List of Excipients in Branded Drug NEW DAY

Generic Drugs Containing NEW DAY

Company	Ingredient	NDC	Excipient
Northstar Rx LLC	levonorgestrel	16714-809	FD&C BLUE NO. 1
Northstar Rx LLC	levonorgestrel	16714-809	FD&C RED NO. 40
Northstar Rx LLC	levonorgestrel	16714-809	FD&C YELLOW NO. 6
Northstar Rx LLC	levonorgestrel	16714-809	LACTOSE MONOHYDRATE

What are the Most Frequently-Used Excipients in NEW DAY?

# Of NDCs	Excipient
2	FD&C BLUE NO. 1
2	FD&C RED NO. 40
2	FD&C YELLOW NO. 6
2	LACTOSE MONOHYDRATE

New Day Levonorgestrel Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 23, 2026

New Day is an over-the-counter emergency contraceptive containing levonorgestrel 1.5 mg in a single oral tablet. Its commercial opportunity is driven less by active-ingredient exclusivity than by low-cost manufacturing, rapid disintegration, packaging, retail availability, and private-label distribution. The principal excipient strategy is a conventional immediate-release tablet platform using lactose, starch, povidone, magnesium stearate, talc, and colloidal silicon dioxide. Differentiation opportunities exist in tablet robustness, low-moisture packaging, taste management, compact dosing, and channel-specific presentation.

What drug is New Day and how is it regulated?

New Day is a levonorgestrel emergency contraceptive tablet. Levonorgestrel is a synthetic progestin used to reduce the probability of pregnancy after unprotected intercourse or contraceptive failure.

Attribute	New Day profile
Brand	New Day
Active ingredient	Levonorgestrel
Strength	1.5 mg
Dosage form	Immediate-release oral tablet
Primary use	Emergency contraception
Distribution	OTC
FDA pathway	OTC emergency-contraceptive framework and product labeling
Biosimilar exposure	None
Primary competitive products	Plan B One-Step, Take Action, My Choice, Aftera, generic levonorgestrel tablets
Principal commercial barrier	Retail access, price, supply reliability, and consumer recognition

FDA approved Plan B One-Step for nonprescription use, creating the regulatory precedent for a single-dose levonorgestrel emergency contraceptive sold without a prescription. New Day competes within that established product category rather than relying on a novel active pharmaceutical ingredient or proprietary mechanism of action.[1]

What excipients are used in New Day?

Public labeling for New Day identifies conventional tablet excipients, including colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, and talc.[2] The formulation is consistent with a conventional wet-granulated or direct-compression immediate-release tablet.

Excipient	Likely functional role	Commercial and technical considerations
Lactose monohydrate	Diluent and compressibility aid	Supports tablet mass and manufacturability; creates a dairy-derived excipient consideration
Corn starch	Filler, disintegrant, or binder	Supports rapid tablet breakup and cost-efficient processing
Povidone	Binder	Improves granule cohesion and tablet strength
Magnesium stearate	Lubricant	Reduces sticking and ejection force; excessive use can slow dissolution
Talc	Glidant or anti-adherent	Supports powder flow and tooling performance
Colloidal silicon dioxide	Glidant and moisture-management aid	Improves powder flow and may reduce processing variability

The formulation target is rapid release rather than modified release. The 1.5 mg dose is small relative to tablet mass, so content uniformity, blend segregation, and assay control are important manufacturing issues. A low-dose formulation must distribute levonorgestrel uniformly through the powder blend or granulation.

How should an excipient strategy be designed for New Day?

A commercially attractive New Day formulation should prioritize rapid disintegration, chemical stability, dose uniformity, tablet strength, and low production cost. The formulation does not require complex delivery technology.

Immediate-release performance

A target disintegration time materially below the applicable compendial limit can provide manufacturing headroom and protect performance across humidity and temperature excursions. Starch-based disintegration is cost-effective, but the formulation should be optimized to avoid excessive lubricant sensitivity.

