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Lorlatinib Tablet shortage

Lorlatinib Tablet is currently listed in shortage by the FDA. The FDA lists 1 affected product. This page was last refreshed from FDA data on Sep 24, 2026.

To Be Discontinued ⚠ Supply risk: High Oncology 1 product 102 days First posted Jun 15, 2026 Updated Jun 15, 2026
Here’s the bottom line

Pfizer is stopping the 25 mg lorlatinib 120-tablet bottle, with supply expected to run out by June 30, 2026. A 30-tablet bottle of the same 25 mg strength will keep being made, and Lorbrena (lorlatinib) in both 25 mg and 100 mg tablets remains listed from Pfizer as available.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
1
Affected NDCs
1
Reporting manufacturers
0/1
Reporting mfrs supplying
0/1
Affected strengths supplied
102
Days in shortage
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Sep 24, 2026 · yesterday

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Lorlatinib Tablet. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
1 NDCs
To be discontinued 1
Affected strengths still supplied
Among manufacturers reporting this shortage
0/1 strengths
No supply 1
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
0/1 makers
No supply 1
✓ Other manufacturers not reporting a shortage
Still-marketed Lorlatinib Tablet from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Pfizer Laboratories Div Pfizer Inc
See all other options & details →
Shortage timeline
  1. Jun 15, 2026
    Currently in shortage
    1 of 1 product affected.
  2. Jun 15, 2026
    First reported to the FDA
    1 product first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Pfizer Inc. 📞 800-533-4535 1 NDC click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued Lorbrena, Tablet, 25 mg; 120 tablets bottle with a child-resistant closure (NDC 0069-0227-03) NDC 00069-0227-03 — — Supply expected to exhaust 6/30/2026; NDC 0069-0227-01 25 mg; 30 tablets bottle with a child-resistant closure will continue to be manufactured; Discontinuation of the manufacture of this presentation —

These rows are manufacturer reports to the FDA for Lorlatinib Tablet — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Lorlatinib Tablet? options further down this page.

Why is Lorlatinib Tablet in shortage?

Pfizer has let the FDA know that they are permanently stopping production of one specific package size of Lorbrena (lorlatinib) 25 mg — the larger 120-tablet bottle. They haven't shared a specific public reason for this decision. The supply of that 120-tablet bottle is expected to run out around June 30, 2026.

The good news is that the 30-tablet bottle of Lorbrena 25 mg is not going away — Pfizer says they will continue manufacturing that size. So this is about one particular bottle size being discontinued, not the 25 mg strength itself, at least from Pfizer.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Lorlatinib Tablet, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Lorlatinib Tablet?

Lorlatinib (brand name Lorbrena) tablets are currently on the FDA shortage list, so I want to walk you through what this means for you.

The affected item is the 25 mg strength sold in the 120-tablet bottle with a child-resistant closure. That specific package has no available source right now and is listed as being discontinued, with existing supply expected to run out by June 30, 2026. The important detail is that this affects only that one bottle size. The same 25 mg tablet packaged in a 30-tablet bottle is reported to continue being made, and the same medicine (Lorbrena) is also listed in a 100 mg tablet. So the medicine itself remains on the market — it is the larger bottle that is going away.

Here is what I suggest:

  • Do not stop, skip, or change your dose on your own.
  • Ask your pharmacy whether they can order the same medicine in the 30-tablet bottle, or another available package, through their wholesalers — though it may not be in local stock.
  • Because this bottle size is being discontinued, talk with your prescriber or pharmacist about a steady plan going forward, such as a different package or strength to make up your dose.

The manufacturer's contact number is listed on this page for reference; pharmacies usually handle those calls. This is general national information and may not match your local pharmacy's actual stock.

See “Where else can I get Lorlatinib Tablet?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Lorlatinib guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Lorlatinib guide →

Where else can I get Lorlatinib Tablet?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Lorlatinib Tablet is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Lorbrena LORLATINIB 25 mg/1 Tablet, Film Coated · Oral Pfizer Laboratories Div Pfizer Inc 00069-0227-01
Lorbrena LORLATINIB 100 mg/1 Tablet, Film Coated · Oral Pfizer Laboratories Div Pfizer Inc 00069-0231-01
Therapeutic equivalents & pricing 2 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Lorbrena 25 mgNDC 00069-0227-03 Pfizer 120 tablets — — FDA listed
Lorbrena 25 mgNDC 63539-0927-01 U.S. 30 tablets — — FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Lorlatinib Tablet — that fall in the same broad treatment class (antineoplastic systemic enzyme inhibitors) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 079228
GCN 45687
HICL code 045448
Ingredient (HICL) Lorlatinib
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name LORBRENA 25 MG TABLET
FDB brand name Lorbrena
Legend status F — Federal legend — prescription drug or device
GPI-1421530556000320
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other oncology shortages

Lorlatinib Tablet shortage FAQs

Is Lorlatinib Tablet in shortage?
Yes — the FDA currently lists Lorlatinib Tablet in shortage (status: “To Be Discontinued”, first reported Jun 15, 2026). 1 of 1 product is affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Lorbrena, Tablet, 25 mg; 120 tablets bottle with a child-resistant closure (NDC 0069-0227-03) (NDC 00069-0227-03). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Lorlatinib Tablet be available again?
The manufacturer reports: Supply expected to exhaust 6/30/2026; NDC 0069-0227-01 25 mg; 30 tablets bottle with a child-resistant closure will continue to be manufactured; Disco. The FDA does not publish a single guaranteed restock date — confirm with your pharmacy.
Can I still get Lorlatinib somewhere?
Other manufacturers (Pfizer Laboratories Div Pfizer Inc) still market it and have not reported a shortage. See “Where else can I get Lorlatinib Tablet?” above — stock still varies by pharmacy.
What should I do if I take Lorlatinib Tablet?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Lorlatinib Tablet shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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