List of Excipients in Branded Drug PLAN B ONE-STEP

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Rebel Distributors Corp	PLAN B ONE-STEP	levonorgestrel	21695-973	LACTOSE MONOHYDRATE
Rebel Distributors Corp	PLAN B ONE-STEP	levonorgestrel	21695-973	MAGNESIUM STEARATE
Rebel Distributors Corp	PLAN B ONE-STEP	levonorgestrel	21695-973	SILICON DIOXIDE
Rebel Distributors Corp	PLAN B ONE-STEP	levonorgestrel	21695-973	STARCH, CORN

Last updated: August 7, 2026

Plan B One-Step is an OTC levonorgestrel emergency contraceptive with a simple, low-cost oral tablet formulation. Its commercial protection depends mainly on brand equity, FDA OTC status, retail distribution, packaging, and consumer trust rather than a differentiated excipient patent estate. The core excipient platform uses lactose, starches, povidone, magnesium stearate, talc, and colloidal silicon dioxide. The strongest product opportunities are lactose-free tablets, rapid-disintegration formats, discreet packaging, pharmacy and e-commerce distribution, and lower-cost private-label or licensed alternatives.

Plan B One-Step Excipient Strategy, Patent Position, and Commercial Opportunities

What is the formulation of Plan B One-Step?

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

Component	Likely formulation function
Levonorgestrel	Active pharmaceutical ingredient
Lactose monohydrate	Diluent and tablet bulking agent
Corn starch	Filler and disintegrant
Potato starch	Disintegrant and filler
Povidone	Binder
Magnesium stearate	Lubricant
Talc	Glidant and processing aid
Colloidal silicon dioxide	Glidant and moisture-flow aid

The product is a conventional compressed tablet. Its formulation is commercially efficient because it uses widely available excipients, standard tableting equipment, and a short manufacturing process. The label does not indicate a controlled-release system, taste-masking technology, novel delivery vehicle, or specialized absorption enhancer.[1]

Why does Plan B use multiple starches?

The combination of corn starch and potato starch supports tablet breakup after ingestion while also contributing to tablet bulk. Povidone improves granule and tablet cohesion. Magnesium stearate reduces adhesion to manufacturing equipment. Colloidal silicon dioxide improves powder flow, which is important for dose uniformity at a low 1.5 mg drug load.

The formulation reflects a cost-sensitive product design. Levonorgestrel is potent, so most tablet mass comes from excipients. The manufacturing objective is uniform distribution of a small quantity of active ingredient without creating a tablet that is too hard to disintegrate.

What excipients are protected by Plan B One-Step patents?

No publicly apparent commercial opportunity depends on an active, broad excipient patent covering the listed Plan B One-Step ingredients. Lactose, starches, povidone, talc, magnesium stearate, and colloidal silicon dioxide are established pharmaceutical excipients with extensive prior art and multiple suppliers.

The commercial formulation may be protected through confidential manufacturing controls, specifications, process parameters, supplier qualification, and trademarks. Those protections differ from an enforceable patent claim covering the excipients themselves.

Protection category	Relevance to Plan B One-Step
Excipient composition patent	Limited apparent relevance
Tablet manufacturing know-how	Potentially relevant but generally confidential
Product trademark	High commercial relevance
FDA OTC approval	High regulatory relevance
Packaging and labeling	High compliance and brand relevance
Method-of-use patent	Limited current relevance for the basic emergency-contraception indication
Trade secret controls	Potential relevance for process and quality specifications

The principal barrier to substitution is therefore commercial execution, not an unusual excipient combination.

What is the FDA regulatory status of Plan B One-Step?

Plan B One-Step is an FDA-authorized OTC emergency contraceptive containing levonorgestrel. The FDA approved the product under NDA 021998 and later permitted OTC marketing without a prescription.[2] FDA labeling directs users to take one tablet as soon as possible within 72 hours after unprotected sex or contraceptive failure.[1]

The FDA approved nonprescription access for all ages in 2013. That action removed the prescription-access barrier and made retail availability, shelf placement, and consumer recognition central to the product’s commercial position.[2]

Does Plan B One-Step have FDA exclusivity?

The original regulatory exclusivity associated with the product has expired. Plan B One-Step is not commercially protected by a current new-molecular-entity exclusivity period. Levonorgestrel emergency-contraceptive products are available from multiple manufacturers.

