List of Excipients in Branded Drug PLAN B

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Physicians Total Care Inc	PLAN B	levonorgestrel	54868-4894	GELATIN
Physicians Total Care Inc	PLAN B	levonorgestrel	54868-4894	LACTOSE MONOHYDRATE
Physicians Total Care Inc	PLAN B	levonorgestrel	54868-4894	MAGNESIUM STEARATE
Physicians Total Care Inc	PLAN B	levonorgestrel	54868-4894	SILICON DIOXIDE
Physicians Total Care Inc	PLAN B	levonorgestrel	54868-4894	STARCH, CORN

Last updated: August 19, 2026

ecutive summary: Plan B is a mature, widely available over-the-counter emergency contraceptive containing 1.5 mg levonorgestrel. Its commercial protection is driven primarily by brand recognition, retail distribution, regulatory status, packaging, and consumer trust rather than by an active patent estate. The current tablet uses conventional excipients: lactose monohydrate, corn starch, povidone, magnesium stearate, talc, and colloidal silicon dioxide.[1] The strongest excipient opportunities are differentiated dosage forms, faster disintegration, improved swallowability, heat and humidity stability, and lower-cost manufacturing. Any reformulation must preserve levonorgestrel dissolution, assay, content uniformity, stability, and the FDA’s OTC monograph and labeling requirements.

Plan B Excipient Strategy and Commercial Opportunities

What excipients are used in Plan B One-Step?

Plan B One-Step is a single-dose oral tablet containing 1.5 mg levonorgestrel. The FDA labeling identifies the inactive ingredients as colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, and talc.[1]

Excipient	Functional role in a levonorgestrel tablet	Commercial relevance
Lactose monohydrate	Diluent and tablet bulk	Supports low-dose drug uniformity and conventional direct-compression or granulation processes
Corn starch	Diluent and disintegrant	Helps tablet breakup after ingestion
Povidone	Binder	Improves granule and tablet cohesion
Magnesium stearate	Lubricant	Reduces manufacturing friction and tooling adhesion
Talc	Glidant or processing aid	Supports powder flow and manufacturing consistency
Colloidal silicon dioxide	Glidant and moisture-management aid	Improves flow and may reduce powder cohesion

The formulation is conventional and does not create a material barrier to generic competition. Excipients are widely used, inexpensive, and generally available from multiple suppliers. The commercial value lies in how the excipients are selected, processed, and combined with the active ingredient.

What is the regulatory status of Plan B?

Plan B One-Step is an FDA-approved levonorgestrel emergency contraceptive that is marketed without a prescription. The product moved from prescription availability to nonprescription status through FDA regulatory actions in 2013.[2]

Levonorgestrel emergency contraception is also covered by the FDA’s nonprescription emergency contraceptive framework. A competing manufacturer can pursue an abbreviated or monograph-based pathway depending on the product, formulation, labeling, and regulatory classification.[3]

The main regulatory advantages of a new Plan B-like formulation are:

• No requirement to establish a new chemical entity.
• A well-characterized active pharmaceutical ingredient.
• Extensive clinical and postmarketing experience.
• Established consumer use and recognized dosing.
• Potential reliance on comparative dissolution, bioequivalence, and quality data rather than a full development program.

A materially different dosage form, such as an orally disintegrating tablet or chewable product, may require a new application, a supplement, or a different regulatory strategy. The pathway depends on the proposed claims, formulation, labeling, manufacturing process, and whether the product is therapeutically equivalent to an approved reference product.

What patents protect Plan B and its excipient formulation?

Plan B’s original commercial protection has largely expired. Levonorgestrel is an old active ingredient, and the central commercial product is exposed to generic and store-brand competition.

The principal patent categories historically associated with levonorgestrel emergency contraception include:

1. Composition-of-matter or active-ingredient patents covering levonorgestrel.
2. Tablet-composition patents.
3. Dosing and emergency-contraception method patents.
4. Manufacturing and processing patents.
5. Product-specific patents covering a formulation, delivery system, or packaging configuration.

