NORGESTREL - Generic Drug Details

What are the generic sources for norgestrel and what is the scope of freedom to operate?

Norgestrel is the generic ingredient in one branded drug marketed by Laboratoire Hra and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for NORGESTREL

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	14
What excipients (inactive ingredients) are in NORGESTREL?	NORGESTREL excipients list
DailyMed Link:	NORGESTREL at DailyMed

Recent Clinical Trials for NORGESTREL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Al-Azhar University	NA
Sohag University	Early Phase 1
HRA Pharma	Phase 2

See all NORGESTREL clinical trials

Medical Subject Heading (MeSH) Categories for NORGESTREL

Contraceptives, Oral, Synthetic

US Patents and Regulatory Information for NORGESTREL

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 NORGESTREL

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
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031-001	Approved Prior to Jan 1, 1982

Norgestrel Market Dynamics, Patent Position, Opill Sales Outlook, and Financial Trajectory

Last updated: August 31, 2026

Norgestrel is a mature progestin whose commercial value has shifted from prescription contraception to over-the-counter access. The principal current U.S. product is Opill, a 0.075 mg norgestrel progestin-only oral contraceptive marketed by Perrigo after FDA approval for nonprescription use in 2023. Norgestrel’s underlying molecule has no meaningful remaining composition-of-matter exclusivity. The investment case therefore depends on consumer adoption, retail distribution, pricing, brand execution, regulatory barriers, and the timing of competing products rather than on a conventional patent-protected lifecycle.

Perrigo has not established a separately reported, fully transparent Opill revenue line in its public financial reporting. Public disclosures identify Opill as a growth initiative within Perrigo’s Consumer Self-Care portfolio, but investors cannot independently reconstruct product-level profitability from the company’s consolidated filings.[1]

What is norgestrel and how is it used commercially?

Norgestrel is a synthetic progestin used in oral contraception. It is chemically related to levonorgestrel, the more commercially prominent active enantiomer used in emergency contraception and several contraceptive products.

The U.S. commercial product with the strongest current relevance is Opill:

Attribute	Norgestrel and Opill
Active ingredient	Norgestrel
Dose	0.075 mg per tablet
Product type	Progestin-only oral contraceptive
U.S. sponsor	Perrigo
FDA pathway	Prescription-to-over-the-counter switch
FDA approval	July 13, 2023
Commercial availability	2024
Prescription status	OTC in the United States
Primary market	Consumer contraception
Biosimilar exposure	None
Main competitive substitutes	Combined oral contraceptives, progestin-only pills, implants, IUDs, emergency contraception

The product differs from levonorgestrel emergency contraception. Opill is intended for continuous daily use, while Plan B and equivalent products are used after unprotected intercourse. Confusing the two ingredients can produce incorrect market-size and patent analyses.

When did Opill lose prescription status and become over the counter?

The FDA approved Opill for nonprescription use in July 2023. The agency’s decision followed a sponsor-funded application showing that consumers could understand the label and determine whether the product was appropriate for them without a healthcare professional.[2]

Retail and online availability began in 2024. The launch created the first widely available daily oral contraceptive in the United States that consumers could obtain without a prescription. That regulatory change expanded the addressable population beyond insured patients and patients with routine access to prescribers.

The transition has three commercial effects:

1. It reduces prescription-channel friction.
2. It shifts payment from insurers and pharmacy benefit managers toward consumers.
3. It places greater importance on shelf placement, search visibility, price, and retailer distribution.

The regulatory approval does not establish permanent exclusivity. It authorizes the product and its labeling. Competitors can potentially pursue their own FDA applications or other legally available pathways.

What patents protect norgestrel and Opill?

The original norgestrel composition and early oral contraceptive patents are long expired. No current U.S. market value appears to depend on an active molecule patent covering norgestrel itself.

Composition-of-matter protection

Norgestrel entered the market decades ago. Any original compound patent would have expired before the current Opill launch. The active ingredient therefore does not create a conventional patent barrier against generic or alternative norgestrel products.

Formulation patents

Potential protection may arise from:

• tablet composition;
• manufacturing processes;
• impurity specifications;
• packaging;
• stability systems;
• consumer-facing delivery formats; and
• claims tied to OTC use or labeling.

These rights would need to be assessed in the current Orange Book and relevant patent databases. They are materially weaker than a valid composition patent because competitors can often design around them or use a different formulation.

Method-of-use patents

A method-of-use patent directed to daily contraception with norgestrel would face substantial validity and obviousness risks given the long history of progestin-only contraception. A novel dosing schedule, patient population, or clinical application could alter that assessment, but no such patent appears to define the current norgestrel market.

