List of Excipients in Branded Drug MY WAY

Generic Drugs Containing MY WAY

Company	Ingredient	NDC	Excipient
GAVIS Pharmaceuticals LLC	levonorgestrel	43386-620	LACTOSE MONOHYDRATE
GAVIS Pharmaceuticals LLC	levonorgestrel	43386-620	MAGNESIUM STEARATE
GAVIS Pharmaceuticals LLC	levonorgestrel	43386-620	SILICON DIOXIDE
GAVIS Pharmaceuticals LLC	levonorgestrel	43386-620	STARCH, CORN
GAVIS Pharmaceuticals LLC	levonorgestrel	43386-620	TALC

What are the Most Frequently-Used Excipients in MY WAY?

# Of NDCs	Excipient
6	LACTOSE MONOHYDRATE
6	MAGNESIUM STEARATE
4	POVIDONE K30
6	SILICON DIOXIDE
6	STARCH, CORN

My Way Levonorgestrel Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

My Way is an oral emergency contraceptive containing 1.5 mg of levonorgestrel. Its commercial position depends more on reliable over-the-counter access, low manufacturing cost, rapid tablet performance, packaging, and channel distribution than on patent exclusivity. The listed formulation uses conventional immediate-release excipients, creating opportunities for cost reduction, lactose-free reformulation, improved moisture protection, private-label supply, and international registration.

What is My Way and how is it regulated?

My Way is a single-dose levonorgestrel emergency contraceptive tablet. The product is intended to prevent pregnancy after unprotected intercourse or contraceptive failure. It is not an abortifacient and does not terminate an established pregnancy.[1]

Product attribute	My Way profile
Active ingredient	Levonorgestrel
Strength	1.5 mg
Dosage form	Immediate-release oral tablet
Route	Oral
Therapeutic class	Emergency contraceptive
FDA status	Nonprescription emergency contraceptive
Dose	One tablet as soon as possible within the labeled time period
Primary commercial comparators	Plan B One-Step, Take Action, Aftera, generic levonorgestrel 1.5 mg tablets
Key formulation objective	Rapid and reproducible dissolution
Principal market constraint	Low price and intense generic competition

FDA approval of nonprescription levonorgestrel emergency contraceptives expanded consumer access and reduced the commercial value of prescription distribution infrastructure.[2] My Way competes in a market where consumers, retailers, and health plans often treat equivalent 1.5 mg levonorgestrel products as interchangeable.

What excipients are used in My Way?

Public labeling identifies a conventional tablet platform built around diluents, disintegrants, binders, glidants, and lubricants. The listed inactive ingredients include:

Excipient	Likely formulation function	Commercial and technical considerations
Lactose monohydrate	Diluent and tablet mass builder	Low cost and widely available; creates a lactose-free positioning issue
Microcrystalline cellulose	Diluent, dry binder, and compression aid	Supports tablet hardness and content uniformity
Pregelatinized starch	Binder and disintegrant	Helps direct compression or dry granulation performance
Croscarmellose sodium	Superdisintegrant	Supports rapid tablet breakup and dissolution
Povidone	Binder	Improves granule strength; excessive use can slow disintegration
Colloidal silicon dioxide	Glidant and moisture-control aid	Improves powder flow and may reduce manufacturing variability
Magnesium stearate	Lubricant	Excessive lubrication can reduce tablet wettability and dissolution

The excipient system is technically ordinary, which is commercially useful. Manufacturers can source each component from multiple qualified suppliers and can develop alternative formulations without depending on a specialized delivery technology.

The formulation should be treated as a rapid-release solid oral dosage form. Levonorgestrel is present at a very low dose relative to total tablet mass. Content uniformity, powder segregation, blend homogeneity, and sampling strategy are therefore central manufacturing risks.

What excipient strategy best supports My Way?

The strongest strategy is to preserve the low-cost immediate-release platform while improving robustness in four areas: dissolution, content uniformity, moisture control, and consumer tolerability.

Rapid disintegration and dissolution

The product should maintain fast tablet breakup without excessive compression force or hydrophobic lubrication. A croscarmellose sodium or crospovidone system can be evaluated against the current starch-based approach. The relevant development variables include:

• Superdisintegrant concentration and intra-granular versus extra-granular placement.
• Magnesium stearate concentration and blending time.
• Tablet hardness and friability.
• Levonorgestrel particle size and dispersion.
• Dissolution performance across pH conditions.
• Stability after exposure to elevated temperature and humidity.

