Qdolo Generic: When Will Generic Tramadol 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
Qdolo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2027 to 2028 A wide window Why then?
- Has the FDA approved a generic? June 2002 13 companies approved
- When does the last patent end? September 2040 2 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 55 companies list one
It already is. A generic tramadol hydrochloride is listed for sale by 55 companies, so ask your pharmacy whether it can fill your prescription with one.
Why 2027 to 2028?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Qdolo’s last patent runs to September 2040, how can a generic come sooner?
The 2 patents that run past the expected month, to September 2040 (11,103,452 and 11,752,103), 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Qdolo’s patents with the FDA since September 2024. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Qdolo, 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.
Qdolo by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2020 September 2020 FDA Orange Book
- Patents listed 2 last runs to September 2040 FDA Orange Book
- Generics FDA-approved 13 companies, the first approved June 2002 FDA Orange Book
Qdolo’s Road to a Generic
Qdolo has had the market to itself since the FDA approved it in September 2020 (Rosemount Pharmaceuticals LLC). Its 2 listed patents run to September 2040. Generic companies have challenged its patents with the FDA since September 2024.
The first generic of Qdolo is expected between 2027 and 2028.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before September 2040
The last listed patent runs to September 2040, 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.
Qdolo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Qdolo’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 |
|---|---|---|---|
| 11,103,452 | The product’s formulation; a way of using it (U-3197) | September 2040 | Active |
| 11,752,103 | The product’s formulation; a way of using it (U-3197) | September 2040 | Active |
Source: FDA Orange Book, application 214044. Patent numbers open the patent on Google Patents.
Patent Challenges to Qdolo
The first patent challenge to Qdolo reached the FDA in September 2024, from one company on that first day. The FDA approved a first challenger’s generic in June 2026, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Qdolo’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 | |||||
| Oral solution, 5 mg/mL | September 2024 | 1 company | First challenger eligible decided July 2026 | June 2026 | Not yet | September 2040 |
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 Tramadol Hydrochloride
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
At least 13 companies have applied to the FDA to make generic tramadol hydrochloride.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Qdolo’s patents with the FDA since September 2024: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 13 companies, the first in June 2002. 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 tramadol hydrochloride is listed for sale by 55 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, ACI Healthcare USA, Inc., Advagen Pharma Limited, Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC, American Health Packaging and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Sun Pharmaceutical Industries Inc | June 2002 | 50MG | AB |
| Teva Pharmaceuticals USA Inc | June 2002 | 50MG | AB |
| Amneal Pharmaceuticals Of New York LLC | June 2002 | 50MG | AB |
| Graviti Pharmaceuticals Private Ltd | June 2002 | 25MG, 50MG, 100MG | AB |
| Senores Pharmaceuticals Inc | January 2011 | 50MG | AB |
| Lupin Ltd | August 2011 | 100MG, 200MG, 300MG | AB1 |
| Strides Pharma Global Pte Ltd | November 2011 | 25MG, 50MG | AB |
| Cspc Ouyi Pharmaceutical Co Ltd | March 2013 | 50MG | AB |
| Aurobindo Pharma Ltd | March 2014 | 50MG, 100MG, 200MG, 300MG | AB |
| Macleods Pharmaceuticals Ltd | September 2015 | 50MG, 100MG, 200MG, 300MG | AB1 |
| Rubicon Research Ltd | June 2019 | 25MG, 50MG, 75MG, 100MG | AB |
| Unichem Laboratories Ltd | August 2019 | 50MG | AB |
| Novitium Pharma LLC | June 2026 | 5MG/ML | – |
| Actavis Elizabeth LLC discontinued | June 2002 | 50MG, 100MG, 200MG, 300MG | – |
| Mylan Pharmaceuticals Inc discontinued | June 2002 | 50MG, 100MG, 200MG, 300MG | – |
| Watson Laboratories discontinued | June 2002 | 50MG | – |
| Specgx LLC discontinued | June 2002 | 50MG | – |
| Pliva Inc discontinued | July 2002 | 50MG | – |
| Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals USA discontinued | July 2002 | 50MG | – |
| Apotex Inc discontinued | July 2002 | 50MG | – |
| Asta Medica Inc discontinued | July 2002 | 50MG | – |
| Strides Pharma International AG discontinued | November 2009 | 100MG, 200MG, 300MG | – |
| Northstar Healthcare Holdings Ltd discontinued | May 2010 | 50MG | – |
| Sun Pharmaceutical Industries Ltd discontinued | December 2011 | 100MG, 200MG, 300MG | – |
| Ph Health Ltd discontinued | June 2012 | 100MG, 200MG, 300MG | – |
| Ipca Laboratories Ltd discontinued | November 2012 | 50MG | – |
| Accord Healthcare Inc discontinued | May 2013 | 50MG | – |
| Puracap Laboratories LLC Dba Blu Pharmaceuticals discontinued | July 2019 | 50MG | – |
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).
Qdolo 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 Qdolo, 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.
Qdolo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 5MG/ML | Solution | Oral | September 2020 | Discontinued reference product |
Source: FDA Orange Book, Rosemount Pharmaceuticals LLC. Listed for sale today by Athena Bioscience, LLC (FDA NDC Directory).
Qdolo NDC Codes and Packages
Each Qdolo 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 |
|---|---|---|---|
| 71511-0301-16 | 5 mg/mL solution | bottle of 473 mL | Athena Bioscience, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Qdolo’s own FDA approval (NDA 214044) are listed, never a generic. Some codes belong to companies that repackage Qdolo: it is the same medicine in a different package.
What a Generic Qdolo 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 Qdolo
Is there a generic for Qdolo right now?
Yes. The FDA NDC Directory lists a generic tramadol hydrochloride from 55 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Qdolo go generic?
It already has. The FDA NDC Directory lists a generic tramadol hydrochloride from 55 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic tramadol hydrochloride be the same as Qdolo?
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. At least 13 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Qdolo?
Yes. The FDA Orange Book lists approved generic versions from 13 companies, the first approved in June 2002: Sun Pharmaceutical Industries Inc, Teva Pharmaceuticals USA Inc, Amneal Pharmaceuticals Of New York LLC, Graviti Pharmaceuticals Private Ltd and 9 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 Qdolo patent expire?
The FDA Orange Book lists 2 patents for Qdolo; the last runs to September 2040. 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 (2027 to 2028) weighs all of that.
Has anyone challenged the Qdolo patents?
Yes. The first patent challenge to Qdolo reached the FDA in September 2024, from one company on that first day. The FDA approved a first challenger’s generic in June 2026, and the list records no sale by a first challenger 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 2027 to 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
- SolosecSecnidazoleSeptember 2027
- JelmytoMitomycin2029 to 2030
- OnapgoApomorphine HydrochlorideFebruary 2032
- Vykat XRDiazoxide Choline2034 to 2035
- Aristada InitioAripiprazole LauroxilApril 2039
- EluciremGadopiclenolJanuary 2040
About Qdolo
- Generic name tramadol hydrochloride
- How it is taken By mouth
- Company Rosemount Pharmaceuticals LLC
- Patent challenges Since September 2024 (FDA)
- More drugs Brand-name drugs starting with Q
- Have a question? A pharmacist answers, free. Ask about Qdolo
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.