Prescription medicine
Ethinyl estradiol and segesterone Brand names: Annovera
Ethinyl estradiol and segesterone (Annovera) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $2,315.29 per ring (Annovera vaginal ring) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and segesterone FDA label on DailyMed (effective April 23, 2025); the NDA 209627 record on Drugs@FDA; every ethinyl estradiol and segesterone label on DailyMed.
Highlights of the record
FDA label of April 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.
Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHC should not be used by females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.5) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Females over 35 years old who smoke should not use ANNOVERA. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use.
Used for
From the label: indications and usageANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy.
Forms and strengths
- 103 mg / 17.4 mg
Ring.
On the market
- Earliest approval on file
- August 10, 2018 Annovera, Mayne Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 21, 2039 Annovera ring; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2,315.29 per ring Annovera vaginal ring
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is ethinyl estradiol and segesterone used for?
From the label: indications and usageANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. ANNOVERA is a progestin/estrogen CHC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Usage Not adequately evaluated in females with a body mass index of >29 kg/m 2 . ( 1 ) Limitations of Use ANNOVERA has not been adequately studied in females with a BMI >29 kg/m 2 .
Conditions named in the indications of ethinyl estradiol and segesterone's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Annovera), Mayne Pharma, effective April 23, 2025 (SPL set eb18194f-2021-41fa-8bdf-31e0c0eb646b), via openFDA; the full label on DailyMed
What does the patient leaflet for ethinyl estradiol and segesterone 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 ANNOVERA?Do not use ANNOVERA if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke. ANNOVERA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).
Source: FDA drug label (Annovera), Mayne Pharma, effective April 23, 2025 (SPL set eb18194f-2021-41fa-8bdf-31e0c0eb646b), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and segesterone (Annovera)?
No generic ethinyl estradiol and segesterone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Annovera ring, the last expiring on June 21, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ethinyl estradiol and segesterone (Annovera)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2,315.29 per ring (Annovera vaginal ring), about the same as a year earlier. 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.
- Annovera vaginal ring (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Annovera vaginal ring | Brand | $2,315.29 per ring | n/a | -0.1% |
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 ethinyl estradiol and segesterone label say about other medicines?
The ethinyl estradiol and segesterone label names 36 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 |
|---|---|---|
| Acetaminophen | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Aprepitant | drug interactions | Continue back-up contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Atazanavir | drug interactions | In contrast, significant increases in systemic exposure of estrogen and/or progestin have been noted when CHCs are co-administered with certain other HIV protease inhibitors (eg, indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (eg, etravirine). |
| Atorvastatin | drug interactions | Co- administration of atorvastatin or rosuvastatin and certain CHCs containing EE increase systemic exposure of EE by approximately 20–25%. |
| Bosentan | drug interactions | Continue back-up contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
| Carbamazepine | drug interactions | Continue back-up contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
| Cyclosporine | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (eg, cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Darunavir | drug interactions | Significant decreases in systemic exposure of estrogen and/or progestin have been noted when CHCs are co-administered with some HIV protease inhibitors (eg, nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (eg … |
| Efavirenz | drug interactions | Continue back-up contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
| Etravirine | drug interactions | In contrast, significant increases in systemic exposure of estrogen and/or progestin have been noted when CHCs are co-administered with certain other HIV protease inhibitors (eg, indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (eg, etravirine). |
| Felbamate | drug interactions | Continue back-up contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
| Fluconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of ANNOVERA. |
| Griseofulvin | drug interactions | Continue back-up contraception for 28 days after discontinuing the enzyme inducer to maintain contraceptive reliability. Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
Every other medicine the ethinyl estradiol and segesterone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Itraconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of ANNOVERA. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of ANNOVERA. |
| Lamotrigine | drug interactions | Clinical effect; Concomitant use of CHCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation. |
| Lopinavir and ritonavir | drug interactions | Significant decreases in systemic exposure of estrogen and/or progestin have been noted when CHCs are co-administered with some HIV protease inhibitors (eg, nelfinavir, ritonavir … |
| Miconazole | drug interactions | Products with ANNOVERA In a drug-drug interaction study with ANNOVERA and the concurrent use of three different formulations of vaginal miconazole, the use of water-based vaginal miconazole cream … |
| Morphine | drug interactions | Other Drugs Clinical effect Concomitant use of CHCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. |
| Nelfinavir | drug interactions | … when CHCs are co-administered with some HIV protease inhibitors (eg, nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV … |
| Nevirapine | drug interactions | … telaprevir), and some non-nucleoside reverse transcriptase inhibitors (eg, nevirapine). |
| Oxcarbazepine | drug interactions | … barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. … |
| Phenytoin | drug interactions | … carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's wort Induction potency of St. … |
| Prednisolone | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (eg, cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Rifabutin | drug interactions | … efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's wort Induction potency of St. … |
| Rifampin | drug interactions | … carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's wort Induction potency of St. … |
| Ritonavir | contraindications | Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine transaminase (ALT) elevations [see Warnings and … |
| Rosuvastatin | drug interactions | Co- administration of atorvastatin or rosuvastatin and certain CHCs containing EE increase systemic exposure of EE by approximately 20–25%. |
| Rufinamide | drug interactions | … felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's wort Induction potency of St. … |
| Salicylic acid | drug interactions | Other Drugs Clinical effect Concomitant use of CHCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. |
| Temazepam | drug interactions | Other Drugs Clinical effect Concomitant use of CHCs may decrease systemic exposure of acetaminophen, morphine, salicylic acid, and temazepam. |
| Theophylline | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (eg, cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Tizanidine | drug interactions | Concomitant use with ethinyl estradiol-containing CHCs may increase systemic exposure of other drugs (eg, cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole). |
| Topiramate | drug interactions | … griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St. John's wort Induction potency of St. John's wort may vary widely based on preparation. … |
| Voriconazole | drug interactions | CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase systemic exposure of the estrogen and/or progestin component of ANNOVERA. |
Check ethinyl estradiol and segesterone against other medicines
Source: FDA drug label (Annovera), Mayne Pharma, effective April 23, 2025 (SPL set eb18194f-2021-41fa-8bdf-31e0c0eb646b), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as ethinyl estradiol and segesterone?
1 other medicine is given the same way (vaginal) and in the same FDA class as ethinyl estradiol and segesterone or labeled mainly for the same use (birth control), the same class first. Birth control lists all 24 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 (vaginal) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Citric acid and lactic acid l- and potassium bitartrate | Birth control | none listed | $6.05 per gram 1.8-1-0.4% vaginal gel | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other estrogens
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other