Lodoco Generic: When Will Generic Colchicine 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
Lodoco Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2033 About 7 years away Why then?
- Has the FDA approved a generic? September 2016 14 companies approved
- When does the last patent end? May 2034 13 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 37 companies list one
It already is. A generic colchicine is listed for sale by 37 companies, so ask your pharmacy whether it can fill your prescription with one.
Why November 2033?
It is when Lodoco’s patents 9,744,144, 10,206,891, 10,265,281, 10,842,762 and 6 more end. They cover 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 probable: more likely than not, but it can still move.
If Lodoco’s last patent runs to May 2034, how can a generic come sooner?
The patent that runs to May 2034 (10,130,585) covers 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. 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 Lodoco, 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.
Lodoco by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $3M a yearSmaller seller
- FDA approved 2023 June 2023 FDA Orange Book
- Patents listed 13 last runs to May 2034 FDA Orange Book
- Generics FDA-approved 14 companies, the first approved September 2016 FDA Orange Book
- Pharmacies pay $17.00 per tablet NADAC, October 2026
- Medicare Part D spent $920.9K in 2025, for 382 people CMS Part D Spending by Drug
- Medicaid prescriptions 259 in the last four reported quarters, $137.7K CMS Medicaid drug utilization, to Q1 2026
Lodoco’s Road to a Generic
Lodoco has had the market to itself since the FDA approved it in June 2023 (Agepha Pharma Fz LLC). Its 13 listed patents run to May 2034.
The first generic of Lodoco is expected in November 2033.
Why that month: patents 9,744,144, 10,206,891, 10,265,281, 10,842,762 and 6 more, on a way of using it, end then. That is a few months before the last listed patent runs out, in May 2034.
Why a Generic Can Come Before May 2034
The last listed patent runs to May 2034, but it covers 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.
Lodoco Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lodoco’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 9,744,144, 10,206,891, 10,265,281, 10,842,762 and 6 more, which end in November 2033, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,744,144 Sets the expected month of generic availability | A way of using it (U-3643) | November 2033 | Active |
| 10,206,891 Sets the expected month of generic availability | A way of using it (U-3641) | November 2033 | Active |
| 10,265,281 Sets the expected month of generic availability | A way of using it (U-3639) | November 2033 | Active |
| 10,842,762 Sets the expected month of generic availability | A way of using it (U-3640) | November 2033 | Active |
| 11,026,899 Sets the expected month of generic availability | A way of using it (U-3639) | November 2033 | Active |
| 11,026,900 Sets the expected month of generic availability | A way of using it (U-3639) | November 2033 | Active |
| 11,026,901 Sets the expected month of generic availability | A way of using it (U-3638) | November 2033 | Active |
| 11,944,594 Sets the expected month of generic availability | A way of using it (U-3864) | November 2033 | Active |
| 11,944,595 Sets the expected month of generic availability | A way of using it (U-3867, U-3868) | November 2033 | Active |
| 12,233,035 | A way of using it (U-4132) | November 2033 | Active |
| 12,280,025 Sets the expected month of generic availability | A way of using it (U-4168) | November 2033 | Active |
| 12,364,675 | A way of using it (U-3639) | November 2033 | Active |
| 10,130,585 | A way of using it (U-3642) | May 2034 | Active |
Source: FDA Orange Book, application 215727. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Colchicine
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 application count is on record for Lodoco, but the FDA has already approved 14 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 14 companies, the first in September 2016. 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 colchicine is listed for sale by 37 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Actavis Pharma, Inc., American Health Packaging, Amneal Pharmaceuticals LLC, Aphena Pharma Solutions - Tennessee, LLC, Ascend Laboratories, LLC and 31 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Amneal Pharmaceuticals | September 2016 | 0.6MG | AB |
| Ph Health Ltd | November 2018 | 0.6MG | AB |
| Alkem Laboratories Ltd | February 2019 | 0.6MG | AB |
| Zydus Pharmaceuticals USA Inc | February 2019 | 0.3MG, 0.6MG | AB |
| Watson Laboratories Inc | July 2019 | 0.6MG | AB |
| Dr Reddys Laboratories Ltd | September 2019 | 0.6MG | AB |
| Mylan Pharmaceuticals Inc | September 2019 | 0.6MG | AB |
| Granules Pharmaceuticals Inc | February 2020 | 0.6MG | AB |
| Hetero Labs Ltd Unit V | August 2021 | 0.6MG | AB |
| Aurobindo Pharma Ltd | January 2022 | 0.6MG | AB |
| Strides Pharma Global Pte Ltd | March 2022 | 0.6MG | AB |
| Annora Pharma Private Ltd | April 2024 | 0.6MG | AB |
| Macleods Pharmaceuticals Ltd | February 2026 | 0.6MG | AB |
| Micro Labs Ltd | February 2026 | 0.6MG | AB |
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).