The current conventional tablet formulation is unlikely to provide a strong standalone patent position because its excipients are standard pharmaceutical materials. A new excipient strategy would require a narrower, technically defensible claim, such as:

• A defined excipient ratio that improves dissolution.
• A low-moisture formulation that extends stability.
• A specific granulation or compaction process.
• A taste-masking matrix for a chewable or orally disintegrating tablet.
• A formulation that maintains content uniformity at a lower tablet weight.
• A preservative-free liquid or dispersible system.
• A packaging and formulation combination that limits degradation under heat and humidity.

A patent directed only to the presence of lactose, starch, povidone, magnesium stearate, talc, or silica would face substantial novelty and obviousness risk. Patent strength would improve if the formulation produced a measurable, unexpected result tied to a defined composition and manufacturing process.

When does Plan B lose exclusivity?

Plan B no longer depends on meaningful market exclusivity from a single active-ingredient patent. Generic levonorgestrel emergency contraceptives have entered the market, and consumers can purchase competing products from multiple manufacturers and retailers.

Exclusivity element	Plan B position
Active ingredient	Old, widely available levonorgestrel
Prescription-to-OTC status	OTC availability established
Generic competition	Present
Brand protection	Trademark, trade dress, retail positioning, and consumer recognition
Formulation protection	Conventional excipient system has limited differentiation
Distribution protection	Broad retail, pharmacy, online, and public-health channels
Biosimilar exposure	Not applicable; levonorgestrel is a small molecule
Paragraph IV exposure	Relevant primarily to any active Orange Book-listed patent tied to a particular NDA

The principal commercial question is no longer whether competitors can launch levonorgestrel tablets. It is whether a competitor can create a differentiated OTC product that earns shelf space, online search visibility, institutional procurement, or a price premium.

What is the Orange Book status of Plan B?

The Orange Book is relevant to Plan B only to the extent that the reference product has active patents or exclusivity listed against its approved application.[4] A conventional generic competitor would evaluate any current NDA-linked patents, pediatric exclusivity, regulatory exclusivity, and labeling requirements before filing.

For a new excipient-based product, the Orange Book strategy depends on whether the product is submitted as:

• An ANDA referencing an approved levonorgestrel product.
• A supplemental application for an existing product.
• A new NDA for a distinct dosage form or delivery system.
• A product regulated under an OTC monograph or monograph order.

Formulation patents can be listed in the Orange Book only if they meet FDA listing requirements and are properly tied to the approved drug product. A broad formulation patent that is not reflected in approved labeling or product composition may not provide the same litigation leverage as a properly listed patent.

How do Paragraph IV challenges affect Plan B competitors?

A generic manufacturer filing an ANDA with a Paragraph IV certification would challenge any relevant listed patent as invalid, unenforceable, or not infringed. The filing can create litigation risk and, in certain circumstances, trigger a 30-month stay of approval under the Hatch-Waxman framework.[5]

For a mature levonorgestrel product, the commercial value of Paragraph IV litigation is limited unless an active patent materially delays approval or provides a meaningful launch advantage. A competitor may instead pursue:

• A Paragraph III certification for later launch.
• A noninfringement position based on a different formulation.
• A product that does not rely on the reference formulation.
• An OTC pathway that avoids dependence on a specific listed patent.
• A brand strategy focused on price, access, or dosage-form differentiation.

The litigation risk increases if a new product claims a specialized formulation, such as a rapid-disintegration tablet, taste-masked chewable tablet, or moisture-protected composition.

What formulation patents could create a stronger Plan B product?

Orally disintegrating tablet

An orally disintegrating tablet could address consumers who have difficulty swallowing conventional tablets. Candidate excipients include superdisintegrants, directly compressible fillers, porous carriers, and taste-masking agents.

Potential claim elements include:

• Disintegration time below a defined threshold.
• Defined hardness and friability ranges.
• Levonorgestrel particle-size distribution.
• A specific superdisintegrant-to-filler ratio.
• A composition that maintains dissolution after high-humidity storage.

The main technical risk is that levonorgestrel is a low-dose, poorly water-soluble steroid. Improving disintegration does not automatically improve dissolution or systemic exposure.

Chewable tablet

A chewable product could support consumer convenience and reduce swallowing barriers. It would require taste control because levonorgestrel can create an unpleasant oral sensory profile.