The practical market position is consistent with an established OTC product:

• No current NCE exclusivity protects levonorgestrel.
• Generic and store-brand levonorgestrel emergency contraceptives compete with Plan B.
• FDA approval and labeling requirements still govern competing products.
• Brand recognition and distribution remain important despite the absence of exclusivity.

What is the Orange Book status of Plan B One-Step?

The Orange Book analysis is limited because Plan B One-Step is marketed as an OTC product and its current competitive protection does not appear to depend on a live Orange Book patent estate. Any historical NDA and patent records should be checked against the current FDA Orange Book database before relying on them for litigation or launch planning.[3]

For commercial strategy, the relevant conclusion is that a competitor is more likely to face formulation, labeling, trademark, and regulatory execution issues than a meaningful patent barrier covering the standard tablet.

Are there Paragraph IV challenges to Plan B One-Step?

Paragraph IV litigation is not the principal competitive mechanism for this product today. Generic levonorgestrel emergency-contraceptive products have reached the market, and the product category has long operated without meaningful exclusivity based on the original Plan B formulation.

A new entrant should still review:

1. Current Orange Book listings for NDA 021998.
2. FDA-approved labeling for any listed patents or exclusivity.
3. Trademark and trade-dress risk.
4. Any product-specific litigation involving manufacturing, advertising, or distribution.

When does Plan B One-Step lose exclusivity?

Plan B One-Step has already lost the exclusivity that once limited OTC access and competition. The product’s current economic moat is brand-based rather than exclusivity-based.

Milestone	Date or status
Original levonorgestrel emergency-contraception approval	1999 for the predecessor Plan B product
Plan B One-Step approval	FDA NDA 021998
OTC approval	2006
OTC availability without age or prescription restrictions	2013
Current NCE exclusivity	Expired
Generic competition	Established
Biosimilar exposure	Not applicable

Levonorgestrel is a small-molecule active ingredient, not a biologic. Biosimilar regulation does not apply. The relevant competitors are generic and private-label oral contraceptive products.

What excipient strategy could improve Plan B One-Step?

The current formulation is functional, but several excipient changes could support differentiated products.

Lactose-free formulation

The listed product contains lactose monohydrate.[1] A lactose-free version could replace lactose with microcrystalline cellulose, mannitol, dibasic calcium phosphate, or another established diluent. The commercial value would be mainly consumer positioning and broader tolerance claims, not improved clinical efficacy.

A lactose-free product would require comparative development work covering:

• Assay and content uniformity
• Tablet hardness and friability
• Disintegration and dissolution
• Stability under heat and humidity
• Packaging compatibility
• Labeling and inactive-ingredient disclosure

Starch-free formulation

Corn and potato starch are used in the current product. Replacing them with crospovidone, croscarmellose sodium, sodium starch glycolate from a different source, or a direct-compression diluent could support starch-avoidance positioning.

This change could appeal to consumers seeking specific dietary or excipient profiles. The claim must be tightly controlled because starch source, processing aids, and cross-contact can affect the accuracy of “starch-free” marketing.

Rapid-disintegration tablet

A formulation with crospovidone, croscarmellose sodium, or optimized mannitol could reduce disintegration time. The product should not imply that faster tablet breakup changes the approved efficacy window unless supported by clinical evidence and accepted labeling.

The commercial opportunity is strongest when rapid disintegration is paired with:

• Small tablet size
• Easy opening
• Water-free administration
• Improved portability
• Discreet packaging

Orally disintegrating or chewable tablet

An orally disintegrating tablet could improve convenience for consumers without immediate access to water. A chewable product could expand administration options but would create taste-masking requirements because levonorgestrel can produce an unpleasant taste.

Potential excipient systems include:

• Mannitol for mouthfeel and bulk
• Crospovidone for rapid breakup
• Sucralose or other sweeteners
• Flavor systems
• Ion-exchange resins or polymeric taste-maskers

Taste masking would increase formulation complexity and could reduce the cost advantage of the current tablet.

Low-moisture formulation

Levonorgestrel tablet products require stability assessment under standard ICH conditions. Moisture-sensitive excipients, hygroscopic fillers, and packaging choices can affect tablet hardness, dissolution, and degradation. A low-moisture formulation with a high-barrier blister or desiccant-enabled package could support hot-climate distribution and longer shelf-life management.

The opportunity is more relevant to international markets and emergency kits than to a basic U.S. retail carton.