Lodoco Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Lodoco 0.5 mg tablet
$17.00 per tablet in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $17.00 |
| September 2026 | $17.00 |
| August 2026 | $17.00 |
| July 2026 | $17.00 |
| June 2026 | $17.00 |
| May 2026 | $17.00 |
| April 2026 | $17.00 |
| March 2026 | $17.00 |
| February 2026 | $17.00 |
| January 2026 | $17.00 |
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 Lodoco today: $17.00 per tablet for Lodoco 0.5 mg tablet 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 $17.00 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 Lodoco
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 Lodoco, before manufacturer rebates.
- $317.3K
- January to March 2026, the latest CMS has posted
For 259 people, about $829 per prescription fill - $920.9K
- 2025, the whole year
For 382 people, about $801 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $317,331 | 259 | $828.54 |
| 2025 | $920,879 | 382 | $801.46 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Lodoco only, so no generic is counted in it. What CMS says it is used for: Colchicine is used by people with heart disease or people who have multiple risk factors for heart disease to help reduce the risk of getting serious related heart and blood vessel problems (such as stroke, heart attack). It is thought to work by decreasing inflammation in the arteries.
Medicaid Prescriptions by Quarter
259 prescriptions in the four quarters to Q1 2026, $137.7K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 111 | $63,688 |
| Q4 2025 | 65 | $32,538 |
| Q3 2025 | 45 | $22,333 |
| Q2 2025 | 38 | $19,109 |
| Q1 2025 | 17 | $8,747 |
Source: CMS Medicaid State Drug Utilization Data, over Lodoco’s own package codes.
Lodoco Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.5MG | Tablet | Oral | June 2023 | Prescription reference product |
Source: FDA Orange Book, Agepha Pharma Fz LLC. Listed for sale today by AGEPHA Pharma USA, LLC (FDA NDC Directory).
Lodoco NDC Codes and Packages
Each Lodoco 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 |
|---|---|---|---|
| 82867-0001-01 | COLCHICINE .5 mg/1 tablet | blister pack of 30 tablets | AGEPHA Pharma USA, LLC |
| 82867-0001-01 | COLCHICINE .5 mg/1 tablet | blister pack of 30 tablets | AGEPHA Pharma USA, LLC |
| 82867-0001-02 | COLCHICINE .5 mg/1 tablet | blister pack of 30 tablets | AGEPHA Pharma USA, LLC |
| 82867-0001-02 | COLCHICINE .5 mg/1 tablet | blister pack of 30 tablets | AGEPHA Pharma USA, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lodoco’s own FDA approval (NDA 215727) are listed, never a generic. Some codes belong to companies that repackage Lodoco: it is the same medicine in a different package.
What a Generic Lodoco 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 Lodoco
Is there a generic for Lodoco right now?
Yes. The FDA NDC Directory lists a generic colchicine from 37 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Lodoco go generic?
It already has. The FDA NDC Directory lists a generic colchicine from 37 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic colchicine be the same as Lodoco?
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 14 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Lodoco?
Yes. The FDA Orange Book lists approved generic versions from 14 companies, the first approved in September 2016: Amneal Pharmaceuticals, Ph Health Ltd, Alkem Laboratories Ltd, Zydus Pharmaceuticals USA Inc and 10 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 Lodoco patent expire?
The FDA Orange Book lists 13 patents for Lodoco; the last runs to May 2034. The one behind the expected month is patents 9,744,144, 10,206,891, 10,265,281, 10,842,762 and 6 more, which end in November 2033. 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 (November 2033) weighs all of that.
How much does Lodoco cost now?
Pharmacies paid about $17.00 per tablet for Lodoco 0.5 mg tablet 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 November 2033 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
- AmyvidFlorbetapir F 18April 2027
- Signifor LARPasireotide PamoateMay 2028
- VivjoaOteseconazoleApril 2036
- IqirvoElafibranorJune 2038
- DuaveeBazedoxifene Acetate and Estrogens, ConjugatedTBD no date yet
- OcalivaObeticholic AcidTBD no date yet
About Lodoco
- Generic name colchicine
- How it is taken By mouth
- Company Agepha Pharma Fz LLC
- More drugs Brand-name drugs starting with L
- Have a question? A pharmacist answers, free. Ask about Lodoco
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.