Relevant excipient classes include:

• Sweeteners and sugar alcohols.
• Flavor systems.
• Polymer or lipid taste-masking coatings.
• Compressible fillers.
• Saliva-triggered disintegration systems.

A chewable product may command a price premium, but flavor acceptance, dose uniformity, texture, and shelf stability become critical development constraints.

Fast-dissolving granules or powder

A single-dose sachet or orally dispersible granule could support public-health distribution, travel use, and use by individuals unable to swallow tablets. The product would need moisture-resistant packaging and careful control of segregation between the low-dose active and bulk excipients.

The commercial opportunity is strongest in institutional, humanitarian, and pharmacy-access channels. Unit-dose packaging can improve dispensing control but may increase packaging cost.

Low-moisture and heat-stable tablet

Emergency contraceptives are often stored in handbags, vehicles, pharmacies, clinics, and environments with variable temperature and humidity. A formulation that maintains potency and dissolution under stressed conditions could support broader distribution and lower product-loss rates.

Potential strategies include:

• Low-water-activity excipients.
• Moisture-barrier film coating.
• Desiccant-enabled packaging.
• High-barrier blister systems.
• Reduced hygroscopicity.
• Improved API-excipient compatibility.

The strongest patent position would likely cover the formulation and packaging combination, supported by comparative stability data.

How strong is the patent estate for an excipient-based Plan B competitor?

A new excipient patent estate would be moderate at best unless it includes a proven performance advantage. The patentability profile can be summarized as follows:

Strategy	Patentability	Regulatory complexity	Commercial potential
Conventional tablet with different filler	Low	Low	Low
Improved direct-compression process	Moderate	Low to moderate	Moderate
Orally disintegrating tablet	Moderate	Moderate	Moderate to high
Taste-masked chewable tablet	Moderate	Moderate	Moderate
Moisture-stable tablet and blister	Moderate	Low to moderate	Moderate
Novel delivery system with superior exposure	High if data support it	High	High
Liquid formulation	Moderate	Moderate to high	Niche
Combination product	Potentially high	High	Uncertain

Patent claims should be drafted around measurable technical outcomes rather than excipient identities alone. Useful evidence would include dissolution profiles, accelerated stability, content-uniformity data, impurity control, disintegration time, mechanical properties, and comparative bioavailability.

What commercial opportunities exist for Plan B excipient innovation?

Premium consumer product

A differentiated product could compete through convenience rather than price. An orally disintegrating or chewable dosage form may support premium pricing if consumers perceive a meaningful benefit.

Private-label and retail partnerships

Retailers can use a differentiated levonorgestrel dosage form as a private-label product. The manufacturer could license the formulation and supply the product under multiple store brands. This approach increases volume but weakens brand exclusivity.

Institutional procurement

Public-health agencies, college health systems, clinics, military health services, and nonprofit organizations may value:

• Long shelf life.
• Heat and humidity tolerance.
• Compact packaging.
• Unit-dose handling.
• Lower total delivered cost.
• Simple administration instructions.

A robust formulation with low-cost packaging may be more commercially valuable in these channels than a premium consumer product.

Geographic expansion

The excipient strategy should reflect local climate and distribution conditions. High humidity and temperature can affect powder flow, tablet hardness, dissolution, and packaging performance. A formulation optimized for tropical distribution may support licensing opportunities in Latin America, Southeast Asia, Africa, and other markets where supply-chain conditions are difficult.

Manufacturing and supply-chain licensing

A formulation patent can be paired with:

• Contract manufacturing rights.
• Regional commercialization licenses.
• Technology-transfer packages.
• Approved supplier lists.
• Process validation support.
• Packaging know-how.

The most defensible licensing asset may be the combination of formulation, process parameters, analytical methods, and packaging specifications rather than the excipient list alone.

How does Plan B compare with other emergency contraceptive products?