A faster dissolution profile may support manufacturing resilience, but it does not automatically create a separate regulatory claim. Any change must remain within the approved quality and bioequivalence framework.

Low-dose content uniformity

Levonorgestrel represents a small fraction of the tablet. Direct blending can be economical but may increase segregation risk. A controlled granulation approach, ordered mixing, or pre-dilution of the active ingredient can improve uniformity.

The preferred process depends on active-particle properties, supplier controls, and equipment. Excipient selection should be linked to the process rather than treated as a standalone composition exercise. Microcrystalline cellulose, pregelatinized starch, and povidone offer several routes to improve blend and compression performance without introducing expensive specialty excipients.

Moisture and packaging

The formulation contains excipients that can respond to humidity. Croscarmellose sodium and starch-based materials can affect tablet mechanical properties and dissolution after moisture exposure. Packaging can create more commercial value than a complex reformulation.

Relevant options include:

• High-barrier aluminum blister packaging.
• Unit-dose blister cards for discreet carrying.
• Desiccant-protected bottles.
• Child-resistant packaging where required by the market.
• Tamper-evident secondary packaging.
• Individual foil pouches for vending-machine and clinic distribution.

A blister format can reduce moisture exposure and improve dose portability. Its added packaging cost may be justified in institutional, travel, vending, and public-health channels.

Lactose-free positioning

Lactose is a low-cost and widely accepted tablet filler, but its presence limits a lactose-free or vegan positioning. A replacement platform could use combinations of microcrystalline cellulose, mannitol, dibasic calcium phosphate, starch, or direct-compression co-processed excipients.

Mannitol could support a cleaner consumer message and improved mouthfeel, but it may increase cost and alter tablet density. Dibasic calcium phosphate can improve compressibility but may require careful dissolution work. A lactose-free product would have the greatest value if paired with a clear consumer benefit, such as improved tolerability, broader dietary compatibility, or global market harmonization.

The commercial case is weaker if the only change is removal of lactose without a visible consumer benefit. In a low-price emergency contraceptive category, unnecessary excipient changes can reduce gross margin and complicate regulatory maintenance.

What formulation patents protect My Way?

No specialized delivery technology is required to commercialize a levonorgestrel 1.5 mg immediate-release tablet. The core formulation uses common pharmaceutical excipients and is exposed to conventional generic competition.

The main intellectual-property conclusions are:

IP category	Assessment
Levonorgestrel active ingredient	Old, widely available active ingredient
1.5 mg emergency contraceptive use	Mature technology with limited composition differentiation
Immediate-release tablet	Generally vulnerable to alternative generic formulations
Conventional excipient combination	Low likelihood of meaningful standalone exclusivity
Packaging configuration	May support design or trade-dress rights, but rarely blocks tablet competition
Manufacturing process	Potentially protectable if a novel process produces a measurable quality or cost advantage
Consumer-facing brand	Trademark and channel value are more important than formulation patents

An excipient patent strategy would need a genuine technical contribution. Examples could include a composition that produces a documented dissolution advantage, a stabilizing system that extends shelf life, or a manufacturing process that improves low-dose content uniformity at commercial scale.

A patent directed only to substituting one routine filler for another would face substantial validity and obviousness risk. Trade secrets covering blending order, granulation parameters, active-particle engineering, and packaging qualification may provide more practical protection than a narrow formulation patent.

What is the Orange Book and exclusivity status of My Way?

My Way does not depend on a long remaining new-drug exclusivity period. The commercial product is part of a mature levonorgestrel emergency-contraception market with multiple competing products.

Exclusivity factor	Commercial implication
New chemical entity exclusivity	Not relevant to the mature levonorgestrel ingredient
Orphan exclusivity	Not applicable
Pediatric exclusivity	Not a central barrier to market entry
Formulation exclusivity	Limited unless supported by a distinct approved innovation
Orange Book patents	Any listed patents must be assessed by current FDA Orange Book record and product-specific litigation history
Generic competition	High
Switching risk	Low for a standard 1.5 mg tablet if quality and labeling are equivalent

A Paragraph IV challenge would be commercially plausible against any listed patent covering the product, but conventional levonorgestrel tablet products generally offer limited patent-based protection. A competitor would more likely rely on an ANDA or another abbreviated pathway than attempt to design around a complex delivery system.

