When will Opill be available?

Official answer

by Drugs.com

Opill is expected to be available over-the-counter (OTC) on pharmacy shelves, retail shops and online in the first quarter of 2024. It is manufactured by Perrigo Company.

How much does Opill cost?

The Opill OTC price is not yet known. Perrigo, the manufacturer, has stated that the company plans to make the product accessible and affordable for everyone and expects to provide financial assistance for eligible women.

It remains to be seen if insurance will cover the cost of Opill as an over-the-counter (OTC) product in the U.S. Currently, the cost of prescription birth control is covered under the Affordable Care Act. Congress is now taking steps to require coverage for OTC birth control, but this is not yet finalized.

Who makes Opill?

Opill is manufactured by Perrigo Company, headquartered in Dublin, Ireland. The North American base is located in Grand Rapids, Michigan.

What is Opill?

Opill (norgestrel 0.075 mg) is the first nonprescription, over-the-counter (OTC) birth control pill (oral contraceptive), now approved in the United States for all ages. On July 13, 2023 the US Food and Drug Administration approved Opill in an Rx-to-OTC switch. Opill is expected to be available in the first quarter of 2024.

Opill is a progestin-only pill (POP), often referred to as a “mini-pill”. It does not contain estrogen, another hormone also found in combination birth control pills.

Is Opill OTC?

Opill was first approved in 1973 and was previously only available with a prescription. OTC status will help to remove barriers to more effective forms of birth control in the US and buying Opill will not require a doctor visit.

How effective is Opill at preventing pregnancy?

The OTC version of Opill is identical to the prescription norgestrel product. Progestins like norgestrel are estimated to be about 91% effective at preventing pregnancy with typical use, according to ACOG. As with any birth control method, Opill does not prevent pregnancy all the time.

In 8 US clinical trials, Opill was effective in preventing pregnancy in 98% of women. Approximately 98 out of 100 sexually active women who used Opill for a year did not become pregnant in that time, according to the product label.

Nonetheless, when used as directed, Opill is expected to be the most effective form of over-the-counter birth control. It is more effective than the condom or spermicide, other over-the-counter options.

In addition, the FDA has stated the product can be used by consumers safely and effectively by following the nonprescription Drug Facts labeling, without any assistance from a healthcare provider.

Opill is NOT for use as an emergency contraceptive and will not prevent pregnancy after unprotected sex.

If you have questions about how to take Opill, refer to the Drug Facts Label and consumer information leaflet found with your pack, or ask your doctor or pharmacist.

When did the FDA approve Opill?

On July 13, 2023 the FDA granted full approval to Opill through an Rx-to-OTC switch. Before that, in May 2023, the U.S. FDA advisory committee voted unanimously 17 to 0 that the benefits of making Opill (norgestrel 0.075 mg), a progestin only oral contraceptive, available as an over-the-counter (OT) option for women outweighed the risks. It is expected to be available in pharmacies and retail shops in the early part of 2024.

In the U.S., close to one-half of all pregnancies each year are unintended, and about a third of women have reported having trouble getting a prescription or refill for birth control like the pill, patch or vaginal ring. Access and affordability of safe and effective forms of birth control can often be difficult for many U.S. women.

In an FDA advisory committee meeting, company representatives stated that in a study of 955 participants, only 6 became pregnant while using Opill.

Opill has a long history of safe and effective use. It was first approved as a prescription product in 1973. Evidence has shown that progestin-only pills are effective at preventing pregnancy and safe for most women.

Prior to approval, the FDA reviewed several studies confirming that consumers could understand the OTC label and use the Opill product correctly. Removing the prescription requirement for Opill will help to improve access to an effective form of birth control that works better than current OTC methods, including condoms and spermicides.

In addition, availability of over-the-counter (OTC) oral birth control has support from major medical groups, including the American College of Obstetricians and Gynecologists (ACOG), the American Medical Association (AMA), the Society for Adolescent Health and Medicine and the American Academy of Family Physicians (AAFP), according to the manufacturer.

How do I take Opill?

If you are switching from another oral contraceptive, vaginal ring, or patch, start taking Opill the day after you stop the other method.

If you have taken an emergency contraceptive in the last 5 days, talk to your doctor or pharmacist before you start Opill.

Oral contraceptives do not protect against HIV, AIDS and other sexually transmitted diseases (STDs). Use condoms to prevent STDs.

This is not all the information you need to know about Opill (norgestreol 0.075 mg) for safe and effective use. Review the full Drug Facts Label and Consumer Product Information and discuss this information and any questions you have with your doctor or other health care provider.