Seglentis Generic: When Will Generic Celecoxib and Tramadol Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Seglentis Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? April 2030 About 3.5 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? June 2031 7 patents listed with the FDA Why is a generic expected sooner?
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic celecoxib and tramadol hydrochloride is expected to be available in April 2030, about 3.5 years away. None is for sale yet.

Why April 2030?

It is when Seglentis’s patents 8,598,152, 9,012,440, 10,238,668, 10,245,276 and 2 more end. They cover the active ingredient, the product’s formulation and a way of using it, and once they end, generics should be able to 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.

If Seglentis’s last patent runs to June 2031, how can a generic come sooner?

The patent that runs to June 2031 (8,846,744) covers the product’s formulation. 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. That is why the expected month comes before the last protection ends. See the road to a generic

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 Seglentis 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.

Seglentis 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 2021 October 2021 FDA Orange Book
  • Patents listed 7 last runs to June 2031 A generic is expected sooner, in April 2030. See why FDA Orange Book
  • Pharmacies pay $4.35 per tablet NADAC, February 2024
  • Medicare Part D spent $4,328 in 2025, for 11 people CMS Part D Spending by Drug

Seglentis’s Road to a Generic

Seglentis has had the market to itself since the FDA approved it in October 2021 (Kowa Pharmaceuticals America Inc). Its 7 listed patents run to June 2031.

The first generic of Seglentis is expected in April 2030.

Why that month: patents 8,598,152, 9,012,440, 10,238,668, 10,245,276 and 2 more, on the active ingredient, the product’s formulation and a way of using it, end then. That is about a year before the last listed patent runs out, in June 2031.

Brand alone on the market Since FDA approval, October 2021
Patent 8,598,152 Expires April 2030 Ends in the expected month of generic availability
Patent 9,012,440 Expires April 2030 Ends in the expected month of generic availability
Patent 10,238,668 Expires April 2030 Ends in the expected month of generic availability
Patent 10,245,276 Expires April 2030 Ends in the expected month of generic availability
Patent 11,478,488 Expires April 2030 Ends in the expected month of generic availability
Patent 8,846,744 Expires June 2031
Brand alone on the market Patent on the active ingredient Patent on the formulation Patent on a use First generic expected 1 more patent ends earlier; every patent is in the table below. Swipe the chart sideways to see every year.

Why a Generic Can Come Before June 2031

The last listed patent runs to June 2031, but it covers the product’s formulation, 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.

Seglentis Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Seglentis’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 8,598,152, 9,012,440, 10,238,668, 10,245,276 and 2 more, which end in April 2030, the month the first generic is expected. Why the later ones may not hold it back

Patents listed with the FDA (7)
PatentWhat it coversProtects untilStatus
8,598,152 Sets the expected month of generic availability The active ingredient; the product’s formulation April 2030 Active
9,012,440 Sets the expected month of generic availability The active ingredient; the product’s formulation April 2030 Active
10,238,668 Sets the expected month of generic availability The active ingredient; the product’s formulation; a way of using it (U-3244) April 2030 Active
10,245,276 Sets the expected month of generic availability The active ingredient; the product’s formulation April 2030 Active
10,548,909 Sets the expected month of generic availability A way of using it (U-3244) April 2030 Active
11,478,488 Sets the expected month of generic availability A way of using it (U-3244) April 2030 Active
8,846,744 The product’s formulation June 2031 Active

Source: FDA Orange Book, application 213426. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Celecoxib and 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.

1

Applied to the FDA

No company is recorded as having applied to the FDA to make a generic Seglentis yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic celecoxib and tramadol hydrochloride. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic celecoxib and tramadol hydrochloride 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).

Seglentis Price: What Pharmacies Pay and What Generics Usually Do

What a Generic Could Cost

How we estimate it. We start from what pharmacies pay for Seglentis today: $4.35 per tablet for Seglentis 56 mg-44 mg tablet in February 2024, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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).

Dollar figures apply FDA’s median drops to the $4.35 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

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.

What Medicare and Medicaid Spend on Seglentis

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Medicare Part D Spending

What Medicare drug plans spent on Seglentis, before manufacturer rebates.

$4,328
2025, the whole year
For 11 people, about $361 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
2025$4,32811$360.63

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Seglentis only, so no generic is counted in it. What CMS says it is used for: See also Warning section. This product is used to help relieve moderate to severe acute pain.

Seglentis Strengths and Forms

StrengthFormHow it is takenApprovedStatus
56MG;44MGTabletOralOctober 2021Discontinued reference product

Source: FDA Orange Book, Kowa Pharmaceuticals America Inc. Listed for sale today by Kowa Pharmaceuticals America, Inc. (FDA NDC Directory).

Seglentis NDC Codes and Packages

Each Seglentis 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.

Seglentis packages (3)
NDCProductPackageCompany
66869-0564-3056 mg / 44 mg tabletbottle of 30 tabletsKowa Pharmaceuticals America, Inc.
66869-0564-3556 mg / 44 mg tabletbottle of 35 tabletsKowa Pharmaceuticals America, Inc.
66869-0564-9056 mg / 44 mg tabletbottle of 90 tabletsKowa Pharmaceuticals America, Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Seglentis’s own FDA approval (NDA 213426) are listed, never a generic. Some codes belong to companies that repackage Seglentis: it is the same medicine in a different package.

What a Generic Seglentis Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Seglentis 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 Seglentis”. 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 Seglentis

Is there a generic for Seglentis right now?

No. As of October 9, 2026 no generic celecoxib and tramadol hydrochloride is listed for sale in the FDA NDC Directory.

When will Seglentis go generic?

April 2030 is the expected month, and that is toss-up but not certain. It is when Seglentis’s patents 8,598,152, 9,012,440, 10,238,668, 10,245,276 and 2 more end. They cover the active ingredient, the product’s formulation and a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to June 2031, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge.

Will generic celecoxib and tramadol hydrochloride be the same as Seglentis?

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 Seglentis?

Not yet. The FDA Orange Book lists no approved generic version of Seglentis.

When does the Seglentis patent expire?

The FDA Orange Book lists 7 patents for Seglentis; the last runs to June 2031. The one behind the expected month is patents 8,598,152, 9,012,440, 10,238,668, 10,245,276 and 2 more, which end in 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 month on this page (April 2030) weighs all of that.

How much does Seglentis cost now?

Pharmacies paid about $4.35 per tablet for Seglentis 56 mg-44 mg tablet in February 2024, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected April 2030 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

All upcoming generics

About Seglentis

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, NADAC (CMS), CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.