List of Excipients in Branded Drug OPCICON ONE-STEP

Generic Drugs Containing OPCICON ONE-STEP

Company	Ingredient	NDC	Excipient
Sun Pharmaceutical Industries Inc	levonorgestrel	62756-718	HYPROMELLOSES
Sun Pharmaceutical Industries Inc	levonorgestrel	62756-718	LACTOSE MONOHYDRATE
Sun Pharmaceutical Industries Inc	levonorgestrel	62756-718	MAGNESIUM STEARATE
Sun Pharmaceutical Industries Inc	levonorgestrel	62756-718	SILICON DIOXIDE

What are the Most Frequently-Used Excipients in OPCICON ONE-STEP?

# Of NDCs	Excipient
1	HYPROMELLOSES
1	LACTOSE MONOHYDRATE
1	MAGNESIUM STEARATE
1	SILICON DIOXIDE

OPCICON ONE-STEP Excipient Strategy and Commercial Opportunities

Last updated: August 9, 2026

OPCICON ONE-STEP is an over-the-counter levonorgestrel 1.5 mg emergency contraceptive tablet. Its excipient system is designed for rapid disintegration, dissolution, dose uniformity, and low-cost high-volume manufacturing. The strongest commercial opportunities are differentiated delivery formats, private-label supply, e-commerce packaging, global regulatory adaptation, and supply-chain control rather than new active-ingredient patent protection.

What is OPCICON ONE-STEP and how is it regulated?

OPCICON ONE-STEP contains 1.5 mg of levonorgestrel, a synthetic progestin used for emergency contraception. It is taken as a single oral dose as soon as possible after unprotected intercourse or contraceptive failure.

Attribute	Product position
Product	OPCICON ONE-STEP
Active ingredient	Levonorgestrel
Strength	1.5 mg
Dosage form	Immediate-release oral tablet
Route	Oral
Therapeutic category	Emergency contraception
U.S. regulatory status	OTC levonorgestrel emergency contraceptive product
Biosimilar exposure	None
Primary commercial competitors	Plan B One-Step, Take Action, My Choice, Aftera, generic levonorgestrel products
Principal formulation objective	Rapid release from a compact single-dose tablet

The FDA permits levonorgestrel emergency contraception to be sold without a prescription, without age or point-of-sale restrictions. The FDA describes levonorgestrel emergency contraception as an OTC product available under multiple brand and generic names.[1]

What excipients are used in OPCICON ONE-STEP?

Public product labeling identifies an excipient system centered on direct-compression or conventional immediate-release tablet performance. The listed inactive ingredients include:

Excipient	Primary formulation function	Commercial relevance
Microcrystalline cellulose	Diluent, compression aid, compactability	Supports robust tablet manufacture at low dose
Lactose monohydrate	Filler and bulking agent	Low cost, established regulatory history
Croscarmellose sodium	Superdisintegrant	Accelerates tablet breakup after swallowing
Sodium starch glycolate	Superdisintegrant	Improves water uptake and tablet disintegration
Polacrilin potassium	Disintegrant and ion-exchange excipient	Can improve breakup and dissolution
Povidone K30	Binder	Supports granule or tablet mechanical strength
Colloidal silicon dioxide	Glidant and moisture-control aid	Improves powder flow and blend uniformity
Magnesium stearate	Lubricant	Reduces ejection force and tooling adhesion

The formulation uses multiple disintegration mechanisms rather than relying on a single superdisintegrant. Croscarmellose sodium, sodium starch glycolate, and polacrilin potassium can provide complementary swelling, wicking, and water-uptake behavior. That combination is commercially useful for a low-dose hormonal tablet because the 1.5 mg active ingredient must be distributed uniformly through a relatively larger excipient matrix.

The principal technical risk is over-lubrication. Excess magnesium stearate or prolonged lubrication can create hydrophobic tablet surfaces and slow dissolution. Excipient particle size, blending order, lubricant residence time, compression force, and tablet porosity are therefore important process-control variables.

How does the OPCICON ONE-STEP excipient system support rapid release?

The product must release levonorgestrel promptly and consistently. The excipient strategy supports that objective through four mechanisms:

1. Microcrystalline cellulose provides tablet structure and capillary pathways.
2. Superdisintegrants promote rapid water penetration and tablet breakup.
3. Povidone supports mechanical integrity without requiring an unusually hard tablet.
4. Colloidal silicon dioxide and magnesium stearate improve manufacturing consistency.

