Camcevi Generic: When Will Generic Leuprolide 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

Camcevi Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? January 2039 About 12 years away Why then?
  2. Has the FDA approved a generic? Unknown No FDA Orange Book record under this name
  3. When does the brand’s protection end? Unknown Not in the FDA record we could read
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic leuprolide mesylate is expected to be available in January 2039, about 12 years away. None is for sale yet.

Why January 2039?

A patent that protects the brand runs out. After that, approved generics can be sold. We rate it toss-up: still unsettled. Just as likely to slip as to hold.

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 Camcevi 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.

Camcevi 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
$104M a yearBig seller
  • Medicaid prescriptions 489 in the last four reported quarters, $976.7K CMS Medicaid drug utilization, to Q1 2026

Camcevi’s Road to a Generic

The first generic of Camcevi is expected in January 2039.

Why that month: a patent that protects the brand runs out. After that, approved generics can be sold.

Brand alone on the market Approval date not in the Orange Book
Brand alone on the market First generic expected Swipe the chart sideways to see every year.

The bar shows Camcevi on the market on its own until the month we expect the first generic (the green band), a month and never a day. Its approval date and patents are not in the FDA Orange Book under this name, so the bar fades in from the left. The expected month comes from court records and company announcements.

Who Is Lined Up to Make Generic Leuprolide Mesylate

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 Camcevi yet.

2

Approved by the FDA

We could not find Camcevi’s own record in the FDA Orange Book under this name, so the approved generic makers are not shown.

3

For Sale in Pharmacies

Not yet. No company lists a generic leuprolide mesylate for sale with the FDA.

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).

Camcevi 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 Camcevi, 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 Camcevi

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.

Medicaid Prescriptions by Quarter

489 prescriptions in the four quarters to Q1 2026, $976.7K paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 202680$165,070
Q4 2025109$305,079
Q3 2025126$194,066
Q2 2025174$312,490
Q1 2025198$362,384

Source: CMS Medicaid State Drug Utilization Data, over Camcevi’s own package codes.

Camcevi NDC Codes and Packages

Each Camcevi 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.

Camcevi packages (3)
NDCProductPackageCompany
69448-0014-63LEUPROLIDE MESYLATE 42 mg/.37g injection, emulsionsyringe of .37 gAccord BioPharma, Inc.
69448-0014-63LEUPROLIDE MESYLATE 42 mg/.37g injection, emulsionsyringe of .37 gAccord BioPharma, Inc.
69448-0023-63LEUPROLIDE MESYLATE 42 mg/.37g injection, emulsionsyringe of .37 gAccord BioPharma, Inc.

Source: the FDA NDC Directory, current listings only. Some codes belong to companies that repackage Camcevi: it is the same medicine in a different package.

What a Generic Camcevi Means for You

Nothing Changes Until It Is in Pharmacies

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

Is there a generic for Camcevi right now?

No. As of October 9, 2026 no generic leuprolide mesylate is listed for sale in the FDA NDC Directory.

When will Camcevi go generic?

January 2039 is the expected month, and that is toss-up but not certain. A patent that protects the brand runs out. After that, approved generics can be sold.

Will generic leuprolide mesylate be the same as Camcevi?

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.

Changes to This Projection

  • First generic expected January 2039 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 Camcevi

  • Generic name leuprolide mesylate
  • How it is taken Injection under the skin
  • Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
  • More drugs Brand-name drugs starting with C
  • Have a question? A pharmacist answers, free. Ask about Camcevi

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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.