Oxlumo Generic: When Will Generic Lumasiran 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
Oxlumo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2038 to 2039 A wide window Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? November 2038 14 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic lumasiran is expected to be available between 2038 and 2039. None is for sale yet.
Why 2038 to 2039?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
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 Oxlumo 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.
Oxlumo by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2020 November 2020 FDA Orange Book
- Patents listed 14 last runs to November 2038 FDA Orange Book
- Medicare Part D spent $11M in 2025, for 17 people CMS Part D Spending by Drug
Oxlumo’s Road to a Generic
Oxlumo has had the market to itself since the FDA approved it in November 2020 (Alnylam Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to October 2029. Its 14 listed patents run to November 2038.
The first generic of Oxlumo is expected between 2038 and 2039.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public 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.
Oxlumo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Oxlumo’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 |
|---|---|---|---|
| 10,131,907 | The active ingredient; the product’s formulation; a way of using it (U-2995) | August 2028 | Active |
| 8,828,956 | The active ingredient; the product’s formulation; a way of using it (U-2995) | December 2028 | Active |
| 8,106,022 | The active ingredient; the product’s formulation; a way of using it (U-2995) | December 2029 | Active |
| 9,828,606 | The active ingredient; the product’s formulation | December 2034 | Active |
| 10,435,692 | A way of using it (U-2995) | December 2034 | Active |
| 10,465,195 | The active ingredient; the product’s formulation; a way of using it (U-2995) | December 2034 | Active |
| 10,487,330 | The active ingredient; the product’s formulation; a way of using it (U-2995) | December 2034 | Active |
| 11,060,093 | The active ingredient; the product’s formulation; a way of using it (U-2995) | December 2034 | Active |
| 10,612,024 | The active ingredient; the product’s formulation; a way of using it (U-2995) | August 2035 | Active |
| 10,612,027 | The active ingredient; the product’s formulation; a way of using it (U-2995) | August 2035 | Active |
| 11,401,517 | The active ingredient; the product’s formulation; a way of using it (U-2995) | August 2035 | Active |
| 10,478,500 | The active ingredient; the product’s formulation; a way of using it (U-2995) | October 2035 | Active |
| 11,446,380 | The active ingredient; the product’s formulation | October 2035 | Active |
| 11,261,447 | The active ingredient; the product’s formulation; a way of using it (U-2995) | November 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-339 | Seven years of protection for a use in a rare disease. | November 2027 | Active |
| Orphan drug ODE-415 | Seven years of protection for a use in a rare disease. | October 2029 | Active |
Source: FDA Orange Book, application 214103. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Lumasiran
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 company is recorded as having applied to the FDA to make a generic Oxlumo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic lumasiran. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic lumasiran for sale with the FDA.
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).
Oxlumo 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 Oxlumo, 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 Oxlumo
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 Oxlumo, before manufacturer rebates.
- $2.4M
- January to March 2026, the latest CMS has posted
For 13 people, about $181,906 per prescription fill - $11M
- 2025, the whole year
For 17 people, about $159,352 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,364,781 | 13 | $181,906.21 |
| 2025 | $10,995,276 | 17 | $159,351.82 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Oxlumo only, so no generic is counted in it. What CMS says it is used for: Drug uses not available.
Oxlumo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) | Solution | Subcutaneous | November 2020 | Prescription reference product |
Source: FDA Orange Book, Alnylam Pharmaceuticals Inc. Listed for sale today by Alnylam Pharmaceuticals, Inc. (FDA NDC Directory).
Oxlumo NDC Codes and Packages
Each Oxlumo 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 |
|---|---|---|---|
| 71336-1002-01 | LUMASIRAN SODIUM 94.5 mg/.5mL injection, solution | vial of .5 mL | Alnylam Pharmaceuticals, Inc. |
| 71336-1002-01 | LUMASIRAN SODIUM 94.5 mg/.5mL injection, solution | vial of .5 mL | Alnylam Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Oxlumo’s own FDA approval (NDA 214103) are listed, never a generic. Some codes belong to companies that repackage Oxlumo: it is the same medicine in a different package.
What a Generic Oxlumo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Oxlumo 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 Oxlumo”. 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 Oxlumo
Is there a generic for Oxlumo right now?
No. As of October 9, 2026 no generic lumasiran is listed for sale in the FDA NDC Directory.
When will Oxlumo go generic?
2038 to 2039 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Will generic lumasiran be the same as Oxlumo?
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.
Has the FDA approved a generic Oxlumo?
Not yet. The FDA Orange Book lists no approved generic version of Oxlumo.
When does the Oxlumo patent expire?
The FDA Orange Book lists 14 patents for Oxlumo; the last runs to November 2038. 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 (2038 to 2039) weighs all of that.
Changes to This Projection
- First generic expected 2038 to 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
- AdempasRiociguatOctober to December 2026
- RisvanRisperidoneMay 2031
- ImcivreeSetmelanotide AcetateJuly 2034
- VelsipityEtrasimod ArginineJanuary 2036
- Daybue StixTrofinetide2038 to 2039
- NeuproRotigotineTBD no date yet
About Oxlumo
- Generic name lumasiran
- How it is taken Injection under the skin
- Company Alnylam Pharmaceuticals Inc
- 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 O
- Have a question? A pharmacist answers, free. Ask about Oxlumo
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, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.