Subvenite Generic: When Will Generic Lamotrigine 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

Subvenite Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? May 2040 About 13.5 years away Why then?
  2. Has the FDA approved a generic? June 2006 21 companies approved
  3. When does the last patent end? May 2040 4 patents listed with the FDA
  4. Can you buy a generic today? Yes 65 companies list one

Explains

PharmD, BCPS · Clinical pharmacist Updated

It already is. A generic lamotrigine is listed for sale by 65 companies, so ask your pharmacy whether it can fill your prescription with one.

Why May 2040?

It is when Subvenite’s patents 11,596,634, 11,612,566, 12,629,377 and 12,636,289 end. They cover a way of using it and the product’s formulation, 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.

What should I do now?

Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Subvenite, 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.

Subvenite 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
under $10M a yearSmall seller
  • FDA approved 2025 September 2025 FDA Orange Book
  • Patents listed 4 last runs to May 2040 FDA Orange Book
  • Generics FDA-approved 21 companies, the first approved June 2006 FDA Orange Book
  • Pharmacies pay $2.86 per mL NADAC, October 2026
  • Medicare Part D spent $9,942 in 2025, for 168 people CMS Part D Spending by Drug
  • Medicaid prescriptions 52 in the last four reported quarters, $101.1K CMS Medicaid drug utilization, to Q1 2026

Subvenite’s Road to a Generic

Subvenite has had the market to itself since the FDA approved it in September 2025 (Owp Pharmaceuticals Inc). Its 4 listed patents run to May 2040.

The first generic of Subvenite is expected in May 2040.

Why that month: patents 11,596,634, 11,612,566, 12,629,377 and 12,636,289, on a way of using it and the product’s formulation, end then.

Brand alone on the market Since FDA approval, September 2025
Patent 11,596,634 Expires May 2040 The patent behind the expected month of generic availability
Patent 11,612,566 Expires May 2040 The patent behind the expected month of generic availability
Patent 12,629,377 Expires May 2040 The patent behind the expected month of generic availability
Patent 12,636,289 Expires May 2040 The patent behind the expected month of generic availability
Brand alone on the market Patent on the formulation Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Subvenite Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Subvenite’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 11,596,634, 11,612,566, 12,629,377 and 12,636,289, which end in May 2040, the month the first generic is expected.

Patents listed with the FDA (4)
PatentWhat it coversProtects untilStatus
11,596,634 Sets the expected month of generic availability A way of using it (U-4271, U-4272, U-4273) May 2040 Active
11,612,566 Sets the expected month of generic availability A way of using it (U-4271, U-4272, U-4273) May 2040 Active
12,629,377 Sets the expected month of generic availability The product’s formulation; a way of using it (U-4539, U-4540, U-4541) May 2040 Active
12,636,289 Sets the expected month of generic availability The product’s formulation May 2040 Active

Source: FDA Orange Book, application 218879. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Lamotrigine

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 application count is on record for Subvenite, but the FDA has already approved 21 companies (step 2), and every approval starts with an application.

2

Approved by the FDA

The FDA has approved generic versions from 21 companies, the first in June 2006. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

3

For Sale in Pharmacies

Yes. A generic lamotrigine is listed for sale by 65 companies. Ask your pharmacy whether it can fill your prescription with it.

A-S Medication Solutions, Actavis Pharma, Inc., Advagen Pharma Limited, Advanced Rx Pharmacy of Tennessee, LLC, Ajanta Pharma USA Inc., Alembic Pharmaceuticals Inc. and 34 more

