Ocaliva Generic: When Will Generic Obeticholic Acid 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
Ocaliva 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? May 2023 Since discontinued
- When does the last patent end? April 2036 7 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic obeticholic acid. None is for sale yet.
Will the generic cost less?
Usually, and more so as more companies sell one. 7 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. See the price pattern
What should I do now?
Keep taking Ocaliva 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.
Ocaliva by the Numbers
- Reason
- Not yet clear7 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
- How sure
- Not rated Too early to rate.
- Price competition
- Very strong 7 companies have filed, 5 first in line
- Brand sales
- Sales not reported
- FDA approved 2016 May 2016 FDA Orange Book
- Patents listed 7 last runs to April 2036 FDA Orange Book
- Medicare Part D spent $119.7M in 2025, for 1,745 people CMS Part D Spending by Drug
- Medicaid prescriptions 378 in the last four reported quarters, $4.4M CMS Medicaid drug utilization, to Q4 2025
Ocaliva’s Road to a Generic
Ocaliva has had the market to itself since the FDA approved it in May 2016 (Intercept Pharmaceuticals Inc). Its 7 listed patents run to April 2036. Generic companies have challenged its patents with the FDA since May 2020.
7 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
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.
Ocaliva Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ocaliva’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 |
|---|---|---|---|
| RE48286 | The active ingredient; the product’s formulation | February 2027 | Active |
| 9,238,673 | The product’s formulation | June 2033 | Active |
| 10,174,073 | The active ingredient | June 2033 | Active |
| 10,047,117 | A way of using it (U-1854) | September 2033 | Active |
| 10,052,337 | The product’s formulation | April 2036 | Active |
| 10,751,349 | The product’s formulation | April 2036 | Active |
| 10,758,549 | A way of using it (U-2945) | April 2036 | Active |
Source: FDA Orange Book, application 207999. Patent numbers open the patent on Google Patents.
Patent Challenges to Ocaliva
The first patent challenge to Ocaliva reached the FDA in May 2020, from 5 companies on that first day. The FDA approved a first challenger’s generic in May 2023, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Ocaliva’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 | |||||
| Tablets, 5 mg and 10 mg | May 2020 | 5 companies | First challenger eligible decided June 2023 | May 2023 | Not yet | April 2036 |
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 Obeticholic Acid
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
7 companies have applied to the FDA to make generic obeticholic acid.
The FDA has tentatively approved one company’s generic: Optimus Pharma Private Ltd (July 2023). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 5 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Ocaliva’s patents with the FDA since May 2020: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic obeticholic acid. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic obeticholic acid for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Apotex Inc discontinued | May 2023 | 5MG, 10MG | – |
| Lupin Ltd discontinued | May 2023 | 5MG, 10MG | – |
| Msn Laboratories Private Ltd discontinued | May 2023 | 5MG, 10MG | – |
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).
Ocaliva 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 Ocaliva, 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 Ocaliva
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 Ocaliva, before manufacturer rebates.
- $119.7M
- 2025, the whole year
For 1,745 people, about $10,919 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| 2025 | $119,740,577 | 1,745 | $10,919.26 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ocaliva only, so no generic is counted in it. What CMS says it is used for: This medication is used alone or in combination treatment for a certain liver disease (primary biliary cholangitis-PBC). This disease slowly destroys the bile ducts in the liver.
Medicaid Prescriptions by Quarter
378 prescriptions in the four quarters to Q4 2025, $4.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 0 | $0 |
| Q3 2025 | 112 | $1,330,034 |
| Q2 2025 | 106 | $1,270,025 |
| Q1 2025 | 160 | $1,777,124 |
Source: CMS Medicaid State Drug Utilization Data, over Ocaliva’s own package codes.
Ocaliva Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG | Tablet | Oral | May 2016 | Discontinued reference product |
| 5MG | Tablet | Oral | May 2016 | Discontinued reference product |
Source: FDA Orange Book, Intercept Pharmaceuticals Inc. Listed for sale today by Intercept Pharmaceuticals Inc (FDA NDC Directory).
Ocaliva NDC Codes and Packages
Each Ocaliva 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 |
|---|---|---|---|
| 69516-0005-30 | 5 mg tablet, film coated | bottle of 30 tablets | Intercept Pharmaceuticals Inc |
| 69516-0010-30 | 10 mg tablet, film coated | bottle of 30 tablets | Intercept Pharmaceuticals Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ocaliva’s own FDA approval (NDA 207999) are listed, never a generic. Some codes belong to companies that repackage Ocaliva: it is the same medicine in a different package.
What a Generic Ocaliva Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Ocaliva 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 Ocaliva”. 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 Ocaliva
Is there a generic for Ocaliva right now?
No. As of October 9, 2026 no generic obeticholic acid is listed for sale in the FDA NDC Directory. 3 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Ocaliva go generic?
There is no expected month yet. 7 generic makers have filed applications with FDA. What opens the door, a ruling, a deal or an expiry, is not settled yet.
Will generic obeticholic acid be the same as Ocaliva?
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. 7 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 Ocaliva?
Not yet. The FDA Orange Book lists no approved generic version of Ocaliva that is still marketed.
When does the Ocaliva patent expire?
The FDA Orange Book lists 7 patents for Ocaliva; the last runs to April 2036. 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 Ocaliva patents?
Yes. The first patent challenge to Ocaliva reached the FDA in May 2020, from 5 companies on that first day. The FDA approved a first challenger’s generic in May 2023, and the list records no sale by a first challenger 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 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
- LorbrenaLorlatinibMarch 2033
- FulvestrantFulvestrantMay 2034
- BysantiMilsaperidone2036 to 2037
- ZegfrovySunvozertinibJuly 2039
- TreandaBendamustine HydrochlorideTBD no date yet
- PrezistaDarunavir EthanolateTBD no date yet
About Ocaliva
- Generic name obeticholic acid
- How it is taken By mouth
- Company Intercept Pharmaceuticals Inc
- Patent challenges Since May 2020 (FDA)
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Ocaliva
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.