Oleptro Generic: When Will Generic Trazodone 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
Oleptro 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? October 1986 12 companies approved
- When does the last patent end? March 2029 2 patents listed with the FDA
- Can you buy a generic today? Yes 50 companies list one
It already is. A generic trazodone hydrochloride is listed for sale by 50 companies, 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 Oleptro, 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.
Oleptro 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
- Not rated Too early to rate.
- Price competition
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2010 February 2010 FDA Orange Book
- Patents listed 2 last runs to March 2029 FDA Orange Book
- Generics FDA-approved 12 companies, the first approved October 1986 FDA Orange Book
Oleptro’s Road to a Generic
Oleptro has had the market to itself since the FDA approved it in February 2010 (Angelini Pharma Inc). Its 2 listed patents run to March 2029. Generic companies have challenged its patents with the FDA since October 2010.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Oleptro Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Oleptro’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 |
|---|---|---|---|
| 7,829,120 | The product’s formulation; a way of using it (U-796) | March 2027 | Active |
| 8,133,893 | The active ingredient; the product’s formulation | March 2029 | Active |
Source: FDA Orange Book, application 022411. Patent numbers open the patent on Google Patents.
Patent Challenges to Oleptro
The first patent challenge to Oleptro reached the FDA in October 2010, from one company on that first day. 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 Oleptro’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 | |||||
| Extended-release tablets, 150 mg and 300 mg | October 2010 | 1 company | Head start no longer applies decided August 2020 | Not yet | Not yet | June 2020 |
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 Trazodone 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 12 companies have applied to the FDA to make generic trazodone 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 Oleptro’s patents with the FDA since October 2010: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 12 companies, the first in October 1986. 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 trazodone hydrochloride is listed for sale by 50 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Accord Healthcare, Inc., Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC, American Health Packaging, Aphena Pharma Solutions - Tennessee, LLC and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Apotex Inc | March 1987 | 50MG, 100MG, 150MG, 300MG | AB |
| Teva Pharmaceuticals USA Inc | December 1987 | 50MG, 100MG, 150MG | AB |
| Pliva Inc | March 1988 | 150MG | AB |
| Oxford Pharmaceuticals LLC | February 1989 | 25MG, 50MG, 75MG, 100MG | AB |
| Sun Pharmaceutical Industries Inc | March 1993 | 50MG, 100MG, 150MG | AB |
| Torrent Pharmaceuticals Ltd | November 2013 | 50MG, 100MG, 150MG, 300MG | AB |
| Accord Healthcare Inc | September 2017 | 50MG, 100MG, 150MG, 300MG | AB |
| Zydus Pharmaceuticals USA Inc | October 2017 | 50MG, 100MG, 150MG, 300MG | AB |
| Aurobindo Pharma Ltd | February 2020 | 50MG, 100MG, 150MG, 300MG | AB |
| Crossmedika SA | May 2024 | 50MG, 100MG, 150MG, 300MG | AB |
| Granules India Ltd | August 2024 | 50MG, 100MG, 150MG, 300MG | AB |
| Graviti Pharmaceuticals Private Ltd | August 2024 | 50MG, 100MG, 150MG, 300MG | AB |
| Watson Laboratories Inc discontinued | October 1986 | 50MG, 100MG | – |
| American Therapeutics Inc discontinued | October 1986 | 50MG, 100MG | – |
| Quantum Pharmics Ltd discontinued | December 1986 | 50MG, 100MG | – |
| Usl Pharma Inc discontinued | April 1987 | 50MG, 100MG | – |
| Alvogen Inc discontinued | April 1988 | 50MG, 100MG | – |
| Aiping Pharmaceutical Inc discontinued | April 1990 | 100MG | – |
| Rising Pharma Holdings Inc discontinued | April 1990 | 50MG | – |
| Natco Pharma Ltd discontinued | February 1991 | 50MG, 100MG | – |
| Pharmobedient Consulting LLC discontinued | June 2009 | 50MG, 100MG, 150MG, 300MG | – |
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).
Oleptro 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 Oleptro, 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.
Oleptro Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Tablet, extended release | Oral | February 2010 | Discontinued reference product |
| 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Tablet, extended release | Oral | February 2010 | Discontinued reference product |
Source: FDA Orange Book, Angelini Pharma Inc.
What a Generic Oleptro 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 Oleptro
Is there a generic for Oleptro right now?
Yes. The FDA NDC Directory lists a generic trazodone hydrochloride from 50 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Oleptro go generic?
It already has. The FDA NDC Directory lists a generic trazodone hydrochloride from 50 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic trazodone hydrochloride be the same as Oleptro?
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 12 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 Oleptro?
Yes. The FDA Orange Book lists approved generic versions from 12 companies, the first approved in October 1986: Apotex Inc, Teva Pharmaceuticals USA Inc, Pliva Inc, Oxford Pharmaceuticals LLC and 8 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 Oleptro patent expire?
The FDA Orange Book lists 2 patents for Oleptro; the last runs to March 2029. 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 Oleptro patents?
Yes. The first patent challenge to Oleptro reached the FDA in October 2010, 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
- TrintellixVortioxetine HydrobromideDecember 2026
- ZepatierElbasvir and GrazoprevirMay 2031
- CalquenceAcalabrutinib2033 to 2034
- Pylarify TruvuPiflufolastat F 18June 2034
- LumryzSodium Oxybate2039 to 2040
- GelniqueOxybutynin ChlorideTBD no date yet
About Oleptro
- Generic name trazodone hydrochloride
- How it is taken By mouth
- Company Angelini Pharma Inc
- Patent challenges Since October 2010 (FDA)
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Oleptro
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.