court ruling or a settlement can bring a generic sooner.
Will generic oritavancin diphosphate be the same as Kimyrsa?
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 Kimyrsa?
Not yet. The FDA Orange Book lists no approved generic version of Kimyrsa.
When does the Kimyrsa patent expire?
The FDA Orange Book lists 4 patents for Kimyrsa; the last runs to July 2035. The one behind the expected month is patents 8,420,592 and 12,514,899, which end in August 2029. 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 (August 2029) weighs all of that.
Changes to This Projection
- First generic expected August 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
- RexultiBrexpiprazoleDuring 2029
- IbsrelaTenapanor HydrochlorideAugust 2033
- CrexontCarbidopa and Levodopa2035 to 2038
- MycapssaOctreotide Acetate2037 to 2039
- VabomereMeropenem and VaborbactamApril 2039
- ZydeligIdelalisibTBD no date yet
About Kimyrsa
- Generic name oritavancin diphosphate
- How it is taken Injection
- Company Melinta Therapeutics LLC
- More drugs Brand-name drugs starting with K
- Have a question? A pharmacist answers, free. Ask about Kimyrsa
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.