List of Excipients in Branded Drug MY CHOICE TM

Generic Drugs Containing MY CHOICE TM

Company	Ingredient	NDC	Excipient
SUN PHARMACEUTICAL INDUSTRIES INC	levonorgestrel	62756-720	HYPROMELLOSE
SUN PHARMACEUTICAL INDUSTRIES INC	levonorgestrel	62756-720	LACTOSE MONOHYDRATE
SUN PHARMACEUTICAL INDUSTRIES INC	levonorgestrel	62756-720	MAGNESIUM STEARATE
SUN PHARMACEUTICAL INDUSTRIES INC	levonorgestrel	62756-720	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in MY CHOICE TM?

# Of NDCs	Excipient
2	HYPROMELLOSE
1	HYPROMELLOSES
3	LACTOSE MONOHYDRATE
3	MAGNESIUM STEARATE

My Choice Levonorgestrel: Excipient Strategy, Patent Position and Commercial Opportunities

Last updated: August 9, 2026

My Choice is an over-the-counter emergency contraceptive containing levonorgestrel 1.5 mg. Its commercial opportunity is driven primarily by low-cost manufacturing, rapid disintegration, broad retail distribution, and consumer-facing differentiation rather than by a durable patent estate. The most valuable excipient strategy is a compact, robust immediate-release tablet that supports fast dissolution, low unit cost, long shelf life, and broad tolerance across global manufacturing sites.

What is My Choice and what active ingredient does it contain?

My Choice is a single-dose emergency contraceptive tablet containing 1.5 mg of levonorgestrel. The product is intended for use after unprotected intercourse or contraceptive failure and is marketed without a prescription in the United States.

Levonorgestrel is a synthetic progestin. Emergency contraceptive products containing levonorgestrel are generally positioned for use as soon as possible after intercourse, with efficacy declining as the interval increases. The product is not an abortifacient and does not terminate an established pregnancy. [1]

Attribute	My Choice
Active ingredient	Levonorgestrel
Strength	1.5 mg
Dosage form	Immediate-release oral tablet
Primary use	Emergency contraception
U.S. regulatory category	OTC drug
Biological product status	Not a biologic
Biosimilar pathway	Not applicable
Main commercial comparators	Plan B One-Step, Take Action, Aftera, My Way, EContra EZ
Core formulation objective	Rapid, reliable oral release at low cost

The trademark does not create patent protection. Commercial protection depends on formulation know-how, manufacturing economics, regulatory compliance, brand recognition, retailer access, and supply reliability.

What excipients are used in My Choice tablets?

Public drug-label sources identify the excipients used in the marketed product. Exact composition should be controlled against the current FDA-approved labeling and the relevant manufacturer’s product specification before a regulatory, licensing, or formulation decision. [2]

Typical excipient functions in a levonorgestrel immediate-release tablet include:

Excipient category	Typical function	Commercial importance
Lactose or another soluble filler	Provides tablet bulk and improves mouthfeel	Low cost, but relevant to lactose-free positioning
Microcrystalline cellulose	Filler and dry-compression aid	Supports tablet hardness and manufacturing robustness
Maize starch or pregelatinized starch	Disintegrant and binder	Helps achieve rapid breakup after ingestion
Povidone	Binder	Improves granule or tablet cohesion
Crospovidone or related superdisintegrant	Accelerates tablet disintegration	Directly linked to dissolution performance
Colloidal silicon dioxide	Glidant and moisture-control aid	Improves powder flow and blend uniformity
Magnesium stearate	Lubricant	Required for ejection, but excessive levels can slow wetting
Film-coating materials, where used	Appearance, handling and swallowability	Supports brand differentiation and moisture protection

The low dose of levonorgestrel creates a content-uniformity challenge. The active ingredient represents only a small percentage of total tablet weight. Blend segregation, electrostatic charging, particle-size mismatch, and over-lubrication can produce unacceptable potency variation even when the manufacturing process appears straightforward.

An excipient platform must therefore be evaluated as a system. Replacing one excipient without reassessing blend uniformity, tablet tensile strength, friability, disintegration, dissolution, assay, and content uniformity can create regulatory and commercial risk.

What excipient strategy best supports My Choice?

The strongest strategy is a conventional immediate-release formulation optimized for direct compression or a short, scalable granulation process.

Rapid disintegration and dissolution

Emergency contraception is a time-sensitive product. The formulation should support rapid tablet wetting, breakup, and dissolution across physiologic pH conditions. A superdisintegrant can improve performance, but its concentration must be balanced against tablet strength and lubricant exposure.

The critical quality attributes are:

• Disintegration time
• Dissolution rate
• Assay and content uniformity
• Tablet hardness
• Friability
• Stability under heat and humidity
• Moisture uptake
• Blend uniformity

The most defensible formulation-development approach is to establish a dissolution design space rather than rely on a single disintegration result. A tablet can disintegrate quickly while still showing delayed dissolution if the levonorgestrel particles agglomerate or become hydrophobic from excessive lubricant.