Orange Book status

The FDA Orange Book is the controlling source for patents and regulatory exclusivity listed against an approved drug application.[3] Norgestrel’s commercial opportunity should not be analyzed as an Orange Book-protected innovative medicine unless a current listing is verified for the relevant NDA and product. The mature active ingredient and long commercial history indicate a low patent-barrier profile.

How strong is the norgestrel patent estate?

The norgestrel patent estate is weak from a molecule-exclusivity perspective and potentially moderate only at the product or regulatory level.

Protection category	Commercial strength	Reason
Norgestrel molecule patent	Very low	Historical protection expired
Basic oral tablet claims	Low	Older technology with substantial prior art
Manufacturing process	Low to moderate	May create operational friction but is design-aroundable
Opill branding and trademarks	Moderate	Brand can support consumer recognition but does not block generic entry
OTC regulatory know-how	Moderate	Consumer-labeling studies and switch expertise can delay competitors
Distribution relationships	Moderate	Retail access may influence launch speed
Biosimilar protection	None	Norgestrel is a small molecule

The most defensible assets are likely commercial and regulatory rather than patent-based. Perrigo’s advantage includes first-mover status, FDA experience with the OTC switch, retailer access, and consumer awareness. Those advantages can erode if a rival obtains FDA approval for a competing OTC progestin-only pill.

What is the financial trajectory for norgestrel and Opill?

The financial trajectory is best described as an early-stage consumer-health launch within a mature pharmaceutical category.

Perrigo’s acquisition of HRA Pharma expanded the company’s consumer-health portfolio and added brands in women’s health and self-care.[4] Opill then became a strategic product because it opened a new U.S. OTC category rather than because it had remaining patent exclusivity.

Revenue drivers

Opill revenue depends on five variables:

• U.S. household awareness of OTC daily contraception;
• the conversion of prescription users to cash-pay purchases;
• access through mass retailers, pharmacies, and e-commerce;
• monthly and multi-month pricing; and
• repeat adherence.

Typical retail pricing has been positioned around the low-to-mid-$20 range for a one-month supply, with lower per-month pricing for multipacks. Cash-pay pricing creates a substantial access barrier for consumers accustomed to insurance-covered prescription contraception. Perrigo’s commercial strategy therefore must balance margin against category adoption.

Margin profile

The product has favorable manufacturing characteristics:

• a small-molecule active ingredient;
• an established tablet dosage form;
• no cold chain;
• no biologic manufacturing;
• no specialized administration device; and
• no infusion or clinical-service requirement.

Gross margins could be attractive after launch costs normalize. Early profitability is constrained by national advertising, retailer promotions, consumer education, digital acquisition, regulatory support, and inventory expansion.

Perrigo reports at the segment level rather than presenting a detailed Opill income statement. As a result, public investors generally cannot isolate:

• Opill net sales;
• product gross margin;
• advertising spend;
• contribution profit;
• repeat-purchase rates; or
• retailer inventory levels.

The correct financial interpretation is that Opill is strategically important but not yet a separately measurable earnings engine in public filings.[1]

Which companies compete with norgestrel?

Norgestrel competes with products rather than only with chemically identical pills.

Direct competition

The most direct future competitors would be manufacturers seeking OTC approval for a progestin-only oral contraceptive. A competitor could use norgestrel, levonorgestrel, desogestrel, or another progestin, subject to FDA requirements and product-specific safety and labeling data.

Prescription oral contraception

Prescription combined pills and progestin-only pills remain the largest substitutes. They compete through clinician familiarity, insurance reimbursement, established generic pricing, and broad formulary coverage.

Long-acting contraception

Hormonal IUDs, implants, and injections compete for patients seeking high contraceptive efficacy and less frequent dosing. Their clinical and financial models differ from Opill because they require healthcare-provider involvement and often receive insurance reimbursement.

Emergency contraception

Levonorgestrel emergency contraception is adjacent rather than directly substitutable. Products such as Plan B and store-brand equivalents address post-intercourse use, not daily contraception.

Competitive comparison

Product category	Prescription required	Typical payment model	Dosing	Main advantage
Opill norgestrel	No in the U.S.	Cash pay or retail benefit	Daily	Convenience and privacy
Generic combined pill	Generally yes	Insurance or cash	Daily	Low generic cost and familiarity
Prescription progestin-only pill	Generally yes	Insurance or cash	Daily	Clinician-directed treatment
Hormonal IUD	Yes	Insurance or procedure payment	Multi-year	High efficacy and low user maintenance
Implant	Yes	Insurance or procedure payment	Multi-year	Long duration
Levonorgestrel emergency contraception	No	Cash pay or retail benefit	Single use	Post-intercourse use

What generic entry risks exist for Opill?