The relevant legal workstream is a current review of:

1. The Orange Book record for the applicable NDA.
2. Any listed formulation, method-of-use, or manufacturing patents.
3. FDA-approved labeling and therapeutic equivalence information.
4. Paragraph IV certifications and associated notices.
5. Federal district court docket activity involving the product or listed patents.

When does My Way lose exclusivity?

The practical loss of exclusivity occurred when competing levonorgestrel 1.5 mg emergency contraceptives entered the market. The key commercial event was not the expiration of one dominant formulation patent. It was the transition from a branded emergency contraceptive market to broad over-the-counter competition.

My Way’s ongoing market access therefore depends on:

• Retail placement.
• Search visibility and brand recognition.
• Wholesale acquisition cost.
• Availability in pharmacies and mass merchants.
• E-commerce fulfillment.
• Public-health and campus procurement.
• Stock reliability.
• Packaging convenience.
• Consumer trust in the brand.

The absence of a high-value patent barrier allows rapid competitive entry. Product-level differentiation must come from distribution, price, packaging, formulation claims supported by evidence, or contractual access to retail and institutional channels.

What generic entry risks exist for My Way?

Generic and private-label entry risk is high. Levonorgestrel tablets can be manufactured using common excipients and conventional equipment. A competitor can target the same indication with a low-cost tablet and compete primarily on price.

Principal entry routes

• ANDA-based generic levonorgestrel tablets.
• Authorized generic or contract-manufactured products.
• Retailer private-label products.
• Institutional products for clinics, universities, and public-health agencies.
• International products using local regulatory pathways.
• E-commerce brands using third-party pharmaceutical manufacturers.

Product-level vulnerabilities

The principal vulnerability is substitutability. Consumers generally need a single tablet with a recognized active ingredient, not a differentiated delivery platform. A new entrant that matches assay, dissolution, stability, packaging, and labeling can compete without copying every excipient.

The main barriers are operational:

• FDA-compliant manufacturing.
• Reliable levonorgestrel supply.
• Validation of low-dose blend uniformity.
• Stability data.
• OTC labeling compliance.
• Pharmacovigilance.
• Retail and wholesale distribution.

These barriers are real but manageable for established generic manufacturers.

Which excipient-based commercial opportunities are strongest?

Lactose-free and vegan tablets

A lactose-free platform can support a differentiated brand or retailer line. The opportunity is strongest where consumers actively search for ingredient exclusions. The product should avoid unsupported medical claims and focus on transparent labeling.

Better moisture protection

A blister-packaged My Way equivalent could target travel, emergency kits, pharmacies, campus health programs, and vending distribution. The packaging proposition is easy for consumers to understand and may reduce product degradation caused by storage conditions.

Unit-dose institutional products

Clinics, universities, public-health departments, military systems, and humanitarian organizations may value individually packaged tablets, serialized cartons, and predictable replenishment. Excipient changes are not required, but packaging and supply terms can create a defensible commercial position.

Lower-cost private-label supply

The simplest opportunity is contract manufacturing for retailers, telehealth providers, family-planning organizations, and e-commerce distributors. A standard excipient platform minimizes development expense and supports multiple customers under separate labels.

Improved tablet handling

A smaller, stronger tablet with controlled friability can reduce breakage during blistering, transport, and automated dispensing. The opportunity is operational rather than therapeutic. It can improve yield and reduce complaints without changing the active ingredient.

Global formulation harmonization

A lactose-free or broadly accepted excipient platform may simplify registration across jurisdictions that impose different excipient, labeling, or dietary requirements. The benefit must be balanced against the cost of bridging stability and comparative dissolution data.

How does My Way compare with Plan B One-Step and other levonorgestrel products?

Factor	My Way	Plan B One-Step	Retail generics and private labels
Active ingredient	Levonorgestrel	Levonorgestrel	Levonorgestrel
Strength	1.5 mg	1.5 mg	Usually 1.5 mg
Dosage form	Immediate-release tablet	Immediate-release tablet	Immediate-release tablet
Consumer differentiation	Brand and price	Strongest historical brand recognition	Usually price and availability
Excipient differentiation	Limited	Limited at consumer level	Often minimal
Patent leverage	Limited practical leverage	Historical brand and regulatory position	Usually low
Commercial strength	Distribution and value pricing	Brand trust and recognition	Low cost and retailer access
Main risk	Substitution by cheaper equivalents	Brand erosion and price pressure	Low margins and channel dependence

The critical comparison is not whether one product uses a superior excipient. It is whether the product has stronger distribution, consumer recognition, and supply economics. For a new entrant, a differentiated package and reliable retail access may produce more value than a novel tablet composition.