Low-dose content uniformity

Levonorgestrel’s low loading favors a narrow particle-size distribution and a controlled blending sequence. The active ingredient should be characterized for:

• Particle-size distribution
• Bulk and tapped density
• Surface area
• Electrostatic behavior
• Polymorphic form
• Moisture sensitivity
• Assay variability between lots

A premix or ordered-blend process can reduce segregation. The selected filler should have compatible density and flow properties. Continuous manufacturing may improve control if the manufacturer has suitable low-dose feeding and process-analytical technology, but conventional batch production remains commercially practical.

Moisture and heat stability

Emergency contraceptives are frequently stored in pharmacies, convenience stores, vending environments, handbags, and home medicine cabinets. Exposure to elevated temperature and humidity is a meaningful product-quality risk.

An excipient package should limit:

• Hydrolytic degradation
• Tablet softening
• Disintegration drift
• Coating defects
• Packaging-related moisture ingress

Aluminum-aluminum blister packaging offers stronger moisture protection than many low-cost plastic bottle formats. However, the packaging cost can materially affect a low-price product. A high-barrier PVC or PVdC blister may provide a more competitive balance where stability data support the approach.

Allergy and dietary positioning

A lactose-free formulation could expand the addressable market and simplify international positioning. Gluten-free claims may also have value if the formulation and excipient supply chain support substantiation. These claims should not be made solely from the absence of wheat starch in the formula. Supplier controls, cross-contamination procedures, and documentation are needed.

A preservative-free tablet is commercially straightforward because the product is a solid oral dosage form. Colorants and coatings should be limited where they add no functional value, particularly for private-label and international products.

What formulations are protected by patents?

The principal levonorgestrel emergency-contraception market is mature and genericized. The core composition of a conventional 1.5 mg immediate-release tablet is unlikely to provide meaningful exclusivity by itself. A manufacturer seeking differentiated protection would need to claim a specific technical feature, such as:

• A defined particle-size distribution
• A particular solid-state form
• A rapid-dissolution formulation
• A taste-masked orally disintegrating tablet
• A moisture-protective dosage form
• A unit-dose packaging system
• A novel manufacturing process
• A new delivery route
• A specific combination with another contraceptive agent

Patentability would depend on novelty, nonobviousness, enablement, and claim scope. Broad claims covering levonorgestrel tablets with standard fillers, binders, disintegrants, and lubricants would face substantial prior-art risk.

The trademark "My Choice" is a branding asset, not a patent right. Trademark protection can support retail continuity and consumer recognition, but it does not block another company from selling an equivalent levonorgestrel tablet under a different name.

What is the Orange Book status of My Choice?

My Choice is regulated as an approved drug product, not as a biologic. Its regulatory position should be assessed through the current FDA Orange Book and Drugs@FDA records for the specific application and marketing holder. [3,4]

The practical implications are:

1. The product does not receive biologic exclusivity.
2. Biosimilar competition is not relevant.
3. Any remaining regulatory exclusivity depends on the specific approval history.
4. Patent protection must be reviewed through current Orange Book records and related FDA submissions.
5. OTC market entry is influenced by FDA labeling, manufacturing compliance, monograph policy, and retailer requirements.

For a mature levonorgestrel product, the central question is usually not whether a competitor can obtain a basic composition patent. It is whether the competitor can meet FDA quality requirements at a lower cost while maintaining reliable supply and acceptable consumer labeling.

When does My Choice lose exclusivity?

My Choice’s commercial exclusivity is primarily limited by the absence of a durable barrier around the active ingredient and dosage form. Levonorgestrel has long been available in contraceptive products, and multiple emergency-contraception brands compete in the U.S. market.

The relevant exclusivity layers are:

Exclusivity layer	Relevance to My Choice
Active-ingredient exclusivity	No meaningful current barrier for levonorgestrel
New chemical entity exclusivity	Not applicable to this mature active ingredient
Orphan exclusivity	Not applicable
Pediatric exclusivity	Product-specific and requires confirmation in FDA records
Patent exclusivity	Must be checked against current Orange Book entries
Trademark exclusivity	Protects the name, not the formulation
Retail exclusivity	May arise through private-label or pharmacy contracts
Supply exclusivity	May arise through contract manufacturing agreements

The practical loss of exclusivity occurred through market maturation rather than a single cliff date. Generic and store-brand emergency contraceptives have already established competitive pricing and broad availability.

Are Paragraph IV challenges relevant to My Choice?

Paragraph IV challenges are relevant only if a listed patent creates a meaningful barrier to an ANDA applicant. They are less central for a mature OTC levonorgestrel product than for a newly launched prescription medicine.

