Zyclara Generic: When Will Generic Imiquimod 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
Zyclara Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? February 2010 4 companies approved
- When does the last patent end? April 2030 10 patents listed with the FDA
- Can you buy a generic today? Yes 9 companies list one
It already is. A generic imiquimod is listed for sale by 9 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Zyclara, 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.
Zyclara 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
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2010 March 2010 FDA Orange Book
- Patents listed 10 last runs to April 2030 FDA Orange Book
- Generics FDA-approved 4 companies, the first approved February 2010 FDA Orange Book
Zyclara’s Road to a Generic
Zyclara has had the market to itself since the FDA approved it in March 2010 (Bausch Health US LLC). Its 10 listed patents run to April 2030. Generic companies have challenged its patents with the FDA since August 2012.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Zyclara Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zyclara’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 |
|---|---|---|---|
| 8,598,196 | A way of using it (U-172, U-1455) | August 2029 | Active |
| 10,238,645 | A way of using it (U-172, U-1455) | August 2029 | Active |
| 8,222,270 | A way of using it (U-68) | December 2029 | Active |
| 8,236,816 | A way of using it (U-68) | December 2029 | Active |
| 8,299,109 | A way of using it (U-68) | December 2029 | Active |
| 10,238,644 | A way of using it (U-68) | December 2029 | Active |
| 11,318,130 | A way of using it (U-68) | December 2029 | Active |
| 10,918,635 | A way of using it (U-172, U-1455) | April 2030 | Active |
| 11,202,752 | A way of using it (U-1455, U-172) | April 2030 | Active |
| 11,850,245 | A way of using it (U-1455, U-172) | April 2030 | Active |
Source: FDA Orange Book, application 022483. Patent numbers open the patent on Google Patents.
Patent Challenges to Zyclara
The first patent challenge to Zyclara reached the FDA in August 2012, from one company on that first day. The FDA’s list has 2 entries for Zyclara, by form and strength. A first challenger began selling its generic in July 2020.
What Is a Patent Challenge?
A generic company that wants to sell its version before Zyclara’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 | |||||
| Cream, 0.0375 | August 2012 | 1 company | Head start still held decided July 2019 | Not yet | July 2020 | December 2029 |
| Cream, 0.025 | June 2014 | 1 company | Not posted | Not posted | Not posted | December 2029 |
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 Imiquimod
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 Zyclara, but the FDA has already approved 4 companies (step 2), and every approval starts with an application.
Generic companies have challenged Zyclara’s patents with the FDA since August 2012: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 4 companies, the first in February 2010. 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 imiquimod is listed for sale by 9 companies. Ask your pharmacy whether it can fill your prescription with it.
Anvi Pharmaceuticals Inc., Bryant Ranch Prepack, DIRECT RX, E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., Glenmark Pharmaceuticals Inc., USA, Padagis Israel Pharmaceuticals Ltd and 3 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Fougera Pharmaceuticals Inc | February 2010 | 5% | AB |
| Padagis Israel Pharmaceuticals Ltd | September 2010 | 5% | AB |
| Taro Pharmaceutical Industries Ltd | April 2011 | 3.75%, 5% | AB |
| Glenmark Pharmaceuticals Inc USA | March 2012 | 5% | AB |
| Encube Ethicals Private Ltd discontinued | February 2011 | 5% | – |
| Cosette Pharmaceuticals Nc Laboratories LLC discontinued | April 2011 | 5% | – |
| Apotex Inc discontinued | April 2012 | 5% | – |
| Strides Pharma Global Pte Ltd discontinued | June 2014 | 5% | – |
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).
Zyclara 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 Zyclara, 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.
Zyclara Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 3.75% | Cream | Topical | March 2010 | Prescription reference product |
| 2.5% | Cream | Topical | July 2011 | Prescription reference product |
Source: FDA Orange Book, Bausch Health US LLC. Listed for sale today by Bausch Health US, LLC (FDA NDC Directory).
Zyclara NDC Codes and Packages
Each Zyclara 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 |
|---|---|---|---|
| 99207-0276-01 | IMIQUIMOD 2.5 mg/g cream | bottle of 7.5 g | Bausch Health US, LLC |
| 99207-0276-01 | IMIQUIMOD 2.5 mg/g cream | bottle of 7.5 g | Bausch Health US, LLC |
| 99207-0276-75 | IMIQUIMOD 2.5 mg/g cream | bottle of 7.5 g | Bausch Health US, LLC |
| 99207-0270-01 | IMIQUIMOD 37.5 mg/g cream | carton of 4 packets of .25 g | Bausch Health US, LLC |
| 99207-0270-01 | IMIQUIMOD 37.5 mg/g cream | carton of 4 packets of .25 g | Bausch Health US, LLC |
| 99207-0270-28 | IMIQUIMOD 37.5 mg/g cream | carton of 28 packets of .25 g | Bausch Health US, LLC |
| 99207-0271-01 | IMIQUIMOD 37.5 mg/g cream | bottle of 7.5 g | Bausch Health US, LLC |
| 99207-0271-01 | IMIQUIMOD 37.5 mg/g cream | bottle of 7.5 g | Bausch Health US, LLC |
| 99207-0271-75 | IMIQUIMOD 37.5 mg/g cream | bottle of 7.5 g | Bausch Health US, LLC |
| 99207-0271-75 | IMIQUIMOD 37.5 mg/g cream | bottle of 7.5 g | Bausch Health US, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zyclara’s own FDA approval (NDA 22483) are listed, never a generic. Some codes belong to companies that repackage Zyclara: it is the same medicine in a different package.
What a Generic Zyclara 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 Zyclara
Is there a generic for Zyclara right now?
Yes. The FDA NDC Directory lists a generic imiquimod from 9 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Zyclara go generic?
It already has. The FDA NDC Directory lists a generic imiquimod from 9 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic imiquimod be the same as Zyclara?
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 4 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Zyclara?
Yes. The FDA Orange Book lists approved generic versions from 4 companies, the first approved in February 2010: Fougera Pharmaceuticals Inc, Padagis Israel Pharmaceuticals Ltd, Taro Pharmaceutical Industries Ltd and Glenmark Pharmaceuticals Inc USA. 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 Zyclara patent expire?
The FDA Orange Book lists 10 patents for Zyclara; the last runs to April 2030. 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Zyclara patents?
Yes. The first patent challenge to Zyclara reached the FDA in August 2012, from one company on that first day. A first challenger began selling its generic in July 2020. 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 a date that is not known yet 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
- OsphenaOspemifene2026 to 2027
- XareltoRivaroxabanMarch 2027
- SymdekoIvacaftor and TezacaftorJuly 2031
- KorsuvaDifelikefalin AcetateJuly to December 2032
- BafiertamMonomethyl FumarateFebruary 2035
- EtcamahCamizestrantSeptember 2041
About Zyclara
- Generic name imiquimod
- How it is taken On the skin
- Company Bausch Health US LLC
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since August 2012 (FDA)
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Zyclara
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.