Key development variables include:

• Levonorgestrel particle size and dispersion
• Starch concentration and grade
• Povidone molecular weight and binder level
• Magnesium stearate concentration and blending time
• Tablet hardness and friability
• Dissolution profile under relevant pH conditions
• Blend uniformity at commercial batch scale

Because levonorgestrel is a low-dose, poorly water-soluble steroid, particle engineering and wetting can have greater impact than simply increasing disintegrant concentration. A surfactant or improved wetting system could be evaluated, but the commercial benefit must justify added regulatory and supply-chain complexity.

Lactose-free and alternative-excipient versions

A lactose-free version could expand institutional, international, and consumer-access channels. Suitable alternatives include microcrystalline cellulose, mannitol, dibasic calcium phosphate, or pregelatinized starch. Each alternative changes tablet density, compactability, mouthfeel, and dissolution.

Mannitol may support a cleaner consumer profile and better taste perception, but it generally costs more than lactose. Microcrystalline cellulose can improve compactability but may produce a larger tablet at equivalent dose and target hardness. A lactose-free product could be positioned for consumers seeking allergen-conscious or simplified formulations, although the commercial value of that claim is likely lower than the value of broad retail distribution.

Taste and swallowability

New Day is a tablet rather than a chewable product, so taste masking is secondary. It becomes important if a manufacturer develops:

• A chewable emergency contraceptive
• An orally disintegrating tablet
• A smaller tablet for discreet use
• A pediatric-style presentation for younger consumers, subject to regulatory review
• A product designed for consumers with swallowing difficulty

Film coating can reduce mouth contact and improve appearance. A coating based on hypromellose, polyvinyl alcohol, polyethylene glycol, and titanium dioxide or approved colorants could provide branding and swallowability benefits. The coating must not materially delay dissolution.

Moisture and packaging

Moisture control is a practical value driver. Levonorgestrel tablets must retain assay, dissolution, hardness, and appearance throughout shelf life. High-barrier blister packaging can protect individual doses and support discreet carrying. Alu-Alu blister packs provide stronger moisture and oxygen protection than standard PVC blister systems, but they increase material and packaging costs.

Commercial packaging options include:

Format	Advantages	Limitations
Unit-dose blister	Strong protection, discreet, portable	Higher packaging cost
Bottle with desiccant	Lower unit cost at scale	Greater exposure after opening; less discreet
Calendar or wallet pack	Retail visibility and portability	More complex packaging operations
Two-dose value pack	Useful for household preparedness	Can increase inventory and regulatory labeling complexity
E-commerce shipper	Supports direct-to-consumer distribution	Requires privacy and temperature-management controls

For a single-dose emergency product, the blister is strategically important. The package is part of product performance, not only a marketing component.

What patents protect New Day and when does exclusivity expire?

New Day is a branded OTC levonorgestrel product operating in a mature generic market. The principal active ingredient is long established, and the product does not depend on a current composition-of-matter patent for levonorgestrel.

The relevant protection categories are:

1. Active-ingredient patents, which are no longer a meaningful barrier for levonorgestrel emergency contraception.
2. Formulation patents, if any, covering a specific excipient combination, particle-size distribution, coating, or dissolution profile.
3. Manufacturing patents covering granulation, compression, coating, or packaging.
4. Trademark rights covering the New Day brand.
5. Regulatory exclusivity associated with the original prescription-to-OTC transition, which is separate from patent protection.

Public OTC labeling does not establish a significant product-specific patent estate for New Day. The product’s competitive position is therefore more dependent on manufacturing economics, regulatory compliance, distribution, and brand placement than on blocking patents.

What is the Orange Book status of New Day?

The Orange Book is principally relevant to FDA-approved prescription and certain approved nonprescription products with listed applications. An OTC levonorgestrel product marketed under an OTC framework may not have an Orange Book patent listing comparable to a prescription NDA product.

New Day should not be treated as having a meaningful Orange Book-based barrier without a current FDA product record confirming an NDA, ANDA, or listed patent entry. The commercial implication is that a competitor may be able to enter with an equivalent levonorgestrel product without confronting a conventional Orange Book Paragraph IV campaign against New Day.