A potential challenger would typically evaluate:

• Whether My Choice has listed patents
• Whether those patents cover the active ingredient, formulation, method of use, or packaging
• Whether the patents are valid and enforceable
• Whether the proposed product can be designed around them
• Whether the product can rely on an OTC pathway or an ANDA
• Whether a first-filer advantage exists

A generic applicant would likely focus on a standard immediate-release tablet and challenge any narrow formulation patent only if the commercial opportunity justified litigation expense. For a low-price emergency contraceptive, the expected return may favor design-around strategies over Paragraph IV litigation.

What generic entry risks exist for My Choice?

Generic and private-label entry risk is high. The product has several characteristics that reduce barriers:

• Mature active ingredient
• Simple oral dosage form
• Low manufacturing complexity
• Broad consumer familiarity
• Multiple existing competitors
• Limited dependence on physician prescribing
• No biologic comparability burden
• No cold-chain requirement
• Straightforward unit-dose packaging

The main barriers are economic rather than scientific. A new entrant must secure:

• FDA-compliant manufacturing
• Reliable levonorgestrel supply
• Low-cost packaging
• Stable retail distribution
• Competitive wholesale pricing
• Adequate inventory for demand spikes
• Effective OTC labeling and packaging

A launch could occur in several formats:

Launch scenario	Competitive effect
National branded generic	Direct price and shelf-space pressure
Retailer private label	Margin compression and high-volume substitution
E-commerce value brand	Lower acquisition cost and targeted marketing
Club-pack or multipack format	Higher unit volume and lower per-dose price
International contract-manufactured product	Geographic expansion with limited U.S. differentiation
Novel orally disintegrating tablet	Potential premium pricing if consumer benefits are demonstrated

How can excipients create commercial differentiation?

Excipient differentiation is most valuable when it produces a measurable consumer or supply-chain benefit.

Lactose-free and allergen-controlled products

A lactose-free tablet can support pharmacy, institutional, and international sales. The benefit is more credible when supported by a transparent excipient declaration and controlled supplier qualification.

Orally disintegrating and chewable formats

An orally disintegrating tablet may improve convenience for consumers who cannot access water. A chewable format could support discreet use, but taste masking is a major development issue. Levonorgestrel can require flavor and mouthfeel optimization, which may increase formulation complexity.

Potential excipient tools include:

• Mannitol for cooling mouthfeel
• Crospovidone or co-processed excipients for rapid breakup
• Polymer-based taste-masking systems
• Sweeteners and flavors
• Effervescent components, if stability is adequately controlled

These formats may create stronger patent opportunities than a conventional swallowed tablet, but they also introduce greater manufacturing and stability risk.

Moisture-resistant packaging

A formulation that is only modestly differentiated can gain commercial value through packaging that supports long shelf life in hot and humid markets. High-barrier blister systems, desiccant-enabled cartons, and tamper-evident unit doses can reduce field failures and support government or humanitarian procurement.

Supply-chain simplification

Direct compression, fewer excipients, and fewer processing steps can lower conversion cost and reduce manufacturing-site qualification burden. A simple formula also makes technology transfer easier. That advantage is important for companies seeking dual sourcing or regional production.

How strong is the patent estate for My Choice?

The patent estate is likely weak around the basic product concept and potentially stronger around narrowly defined improvements.

Asset	Expected strength
Levonorgestrel as an emergency contraceptive	Low, due to maturity and prior art
Conventional 1.5 mg tablet	Low
Standard excipient combination	Low unless tied to unexpected technical results
Rapid-dissolution platform	Moderate if claims are narrow and data are strong
Orally disintegrating or taste-masked format	Moderate potential
Moisture-stable formulation	Moderate potential
Manufacturing process	Moderate if process-specific and difficult to design around
Brand name and trade dress	Trademark and commercial value, not patent exclusivity
Packaging configuration	Potentially protectable, but usually narrow

A formulation patent is more defensible when it links a defined excipient ratio or process parameter to an unexpected result, such as faster dissolution after accelerated aging, improved content uniformity, or improved stability under high humidity.

Which companies compete with My Choice?

The U.S. emergency-contraception market includes branded, authorized-generic, generic, and retailer-branded products. Relevant competitors include:

• Plan B One-Step
• Take Action
• Aftera
• My Way
• EContra EZ
• Retailer private-label levonorgestrel products
• International levonorgestrel brands

Competition is based on price, availability, consumer trust, pharmacy placement, packaging clarity, and perceived speed of action. Because the products have similar active ingredients and dosage strengths, formulation differences rarely drive physician choice. Consumer convenience and retail execution matter more.

What licensing and manufacturing opportunities exist?

The strongest opportunities are contract development and manufacturing agreements rather than licensing of the levonorgestrel molecule.

