Kyleena Generic: When Will Generic Levonorgestrel 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
Kyleena Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2029 About 3 years away Why then?
- Has the FDA approved a generic? June 2009 12 companies approved
- When does the last patent end? September 2029 3 patents listed with the FDA
- Can you buy a generic today? Yes 40 companies list one in some form
A generic matching Kyleena is expected to be available in September 2029, about 3 years away. A generic levonorgestrel is already listed for sale in some form by 40 companies, so ask your pharmacy whether one matches Kyleena.
Why September 2029?
It is when Kyleena’s patent 10,561,524 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. It is too early to rate how firm that is.
Will the generic cost less?
Usually. The FDA has already approved 12 companies to make a generic, and how many of them launch decides how far the price falls. See the price pattern
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Kyleena, 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.
Kyleena by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Not rated Too early to rate. The month is where the records point today.
- Price competition
- None filed yet No filers on record
- Brand sales
- $210M a yearBig seller
- FDA approved 2016 September 2016 FDA Orange Book
- Patents listed 3 last runs to September 2029 FDA Orange Book
- Generics FDA-approved 12 companies, the first approved June 2009 FDA Orange Book
- Medicare Part D spent $50.2K in 2025, for 43 people CMS Part D Spending by Drug
- Medicaid prescriptions 21K in the last four reported quarters, $26.1M CMS Medicaid drug utilization, to Q1 2026
Kyleena’s Road to a Generic
Kyleena has had the market to itself since the FDA approved it in September 2016 (Bayer Healthcare Pharmaceuticals Inc). Its 3 listed patents run to September 2029.
The first generic of Kyleena is expected in September 2029.
Why that month: patent 10,561,524, on 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.
Kyleena Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Kyleena’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 10,561,524, which ends in September 2029, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,628,088 | The product’s formulation | February 2027 | Active |
| 11,850,182 | The product’s formulation; a way of using it (U-3819) | September 2029 | Active |
| 10,561,524 Sets the expected month of generic availability | A way of using it (U-2948) | September 2029 | Active |
Source: FDA Orange Book, application 208224. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Levonorgestrel
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 Kyleena, but the FDA has already approved 12 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 12 companies, the first in June 2009. 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 levonorgestrel in some form is listed for sale by 40 companies. Ask your pharmacy whether it can fill your prescription with it.
Afaxys Pharma, LLC, Amazon.com Services LLC, Aurohealth LLC, Cadence Health Inc, Camber Consumer Care Inc, Cardinal Health (Leader) 70000 and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Lupin Ltd | January 2013 | 0.75MG, 1.5MG | – |
| Novel Laboratories Inc | February 2013 | 1.5MG | – |
| Perrigo R And D Co | August 2014 | 1.5MG | – |
| Sun Pharmaceutical Industries Ltd | September 2014 | 1.5MG | – |
| Xiromed LLC | October 2014 | 0.75MG, 1.5MG | – |
| Naari Pte Ltd | May 2015 | 1.5MG | – |
| Aurobindo Pharma Ltd | December 2015 | 1.5MG | – |
| Novast Laboratories Ltd | March 2016 | 1.5MG | – |
| Glenmark Pharmaceuticals Ltd | March 2016 | 1.5MG | – |
| Laboratoire Hra Pharma | July 2018 | 1.5MG | – |
| Xiromed Pharma Espana Sl | September 2018 | 1.5MG | – |
| Annora Pharma Private Ltd | September 2025 | 1.5MG | – |
| Watson Laboratories Inc discontinued | June 2009 | 0.75MG | – |
| Foundation Consumer Healthcare LLC discontinued | August 2009 | 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 1.5MG | – |
| L Perrigo Co discontinued | December 2010 | 0.75MG | – |
| Alvogen Inc discontinued | June 2015 | 1.5MG | – |
| Lotus Pharmaceutical Co Ltd Nantou Plant discontinued | September 2016 | 0.75MG | – |
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).
Kyleena 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 Kyleena, 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 Kyleena
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 Kyleena, before manufacturer rebates.
- $50.2K
- 2025, the whole year
For 43 people, about $1,167 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $50,186 | 43 | $1,167.12 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Kyleena only, so no generic is counted in it. What CMS says it is used for: This product is a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. It is used by women who want to use a reversible birth control method that works for a long time (up to 5 years).
Medicaid Prescriptions by Quarter
21,008 prescriptions in the four quarters to Q1 2026, $26.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 4,287 | $5,513,391 |
| Q4 2025 | 5,119 | $6,387,753 |
| Q3 2025 | 5,762 | $7,145,173 |
| Q2 2025 | 5,840 | $7,098,063 |
| Q1 2025 | 6,477 | $7,848,666 |
Source: CMS Medicaid State Drug Utilization Data, over Kyleena’s own package codes.
Kyleena Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 19.5MG | System | Intrauterine | September 2016 | Prescription reference product |
Source: FDA Orange Book, Bayer Healthcare Pharmaceuticals Inc. Listed for sale today by Bayer HealthCare Pharmaceuticals Inc. (FDA NDC Directory).
Kyleena NDC Codes and Packages
Each Kyleena 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 |
|---|---|---|---|
| 50419-0424-01 | LEVONORGESTREL 19.5 mg/1 intrauterine device | carton of 1 intrauterine device | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0424-01 | LEVONORGESTREL 19.5 mg/1 intrauterine device | carton of 1 intrauterine device | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0424-08 | LEVONORGESTREL 19.5 mg/1 intrauterine device | carton of 1 intrauterine device | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0424-08 | LEVONORGESTREL 19.5 mg/1 intrauterine device | carton of 1 intrauterine device | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0424-71 | LEVONORGESTREL 19.5 mg/1 intrauterine device | carton of 1 intrauterine device | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0424-71 | LEVONORGESTREL 19.5 mg/1 intrauterine device | carton of 1 intrauterine device | Bayer HealthCare Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Kyleena’s own FDA approval (NDA 208224) are listed, never a generic. Some codes belong to companies that repackage Kyleena: it is the same medicine in a different package.
What a Generic Kyleena 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 Kyleena
Is there a generic for Kyleena right now?
Yes. The FDA NDC Directory lists a generic levonorgestrel in some form from 40 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Kyleena go generic?
September 2029 is the expected month. It is when Kyleena’s patent 10,561,524 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic levonorgestrel be the same as Kyleena?
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 12 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Kyleena?
Yes. The FDA Orange Book lists approved generic versions from 12 companies, the first approved in June 2009: Lupin Ltd, Novel Laboratories Inc, Perrigo R And D Co, Sun Pharmaceutical Industries Ltd and 8 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 Kyleena patent expire?
The FDA Orange Book lists 3 patents for Kyleena; the last runs to September 2029. The one behind the expected month is patent 10,561,524, which ends in September 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 (September 2029) weighs all of that.
Changes to This Projection
- First generic expected September 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
- VelphoroFerric OxyhydroxideDuring 2026
- AddyiFlibanserinMay 2028
- RocklatanLatanoprost and Netarsudil Dimesylate2032 to 2033
- ImbruvicaIbrutinibMarch 2032
- DaybueTrofinetide2038 to 2039
- NeuproRotigotineTBD no date yet
About Kyleena
- Generic name levonorgestrel
- How it is taken In the uterus
- Company Bayer Healthcare Pharmaceuticals Inc
- 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 K
- Have a question? A pharmacist answers, free. Ask about Kyleena
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.