What formulations are protected by Plan B One-Step?

The approved commercial formulation is a conventional immediate-release tablet. No publicly established formulation exclusivity appears to prevent competitors from using alternative excipient systems for the same 1.5 mg levonorgestrel dose.

A competitor could pursue:

• Conventional compressed tablets
• Direct-compression tablets
• Orally disintegrating tablets
• Chewable tablets
• Sublingual or buccal systems
• Unit-dose emergency kits
• Combination packages with pregnancy tests or barrier contraceptives

Each alternative would require appropriate FDA review. A new dosage form may require a new drug application or another regulatory pathway, depending on the product’s legal status, formulation, labeling, and reliance on existing FDA findings.

What commercial opportunities exist for Plan B One-Step excipients?

The best opportunities are incremental and segment-specific rather than based on a new active pharmaceutical ingredient.

Opportunity	Commercial rationale	Main development risk
Lactose-free tablet	Expands excipient-sensitive positioning	No direct efficacy advantage
Starch-free tablet	Supports differentiated labeling	Replacement may affect dissolution
ODT	Water-free administration	Taste, friability, packaging
Chewable tablet	Convenience and portability	Taste masking and consumer acceptance
High-barrier blister	Heat and humidity protection	Packaging cost
Private-label tablet	Lower-price retail access	Strong generic competition
Travel or emergency kit	Higher unit economics	Packaging and channel execution
Global low-cost product	Broad access in price-sensitive markets	Regulatory and supply-chain complexity

Which excipients offer the greatest supplier opportunity?

Commodity excipients such as lactose, starch, magnesium stearate, and talc are unlikely to create large standalone value unless supplied with strong quality, regulatory, or geographic advantages. Higher-value opportunities are more likely in:

• Direct-compression excipient blends
• Co-processed disintegrant systems
• Taste-masking platforms
• Low-moisture excipient systems
• Excipient premixes that improve content uniformity
• Global regulatory documentation packages
• Continuous-manufacturing and process-control solutions

A supplier that can reduce tablet weight, improve flow, or shorten manufacturing time may create value for private-label manufacturers even without patenting the individual ingredients.

How strong is the Plan B One-Step patent estate?

The patent estate appears commercially weak relative to the brand and regulatory position. The basic product relies on an old active ingredient, established excipients, and a conventional oral dosage form. Those characteristics reduce the likelihood that a competitor would be blocked by a broad composition-of-matter or excipient patent.

Estate component	Relative strength
Levonorgestrel composition-of-matter rights	Very low for current competition
Standard excipient combination	Low
Immediate-release tablet	Low
Manufacturing process	Potentially moderate if narrowly claimed
Brand and trademark rights	High
Retail distribution and shelf placement	High commercial value
Consumer recognition	High
Regulatory compliance capability	Moderate to high

The strongest defensible assets are likely the Plan B trademark, packaging, advertising claims, quality systems, and channel relationships. A reformulated product could obtain patent protection only if it contains a genuinely novel and non-obvious delivery system or manufacturing process.

Which companies are challenging Plan B One-Step?

Plan B One-Step competes with generic and store-brand levonorgestrel products from manufacturers and marketers including Perrigo, Foundation Consumer Healthcare, and private-label retail suppliers. Product availability changes by retailer and market.

Competition generally occurs through:

• Retail price
• Pharmacy and mass-market placement
• E-commerce availability
• Private-label branding
• Multipack formats
• Packaging clarity
• Distribution to clinics, colleges, public-health organizations, and employers

The relevant competitive set includes any FDA-authorized levonorgestrel 1.5 mg emergency-contraceptive tablet, not only products using the Plan B name.

What patent litigation and settlement risks affect Plan B One-Step?

There is no widely identified current patent litigation threat that materially blocks routine generic levonorgestrel emergency-contraceptive entry. The more relevant legal risks are:

• Trademark infringement involving “Plan B”
• False association with the Plan B brand
• Unsupported comparative or efficacy claims
• Misleading statements about timing or effectiveness
• Packaging and trade-dress similarity
• FDA labeling noncompliance
• Supplier qualification and change-control disputes

Settlement agreements are not a central feature of the current commercial landscape. A new entrant should focus on freedom to operate around trademarks, labeling, advertising, packaging, and any newly developed delivery technology.

What revenue exposure does Plan B One-Step face from generic entry?

