Nextstellis Generic: When Will Generic Drospirenone and Estetrol 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
Nextstellis Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2028 Sometime that year 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? October 2043 7 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 drospirenone and estetrol is expected to be available sometime in 2028. None is for sale yet.
Why 2028?
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. We rate it probable: more likely than not, but it can still move.
If Nextstellis’s last patent runs to October 2043, how can a generic come sooner?
The 6 patents that run past the expected month, to October 2043 (11,793,760, 11,957,694, 11,964,055, 12,427,114 and 2 more), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. 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 Nextstellis 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.
Nextstellis 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
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $148M a yearBig seller
- FDA approved 2021 April 2021 FDA Orange Book
- Patents listed 7 last runs to October 2043 A generic is expected sooner, sometime in 2028. See why FDA Orange Book
- Pharmacies pay $7.67 each, up 10.1% in a year NADAC, October 2026
- Medicare Part D spent $142.3K in 2025, for 107 people CMS Part D Spending by Drug
- Medicaid prescriptions 30.5K in the last four reported quarters, $10.7M CMS Medicaid drug utilization, to Q1 2026
Nextstellis’s Road to a Generic
Nextstellis has had the market to itself since the FDA approved it in April 2021 (Mayne Pharma LLC). Its FDA protections on record ended by April 2026. Its 7 listed patents run to October 2043.
The first generic of Nextstellis is expected sometime in 2028.
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.
Why a Generic Can Come Before October 2043
The last listed patent runs to October 2043, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. 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.
Nextstellis Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Nextstellis’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 |
|---|---|---|---|
| 7,732,430 | The product’s formulation; a way of using it (U-3152) | January 2028 | Active |
| 11,793,760 | The product’s formulation | June 2036 | Active |
| 11,957,694 | The product’s formulation | June 2036 | Active |
| 11,964,055 | The product’s formulation | June 2036 | Active |
| 12,427,114 | The product’s formulation; a way of using it (U-3152) | June 2036 | Active |
| 12,233,074 | The product’s formulation; a way of using it (U-3152) | February 2043 | Active |
| 12,458,649 | A way of using it (U-3152) | October 2043 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | April 2026 | Ended |
Source: FDA Orange Book, application 214154. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Drospirenone and Estetrol
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 Nextstellis yet.
Approved by the FDA
Not yet. The FDA has not approved a generic drospirenone and estetrol. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic drospirenone and estetrol 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).
Nextstellis Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Nextstellis 3-14.2 mg tablet
$7.67 each in October 2026, up 10.1% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid each |
|---|---|
| October 2026 | $7.67 |
| September 2026 | $7.67 |
| August 2026 | $7.67 |
| July 2026 | $7.67 |
| June 2026 | $7.67 |
| May 2026 | $7.30 |
| April 2026 | $7.29 |
| March 2026 | $7.30 |
| February 2026 | $7.29 |
| January 2026 | $7.30 |
| February 2024 | $6.96 |
| January 2024 | $6.96 |
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 Nextstellis today: $7.67 each for Nextstellis 3-14.2 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 $7.67 pharmacies pay each 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 Nextstellis
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 Nextstellis, before manufacturer rebates.
- $37.9K
- January to March 2026, the latest CMS has posted
For 67 people, about $345 per prescription fill - $142.3K
- 2025, the whole year
For 107 people, about $371 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $37,914 | 67 | $344.68 |
| 2025 | $142,348 | 107 | $370.70 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Nextstellis only, so no generic is counted in it. What CMS says it is used for: This medication is a combination of 2 hormones: an estrogen (estetrol) and a progestin (drospirenone). This product is used to prevent pregnancy.
Medicaid Prescriptions by Quarter
30,490 prescriptions in the four quarters to Q1 2026, $10.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 7,053 | $2,551,192 |
| Q4 2025 | 7,578 | $2,681,665 |
| Q3 2025 | 8,007 | $2,812,250 |
| Q2 2025 | 7,852 | $2,679,200 |
| Q1 2025 | 7,714 | $2,647,560 |
Source: CMS Medicaid State Drug Utilization Data, over Nextstellis’s own package codes.
Nextstellis Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 3MG;14.2MG | Tablet | Oral | April 2021 | Prescription reference product |
Source: FDA Orange Book, Mayne Pharma LLC. Listed for sale today by Mayne Pharma (FDA NDC Directory).
Nextstellis NDC Codes and Packages
Each Nextstellis 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 |
|---|---|---|---|
| 51862-0258-00 | kit | 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK | Mayne Pharma |
| 51862-0258-00 | kit | 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK | Mayne Pharma |
| 51862-0258-01 | kit | 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK | Mayne Pharma |
| 51862-0258-01 | kit | 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK | Mayne Pharma |
Source: the FDA NDC Directory, current listings only. Only packages sold under Nextstellis’s own FDA approval (NDA 214154) are listed, never a generic. Some codes belong to companies that repackage Nextstellis: it is the same medicine in a different package.
What a Generic Nextstellis Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Nextstellis 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 Nextstellis”. 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 Nextstellis
Is there a generic for Nextstellis right now?
No. As of October 9, 2026 no generic drospirenone and estetrol is listed for sale in the FDA NDC Directory.
When will Nextstellis go generic?
Sometime in 2028 is the expected window, and that is probable but not certain. 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. The last listed patent runs to October 2043, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic drospirenone and estetrol be the same as Nextstellis?
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 Nextstellis?
Not yet. The FDA Orange Book lists no approved generic version of Nextstellis.
When does the Nextstellis patent expire?
The FDA Orange Book lists 7 patents for Nextstellis; the last runs to October 2043. 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 (Sometime in 2028) weighs all of that.
How much does Nextstellis cost now?
Pharmacies paid about $7.67 each for Nextstellis 3-14.2 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 Sometime in 2028 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
- Tekturna HCTAliskiren Hemifumarate and HydrochlorothiazideJuly 2028
- FetzimaLevomilnacipran Hydrochloride2029 to 2030
- BludigoIndigotindisulfonate Sodium2032 to 2033
- PhexxCitric Acid, L-Lactic Acid, and Potassium BitartrateMarch 2033
- XtoroFinafloxacinNovember 2033
- LeqvioInclisiranDuring 2036
About Nextstellis
- Generic name drospirenone and estetrol
- How it is taken By mouth
- Company Mayne Pharma LLC
- More drugs Brand-name drugs starting with N
- Have a question? A pharmacist answers, free. Ask about Nextstellis
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.