Addyi Generic: When Will Generic Flibanserin 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
Addyi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2028 About a year and a half 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 FDA protection end? December 2028 FDA exclusivity: new use Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic flibanserin is expected to be available in May 2028, about a year and a half away. None is for sale yet.
Why May 2028?
It is when Addyi’s patent 7,151,103 ends. That patent covers a way of using it, and once it ends, 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 Addyi’s last FDA protection runs to December 2028, how can a generic come sooner?
Its FDA protection (new use) runs to December 2028. That protection covers only the use it was granted for, so a generic may be able to launch for other uses and leave that one off its label. 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 Addyi 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.
Addyi 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
- $35M a yearSmaller seller
- FDA approved 2015 August 2015 FDA Orange Book
- Patents listed 1 last runs to May 2028 FDA Orange Book
Addyi’s Road to a Generic
Addyi has had the market to itself since the FDA approved it in August 2015 (Sprout Pharmaceuticals Inc). Its FDA protection (new use) runs to December 2028. Its one listed patent runs to May 2028.
The first generic of Addyi is expected in May 2028.
Why that month: patent 7,151,103, on a way of using it, ends then.
Why a Generic Can Come Before December 2028
Its FDA protection (new use) runs to December 2028, but it covers only the use it was granted for, so a generic may be able to launch for other uses. 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.
Addyi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Addyi’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 7,151,103, which ends in May 2028, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,151,103 Sets the expected month of generic availability | A way of using it (U-1734) | May 2028 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-983 | Three years of protection for a newly approved use (indication). | December 2028 | Active |
Source: FDA Orange Book, application 022526. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Flibanserin
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 Addyi yet.
Approved by the FDA
Not yet. The FDA has not approved a generic flibanserin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic flibanserin 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).
Addyi 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 Addyi, 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.
Addyi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | August 2015 | Prescription reference product |
Source: FDA Orange Book, Sprout Pharmaceuticals Inc. Listed for sale today by Sprout Pharmaceuticals, Inc. (FDA NDC Directory).
Addyi NDC Codes and Packages
Each Addyi 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 |
|---|---|---|---|
| 58604-0214-30 | FLIBANSERIN 100 mg/1 tablet, film coated | bottle of 30 tablets | Sprout Pharmaceuticals, Inc. |
| 58604-0214-30 | FLIBANSERIN 100 mg/1 tablet, film coated | bottle of 30 tablets | Sprout Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Addyi’s own FDA approval (NDA 22526) are listed, never a generic. Some codes belong to companies that repackage Addyi: it is the same medicine in a different package.
What a Generic Addyi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Addyi 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 Addyi”. 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 Addyi
Is there a generic for Addyi right now?
No. As of October 9, 2026 no generic flibanserin is listed for sale in the FDA NDC Directory.
When will Addyi go generic?
May 2028 is the expected month, and that is probable but not certain. It is when Addyi’s patent 7,151,103 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. Its FDA protection (new use) runs to December 2028, but it covers only the use it was granted for, so a generic may be able to launch for other uses.
Will generic flibanserin be the same as Addyi?
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 Addyi?
Not yet. The FDA Orange Book lists no approved generic version of Addyi.
When does the Addyi patent expire?
One patent is listed for Addyi in the FDA Orange Book; it runs to May 2028. The one behind the expected month is patent 7,151,103, which ends in May 2028. 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 (May 2028) weighs all of that.
Changes to This Projection
- First generic expected May 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
- TarpeyoBudesonideDecember 2030
- FerabrightFerumoxytolOctober 2032
- PemfexyPemetrexedFebruary 2036
- BeqalziSonrotoclax2040 to 2041
- LazcluzeLazertinib MesylateAugust 2041
- XocovaEnsitrelvir Fumaric Acid2042 to 2043
About Addyi
- Generic name flibanserin
- How it is taken By mouth
- Company Sprout Pharmaceuticals Inc
- More drugs Brand-name drugs starting with A
- Have a question? A pharmacist answers, free. Ask about Addyi
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.