Onsolis 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
Onsolis 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? July 2027 Its only patent listed with the FDA
- Can you buy a generic today? Yes 1 company lists one
It already is. A generic fentanyl citrate is listed for sale by 1 company, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Onsolis, 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.
Onsolis 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
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2009 July 2009 FDA Orange Book
- Patents listed 1 last runs to July 2027 FDA Orange Book
Onsolis’s Road to a Generic
Onsolis has had the market to itself since the FDA approved it in July 2009 (Adalvo Ltd). Its one listed patent runs to July 2027.
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.
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.
Onsolis Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Onsolis’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 |
|---|---|---|---|
| 9,597,288 | The product’s formulation; a way of using it (U-767) | July 2027 | Active |
Source: FDA Orange Book, application 022266. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Fentanyl Citrate
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 Onsolis yet.
Approved by the FDA
Not yet. The FDA has not approved a generic fentanyl citrate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Yes. A generic fentanyl citrate is listed for sale by 1 company. Ask your pharmacy whether it can fill your prescription with it.
Teva Pharmaceuticals USA, Inc.
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).
Onsolis 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 Onsolis, 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.
Onsolis Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.2MG BASE | Film | Buccal | July 2009 | Discontinued |
| EQ 0.4MG BASE | Film | Buccal | July 2009 | Discontinued |
| EQ 0.6MG BASE | Film | Buccal | July 2009 | Discontinued |
| EQ 0.8MG BASE | Film | Buccal | July 2009 | Discontinued |
| EQ 1.2MG BASE | Film | Buccal | July 2009 | Discontinued |
Source: FDA Orange Book, Adalvo Ltd.
What a Generic Onsolis 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 Onsolis
Is there a generic for Onsolis right now?
Yes. The FDA NDC Directory lists a generic fentanyl citrate from 1 company. Ask your pharmacy whether it can fill your prescription with it.
When will Onsolis go generic?
It already has. The FDA NDC Directory lists a generic fentanyl citrate from 1 company, so ask your pharmacy whether it can fill your prescription with one.
Will generic fentanyl citrate be the same as Onsolis?
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 Onsolis?
Not yet. The FDA Orange Book lists no approved generic version of Onsolis.
When does the Onsolis patent expire?
One patent is listed for Onsolis in the FDA Orange Book; it runs to July 2027. 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.
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
- MekinistTrametinib Dimethyl Sulfoxide2027 to 2028
- ClenpiqCitric Acid, Magnesium Oxide, and Sodium Picosulfate2028 to 2029
- ZolpimistZolpidem TartrateAugust 2032
- QuliptaAtogepant2038 to 2039
- TuralioPexidartinib HydrochlorideJuly 2038
- GomekliMirdametinib2039 to 2040
About Onsolis
- Generic name fentanyl citrate
- How it is taken By mouth
- Company Adalvo Ltd
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Onsolis
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.