Because the active dose is small, blend uniformity is a more important control issue than tablet mass alone. Levonorgestrel segregation can occur if the active and excipient particles have materially different density, morphology, or electrostatic behavior. A manufacturer can reduce that risk through ordered blending, geometric dilution, controlled particle-size distribution, or a wet-granulation process.

A robust commercial formulation should be evaluated against:

• Assay and content uniformity.
• Disintegration time.
• Dissolution profile.
• Tablet friability and hardness.
• Stability under heat and humidity.
• Blend segregation during transfer and filling.
• Lubricant sensitivity.
• Packaging moisture ingress.

What commercial opportunities exist for excipient reformulation?

The current formulation is commercially efficient, but it leaves room for differentiated products. The most attractive opportunities are below.

Lactose-free OPCICON-compatible formulation

A lactose-free version could replace lactose monohydrate with mannitol, anhydrous dibasic calcium phosphate, spray-dried cellulose, or additional microcrystalline cellulose. The value proposition is consumer segmentation and broader private-label positioning.

Mannitol is especially relevant for orally disintegrating or chewable formats because it has a relatively clean taste and cooling mouthfeel. Its lower binding performance may require adjustment of binder level or compression conditions.

Orally disintegrating tablet

An orally disintegrating levonorgestrel tablet could target consumers who lack immediate access to water or have difficulty swallowing conventional tablets. The formulation would require:

• Rapid disintegration, typically under the applicable dosage-form standard.
• Taste masking for levonorgestrel and excipient bitterness.
• Low friability despite high porosity.
• Moisture-protective packaging.
• Controlled mouthfeel and minimal residue.

Mannitol, crospovidone, low-substituted hydroxypropyl cellulose, and taste-masking coatings are potential building blocks. A new dosage form would require regulatory review and could support a separate product identity.

Chewable tablet

A chewable format could create a differentiated OTC product, but levonorgestrel taste and mouthfeel would be central development problems. Sweeteners, flavors, lubricants, and taste-masking technologies would become more important than in the standard swallowed tablet.

The commercial benefit would depend on whether the product delivers a meaningful adherence or convenience advantage over existing tablets. The format would also create additional stability and packaging requirements.

Moisture-protective single-dose packaging

Packaging is an excipient-adjacent commercial opportunity. A low-cost tablet can lose value if the packaging allows moisture uptake that changes disintegration or dissolution.

Potential options include:

• Aluminum-aluminum blister packs.
• High-barrier PVC/PVDC blisters.
• Cold-form foil.
• Individually pouched tablets.
• Unit-dose cartons for pharmacy and vending-channel distribution.

Single-dose blister packaging supports discreet purchase, inventory control, and e-commerce fulfillment. It can also reduce consumer concern about carrying a product associated with time-sensitive use.

Pediatric and global-market adaptation

The U.S. product is intended for emergency contraception and is not positioned as a pediatric treatment. A smaller tablet, dispersible format, or lower-strength presentation could be relevant in international markets, but such products would require separate regulatory and clinical assessment.

Excipient selection also must reflect geographic requirements. Lactose, sodium-containing excipients, colorants, gelatin, and animal-derived materials may affect market access, labeling, or consumer acceptance in selected jurisdictions.

How does OPCICON ONE-STEP compare with competing levonorgestrel products?

Most competing levonorgestrel emergency contraceptives use conventional immediate-release tablets and commodity excipients. Product differentiation therefore tends to arise from brand recognition, price, distribution, packaging, and consumer access.

Product group	Active ingredient	Typical dosage form	Main competitive lever
OPCICON ONE-STEP	Levonorgestrel 1.5 mg	Immediate-release tablet	Cost, private label, retail and online availability
Plan B One-Step	Levonorgestrel 1.5 mg	Immediate-release tablet	Brand recognition and distribution
Take Action	Levonorgestrel 1.5 mg	Immediate-release tablet	Value pricing and retail availability
My Choice / Aftera	Levonorgestrel 1.5 mg	Immediate-release tablet	Generic pricing and channel coverage
Ella	Ulipristal acetate 30 mg	Oral tablet	Different active ingredient and prescription status in the U.S.

