Javadin Generic: When Will Generic Clonidine 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
Javadin Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2042 About 16 years away Why then?
- Has the FDA approved a generic? July 1986 16 companies approved
- When does the last patent end? July 2042 2 patents listed with the FDA
- Can you buy a generic today? Yes 57 companies list one
It already is. A generic clonidine hydrochloride is listed for sale by 57 companies, so ask your pharmacy whether it can fill your prescription with one.
Why July 2042?
It is when Javadin’s patents 12,233,049 and 12,440,474 end. They cover 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 Javadin, 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.
Javadin 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 2025 October 2025 FDA Orange Book
- Patents listed 2 last runs to July 2042 FDA Orange Book
- Generics FDA-approved 16 companies, the first approved July 1986 FDA Orange Book
- Pharmacies pay $1.53 per mL NADAC, October 2026
- Medicare Part D spent $6,368 in January to March 2026 CMS Part D Spending by Drug
- Medicaid prescriptions 538 in the last four reported quarters, $178.6K CMS Medicaid drug utilization, to Q1 2026
Javadin’s Road to a Generic
Javadin has had the market to itself since the FDA approved it in October 2025 (Azurity Pharmaceuticals Inc). Its 2 listed patents run to July 2042.
The first generic of Javadin is expected in July 2042.
Why that month: patents 12,233,049 and 12,440,474, on the product’s formulation, 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.
Javadin Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Javadin’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 12,233,049 and 12,440,474, which end in July 2042, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,233,049 Sets the expected month of generic availability | The product’s formulation | July 2042 | Active |
| 12,440,474 Sets the expected month of generic availability | The product’s formulation | July 2042 | Active |
Source: FDA Orange Book, application 220256. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Clonidine 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 application count is on record for Javadin, but the FDA has already approved 16 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 16 companies, the first in July 1986. 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 clonidine hydrochloride is listed for sale by 57 companies. Ask your pharmacy whether it can fill your prescription with it.
A-S Medication Solutions, Actavis Pharma, Inc., Ajanta Pharma USA Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, American Health Packaging and 34 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Actavis Elizabeth LLC | December 1986 | 0.1MG, 0.2MG, 0.3MG | AB |
| Tp Anda Holdings LLC | September 1987 | 0.05MG, 0.1MG, 0.2MG, 0.3MG | AB |
| Chartwell Molecules LLC | April 1988 | 0.1MG, 0.2MG, 0.3MG | AB |
| Aurobindo Pharma Ltd | August 1988 | 0.1MG, 0.2MG, 0.3MG | AB |
| Prinston Pharmaceutical Inc | March 2007 | 0.1MG, 0.2MG, 0.3MG | AB |
| Unichem Laboratories Ltd | August 2009 | 0.1MG, 0.2MG, 0.3MG | AB |
| Impax Laboratories Inc | August 2009 | 0.1MG, 0.2MG, 0.3MG | AB |
| Alembic Pharmaceuticals Ltd | December 2011 | 0.1MG, 0.2MG, 0.3MG | AB |
| Yung Shin Pharmaceutical Industrial Co Ltd | June 2013 | 0.1MG, 0.2MG, 0.3MG | AB |
| Actavis Elizabeth LLC An Indirect Wholly Owned Sub Of Teva Pharmaceuticals USA Inc | May 2015 | 0.1MG, 0.2MG | AB1 |
| Chartwell Rx Sciences LLC | October 2017 | 0.1MG | AB1 |
| Ajanta Pharma Ltd | November 2017 | 0.1MG | AB1 |
| Xiamen LP Pharmacuetical Co Ltd | November 2017 | 0.1MG | AB1 |
| Jubilant Generics Ltd | January 2018 | 0.1MG | AB1 |
| Somerset Therapeutics LLC | October 2018 | 0.1MG | AB1 |
| Novast Laboratories Ltd | March 2019 | 0.1MG | AB1 |
| American Therapeutics Inc discontinued | July 1986 | 0.1MG, 0.2MG, 0.3MG | – |
| Par Pharmaceutical Inc discontinued | July 1986 | 0.1MG, 0.2MG, 0.3MG | – |
| Teva Pharmaceuticals USA Inc discontinued | July 1986 | 0.1MG, 0.2MG, 0.3MG | – |
| Watson Laboratories Inc discontinued | July 1986 | 0.1MG, 0.2MG, 0.3MG | – |
| Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc discontinued | August 1986 | 0.1MG, 0.2MG, 0.3MG | – |
