Subsys Generic: When Will Generic Fentanyl 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
Subsys Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? April 2030 10 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic fentanyl. None is for sale yet.
Will the generic cost less?
Usually, and more so as more companies sell one. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Subsys 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.
Subsys by the Numbers
- Reason
- Not yet clear2 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
- How sure
- Not rated Too early to rate.
- Price competition
- Moderate 2 companies have filed, 2 first in line
- Brand sales
- Sales not reported
- FDA approved 2012 January 2012 FDA Orange Book
- Patents listed 10 last runs to April 2030 FDA Orange Book
Subsys’s Road to a Generic
Subsys has had the market to itself since the FDA approved it in January 2012 (Btcp Pharma LLC). Its 10 listed patents run to April 2030. Generic companies have challenged its patents with the FDA since May 2017.
2 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
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.
Subsys Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Subsys’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 |
|---|---|---|---|
| 8,835,459 | The product’s formulation | January 2027 | Active |
| 8,835,460 | The product’s formulation; a way of using it (U-55) | January 2027 | Active |
| 9,241,935 | The product’s formulation | January 2027 | Active |
| 9,289,387 | The product’s formulation; a way of using it (U-55) | January 2027 | Active |
| 9,642,797 | The product’s formulation; a way of using it (U-55) | January 2027 | Active |
| 9,642,844 | The product’s formulation | January 2027 | Active |
| 10,016,403 | The product’s formulation | January 2027 | Active |
| 10,610,523 | The product’s formulation | January 2027 | Active |
| 8,486,972 | The product’s formulation | April 2030 | Active |
| 8,486,973 | A way of using it (U-55) | April 2030 | Active |
Source: FDA Orange Book, application 202788. Patent numbers open the patent on Google Patents.
Patent Challenges to Subsys
The first patent challenge to Subsys reached the FDA in May 2017, from one company on that first day. The FDA’s list has 2 entries for Subsys, by form and strength. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Subsys’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Sublingual spray, 0.4 mg/spray | May 2017 | 1 company | Head start no longer applies decided September 2023 | Not yet | Not yet | April 2030 |
| Sublingual spray, 0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray | December 2017 | 1 company | Head start no longer applies decided September 2023 | Not yet | Not yet | April 2030 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Fentanyl
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
2 companies have applied to the FDA to make generic fentanyl.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 2 of them were first in line, both filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Subsys’s patents with the FDA since May 2017: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic fentanyl. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic fentanyl 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).
Subsys 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 Subsys, 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.
Subsys Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray | Sublingual | January 2012 | Discontinued reference product |
| 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray | Sublingual | January 2012 | Discontinued reference product |
| 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray | Sublingual | January 2012 | Discontinued reference product |
| 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray | Sublingual | January 2012 | Discontinued reference product |
| 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray | Sublingual | January 2012 | Discontinued reference product |
| 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray | Sublingual | August 2012 | Discontinued reference product |
| 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Spray | Sublingual | August 2012 | Discontinued reference product |
Source: FDA Orange Book, Btcp Pharma LLC. Listed for sale today by Insys Therapeutics, Inc. and West Therapeutics Development, LLC (FDA NDC Directory).
What a Generic Subsys Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Subsys 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 Subsys”. 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 Subsys
Is there a generic for Subsys right now?
No. As of October 9, 2026 no generic fentanyl is listed for sale in the FDA NDC Directory.
When will Subsys go generic?
There is no expected month yet. 2 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
Will generic fentanyl be the same as Subsys?
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. 2 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Subsys?
Not yet. The FDA Orange Book lists no approved generic version of Subsys.
When does the Subsys patent expire?
The FDA Orange Book lists 10 patents for Subsys; the last runs to April 2030. 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Subsys patents?
Yes. The first patent challenge to Subsys reached the FDA in May 2017, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected a date that is not known yet 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
- MoxatagAmoxicillinMay 2027
- HyftorSirolimusMarch 2029
- RecorlevLevoketoconazole2034 to 2035
- TyzavanVancomycin HydrochlorideNovember 2035
- ZusduriMitomycin2036 to 2037
- CrenessityCrinecerfontJune 2041
About Subsys
- Generic name fentanyl
- How it is taken By mouth
- Company Btcp Pharma LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since May 2017 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Subsys
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 Paragraph IV Patent Certifications list, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.