A differentiated OPCICON product would need more than a minor excipient substitution. A meaningful commercial case would likely require one or more of the following:

• Faster perceived use through oral disintegration.
• Improved swallowability.
• Lactose-free positioning.
• Better heat and humidity stability.
• Discreet unit-dose packaging.
• Lower landed cost.
• Retailer-exclusive or private-label supply.

What patents protect OPCICON ONE-STEP and levonorgestrel emergency contraception?

Levonorgestrel is an established active pharmaceutical ingredient. The principal composition-of-matter and early emergency-contraception patent barriers are no longer the primary commercial constraint in the U.S.

The former Plan B patent estate included U.S. Patent No. 5,985,864, which covered aspects of levonorgestrel emergency contraception. That patent expired before the current generic-heavy market structure developed. Current competition is therefore driven mainly by regulatory status, manufacturing economics, trademarks, formulation know-how, packaging, and distribution.

IP category	OPCICON commercial relevance
Levonorgestrel composition patent	No meaningful current U.S. barrier
Basic emergency-contraception method patent	Mature and generally non-exclusive
Immediate-release tablet formulation	Potentially protectable only if technically distinct
Oral disintegrating formulation	Possible new patent subject matter
Taste-masking system	Possible formulation and process protection
Moisture-barrier packaging	Possible packaging or combination protection
Trademark and trade dress	Commercially relevant
Manufacturing process	Potentially valuable as confidential know-how

A patent search focused only on the product name may miss relevant protection. The practical search should cover levonorgestrel, emergency contraception, orally disintegrating tablets, taste masking, blister packaging, and excipient combinations.

When does OPCICON ONE-STEP lose exclusivity?

OPCICON ONE-STEP does not depend on a long remaining period of new-drug exclusivity in the same way as a recently approved innovative medicine. Levonorgestrel emergency contraception is a mature OTC category with multiple marketed products.

Its commercial exclusivity is better analyzed through four layers:

1. FDA regulatory permission for OTC distribution.
2. Trademark and brand recognition.
3. Product-specific formulation or packaging patents, if any.
4. Manufacturing and distribution contracts.

There is no biosimilar pathway relevant to OPCICON ONE-STEP because levonorgestrel is a small-molecule active ingredient. Generic and private-label competition is the relevant entry risk.

What is the Orange Book status of OPCICON ONE-STEP?

Orange Book analysis depends on the specific FDA application and listing status. For a mature OTC levonorgestrel tablet, the absence of a strong current patent barrier is more commercially important than Orange Book litigation mechanics.

Paragraph IV litigation is unlikely to be the central risk for a commodity levonorgestrel emergency-contraceptive tablet. Generic applicants can generally compete through established abbreviated or OTC regulatory routes, subject to the applicable FDA pathway and product-specific requirements.

The practical regulatory diligence should examine:

• FDA Drugs@FDA application records.
• DailyMed labeling.
• Orange Book patent and exclusivity entries where applicable.
• National Drug Code status.
• FDA establishment and product listings.
• OTC monograph or application basis.
• Any product-specific labeling supplements.

Which companies are challenging or competing with OPCICON ONE-STEP?

Competition comes from branded manufacturers, generic pharmaceutical companies, pharmacy chains, online retailers, and private-label distributors. The category has low switching costs for consumers because products share the same active ingredient and strength.

Competitive pressure is strongest in:

• Retail pharmacy shelf placement.
• Search-engine advertising.
• Amazon and other e-commerce channels.
• Family-planning and sexual-health clinics.
• Campus and public-health distribution.
• Retailer private labels.
• International tenders and pharmacy chains.

Manufacturer economics depend heavily on production scale, packaging costs, channel fees, return rates, and stock availability. Active-ingredient cost is unlikely to be the principal cost driver. Packaging, quality testing, regulatory maintenance, and distribution can account for a larger share of total unit economics.

What generic launch risks exist for OPCICON ONE-STEP?

The principal generic-launch risks are operational rather than patent-based.

Manufacturing risks

• Levonorgestrel blend nonuniformity.
• Tablet weight and content-uniformity failures.
• Slow dissolution caused by over-lubrication.
• Moisture-driven stability changes.
• Tooling adhesion or capping during compression.
• Supply interruptions involving pharmaceutical-grade excipients.

