Gloperba 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
Gloperba Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2027 to 2028 A wide window Why then?
- Has the FDA approved a generic? September 2016 14 companies approved
- When does the last patent end? December 2037 6 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 2027 to 2028?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Gloperba’s last patent runs to December 2037, how can a generic come sooner?
The 6 patents that run past the expected month, to December 2037 (9,907,751, 10,383,820, 10,383,821, 12,274,751 and 2 more), cover the product’s formulation and 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Gloperba’s patents with the FDA since April 2020. 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 Gloperba, 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.
Gloperba 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
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2019 January 2019 FDA Orange Book
- Patents listed 6 last runs to December 2037 FDA Orange Book
- Generics FDA-approved 14 companies, the first approved September 2016 FDA Orange Book
- Medicare Part D spent $81.3K in 2025, for 50 people CMS Part D Spending by Drug
- Medicaid prescriptions 37 in the last four reported quarters, $24.1K CMS Medicaid drug utilization, to Q1 2026
Gloperba’s Road to a Generic
Gloperba has had the market to itself since the FDA approved it in January 2019 (Scilex Pharmaceuticals Inc). Its 6 listed patents run to December 2037. Generic companies have challenged its patents with the FDA since April 2020.
The first generic of Gloperba is expected between 2027 and 2028.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before December 2037
The last listed patent runs to December 2037, but it covers the product’s formulation and 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.
Gloperba Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Gloperba’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 |
|---|---|---|---|
| 9,907,751 | The product’s formulation | November 2036 | Active |
| 10,383,820 | The product’s formulation; a way of using it (U-2814) | November 2036 | Active |
| 10,383,821 | The product’s formulation | November 2036 | Active |
| 12,274,751 | A way of using it (U-2814) | November 2036 | Active |
| 12,514,819 | A way of using it (U-2814) | November 2036 | Active |
| 10,226,423 | The product’s formulation | December 2037 | Active |
Source: FDA Orange Book, application 210942. Patent numbers open the patent on Google Patents.
Patent Challenges to Gloperba
The first patent challenge to Gloperba reached the FDA in April 2020, 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 Gloperba’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 | |||||
| Oral solution, 0.6 mg/5 mL | April 2020 | 1 company | Head start still held decided January 2023 | Not yet | Not yet | December 2037 |
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 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
At least 14 companies have applied to the FDA to make generic colchicine.
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 Gloperba’s patents with the FDA since April 2020: see the patent challenges.
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).
Gloperba 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 Gloperba, 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.
What Medicare and Medicaid Spend on Gloperba
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 Gloperba, before manufacturer rebates.
- $81.3K
- 2025, the whole year
For 50 people, about $625 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $81,275 | 50 | $625.19 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Gloperba only, so no generic is counted in it. What CMS says it is used for: This medication is used to prevent gout attacks (flares). Gout symptoms usually develop suddenly and involve only one or a few joints.
Medicaid Prescriptions by Quarter
37 prescriptions in the four quarters to Q1 2026, $24.1K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q4 2025 | 15 | $10,517 |
| Q3 2025 | 11 | $6,113 |
| Q2 2025 | 11 | $7,463 |
| Q1 2025 | 16 | $9,950 |
Source: CMS Medicaid State Drug Utilization Data, over Gloperba’s own package codes.
Gloperba Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.6MG/5ML | Solution | Oral | January 2019 | Prescription reference product |
Source: FDA Orange Book, Scilex Pharmaceuticals Inc. Listed for sale today by Avion Pharmaceuticals, LLC and Scilex Pharmaceuticals Inc. (FDA NDC Directory).
Gloperba NDC Codes and Packages
Each Gloperba 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 |
|---|---|---|---|
| 75854-0801-01 | 0.6 mg/5mL solution | bottle of 150 mL | Avion Pharmaceuticals, LLC |
| 69557-0222-01 | COLCHICINE .6 mg/5mL solution | bottle of 150 mL | Scilex Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Gloperba’s own FDA approval (NDA 210942) are listed, never a generic. Some codes belong to companies that repackage Gloperba: it is the same medicine in a different package.
What a Generic Gloperba 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 Gloperba
Is there a generic for Gloperba 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 Gloperba 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 Gloperba?
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 14 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 Gloperba?
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 Gloperba patent expire?
The FDA Orange Book lists 6 patents for Gloperba; the last runs to December 2037. 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 (2027 to 2028) weighs all of that.
Has anyone challenged the Gloperba patents?
Yes. The first patent challenge to Gloperba reached the FDA in April 2020, 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 2027 to 2028 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
- VyondysGolodirsenJune 2028
- Spy Agent GreenIndocyanine Green2030 to 2031
- OpsynviMacitentan and TadalafilSeptember 2031
- EmcitateTiratricolMarch 2034
- JideytroZidesamtinib2041 to 2042
- AsteproAzelastine HydrochlorideTBD no date yet
About Gloperba
- Generic name colchicine
- How it is taken By mouth
- Company Scilex Pharmaceuticals Inc
- Patent challenges Since April 2020 (FDA)
- More drugs Brand-name drugs starting with G
- Have a question? A pharmacist answers, free. Ask about Gloperba
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, 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.