What litigation and settlement issues affect My Way?

There is no established commercial rationale to assume that My Way requires a litigation-led market strategy. In this category, disputes would most likely involve:

• ANDA patent certifications.
• Trademark or trade-dress claims.
• Labeling or advertising claims.
• Product quality and recall matters.
• Contract manufacturing disputes.
• Distribution agreements.
• OTC regulatory compliance.

A settlement involving a listed patent could delay generic entry, but the value of such a settlement would depend on the actual patent scope and remaining term. Conventional excipient changes rarely support a durable settlement position unless the patent covers a validated product or process with meaningful market share.

What revenue exposure does My Way create?

Brand-specific revenue data for My Way is not generally disclosed in public company filings. The product’s revenue exposure should therefore be modeled through market share rather than reported brand sales.

A practical model uses:

• Annual U.S. emergency contraceptive unit volume.
• Average net selling price.
• Brand versus private-label mix.
• Retail, e-commerce, clinic, and institutional channel shares.
• Gross-to-net deductions.
• Return and expiry rates.
• Manufacturing cost per tablet.
• Packaging cost per dose.
• Marketing and trade-spend requirements.

The low unit count per treatment does not eliminate price pressure. Gross margin can be attractive when manufacturing is efficient, but retailer fees, wholesaler discounts, and promotional pricing can reduce net revenue materially.

What is the strongest commercial strategy for My Way?

The strongest strategy is a two-tier portfolio:

1. A standard, low-cost My Way tablet using the established excipient platform for mass retail and private-label competition.
2. A premium unit-dose or lactose-free version using higher-barrier packaging and targeted institutional or consumer channels.

The base product should avoid unnecessary formulation complexity. The differentiated product should use a measurable benefit, such as moisture protection, discreet portability, lactose-free composition, or improved supply reliability.

Key Takeaways

• My Way is a 1.5 mg levonorgestrel immediate-release emergency contraceptive tablet.
• Its listed excipients are conventional and broadly available.
• The principal technical priorities are low-dose content uniformity, rapid dissolution, tablet robustness, and moisture stability.
• Patent exclusivity is not the primary commercial defense.
• Generic, private-label, and contract-manufactured competition is structurally strong.
• Lactose-free reformulation, blister packaging, and institutional unit-dose supply offer the clearest excipient-related opportunities.
• A novel excipient combination has limited value unless it creates a measurable quality, stability, manufacturing, or consumer benefit.
• Retail access, price, packaging, and supply reliability are more commercially important than formulation novelty.

FAQs

Is My Way the same as Plan B One-Step?

Both products contain 1.5 mg of levonorgestrel and are immediate-release emergency contraceptive tablets. They may differ in inactive ingredients, manufacturer, packaging, price, and branding.

Can My Way be reformulated without new clinical trials?

Some excipient or manufacturing changes may be supported by comparative pharmaceutical testing, dissolution data, stability studies, and regulatory change procedures. The required evidence depends on the scale and nature of the change.

Is lactose in My Way a commercial disadvantage?

Lactose is a common pharmaceutical filler, but it prevents lactose-free positioning. Its commercial impact depends on consumer demand, labeling strategy, and whether a replacement formulation can maintain equivalent manufacturing and performance at acceptable cost.

Can a company patent a new My Way excipient formulation?

A patent may be available if the formulation produces a non-obvious technical result, such as improved stability, dissolution, content uniformity, or manufacturability. Routine excipient substitution is less likely to provide durable patent protection.

What packaging creates the greatest opportunity for levonorgestrel emergency contraception?

High-barrier unit-dose blister packaging has the broadest potential because it supports moisture protection, portability, discreet use, institutional distribution, vending, and emergency-kit placement.

References

1. U.S. Food and Drug Administration. (2023). Emergency contraception. https://www.fda.gov
2. U.S. Food and Drug Administration. (2013). FDA approves Plan B One-Step emergency contraceptive for nonprescription use. https://www.fda.gov
3. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/
4. National Library of Medicine. (n.d.). DailyMed: My Way levonorgestrel tablet labeling. https://dailymed.nlm.nih.gov/dailymed/
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book