| Interpharm Inc discontinued | October 1986 | 0.1MG, 0.2MG, 0.3MG | – |
| Rising Pharma Holding Inc discontinued | June 1987 | 0.1MG, 0.2MG, 0.3MG | – |
| Warner Chilcott Div Warner Lambert Co discontinued | June 1988 | 0.1MG, 0.2MG, 0.3MG | – |
| Ph Health Ltd discontinued | September 2013 | 0.1MG, 0.2MG | – |
| Sun Pharmaceutical Industries Inc discontinued | July 2014 | 0.1MG, 0.2MG, 0.3MG | – |
| Amneal Pharmaceuticals Of Ny LLC discontinued | November 2017 | 0.1MG | – |
| Rubicon Research Ltd discontinued | April 2018 | 0.1MG | – |
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).
Javadin Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Javadin 0.02 mg/mL solution
$1.53 per mL in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $1.53 |
| September 2026 | $1.53 |
| August 2026 | $1.53 |
| July 2026 | $1.53 |
| June 2026 | $1.53 |
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 Javadin today: $1.53 per mL for Javadin 0.02 mg/mL solution 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 $1.53 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 Javadin
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 Javadin, before manufacturer rebates.
- $6,368
- January to March 2026, the latest CMS has posted
About $455 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $6,368 | – | $454.85 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Javadin only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
Medicaid Prescriptions by Quarter
538 prescriptions in the four quarters to Q1 2026, $178.6K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 538 | $178,560 |
| Q4 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Javadin’s own package codes.
Javadin Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.02MG/ML | Solution | Oral | October 2025 | Prescription reference product |
Source: FDA Orange Book, Azurity Pharmaceuticals Inc. Listed for sale today by Azurity Pharmaceuticals, Inc. (FDA NDC Directory).
Javadin NDC Codes and Packages
Each Javadin 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 |
|---|---|---|---|
| 24338-0115-01 | CLONIDINE HYDROCHLORIDE 20 ug/mL solution | bottle of 250 mL | Azurity Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Javadin’s own FDA approval (NDA 220256) are listed, never a generic. Some codes belong to companies that repackage Javadin: it is the same medicine in a different package.
What a Generic Javadin 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 Javadin
Is there a generic for Javadin right now?
Yes. The FDA NDC Directory lists a generic clonidine hydrochloride from 57 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Javadin go generic?
It already has. The FDA NDC Directory lists a generic clonidine hydrochloride from 57 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic clonidine hydrochloride be the same as Javadin?
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 16 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Javadin?
Yes. The FDA Orange Book lists approved generic versions from 16 companies, the first approved in July 1986: Actavis Elizabeth LLC, Tp Anda Holdings LLC, Chartwell Molecules LLC, Aurobindo Pharma Ltd and 12 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 Javadin patent expire?
The FDA Orange Book lists 2 patents for Javadin; the last runs to July 2042. The one behind the expected month is patents 12,233,049 and 12,440,474, which end in July 2042. 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 (July 2042) weighs all of that.
How much does Javadin cost now?
Pharmacies paid about $1.53 per mL for Javadin 0.02 mg/mL solution 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 July 2042 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.
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- TruseltiqInfigratinib PhosphateOctober 2033
- CequaCyclosporineFebruary 2037
- ZilbrysqZilucoplan sodiumOctober 2039
- LyrfigtuLirafugratinibSeptember 2040
About Javadin
- Generic name clonidine hydrochloride
- How it is taken By mouth
- Company Azurity Pharmaceuticals Inc
- More drugs Brand-name drugs starting with J
- Have a question? A pharmacist answers, free. Ask about Javadin
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.