Prescription medicine
Ospemifene Brand names: Osphena
Ospemifene (Osphena) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $8.17 per Osphena 60 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the ospemifene FDA label on DailyMed (effective February 14, 2025, Duchesnay USA, Inc.); the NDA 203505 record on Drugs@FDA; every ospemifene label on DailyMed.
Highlights of the record
FDA label of February 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS See full prescribing information for complete boxed warning. OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2) ]. Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 1.13 and 3.39 per thousand women years, respectively vs. 3.15 and 0 per thousand women years, respectively with placebo. For deep vein thrombosis, the incidence rate for OSPHENA 60 mg is 2.26 per thousand women years (2 reported cases) vs. 3.15 per thousand women years (1 reported case) with placebo [see Warnings and Precautions (5.1) ]. Endometrial Cancer OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. […]
Used for
From the label: indications and usageOSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Forms and strengths
- 60 mg
Film-coated tablet.
On the market
- Earliest approval on file
- February 26, 2013 Osphena, Duchesnay; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first February 13, 2024; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 9, 2028 Osphena tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $8.17 per tablet Osphena 60 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,601 through July 30, 2026
What is ospemifene used for?
From the label: indications and usageOSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.1 ) The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.2 ) 1.1 The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause. 1.2 The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.
Conditions named in the indications of ospemifene's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen Agonist/Antagonist.
Source: FDA drug label (Osphena), Duchesnay USA, Inc., effective February 14, 2025 (SPL set 9accbcc9-78ee-4f84-9b7e-704f2ab1c413), via openFDA; the full label on DailyMed
What does the patient leaflet for ospemifene say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OSPHENA?OSPHENA is a medicine that works like estrogen in the lining of the uterus (womb) but can work differently in other parts of the body. OSPHENA may increase your chance of getting cancer of the lining of the uterus (womb). Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Tell your healthcare provider right away if you have any unusual vaginal bleeding while you are taking OSPHENA. OSPHENA may increase your chance of getting strokes and blood clots.
From the patient leaflet: How should I store OSPHENA?Store OSPHENA at room temperature between 68°F to 77°F (20°C to 25°C). Keep OSPHENA and all medicines out of the reach of children.
Source: FDA drug label (Osphena), Duchesnay USA, Inc., effective February 14, 2025 (SPL set 9accbcc9-78ee-4f84-9b7e-704f2ab1c413), via openFDA; the full label on DailyMed
Is there a generic for ospemifene (Osphena)?
The FDA approved the first generic ospemifene on February 13, 2024. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 2 patents for Osphena tablets, the last expiring on July 9, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2024 first generic approved
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ospemifene (Osphena)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.17 per Osphena 60 mg tablet, up 5% from $7.79 on October 8, 2025. 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.
- Osphena 60 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Osphena 60 mg tablet | Brand | $8.17 per tablet | $245.19 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ospemifene label say about other medicines?
The ospemifene label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluconazole | drug interactions | Fluconazole increases serum concentrations of OSPHENA. ( 7.2 , 12.3 ) Do not use rifampin concomitantly with OSPHENA. |
| Ketoconazole | drug interactions | Ketoconazole Ketoconazole, a strong CYP3A4 inhibitor, increases the systemic exposure of ospemifene by 1.4-fold. |
| Medroxyprogesterone | warnings and precautions | After a mean follow-up of 5.6 years, the WHI substudy of daily CE (0.625 mg) plus medroxyprogesterone acetate (MPA) (2.5 mg) reported an increased risk of invasive breast cancer in women who took daily CE plus MPA compared to placebo. |
| Rifampin | drug interactions | Fluconazole increases serum concentrations of OSPHENA. ( 7.2 , 12.3 ) Do not use rifampin concomitantly with OSPHENA. |
| Warfarin | drug interactions | Repeated administration of ospemifene had no effect on the pharmacokinetics of a single 10 mg dose of warfarin. |
Source: FDA drug label (Osphena), Duchesnay USA, Inc., effective February 14, 2025 (SPL set 9accbcc9-78ee-4f84-9b7e-704f2ab1c413), via openFDA; the full label on DailyMed
What do FAERS reports show for ospemifene?
The FDA Adverse Event Reporting System holds 2,601 reports that list ospemifene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 118 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.
Reports received each year
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 ospemifene?
6 other medicines are given the same way (oral) and in the same FDA class as ospemifene 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 |
| Elinzanetant | Menopause symptoms | none listed | $9.97 per capsule 60 mg capsule | No current entry |
Every medicine labeled for the same conditions as ospemifene
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ospemifene
- 6 medicines for the same use
- Other estrogen agonist/antagonists
- the pharmacologic class, with prices and generics
- Ospemifene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other