Product type	Active ingredient	Primary differentiation	Excipient opportunity
Levonorgestrel 1.5 mg tablet	Levonorgestrel	Established OTC emergency contraception	Fast disintegration, taste masking, stability, low cost
Ulipristal acetate tablet	Ulipristal acetate	Different pharmacology and prescription status in some markets	Solubility, dose uniformity, storage stability
Copper intrauterine device	Copper device	Long-term emergency and ongoing contraception	Device materials and insertion systems rather than excipients
Generic levonorgestrel tablet	Levonorgestrel	Price and access	Private-label formats and manufacturing efficiency

Levonorgestrel products have the broadest potential for excipient-led OTC differentiation because the active ingredient, dose, and consumer use are well established. Ulipristal products may offer stronger technical differentiation but face different regulatory, clinical, and commercial constraints.

What generic entry risks exist for Plan B?

Generic entry risk is high for a conventional levonorgestrel tablet. A new entrant can compete through:

• Lower price.
• Retailer private-label contracts.
• Online distribution.
• Pharmacy access.
• Institutional supply agreements.
• Simple packaging and low manufacturing cost.

Brand protection remains available through trademark and trade dress, but those rights do not prevent competitors from selling levonorgestrel emergency contraception under different names and packaging.

An innovator or licensee can reduce substitution risk through a protected dosage form, strong channel partnerships, reliable supply, and consumer-facing differentiation. A formulation change without a clear user benefit is unlikely to justify a sustained premium.

What litigation and settlement issues affect Plan B?

No major current patent litigation should be assumed to protect the conventional Plan B tablet from ordinary generic competition. The more relevant legal issues are:

• ANDA certifications against any active listed patents.
• Patent litigation over a new dosage form.
• Trademark and trade-dress disputes.
• Licensing disputes involving formulation know-how.
• Product-liability claims tied to labeling or excipient tolerability.
• Contract disputes with private-label manufacturers or distributors.

A settlement agreement involving a new formulation could include launch dates, geographic rights, authorized-generic arrangements, manufacturing restrictions, or royalty terms. Such agreements would be commercially significant only if tied to an enforceable patent or valuable manufacturing asset.

Key Takeaways

• Plan B uses a conventional excipient system built around lactose, corn starch, povidone, magnesium stearate, talc, and colloidal silicon dioxide.
• The conventional formulation has limited standalone patent value because the excipients are widely used.
• The active ingredient is mature, and generic levonorgestrel competition is established.
• The best commercial opportunities are orally disintegrating, chewable, moisture-stable, and low-cost unit-dose products.
• Patent claims should cover defined compositions, processes, packaging, and measured performance advantages.
• Biosimilar risk does not apply because levonorgestrel is a small molecule.
• Commercial value is more likely to come from consumer convenience, institutional distribution, supply reliability, and licensing than from exclusivity over the basic tablet.
• FDA regulatory classification and Orange Book eligibility must be evaluated product by product.

FAQs

Can a new excipient formulation of Plan B receive FDA exclusivity?

Potentially, but exclusivity would depend on the regulatory pathway and the product’s qualifying clinical, regulatory, or patent characteristics. A conventional reformulation generally does not receive new-chemical-entity exclusivity.

Can a manufacturer patent a lactose-free Plan B tablet?

A lactose-free composition may be patentable only if it is novel, nonobvious, and tied to a meaningful technical advantage. Lactose removal alone is unlikely to provide strong protection.

Is a chewable levonorgestrel emergency contraceptive commercially attractive?

Yes, if the product provides acceptable taste, rapid disintegration, stable potency, and a clear consumer benefit. The opportunity is strongest for consumers who have difficulty swallowing tablets and for premium OTC positioning.

What excipient issue is most important for levonorgestrel tablets?

Content uniformity and dissolution are central because the product contains a low dose of a poorly water-soluble steroid. Moisture control, powder segregation, and tablet disintegration also affect product performance.

Can Plan B formulation know-how be licensed without a patent?

Yes. A licensable package can include manufacturing processes, analytical methods, supplier qualification, stability data, packaging specifications, and regulatory documentation. Trade-secret protection may complement patent rights.

References

1. U.S. Food and Drug Administration. (2024). Plan B One-Step levonorgestrel tablet, 1.5 mg: Prescribing information. DailyMed.
2. U.S. Food and Drug Administration. (2013). FDA approves Plan B One-Step emergency contraceptive for use without a prescription.
3. U.S. Food and Drug Administration. (2023). Emergency contraceptives.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417.