Contract manufacturing

A manufacturer with validated low-dose blending, immediate-release compression, and high-barrier blister packaging can serve:

• National pharmacy chains
• Supermarket and convenience retailers
• E-commerce brands
• International distributors
• Government procurement programs
• Humanitarian and public-health organizations

Private-label platforms

A common core formulation can support multiple labels with different artwork, package sizes, market claims, and distribution channels. The platform must preserve identical critical quality attributes across customers.

Regional supply

Local or regional production may reduce logistics costs and improve access in markets with import constraints. The principal IP barriers are likely to be manufacturing know-how, regulatory dossiers, supplier contracts, and quality systems rather than active-ingredient patents.

Specialty dosage forms

An orally disintegrating or taste-masked product may command a price premium if it offers meaningful convenience. The opportunity is strongest where the product can obtain a clear regulatory pathway and protect its technical features through formulation or process patents.

What is the FDA regulatory status of My Choice?

My Choice is an OTC emergency contraceptive product containing levonorgestrel. FDA oversight focuses on active ingredient identity, dosage, labeling, manufacturing quality, stability, dissolution, packaging, and postmarket compliance. [1,3]

A reformulated product must address:

• Drug Master File and supplier controls
• Comparative dissolution
• Stability under labeled storage conditions
• Content uniformity
• Impurity and degradation profiles
• Extractables and leachables, where relevant
• Packaging compatibility
• Labeling and Drug Facts compliance
• Manufacturing under current good manufacturing practice

A material excipient change may require regulatory reporting even when the active ingredient and strength remain unchanged. The level of filing depends on the change, its effect on product quality, and the applicable FDA reporting category.

What revenue exposure does My Choice face?

Revenue exposure is substantial at the brand level because the market is price-sensitive and substitution is easy. A retailer can replace one levonorgestrel brand with another without changing the consumer’s therapeutic objective.

The highest-risk revenue channels are:

• Pharmacy shelf placement
• Retailer private-label contracts
• Online price-comparison channels
• Government tenders
• High-volume discount programs

The best defenses are:

• Lower conversion cost
• Reliable fill rates
• Dual-source raw materials
• Long shelf life
• Strong retailer relationships
• Distinctive packaging
• Lactose-free or orally disintegrating positioning
• International regulatory dossiers
• Demonstrated stability in hot and humid climates

Key Takeaways

1. My Choice is a levonorgestrel 1.5 mg immediate-release emergency contraceptive tablet.
2. Its core commercial protection is operational, not molecular or patent-based.
3. The highest-value excipient objectives are rapid dissolution, low-dose content uniformity, moisture stability, and low manufacturing cost.
4. A lactose-free, heat-stable, high-barrier blister presentation could support differentiated commercial positioning.
5. Orally disintegrating and taste-masked formats offer greater formulation and patent potential but carry higher development risk.
6. Generic and private-label entry risk is high because the active ingredient and dosage form are mature.
7. Paragraph IV litigation is less likely to be the central competitive issue than price, retailer access, and supply reliability.
8. Biosimilar risk does not apply because levonorgestrel is a small-molecule drug.
9. The strongest licensing opportunities are private-label platforms, regional manufacturing, and differentiated delivery formats.
10. Current FDA Orange Book and Drugs@FDA records should control any final conclusion on application-specific patents, exclusivity, and marketing status.

FAQs

Can My Choice be reformulated without changing the active ingredient?

Yes. A manufacturer can develop a different excipient system, but it must demonstrate acceptable assay, content uniformity, dissolution, stability, and manufacturing performance under the applicable FDA pathway.

Is a rapid-dissolution levonorgestrel tablet patentable?

Potentially, but broad claims are vulnerable to prior art. The strongest claims would link specific formulation parameters to unexpected dissolution or stability results.

Does My Choice need refrigeration?

A conventional levonorgestrel tablet is generally designed for room-temperature storage under labeled conditions. High-temperature and humidity stability should be demonstrated through the product’s stability program.

Can a private-label retailer sell an equivalent My Choice formulation?

A retailer can market an equivalent product through an approved manufacturer or regulatory sponsor, subject to FDA approval, labeling, manufacturing, and trademark requirements. It cannot use the My Choice trademark without authorization.

Is an emergency contraceptive orally disintegrating tablet commercially attractive?

It may be attractive where discreet, water-free administration has consumer value. The main development barriers are taste masking, moisture sensitivity, tablet friability, packaging, and the cost of proving a meaningful product advantage.

References

1. U.S. Food and Drug Administration. (2022). Plan B One-Step levonorgestrel tablet, 1.5 mg: Prescribing information and consumer labeling.
2. U.S. National Library of Medicine. (n.d.). DailyMed: My Choice levonorgestrel tablet labeling.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.