Generic versions the FDA has approved (35 companies)
CompanyFirst approvedStrengthsRated
Dr Reddys Laboratories Ltd January 20095MG, 25MG, 50MG, 100MG, 150MG, 200MG, 250MG, 300MGAB
Watson Laboratories Inc January 20092MG, 5MG, 25MGAB
Zydus Pharmaceuticals USA Inc January 20095MG, 25MG, 50MG, 100MG, 150MG, 200MG, 250MG, 300MGAB
Aurobindo Pharma Ltd January 20095MG, 25MG, 100MG, 150MG, 200MGAB
Jubilant Cadista Pharmaceuticals Inc January 200925MG, 100MG, 150MG, 200MGAB
Rubicon Research Ltd January 200925MG, 50MG, 100MG, 150MG, 200MGAB
Taro Pharmaceutical Industries Ltd January 20095MG, 25MG, 50MG, 100MG, 150MG, 200MGAB
Torrent Pharmaceuticals Ltd January 200925MG, 50MG, 100MG, 150MG, 200MGAB
Glenmark Pharmaceuticals Ltd February 20095MG, 25MG, 100MG, 150MG, 200MGAB
Alembic Pharmaceuticals Ltd January 20115MG, 25MG, 50MG, 100MG, 150MG, 200MG, 250MG, 300MGAB
Unichem Laboratories Ltd October 201125MG, 100MG, 150MG, 200MGAB
Ph Health Ltd December 201225MG, 50MG, 100MG, 200MG, 250MG, 300MGAB
Sciegen Pharmaceuticals Inc January 201325MG, 50MG, 100MG, 200MG, 300MGAB
Alkem Laboratories Ltd June 201325MG, 100MG, 150MG, 200MGAB
Impax Laboratories Inc July 201325MG, 50MG, 100MG, 200MGAB
Actavis Elizabeth LLC October 201325MG, 50MG, 100MG, 200MG, 250MG, 300MGAB
Amneal Pharmaceuticals Of New York LLC November 201825MG, 50MG, 100MG, 200MG, 250MG, 300MGAB
Ajanta Pharma Ltd January 202125MG, 50MG, 100MG, 200MGAB
Yiling Pharmaceutical Ltd December 202125MG, 50MG, 100MG, 200MG, 250MG, 300MGAB
J Molner Holdings Inc February 202225MG, 50MG, 100MG, 200MGAB
Ipca Laboratories Ltd September 202425MG, 100MG, 150MG, 200MGAB
Teva Pharmaceuticals USA Inc discontinued June 20065MG, 25MG, 100MG, 150MG, 200MG–
Chartwell Rx Sciences LLC discontinued January 20095MG, 25MG–
Pharmobedient Consulting LLC discontinued January 20095MG, 25MG, 100MG, 150MG, 200MG–
Aiping Pharmaceutical Inc discontinued January 200925MG, 100MG, 150MG, 200MG–
Granules India Ltd discontinued January 200925MG, 100MG, 150MG, 200MG–
Natco Pharma Ltd discontinued January 200925MG, 100MG, 150MG, 200MG–
Rising Pharma Holding Inc discontinued January 200925MG, 100MG, 150MG, 200MG–
Roxane Laboratories Inc discontinued January 200925MG, 100MG, 150MG, 200MG–
Zennova Pharmaceuticals Chengdu Co Ltd discontinued February 200925MG, 100MG, 150MG, 200MG–
Lupin Ltd discontinued June 201025MG, 100MG, 150MG, 200MG–
Chartwell Molecular Holdings LLC discontinued November 201025MG, 100MG, 150MG, 200MG–
Jubilant Generics Ltd discontinued February 20115MG, 25MG–
Actavis Totowa LLC discontinued April 201125MG, 100MG, 150MG, 200MG–
Hikma Pharmaceuticals discontinued April 201125MG, 100MG, 150MG, 200MG–

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Subvenite Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Subvenite 10 mg/mL suspension

$2.86 per mL in October 2026.

Hover over or tap anywhere on the chart to see that month’s price.

See the numbers
MonthPharmacies paid per mL
October 2026$2.86
September 2026$2.86
August 2026$2.87

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

How we estimate it. We start from what pharmacies pay for Subvenite today: $2.86 per mL for Subvenite 10 mg/mL suspension in October 2026, 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 $2.86 pharmacies pay per mL 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 Subvenite

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 Subvenite, before manufacturer rebates.

$148.7K
January to March 2026, the latest CMS has posted
For 125 people, about $670 per prescription fill
$9,942
2025, the whole year
For 168 people, about $16 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$148,659125$669.64
2025$9,942168$15.81

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Subvenite only, so no generic is counted in it. What CMS says it is used for: Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults.

Subvenite Strengths and Forms

StrengthFormHow it is takenApprovedStatus
10MG/MLSuspensionOralSeptember 2025Prescription reference product

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

Subvenite NDC Codes and Packages

Each Subvenite 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.

Subvenite packages (2)
NDCProductPackageCompany
69102-0418-01LAMOTRIGINE 10 mg/mL suspensionbottle of 240 mLOWP Pharmaceuticals, Inc.
69102-0418-02LAMOTRIGINE 10 mg/mL suspensionpackage of 2 bottles of 240 mLOWP Pharmaceuticals, Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Subvenite’s own FDA approval (NDA 218879) are listed, never a generic. Some codes belong to companies that repackage Subvenite: it is the same medicine in a different package.

What a Generic Subvenite 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 Subvenite

Is there a generic for Subvenite right now?

Yes. The FDA NDC Directory lists a generic lamotrigine from 65 companies. Ask your pharmacy whether it can fill your prescription with it.

When will Subvenite go generic?

It already has. The FDA NDC Directory lists a generic lamotrigine from 65 companies, so ask your pharmacy whether it can fill your prescription with one.

Will generic lamotrigine be the same as Subvenite?

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. The FDA has already approved 21 companies to make a generic, and how many of them launch decides how far the price falls.

Has the FDA approved a generic Subvenite?

Yes. The FDA Orange Book lists approved generic versions from 21 companies, the first approved in June 2006: Dr Reddys Laboratories Ltd, Watson Laboratories Inc, Zydus Pharmaceuticals USA Inc, Aurobindo Pharma Ltd and 17 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 Subvenite patent expire?

The FDA Orange Book lists 4 patents for Subvenite; the last runs to May 2040. The one behind the expected month is patents 11,596,634, 11,612,566, 12,629,377 and 12,636,289, which end in May 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 month on this page (May 2040) weighs all of that.

How much does Subvenite cost now?

Pharmacies paid about $2.86 per mL for Subvenite 10 mg/mL suspension in October 2026, 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 May 2040 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 Subvenite

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