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Palovarotene Capsule shortage

Palovarotene Capsule is currently listed in shortage by the FDA. The FDA lists 1 affected product. This page was last refreshed from FDA data on Oct 3, 2026.

To Be Discontinued ⚠ Supply risk: High Musculoskeletal 1 product 34 days First posted Aug 31, 2026 Updated Aug 31, 2026
Here’s the bottom line

Ipsen Biopharmaceuticals is stopping production of Sohonos (palovarotene) 2.5 mg capsules, and this change may be permanent. Other strengths of Sohonos (1 mg, 1.5 mg, 5 mg, and 10 mg capsules) are still listed as available from Ipsen Biopharmaceuticals.

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
34
Days in shortage
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Oct 3, 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 Palovarotene Capsule. 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 Palovarotene Capsule from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Ipsen Biopharmaceuticals, Inc.
See all other options & details →
Shortage timeline
  1. Aug 31, 2026
    Currently in shortage
    1 of 1 product affected.
  2. Aug 31, 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: Ipsen Biopharmaceuticals, Inc. 📞 (855)-463-5127 1 NDC click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued SOHONOS, Capsule, 2.5 mg (NDC 15054-0025-1) NDC 15054-0025-01 — — Discontinuation of the manufacture of the drug —

These rows are manufacturer reports to the FDA for Palovarotene Capsule — 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 Palovarotene Capsule? options further down this page.

Why is Palovarotene Capsule in shortage?

Ipsen Biopharmaceuticals has reported to the FDA that it is permanently stopping the manufacturing of Sohonos (palovarotene) 2.5 mg capsules. This means that specific product — the 2.5 mg strength — will no longer be made by this company going forward.

Ipsen did not share a more detailed public reason for why they are discontinuing production, so unfortunately I can't give you a clearer explanation beyond what they reported. It's also worth knowing that this report only reflects what Ipsen has filed with the FDA, so it speaks only to their product and their decision.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Palovarotene Capsule, 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 Palovarotene Capsule?

Palovarotene capsules (brand name Sohonos) are currently on the FDA shortage list, and I want to walk you through what this means.

The 2.5 mg strength is the one affected here, and it has no available source right now. The manufacturer, Ipsen Biopharmaceuticals, has reported this as a discontinuation — meaning they are stopping production of the 2.5 mg capsule. Because this is a discontinuation rather than a temporary delay, this supply problem may be permanent, so a conversation with your prescriber is the right next step.

I do want to note that the same medicine, Sohonos, is still listed in other strengths (1 mg, 1.5 mg, 5 mg, and 10 mg). This matters because your care team may be able to use a different strength to reach your prescribed dose.

Here is what I suggest:

  • Do not stop, skip, or change your dose on your own.
  • Ask your prescriber or pharmacist about options — for example, combining other available Sohonos strengths to make up your usual dose, or another clinician-chosen plan.
  • Your pharmacy can check wholesalers and confirm what is currently in stock.

Manufacturer contact numbers are listed on this page for reference, though your pharmacy usually handles those calls.

This is general, national information and may not match your local pharmacy's stock.

See “Where else can I get Palovarotene Capsule?” 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 Palovarotene guide

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

Read the Palovarotene guide →

Where else can I get Palovarotene Capsule?

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 Palovarotene Capsule 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
Sohonos PALOVAROTENE 1 mg/1 Capsule · Oral Ipsen Biopharmaceuticals, Inc. 15054-0010-01
Sohonos PALOVAROTENE 1.5 mg/1 Capsule · Oral Ipsen Biopharmaceuticals, Inc. 15054-0015-01
Sohonos PALOVAROTENE 5 mg/1 Capsule · Oral Ipsen Biopharmaceuticals, Inc. 15054-0050-01
Sohonos PALOVAROTENE 10 mg/1 Capsule · Oral Ipsen Biopharmaceuticals, Inc. 15054-0100-01
Therapeutic equivalents & pricing 1 productclick 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
Sohonos 2.5 mgNDC 15054-0025-01 Ipsen 14 capsules — — 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.

Identity & classification

GCN Seq No 085016
GCN 54452
HICL code 049043
Ingredient (HICL) Palovarotene
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z1
Therapeutic class — intermediate (HIC2) Positive Effects On Wide-Spread Tissue
HIC3 code Z13
Therapeutic class — specific (HIC3) Retinoic Acid Receptor (Rar) Agonists
AHFS code 92:92.00.00
AHFS class Other Miscellaneous Therapeutic Agents
FDB label name SOHONOS 2.5 MG CAPSULE
FDB brand name Sohonos
Legend status F — Federal legend — prescription drug or device
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.

Palovarotene Capsule shortage FAQs

Is Palovarotene Capsule in shortage?
Yes — the FDA currently lists Palovarotene Capsule in shortage (status: “To Be Discontinued”, first reported Aug 31, 2026). 1 of 1 product is affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
SOHONOS, Capsule, 2.5 mg (NDC 15054-0025-1) (NDC 15054-0025-01). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Palovarotene Capsule be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Palovarotene somewhere?
Other manufacturers (Ipsen Biopharmaceuticals, Inc.) still market it and have not reported a shortage. See “Where else can I get Palovarotene Capsule?” above — stock still varies by pharmacy.
What should I do if I take Palovarotene Capsule?
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 Palovarotene Capsule 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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