Tool · FDA Orange Book · read 12 November 2026
Is there a generic of your medicine, and who makes it?
50% of the 2,145 brand medicine forms in the FDA Orange Book have at least one generic listed as marketed, and where both are dated the first generic came a median 9.9 years after the first brand approval. Type a medicine to see how many generic makers are listed for each form, when the first generic was approved, and the patents still listed. It covers 2,760 ingredients. The Orange Book lists what was approved and filed, not what will happen.
Try one
Example result. Open Atorvastatin Calcium as its own page
- Atorvastatin Calcium appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 20 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came 15 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Lipitor. 20 generic makers with 92 generic products listed as marketed; the first generic approval is dated 30 November 2011.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Apotex Inc | 29 May 2012 | 8 |
| Chartwell Rx Sciences Llc | 29 May 2012 | 4 |
| Mylan Pharmaceuticals Inc | 29 May 2012 | 4 |
| Dr Reddys Laboratories Ltd | 17 July 2012 | 8 |
| Lannett Co Inc | 5 April 2013 | 4 |
| Sciegen Pharmaceuticals Inc | 19 May 2016 | 4 |
14 more makers are listed in the data.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Suspension, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Atorvaliq. No generic is listed as marketed.
Patents and exclusivities still listed
- 7 June 2037Patent 11654106 drug product
- 7 June 2037Patent 11925704 drug product
- 7 June 2037Patent 12370136 drug product
- 7 June 2037Patent 12599553 drug product
- 7 June 2037Patent 12168069 drug product
- 7 June 2037Patent 11369567 drug product
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
How do you read a medicine's generic record?
You read a medicine's generic record as a count of makers and a set of dates, not a promise.
- Pick the form you take: a tablet and an injection of the same ingredient are separate groups with separate makers.
- Read how many generic makers are listed as marketed. One maker and twenty makers are very different markets.
- Read the staircase: each step is a generic maker's first approval, and the dashed line is the brand's first approval.
- Read the patents and exclusivities still listed, as the application holder's listing and not a ruling.
- Ask your pharmacist what can be supplied. The Orange Book says nothing about stock or price.
How many brand medicines have a generic?
Most brand medicine forms have a generic listed as marketed. Of 2,145 brand forms the Orange Book lists as marketed, 1,083 have at least one generic listed as marketed and 1,062 do not.
| Group | Groups | Share of brand forms |
|---|---|---|
| Four or more generic makers listed | 982 | 46% |
| One to three generic makers listed | 803 | 37% |
| Brand listed as marketed, no generic listed as marketed | 1,062 | 50% |
Counts of ingredient and dosage-form groups from the FDA Orange Book data files downloaded 12 November 2026. Where both a brand and a generic approval are dated, 1,557 groups, the median gap is 9.9 years.
Which brand medicines have no generic listed?
1,062 brand forms have no generic listed as marketed, and 772 of them still have a patent or exclusivity listed. See the full list, ordered by the date the last listed protection ends. A listed date is not a launch date.
What is the most common way to misread a patent listing?
The most common misreading takes a patent date as the day a generic arrives. The Orange Book lists patents; it does not decide whether they hold.
The misreading
"The patent ends in 2031, so the generic launches in 2031."
The fix
Read the listing as one input. A generic can be approved earlier after a challenge or a settlement, or later if another patent or exclusivity is listed. patent certifications for generic applications explains how generic makers certify against listed patents.
Can you put this check on your own site?
Any ingredient can be shown on another site as a self-sizing panel, free with the source line left in place.
<div data-generic-check data-drug="atorvastatin-calcium"></div>
<script async src="https://omnirx.org/tools/generic-competition-check/embed.js"></script>Set data-drug to the ingredient's key, the last part of its page address.
How was the check built and checked?
The check was built from the FDA Orange Book data files under a method written and hashed before any count was published. Every product row lands in one ingredient and dosage-form group, checked on every build, and a separate reader recomputes the counts for a random sample of groups. The same code produces the result on this page, on each ingredient's page and in the embed. What the independent check found. Further reading: the FDA Orange Book; how generic drugs are approved; the FDA generic drug facts; patent certifications for generic applications; the FDA first generic approvals; 21 CFR Part 314; 21 USC 355; the Purple Book for biologics; the FDA drug shortages page.
Questions
How do I find out whether a generic exists for my medicine?
Type the medicine's brand or generic name into the check. It shows, for each form (tablet, injection and so on), how many generic makers the FDA Orange Book lists as marketed, when the first generic was approved, and the patents and exclusivities still listed.
Does an unexpired patent mean there will not be a generic?
No. The Orange Book lists patents the application holder submitted; it does not rule on them. A generic can be approved while a patent is listed, and the company making it may challenge the patent, settle, or wait. The page shows the listing and says nothing about what will happen.
Why does a brand show no generic?
The data does not say why. It can be that a patent or exclusivity is still listed, that no company has filed, or that the product is hard to copy. The page reports that no generic is listed as marketed and does not guess the reason.
Does "listed as marketed" mean it is in stock?
No. It means the Orange Book does not list the product as discontinued. It says nothing about supply, price or what your pharmacy holds. The FDA keeps a separate shortage list.
Why are biologics missing?
Biologics such as insulin and many injectable antibodies are not in the Orange Book. The FDA keeps them in the Purple Book, a separate record that this check does not read.
Where does the data come from?
The FDA's Orange Book data files (products, patents and exclusivities), downloaded 12 November 2026. The Orange Book is the FDA's list of approved drug products with therapeutic equivalence evaluations.
Can I put this check on my own website?
Yes. The embed code on this page shows any medicine as a self-sizing panel, free to use with the source line left in place.