What Paragraph IV challenges and patent litigation affect New Day?

Paragraph IV litigation is generally not the central entry mechanism for OTC levonorgestrel emergency contraception. A competitor using an ANDA pathway would need to assess the reference product and any listed patents, but the mature generic market reduces the probability that New Day itself creates a substantial patent obstacle.

The principal legal risks are more likely to involve:

• Trademark infringement
• False or misleading comparative advertising
• Trade dress
• Labeling claims
• Distribution agreements
• Contract manufacturing disputes
• Product liability
• Regulatory violations involving emergency-contraception claims

No major public patent settlement structure is associated with New Day comparable to settlements involving high-value patented specialty medicines. A private-label competitor would generally focus on regulatory equivalence, manufacturing capability, and retail contracts rather than a license from the New Day brand owner.

How strong is the New Day patent estate?

The New Day patent estate is commercially weak as a blocking platform because levonorgestrel emergency contraception is an established, low-complexity product with numerous competing brands and generics.

Estate component	Estimated strategic strength
Levonorgestrel active ingredient	Low
Single-dose tablet concept	Low
Conventional excipient formulation	Low to moderate, depending on claim scope and ownership
Specific manufacturing process	Moderate if process yields demonstrated stability or dissolution benefits
Packaging configuration	Low to moderate
Brand and trade dress	Moderate
Distribution relationships	Moderate to strong in selected channels
Regulatory know-how	Moderate

A new formulation patent would need claims that are both technically specific and commercially relevant. Broad claims covering levonorgestrel plus common excipients would face substantial validity and obviousness pressure. Stronger protection could arise from a measurable technical result, such as improved stability under accelerated conditions, reliable content uniformity at very low drug loading, or a distinctive orally disintegrating platform.

What commercial opportunities exist for New Day excipient innovation?

The strongest opportunities are line extensions and private-label platforms.

Lactose-free and allergen-conscious products

A lactose-free formulation could support pharmacy, institutional, and international channels. The product should avoid overreliance on a medical claim that is not clinically meaningful. The commercial value would come from broader formulation compatibility and consumer preference.

Orally disintegrating and chewable tablets

An orally disintegrating tablet could address consumers who need rapid, discreet administration or cannot swallow conventional tablets. Development risks include taste masking, moisture sensitivity, friability, and packaging cost.

A chewable product could improve acceptability but would require more extensive flavor and sweetener development. The active ingredient’s taste, tablet size, and dose perception would be important design inputs.

Higher-stability products

A formulation with improved resistance to heat and humidity could be valuable in emerging markets, disaster-response procurement, vending machines, and e-commerce fulfillment. Stability benefits must be demonstrated through comparative studies and reflected in the approved shelf life or storage conditions.

Private-label and contract-manufacturing platforms

The same excipient platform can support multiple brands with limited technical changes. A manufacturer could offer:

• Standard low-cost tablet
• Lactose-free tablet
• Film-coated premium tablet
• Unit-dose high-barrier blister
• Two-dose preparedness pack
• Institutional bulk package

The core economics favor high-volume production, automated packaging, and a limited number of stock-keeping units. The active ingredient is inexpensive; quality failures, packaging losses, and retailer deductions can have a greater effect on margin than API cost.

How does New Day compare with Plan B One-Step and generic levonorgestrel?

New Day is therapeutically close to Plan B One-Step and other levonorgestrel 1.5 mg products. Consumers and retailers are likely to compare products on price, availability, brand trust, packaging, and ease of purchase rather than on pharmacological differentiation.

Factor	New Day	Plan B One-Step	Generic levonorgestrel products
Active ingredient	Levonorgestrel 1.5 mg	Levonorgestrel 1.5 mg	Levonorgestrel 1.5 mg
Dose	Single dose	Single dose	Usually single dose
OTC access	Yes	Yes	Yes, depending on market
Differentiation	Brand, price, package, distribution	Brand recognition and retail presence	Price and retailer control
Patent barrier	Limited	Historical pioneer-product position; limited practical barrier for generic entry	Generally limited
Excipient opportunity	Moderate	Moderate	High for private-label customization
Main risk	Price erosion and substitution	Brand commoditization	Margin compression

What generic launch risks exist for New Day?

