OPILL Drug Patent Profile

When do Opill patents expire, and when can generic versions of Opill launch?

Opill is a drug marketed by Laboratoire Hra and is included in one NDA.

The generic ingredient in OPILL is norgestrel. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the norgestrel profile page.

Summary for OPILL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	107
Patent Applications:	4,695
Drug Prices:	Drug price information for OPILL
What excipients (inactive ingredients) are in OPILL?	OPILL excipients list
DailyMed Link:	OPILL at DailyMed

See drug prices for OPILL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OPILL

Constraining patent/regulatory exclusivity:

RX TO OTC SWITCH OR OTC USE

NDA:

017031

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for OPILL

OPILL is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on RX TO OTC SWITCH OR OTC USE.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982		OTC	Yes	Yes

Expired US Patents for OPILL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982	3,666,858
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982	3,850,911
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982	3,959,322

International Patents for OPILL

See the table below for patents covering OPILL around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	121369
France	1276081	Nouveaux intermédiaires cétoniques en vue de la synthèse des stéroïdes et leur procédé de préparation
Germany	1443124
Philippines	11431	13-POLYCARBONALKYL-8,14-SECOGONA-1,3,5(10),9(11)-TETRAENE-4,17-DIONES
Switzerland	565730	Steroid intermediates for total synthesis
United Kingdom	1204172
United Kingdom	1141772

Supplementary Protection Certificates for OPILL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for Opill: The First OTC Birth Control Pill

Introduction

The approval and launch of Opill, the first over-the-counter (OTC) birth control pill in the U.S., marks a significant milestone in women's reproductive health. Here, we delve into the market dynamics and financial trajectory of Opill, exploring its impact on the contraceptive market, pricing, and future projections.

FDA Approval and Market Entry

Opill, a progestin-only daily birth control pill, was approved by the FDA on July 13, 2023. This approval followed a long-awaited application submitted by HRA Pharma, which had already sold the pill OTC in England under the brand name Hana[5].

Distribution and Availability

Perrigo, the company responsible for manufacturing and distributing Opill, began shipping the product to thousands of retail stores nationwide in March 2024. Major retailers, including CVS Health, have started selling Opill through their websites, apps, and over 7,500 stores across the U.S.[1].

Impact on the Contraceptive Market

The introduction of Opill is expected to transform the oral contraception market. Historically, therapeutic classes transitioning from prescription-only to OTC have seen significant increases in usage. For example, non-drowsy oral antihistamines and steroid-based nasal allergy sprays took around four to six years to dominate the OTC market[1].

Current Market Size

The U.S. prescription birth control pill market is estimated to be around $3 billion annually, representing 37% of the $8 billion contraceptive market in the country[1].

Potential Market Shift

While it is too early to gauge the exact impact of Opill on the prescription market, industry experts anticipate that OTC access could increase the utilization of oral contraception. David Spangler from the Consumer Healthcare Products Association (CHPA) noted that the transition speed will depend on various factors, including the specific molecule involved[1].

Pricing and Cost Considerations

Opill is priced at $19.99 for a one-month supply, $49.99 for a three-month supply, and $89.99 for a six-month supply. This pricing structure could be a barrier for some Americans, especially since no commercial insurer currently covers Opill unless legally required to do so[1][2].

Financial Assistance Programs

To address the cost issue, Perrigo has launched a cost-assistance program to help uninsured and low-income Americans receive Opill for free. The company is also advocating for insurers to cover Opill under the Affordable Care Act[1].

Financial Projections and Growth

Market Size and Growth Rate

The global oral contraceptive pills market is projected to grow from $23.66 billion in 2023 to $27.12 billion in 2024, with a compound annual growth rate (CAGR) of 14.6%. By 2028, the market is expected to reach $47.15 billion[3].

U.S. Market

The U.S. contraceptive drugs market, which includes oral contraceptives, is valued at $7.27 billion in 2023 and is expected to grow significantly, reaching an estimated $12.06 billion by 2032[4].

Revenue Potential for Opill

While Perrigo has not released specific sales projections for Opill, the company's revenue from this product is unlikely to make a significant dent in its overall revenues immediately. However, as OTC access increases utilization, Opill could contribute substantially to the company's growth in the long term[1].

Distribution Channels and Retail Dominance

The retail pharmacy segment dominates the global contraceptive drugs market, driven by the growing demand for OTC contraception among the general population. Online channels are also seeing rapid growth due to their convenience and availability of various contraceptive products[4].

Consumer Preferences and Awareness

The increasing preference for OTC drugs and growing awareness about birth control methods are key drivers of the market. Public programs and education initiatives are further boosting the adoption of oral contraceptive pills[4].

Regulatory and Insurance Coverage

Opill's approval and availability highlight the need for expanded insurance coverage for OTC contraceptives. Currently, only eight states require insurance companies to cover OTC contraception, and some Medicaid programs have begun to include Opill in their coverage[1].

Future Trends and Innovations

The market is expected to see a focus on minimizing side effects and hormonal disruption, the emergence of non-hormonal and natural contraceptive alternatives, and a shift towards continuous and tailored contraceptive regimens. These trends will likely influence the development and marketing of future contraceptive products[3].

Key Takeaways

• Market Transformation: Opill's OTC approval is set to transform the oral contraception market, potentially increasing utilization and accessibility.
• Pricing and Cost: The cost of Opill could be a barrier, but financial assistance programs and advocacy for insurance coverage are underway.
• Financial Projections: The global and U.S. contraceptive markets are expected to grow significantly, with Opill contributing to this growth.
• Distribution and Retail: Retail pharmacies and online channels will play crucial roles in the distribution of Opill.
• Consumer Awareness: Growing awareness and education initiatives are driving the adoption of oral contraceptive pills.

FAQs

What is Opill, and how is it different from other birth control pills?

Opill is the first over-the-counter (OTC) birth control pill approved in the U.S., containing only norgestrel, a progestin, without estrogen. This makes it distinct from combination pills that include both estrogen and progestin.

How much does Opill cost, and are there any financial assistance programs available?

Opill is priced at $19.99 for a one-month supply, $49.99 for three months, and $89.99 for six months. Perrigo has launched a cost-assistance program to help uninsured and low-income Americans receive Opill for free.

Is Opill covered by insurance?

Currently, no commercial insurer covers Opill unless legally required to do so. However, Perrigo is advocating for expanded insurance coverage under the Affordable Care Act.

Where can I purchase Opill?

Opill is available through various retail stores, including over 7,500 CVS Health locations, as well as through their website and app.

How will Opill impact the overall contraceptive market?

Opill's OTC availability is expected to increase the utilization of oral contraception by eliminating the need for a prescription, potentially siphoning some market share from prescription contraceptives.

Sources

1. BioSpace: Birth Control Market Evolves as OTC Opill Hits US Stores
2. Medical News Today: Cost and Opill: Financial assistance options, savings, more
3. The Business Research Company: Global Oral Contraceptive Pills Market Report 2024
4. Fortune Business Insights: Contraceptive Drugs Market Size, Share | Global Report, 2032
5. Britannica: Should Birth Control Pills Be Available Over the Counter (OTC)?