Public standalone revenue for Plan B One-Step is not reliably disclosed by its private commercial owner. Generic entry creates price pressure because the active ingredient and tablet technology are mature. The brand can retain a premium through recognition, perceived reliability, retail visibility, and consumer urgency.

Revenue exposure is highest in price-transparent channels:

• Online marketplaces
• Retail pharmacy websites
• Store-brand shelves
• Institutional procurement
• Public-health tenders

The brand is more defensible where consumers select the product under time pressure and recognize the name without consulting a pharmacist.

What generic launch scenarios exist for levonorgestrel emergency contraception?

Low-cost conventional tablet

This is the fastest and lowest-risk pathway. The product uses standard excipients and competes primarily on price and distribution. It has limited differentiation but the lowest manufacturing cost.

Premium convenience product

An ODT, chewable, or smaller tablet could command a higher price if the product delivers a clear administration benefit. Taste and stability are the principal technical risks.

Private-label retailer product

Retailers can use a low-cost levonorgestrel product to capture margin and reduce reliance on the Plan B brand. The formulation does not need to be novel if the retailer has strong distribution.

Combination emergency kit

A package containing emergency contraception, a pregnancy test, and clear use instructions could generate higher basket value. The kit would require careful labeling and packaging review because the components may have different regulatory requirements.

How does Plan B One-Step compare with ella?

Plan B One-Step contains levonorgestrel. ella contains ulipristal acetate, a different active ingredient and prescription emergency-contraception product in the United States.[4]

Attribute	Plan B One-Step	ella
Active ingredient	Levonorgestrel	Ulipristal acetate
Dose	1.5 mg	30 mg
U.S. access	OTC	Prescription
Core format	Immediate-release tablet	Immediate-release tablet
Main commercial advantage	Broad access and brand recognition	Different clinical positioning and later-use window
Biosimilar relevance	None	None
Excipient opportunity	Convenience and tolerance reformulation	Similar tablet and access opportunities

Plan B’s strongest advantage is OTC availability. A reformulated levonorgestrel product should preserve that access profile while improving convenience or reducing excipient concerns.

Key Takeaways

• Plan B One-Step is a 1.5 mg levonorgestrel immediate-release tablet.
• Its listed excipients are lactose monohydrate, corn starch, potato starch, povidone, magnesium stearate, talc, and colloidal silicon dioxide.
• The formulation uses established, low-cost excipients and standard tableting technology.
• Current commercial protection is based more on brand, labeling, retail access, and distribution than on active formulation patents.
• NCE exclusivity has expired, and generic levonorgestrel competition is established.
• Biosimilar risk is not applicable because levonorgestrel is a small molecule.
• The strongest reformulation opportunities are lactose-free, starch-free, orally disintegrating, chewable, and high-barrier-packaged products.
• Excipient suppliers are more likely to create value through co-processed systems, taste masking, direct compression, and quality documentation than through commodity ingredients.
• FDA, trademark, packaging, and advertising compliance are more important launch risks than Paragraph IV litigation.
• Plan B’s commercial premium is most vulnerable in price-transparent retail and e-commerce channels.

FAQs

Can Plan B One-Step be reformulated without changing the active ingredient?

Yes. A manufacturer can develop a different excipient system while retaining 1.5 mg of levonorgestrel, but it must demonstrate appropriate quality, performance, stability, and regulatory compliance.

Is lactose in Plan B One-Step?

Yes. The FDA labeling lists lactose monohydrate as an inactive ingredient.[1]

Could a lactose-free levonorgestrel emergency contraceptive compete with Plan B?

Yes. A lactose-free product could compete through excipient differentiation, although lactose removal alone would not establish clinical superiority.

Would an orally disintegrating Plan B product receive a new patent?

It could, but only if the claimed formulation or manufacturing process met novelty, non-obviousness, written-description, and enablement requirements. A routine substitution of known disintegrants would face substantial patentability risk.

Does Plan B One-Step have biosimilar competition?

No. Biosimilars apply to biological products. Levonorgestrel emergency contraceptives compete through generic and OTC drug pathways.

References

1. U.S. Food and Drug Administration. (2023). Plan B One-Step levonorgestrel tablet: Prescribing information.
2. U.S. Food and Drug Administration. (2013). FDA approves Plan B One-Step emergency contraceptive for all females of reproductive potential.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Food and Drug Administration. (2023). Ella ulipristal acetate tablet: Prescribing information.