Generic entry risk is high because the product has a simple dosage form, established active ingredient, and broad consumer demand. A new entrant can compete without developing a novel clinical profile.

The main launch scenarios are:

1. A low-price retailer brand using a conventional tablet.
2. A contract-manufactured private label using high-barrier blister packaging.
3. A lactose-free or chewable line extension.
4. An e-commerce brand competing through discreet shipping and subscription-style preparedness purchasing.
5. An institutional supplier offering multi-unit packs to clinics, public-health agencies, or universities.

The principal barriers are FDA compliance, supply reliability, finished-product testing, packaging qualification, and retail listing fees. Patent litigation is unlikely to be the decisive barrier unless a competitor makes a narrowly claimed formulation or process relevant to a particular product.

What FDA regulatory issues affect excipient commercialization?

Any new New Day formulation must preserve the regulatory status of levonorgestrel emergency contraception and comply with applicable FDA labeling, quality, manufacturing, and stability requirements. A change in excipients can affect dissolution, bioavailability, content uniformity, impurity formation, and shelf life.

The highest-risk changes are:

• Switching from a conventional tablet to an orally disintegrating form
• Adding surfactants or complex solubilizers
• Changing tablet strength or dose presentation
• Introducing a chewable product with new sweeteners and flavors
• Changing packaging without equivalent stability support
• Adding consumer-facing claims about speed, effectiveness, or tolerability

The lowest-risk opportunity is usually a compositionally similar immediate-release tablet with a well-established excipient substitute and comparable dissolution performance.

Key Takeaways

• New Day is a levonorgestrel 1.5 mg OTC emergency contraceptive tablet.
• Its commercial position is based on price, access, packaging, and distribution rather than active-ingredient patent exclusivity.
• The current excipient platform is conventional and cost-efficient.
• A lactose-free version, orally disintegrating tablet, chewable product, or high-stability package could create differentiated commercial positions.
• Patent protection for common levonorgestrel excipient combinations is likely to be limited unless supported by a measurable technical advantage.
• Paragraph IV litigation and patent settlements are less important than FDA compliance, manufacturing capacity, trademarks, and retail access.
• High-barrier single-dose packaging is one of the most practical opportunities for product improvement.
• Generic and private-label entry risk is high because the dosage form is simple and the active ingredient is mature.

FAQs

Can New Day be reformulated without changing its FDA status?

A formulation change may be possible within the applicable regulatory pathway, but excipient substitutions must be evaluated for quality, dissolution, stability, labeling, and regulatory comparability.

Is an orally disintegrating New Day tablet commercially attractive?

Yes. It could improve convenience and create a differentiated product, but taste masking, moisture protection, friability, and packaging costs would materially affect feasibility.

Can a New Day competitor patent a lactose-free levonorgestrel tablet?

A broad lactose-free claim would likely be difficult to defend. A stronger patent position would require a specific composition and demonstrated technical benefit, such as improved stability or dissolution.

Does New Day have biosimilar competition?

No. Levonorgestrel is a synthetic small-molecule active ingredient, so competitive products are generics or equivalent OTC products rather than biosimilars.

Which excipient offers the largest commercial opportunity?

The largest opportunity is not a single excipient. It is a formulation-and-packaging platform that combines rapid disintegration, strong content uniformity, moisture stability, and discreet unit-dose packaging.

References

1. U.S. Food and Drug Administration. (2013). FDA approves Plan B One-Step emergency contraceptive for use without a prescription. FDA.

2. DailyMed. (n.d.). New Day: Levonorgestrel tablet, 1.5 mg. National Library of Medicine.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

4. U.S. Food and Drug Administration. (2023). Over-the-counter monograph M020: Emergency contraceptive. FDA.

5. U.S. Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. USP.