Regulatory risks

• Incomplete OTC labeling compliance.
• Product-specific quality deficiencies.
• Inadequate stability data for new dosage forms.
• Packaging changes that affect shelf life.
• Unsupported claims such as faster efficacy or superior performance.

Commercial risks

• Retailer price compression.
• Brand substitution by lower-priced generics.
• Consumer confusion among similarly named products.
• Dependence on a small number of contract manufacturers.
• Channel restrictions or retailer delisting.

How strong is the patent estate for OPCICON ONE-STEP?

The patent estate is likely weak for the conventional levonorgestrel 1.5 mg immediate-release tablet unless the sponsor owns distinct formulation, manufacturing, or packaging claims. The stronger defensible assets are likely to be:

• Validated manufacturing processes.
• Supplier qualification and dual sourcing.
• Stability data.
• Retail and private-label contracts.
• Trademark rights.
• Packaging execution.
• Regulatory know-how.

A new excipient strategy can improve commercial defensibility if it produces measurable technical benefits, such as faster disintegration, improved stability, taste masking, or reduced manufacturing variability. Simply replacing one filler with another is unlikely to support a durable patent position without unexpected performance data.

What licensing and partnership opportunities exist?

The most realistic licensing opportunities involve manufacturing and distribution rather than the levonorgestrel molecule.

Potential counterparties include:

• Contract development and manufacturing organizations.
• Retail pharmacy chains.
• Consumer-health companies.
• Digital reproductive-health platforms.
• Public-health procurement agencies.
• International generic-drug companies.
• Packaging suppliers with high-barrier unit-dose systems.

A differentiated orally disintegrating or lactose-free product could support a co-development agreement. A standard tablet is more suited to supply, private-label, or regional commercialization agreements.

Key Takeaways

• OPCICON ONE-STEP is a levonorgestrel 1.5 mg OTC emergency contraceptive tablet.
• Its excipient system supports immediate release, dose uniformity, compression, and manufacturing efficiency.
• Croscarmellose sodium, sodium starch glycolate, and polacrilin potassium provide a multi-mechanism disintegration platform.
• The most attractive reformulation opportunities are orally disintegrating, chewable, lactose-free, and enhanced-barrier unit-dose products.
• Biosimilar risk does not apply; generic and private-label competition does.
• Current commercial protection is more likely to come from branding, packaging, regulatory execution, supply contracts, and manufacturing know-how than from the levonorgestrel molecule.
• A new excipient combination has meaningful IP value only if it produces demonstrable technical performance and supports patentable claims.

FAQs

Can OPCICON ONE-STEP be reformulated without changing the active ingredient?

Yes. A sponsor could evaluate new excipients or dosage forms while retaining levonorgestrel 1.5 mg, but the revised product would require appropriate FDA regulatory support and comparative quality data.

Is lactose-free OPCICON ONE-STEP commercially attractive?

It could support consumer segmentation and private-label differentiation. The main technical issue is replacing lactose without losing blend uniformity, tablet strength, dissolution, or acceptable cost.

Could an orally disintegrating levonorgestrel tablet receive patent protection?

Potentially. Patentability would depend on novelty, non-obviousness, and demonstrated technical performance, such as a distinctive taste-masking or rapid-disintegration system.

Does OPCICON ONE-STEP face biosimilar competition?

No. Levonorgestrel is a small-molecule active ingredient. Competition arises through generic, OTC, and private-label products rather than biosimilars.

What is the highest-value commercial improvement for OPCICON ONE-STEP?

A differentiated product combining rapid oral disintegration, acceptable taste, moisture-protective unit-dose packaging, and competitive manufacturing cost would offer the clearest opportunity beyond a conventional generic tablet.

References

1. U.S. Food and Drug Administration. (2024). Emergency contraception. https://www.fda.gov/consumers/free-publications-women/emergency-contraception
2. DailyMed. (n.d.). OPCICON ONE-STEP: Levonorgestrel tablet labeling. National Library of Medicine. https://dailymed.nlm.nih.gov/
3. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
4. U.S. Patent No. 5,985,864. (1999). Contraceptive methods and compositions. U.S. Patent and Trademark Office.