Prescription medicine
Elinzanetant Brand names: Lynkuet
Elinzanetant (Lynkuet) is a prescription medicine with an FDA approval on record since 2025. No generic is listed; pharmacies paid $9.97 per Lynkuet 60 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the elinzanetant FDA label on DailyMed (effective June 16, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 219469 record on Drugs@FDA; every elinzanetant label on DailyMed.
Highlights of the record
FDA label of June 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
Forms and strengths
- 60 mg
Capsule.
On the market
- Earliest approval on file
- October 24, 2025 Lynkuet, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 14, 2045 Lynkuet capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $9.97 per capsule Lynkuet 60 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 251 through July 30, 2026
What is elinzanetant used for?
From the label: indications and usageLYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Conditions named in the indications of elinzanetant's FDA labels, with every medicine labeled for each:
Source: FDA drug label (LYNKUET), Bayer HealthCare Pharmaceuticals Inc., effective June 16, 2026 (SPL set f42884ff-7dff-419c-8a0c-affe2ed73818), via openFDA; the full label on DailyMed
What does the patient leaflet for elinzanetant say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking LYNKUET?Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET. LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away. See " What are the possible side effects of LYNKUET? ".
From the patient leaflet: How should I store LYNKUET?Store LYNKUET at room temperature between 68°F to 77°F (20°C to 25°C). Keep LYNKUET and all medicines out of the reach of children.
Source: FDA drug label (LYNKUET), Bayer HealthCare Pharmaceuticals Inc., effective June 16, 2026 (SPL set f42884ff-7dff-419c-8a0c-affe2ed73818), via openFDA; the full label on DailyMed
Is there a generic for elinzanetant (Lynkuet)?
No generic elinzanetant is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Lynkuet capsules: the compound patent runs to September 15, 2027, and the last listed entry to May 14, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2045 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for elinzanetant (Lynkuet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $9.97 per Lynkuet 60 mg capsule. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lynkuet 60 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lynkuet 60 mg capsule | Brand | $9.97 per capsule | $299.12 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for elinzanetant?
The FDA Adverse Event Reporting System holds 251 reports that list elinzanetant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 12 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as elinzanetant?
6 other medicines are given the same way (oral) and in the same FDA class as elinzanetant or labeled mainly for the same use (menopause symptoms), the same class first. Menopause symptoms lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Estradiol | Menopause symptoms | 21 labelers | $0.0635 per tablet 1 mg tablet | No current entry |
| Estradiol and norethindrone | Menopause symptoms | 7 labelers | $0.802 per tablet 0.5-0.1 mg tablet | No current entry |
| Estrogens conjugated | Menopause symptoms | 1 labeler | $5.47 per tablet 0.625 mg tablet | No current entry |
| Fezolinetant | Menopause symptoms | none listed | $18.58 per tablet 45 mg tablet | No current entry |
| Drospirenone and estradiol | Menopause symptoms | none listed | $6.37 per tablet 0.25 mg-0.5 mg tablet | No current entry |
| Ospemifene | Menopause symptoms | none listed | $8.17 per tablet 60 mg tablet | No current entry |
Every medicine labeled for the same conditions as elinzanetant
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to elinzanetant
- 6 medicines for the same use
- Elinzanetant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other