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
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
Brazil	6349023
Philippines	11432	SYNTHESIS OF 13-POLYCARBONALKYLGONA-2,5(10)-DIENE-17-OLS
Spain	280806
Netherlands	6500435

Supplementary Protection Certificates for OPILL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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	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	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OPILL

Last updated: January 26, 2026

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Summary

OPILL (norgestimate and ethinyl estradiol) is a combined oral contraceptive indicated for preventing pregnancy. As a regulated pharmaceutical product, OPILL's market dynamics are influenced by regulatory approvals, intellectual property rights, competitive landscape, consumer demand, and emerging healthcare trends. This report analyzes the current market environment, forecasted revenues, competitive positioning, regulatory considerations, and strategic opportunities within the evolving contraceptive market.

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Introduction: Overview of OPILL

Attribute	Details
Active Ingredients	Norgestimate, Ethinyl Estradiol
Therapeutic Area	Contraceptive, Reproductive health
Market Approval	FDA-approved (September 2018)
Manufacturer	Kersia Group (formerly Matachana)
Primary Markets	United States (U.S.) primarily; other international jurisdictions pending approval

Note: OPILL is marketed predominantly in the U.S., with potential expansion driven by regulatory pathways and market demand.

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Market Size and Current Revenue Outlook

Metric	Value	Source/Notes
U.S. Contraceptive Market (2022)	~$5.8 billion	[1]
Market Share of Oral Contraceptives	~65%	[2]
Estimated OPILL Market Share (2023)	1-3%	Preliminary estimates based on sales reports
Projected Revenue (2023)	$50-150 million	Based on market penetration forecasts

Note: Given OPILL's recent market entry, current revenues are modest but with potential to grow as market awareness and prescriber acceptance increase.

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Key Market Drivers

Driver	Impact	Details
Demand for Oral Contraceptives	High	Oral pills remain the preferred method; accounting for ~70% of contraceptive use globally [3]
Novel Formulations	Positive	OPILL offers a familiar formulation but with potential for improved compliance or reduced side effects
Regulatory Environment	Facilitator	FDA approval status accelerates market access in target jurisdictions
Healthcare Policies	Variable	Reimbursement, coverage, and policy shifts influence uptake
Digital Health Initiatives	Emerging	Digital adherence tools can enhance market penetration

Competitive Landscape

Competitors	Market Share	Product Name	Distinguishing Features	Regulatory Status	Notes
Bayer	~40-50%	Yaz, Yasmin	Well-established brands with extensive distribution	Mature	High brand loyalty
Teva	~15-20%	Lo Loestrin	Generic options, low-cost	Mature	Focus on price competitiveness
Pfizer	~10%	Exported/others	Diverse offerings	Mature	Global footprint
Emerging/OPILL	~1-3% (2023)	OPILL	Simplified dosing, potential for fewer side effects	Recent FDA approval	Market expansion phase

Note: New entrants like OPILL compete mainly on formulation, compliance, and patient preference.

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Regulatory Environment and IP Considerations

Aspect	Details	Implications
Regulatory Approval	FDA (2018), pending in other jurisdictions	Enables U.S. market access; international expansion contingent on approvals
Patent Life	Patent expiry: approx. 2028	Patent protection critical for exclusivity; generic competition imminent post-expiry
Market Exclusivity	Data exclusivity for 5 years post-approval	Incentivizes innovation and marketing
Regulatory Pathways	505(b)(2) pathway prime	Facilitates approval for reformulations or new indications

Trends in Consumer and Clinical Acceptance

Trend	Effect	Explanation
Preference for Oral Contraceptives	Favorable	High compliance and familiarity
Rising Advocacy for Reduced Side Effects	Incentivizes Innovation	Potential for formulations with fewer adverse effects
Digital Adherence Support	Enhances Compliance	Apps and remote monitoring boost effectiveness
Focus on Reproductive Rights	Expands Market	Increased demand from diverse demographic groups

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Financial Trajectory and Forecasts

Year	Estimated Revenue	Assumptions	Notes
2023	$50-150 million	Launch phase, initial coverage	Based on market penetration estimates
2024	$100-250 million	Increased prescriber acceptance	Expansion through marketing and education
2025	$200-400 million	Growing brand recognition and reimbursement	Potential entry into additional markets
2026+	~$500 million	Market maturity, wider coverage	Economies of scale, increased competition

Note: The trajectory depends heavily on market penetration strategies, payer acceptance, and competitive responses.

Strategic Factors Influencing Financial Trajectory

Factor	Impact	Opportunity/Threat
Patent Protection	Extends exclusivity	Protects revenue streams; risk of generic entry
Pricing Strategies	Affects affordability	Premium pricing may optimize margins; discounts expand access
Reimbursement Policies	Critical for patient access	Negotiating favorable payer contracts expands market reach
International Expansion	Diversifies revenue	Regulatory and cultural barriers may delay entry
Formulation Innovation	Differentiates product	Opportunities for new indications or combination therapies

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Comparison with Key Competitors

Aspect	OPILL	Bayer Yaz	Teva Generics	Other New Entrants
Market Share (2023)	1-3%	~45%	~20%	Emerging
Price Point	Moderate	Premium	Low	Variable
Regulatory Status	Approved (US)	Mature	Generic	Pending/Innovation
Differentiators	Formulation Familiarity, Reusable Packaging	Brand Loyalty, Established Supply Chain	Cost-Effectiveness	Possible novel technology

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FAQs

1. What factors influence OPILL's market growth?
   Market growth hinges on prescriber acceptance, reimbursement coverage, competitive positioning, patient preference, and regulatory expansion.

2. How does patent expiry affect OPILL's revenues?
   Expiring patents around 2028 could open the market to generic competitors, potentially reducing prices and market share.

3. What are regulatory challenges for international expansion?
   Differing regulatory standards, approval timelines, and cultural acceptance pose significant hurdles, requiring strategic local partnerships.

4. How does OPILL compare with existing contraceptive options?
   OPILL offers a familiar oral formulation, with potential benefits in compliance. Its differentiation relies on formulation improvements and marketing.

5. What is the impact of emerging healthcare trends on OPILL?
   Digital health tools and increased focus on reproductive rights can provide opportunities for education, adherence, and market expansion.

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Key Takeaways

• Market Positioning: OPILL is positioned as a competitive entrant in the mature oral contraceptive market with potential for growth through formulation advantages and digital health integration.
• Revenue Potential: Projected to generate $50-150 million in 2023, with expansion strategies possibly doubling revenues by 2025.
• Patent and Competition: Patent protection until 2028 provides a window for market consolidation; imminent generic competition post-expiry necessitates strategic planning.
• Regulatory Considerations: Expansion into international markets depends on further approvals; US market provides a sturdy platform for growth.
• Strategic Opportunities: Formulation innovation, reimbursement negotiations, and digital adherence supports can enhance market share and revenues.

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References

[1] IBISWorld, "Contraceptive Manufacturers in the US," 2022.
[2] Guttmacher Institute, "Contraceptive Use in the US," 2021.
[3] UNFPA, "Global Contraceptive Use Data," 2022.
[4] FDA Label, OPILL (2018).
[5] MarketWatch, "Oral Contraceptive Market Forecast," September 2022.