Generic entry risk is high over the long term because the active ingredient is old and the dosage form is conventional. The first competitor may not need to invalidate a patent. It may instead submit a separate FDA application supported by its own safety, efficacy, labeling, and OTC-use evidence.

The main barriers are therefore:

• the cost of OTC consumer-labeling studies;
• FDA review requirements;
• manufacturing scale;
• retailer access;
• brand investment;
• consumer trust;
• pharmacovigilance; and
• the ability to finance national promotion.

A generic entrant could launch at a lower price, but low price alone may not secure market share. Contraceptive users often value availability, privacy, side-effect information, and confidence in product quality.

What is the Paragraph IV and litigation risk?

Paragraph IV litigation risk appears limited for the underlying norgestrel molecule because the relevant historic patents expired long ago. A future competitor could still challenge any active formulation or regulatory patent listed against the applicable Opill NDA.

Potential disputes could involve:

• Orange Book patent listing accuracy;
• formulation claims;
• manufacturing processes;
• labeling or method-of-use claims;
• trademark or trade-dress rights; and
• antitrust claims involving product hopping or restricted distribution.

No litigation settlement should be assumed without a documented court docket, FDA listing, or company disclosure. The commercial risk is more likely to arise from a rival regulatory approval than from a classic patent cliff.

What FDA regulatory factors affect norgestrel’s market value?

FDA approval gave Perrigo an important first-mover position, but OTC contraception remains subject to continuing regulatory obligations. These include adverse-event reporting, label comprehension, product quality, promotional compliance, and manufacturing compliance.

The FDA decision also created a precedent that can reduce regulatory uncertainty for future OTC contraceptive applications. That precedent increases the probability of eventual competition, even though it does not guarantee a near-term rival.

What is the geographic coverage and international opportunity?

The strongest near-term commercial opportunity is the United States because the OTC switch removes a major access barrier in a large contraceptive market. International markets vary widely. Some countries already permit pharmacy access to oral contraceptives, while others require prescriptions or impose reimbursement and regulatory restrictions.

Norgestrel’s global opportunity is constrained by:

• country-specific approvals;
• local contraceptive guidelines;
• pricing controls;
• public-sector procurement;
• competing generic oral contraceptives; and
• differences in consumer willingness to self-select contraception.

The U.S. OTC launch is therefore more commercially differentiated than a standard international norgestrel expansion.

Key Takeaways

• Norgestrel is a mature progestin with no meaningful remaining molecule patent protection.
• Opill is the primary current U.S. commercial growth vehicle for norgestrel.
• FDA approved Opill for OTC use in July 2023, with U.S. availability beginning in 2024.[2]
• Perrigo’s advantage is based on regulatory execution, brand, distribution, and consumer education rather than patent exclusivity.
• Product-level Opill revenue and profitability are not separately transparent in Perrigo’s public reporting.[1]
• Generic and alternative OTC entry risk is high over the long term.
• Paragraph IV litigation risk is likely lower than regulatory and commercial competition risk.
• The principal financial question is whether Perrigo can convert OTC access into repeat purchases while maintaining pricing and retail visibility.

FAQs

Is norgestrel the same as levonorgestrel?

No. Norgestrel and levonorgestrel are closely related progestins, but they are not the same active ingredient. Levonorgestrel is the active enantiomer used in several emergency contraceptive products.

Is Opill protected by a new chemical patent?

No meaningful new chemical patent protection should be attributed to norgestrel. Any current protection would more likely involve formulation, regulatory, manufacturing, branding, or commercial assets.

Can a generic version of Opill launch immediately?

No. A competitor would need the appropriate FDA authorization and must satisfy applicable safety, quality, labeling, and OTC-use requirements. The absence of a strong molecule patent does not eliminate regulatory barriers.

Does insurance cover Opill?

Coverage depends on the applicable plan, federal and state requirements, employer arrangements, and the dispensing channel. OTC status shifts more of the initial purchase decision toward the consumer and retailer.

Is norgestrel a biologic with biosimilar risk?

No. Norgestrel is a small-molecule pharmaceutical. Biosimilar rules do not apply. Competitive entry would occur through generic or separate drug-approval pathways.

References

1. Perrigo Company plc. (2024). Annual report 2023 and company investor disclosures.
2. U.S. Food and Drug Administration. (2023, July 13). FDA approves first nonprescription daily oral contraceptive.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. Perrigo Company plc. (2021). Perrigo completes acquisition of HRA Pharma.