Osmolex ER Generic: When Will Generic Amantadine 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
Osmolex ER Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2038 About 11.5 years away Why then?
- Has the FDA approved a generic? August 2024 Since discontinued Why not yet?
- When does the last patent end? February 2038 9 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic amantadine hydrochloride is expected to be available in February 2038, about 11.5 years away. None is for sale yet.
Why February 2038?
It is when Osmolex ER’s patents 10,213,393, 10,213,394, 10,500,170, 10,500,171 and 3 more end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
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 Osmolex ER 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.
Osmolex ER by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2018 February 2018 FDA Orange Book
- Patents listed 9 last runs to February 2038 FDA Orange Book
Osmolex ER’s Road to a Generic
Osmolex ER has had the market to itself since the FDA approved it in February 2018 (Supernus Pharmaceuticals Inc). Its 9 listed patents run to February 2038.
The first generic of Osmolex ER is expected in February 2038.
Why that month: patents 10,213,393, 10,213,394, 10,500,170, 10,500,171 and 3 more, on a way of using it, end then.
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.
Osmolex ER Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Osmolex ER’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: patents 10,213,393, 10,213,394, 10,500,170, 10,500,171 and 3 more, which end in February 2038, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,389,578 | A way of using it (U-3054, U-219) | January 2028 | Active |
| 8,252,331 | The product’s formulation | March 2030 | Active |
| 10,213,393 Sets the expected month of generic availability | A way of using it (U-20) | February 2038 | Active |
| 10,213,394 Sets the expected month of generic availability | A way of using it (U-2497) | February 2038 | Active |
| 10,500,170 Sets the expected month of generic availability | A way of using it (U-20) | February 2038 | Active |
| 10,500,171 Sets the expected month of generic availability | A way of using it (U-2497) | February 2038 | Active |
| 10,500,172 Sets the expected month of generic availability | A way of using it (U-2497) | February 2038 | Active |
| 10,512,617 Sets the expected month of generic availability | A way of using it (U-2497) | February 2038 | Active |
| 11,890,261 Sets the expected month of generic availability | A way of using it (U-2497) | February 2038 | Active |
Source: FDA Orange Book, application 209410. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Amantadine 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
No company is recorded as having applied to the FDA to make a generic Osmolex ER yet.
Approved by the FDA
Not yet. The FDA has not approved a generic amantadine hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic amantadine hydrochloride for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Zydus Worldwide Dmcc discontinued | August 2024 | EQ 68.5MG BASE | – |
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).
Osmolex ER 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 Osmolex ER, 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.
Osmolex ER Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 129MG BASE | Tablet, extended release | Oral | February 2018 | Discontinued reference product |
| EQ 193MG BASE | Tablet, extended release | Oral | February 2018 | Discontinued reference product |
| EQ 258MG BASE | Tablet, extended release | Oral | February 2018 | Discontinued reference product |
| EQ 161MG BASE | Tablet, extended release | Oral | April 2020 | Discontinued reference product |
Source: FDA Orange Book, Supernus Pharmaceuticals Inc. Listed for sale today by Vertical Pharmaceuticals, LLC and Adamas Pharma, LLC (FDA NDC Directory).
Osmolex ER NDC Codes and Packages
Each Osmolex ER 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 |
|---|---|---|---|
| 68025-0075-30 | 129 mg tablet, extended release | bottle of 30 tablets | Vertical Pharmaceuticals, LLC |
| 68025-0075-90 | 129 mg tablet, extended release | bottle of 90 tablets | Vertical Pharmaceuticals, LLC |
| 70482-0075-07 | 129 mg tablet, extended release | carton of 2 blister packs of 7 tablets | Adamas Pharma, LLC |
| 70482-0075-14 | 129 mg tablet, extended release | bottle of 14 tablets | Adamas Pharma, LLC |
| 70482-0075-30 | 129 mg tablet, extended release | bottle of 30 tablets | Adamas Pharma, LLC |
| 68025-0021-30 | 161 mg tablet, extended release | bottle of 30 tablets | Vertical Pharmaceuticals, LLC |
| 68025-0021-90 | 161 mg tablet, extended release | bottle of 90 tablets | Vertical Pharmaceuticals, LLC |
| 68025-0076-30 | 193 mg tablet, extended release | bottle of 30 tablets | Vertical Pharmaceuticals, LLC |
Show the other 5 Osmolex ER packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 68025-0076-90 | 193 mg tablet, extended release | bottle of 90 tablets | Vertical Pharmaceuticals, LLC |
| 70482-0076-07 | 193 mg tablet, extended release | carton of 2 blister packs of 7 tablets | Adamas Pharma, LLC |
| 70482-0076-14 | 193 mg tablet, extended release | bottle of 14 tablets | Adamas Pharma, LLC |
| 70482-0076-30 | 193 mg tablet, extended release | bottle of 30 tablets | Adamas Pharma, LLC |
| 68025-0074-62 | kit | 1 KIT in 1 CARTON * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE * 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | Vertical Pharmaceuticals, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Osmolex ER’s own FDA approval (NDA 209410) are listed, never a generic. Some codes belong to companies that repackage Osmolex ER: it is the same medicine in a different package.
What a Generic Osmolex ER Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Osmolex ER 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 Osmolex ER”. 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 Osmolex ER
Is there a generic for Osmolex ER right now?
No. As of October 9, 2026 no generic amantadine hydrochloride is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Osmolex ER go generic?
February 2038 is the expected month, and that is toss-up but not certain. It is when Osmolex ER’s patents 10,213,393, 10,213,394, 10,500,170, 10,500,171 and 3 more end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic amantadine hydrochloride be the same as Osmolex ER?
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 Osmolex ER?
Not yet. The FDA Orange Book lists no approved generic version of Osmolex ER that is still marketed.
When does the Osmolex ER patent expire?
The FDA Orange Book lists 9 patents for Osmolex ER; the last runs to February 2038. The one behind the expected month is patents 10,213,393, 10,213,394, 10,500,170, 10,500,171 and 3 more, which end in February 2038. 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 (February 2038) weighs all of that.
Changes to This Projection
- First generic expected February 2038 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
- RexultiBrexpiprazoleDuring 2029
- Abilify MaintenaAripiprazole2031 to 2032
- IdhifaEnasidenib MesylateSeptember 2034
- CyklxArticaine HydrochlorideMarch 2039
- MyqorzoAficamten2040 to 2041
- ValturnaAliskiren Hemifumarate and ValsartanTBD no date yet
About Osmolex ER
- Generic name amantadine hydrochloride
- How it is taken By mouth
- Company Supernus Pharmaceuticals Inc
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Osmolex ER
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.