List of Excipients in Branded Drug IBUPROFEN 200

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Generic Drugs Containing IBUPROFEN 200

Company	Ingredient	NDC	Excipient
WALGREEN COMPANY	ibuprofen	0363-0222	FD&C RED NO. 40
WALGREEN COMPANY	ibuprofen	0363-0222	FD&C YELLOW NO. 6
WALGREEN COMPANY	ibuprofen	0363-0222	GELATIN

What are the Most Frequently-Used Excipients in IBUPROFEN 200?

# Of NDCs	Excipient
1	ANHYDROUS LACTOSE
1	CARNAUBA WAX
2	CELLULOSE, MICROCRYSTALLINE

Ibuprofen 200 mg Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

Ibuprofen 200 mg is a mature, low-cost OTC NSAID with no meaningful active-ingredient patent barrier in the United States. Commercial differentiation depends on dissolution performance, dosage form, tolerability, packaging, flavor, convenience, and regulatory positioning rather than on new-molecule exclusivity. The strongest opportunities are softgels, fast-dissolving tablets, pediatric liquids, lower-irritancy formulations, private-label products, and combination products that comply with the FDA OTC monograph.

What is the regulatory status of ibuprofen 200 mg?

Ibuprofen 200 mg is an OTC internal analgesic, antipyretic, and antirheumatic drug. FDA permits ibuprofen at OTC strengths and conditions under the applicable monograph framework, subject to dosage, labeling, warnings, and manufacturing requirements.[1]

Attribute	Ibuprofen 200 mg
Active ingredient	Ibuprofen
Drug class	NSAID
Common OTC indications	Temporary relief of minor aches and pains; fever reduction
Typical adult dose	200 mg every 4-6 hours
Maximum OTC daily dose	1,200 mg unless directed by a physician
Common dosage forms	Tablets, caplets, softgels, chewables, oral suspension
FDA pathway	OTC monograph compliance or approved application, depending on product
Prescription status	Also marketed in prescription strengths and formulations
Orange Book status	Conventional OTC monograph products generally are not listed as approved NDA products
Active-ingredient patent barrier	Expired
Main commercial barriers	Manufacturing scale, quality, brand, distribution, formulation know-how, labeling compliance

FDA-required labeling includes NSAID gastrointestinal, cardiovascular, allergic-reaction, pregnancy, and drug-interaction warnings. Product developers must align the Drug Facts label with the applicable monograph and current FDA labeling requirements.[1,2]

What excipients are used in ibuprofen 200 mg tablets?

Conventional ibuprofen tablets typically use excipients for dilution, granulation, lubrication, disintegration, coating, flow control, and appearance. The active ingredient is poorly soluble in water, so tablet performance depends heavily on particle size, wetting, disintegrant selection, and compression conditions.

Common excipient categories include:

Functional role	Common excipient options	Commercial purpose
Diluent	Microcrystalline cellulose, lactose, starch, dibasic calcium phosphate	Controls tablet weight, hardness, and manufacturability
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, sodium starch glycolate, crospovidone	Promotes tablet breakup and dissolution
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces sticking and ejection force
Surfactant	Sodium lauryl sulfate, polysorbates	Improves wetting of hydrophobic ibuprofen particles
Glidant	Colloidal silicon dioxide	Improves powder flow
Coating polymer	Hypromellose, polyvinyl alcohol	Protects the tablet and improves swallowability
Opacifier or colorant	Titanium dioxide, iron oxides, approved colorants	Supports product identification and appearance
Sweetener and flavor	Sucralose, saccharin sodium, mannitol, fruit flavors	Enables chewable or pediatric products

Commercial labels for branded ibuprofen tablets and softgels show that manufacturers use materially different excipient systems while delivering the same 200 mg active dose.[3,4] This creates room for formulation development without changing the drug substance.

How should an ibuprofen 200 mg tablet formulation be designed?

The primary formulation objective is rapid and reproducible dissolution. Ibuprofen is a weak acid with low aqueous solubility in its unionized form. A formulation that disintegrates quickly but wets poorly may still produce slow dissolution.

Conventional immediate-release tablet

A cost-efficient immediate-release tablet usually uses:

1. A controlled-particle-size ibuprofen grade.
2. Microcrystalline cellulose or a comparable diluent.
3. A high-performance disintegrant.
4. A wetting agent at a controlled concentration.
5. Magnesium stearate or an alternative lubricant.
6. Film coating for swallowability, color, and moisture protection.

Direct compression can reduce manufacturing steps, but it requires consistent powder flow, bulk density, and compressibility. Wet granulation can improve content uniformity and tablet robustness but increases process complexity and drying requirements.

Dissolution strategy

The most commercially relevant variables are:

• Ibuprofen particle-size distribution.
• Specific surface area.
• Wetting-agent concentration.
• Disintegrant type and placement.
• Compression force.
• Lubrication time.
• Tablet porosity.
• Granulation moisture.
• Coating weight and permeability.

Over-lubrication can reduce tablet wetting and slow dissolution. Excessive compression can create a strong tablet with delayed breakup. A formulation should be optimized against dissolution, friability, hardness, disintegration, assay, content uniformity, and stability rather than against tablet hardness alone.

Excipient compatibility

Ibuprofen can present compatibility risks with alkaline materials, moisture-sensitive excipients, and certain lubricants. Developers should evaluate:

• Drug-excipient chemical interaction.
• Polymorphic or solid-state changes.
• Moisture uptake.
• Hydrolysis or degradation of excipients.
• Color migration.
• Packaging interaction.
• Dissolution changes after accelerated storage.

FDA’s Inactive Ingredient Database is a useful screening tool for prior use by route and dosage form, but it does not replace formulation-specific safety and stability assessment.[5]

What excipients are best for ibuprofen softgels?

Softgel products offer a strong commercial alternative to compressed tablets. Their main value is ease of swallowing, product differentiation, and the ability to present ibuprofen in a solubilized or dispersed fill.

Typical softgel systems may include:

• Polyethylene glycol vehicles.
• Propylene glycol or related cosolvents.
• Surfactants.
• Water or low-water fill systems.
• Gelatin or non-gelatin shell materials.
• Plasticizers such as sorbitol or glycerin.
• Opacifiers and colorants.

The liquid-fill system can improve wetting and reduce the dependence on tablet disintegration. It does not automatically improve clinical onset, however. Any onset claim requires appropriate comparative evidence.

Softgel development has several technical risks:

• Shell brittleness or tackiness.
• Active migration into the shell.
• Fill-shell interaction.
• Leakage.
• Oxidation.
• Long-term dissolution drift.
• Manufacturing losses during encapsulation.
• Higher packaging and equipment costs.

A lower-cost opportunity is a conventional liquid-filled softgel using an established excipient system. A higher-value opportunity is a self-emulsifying or rapidly dispersing formulation, although that approach creates greater formulation, scale-up, and intellectual-property exposure.

What formulations are protected by ibuprofen patents?

The ibuprofen active ingredient is long off-patent. The original ibuprofen compound and early manufacturing technology do not provide current exclusivity for ordinary 200 mg OTC products. A representative early U.S. ibuprofen patent was U.S. Patent No. 3,385,886, which expired decades ago.[6]

Current patent risk, where it exists, is more likely to involve:

• Solubilized ibuprofen liquids.
• Rapid-release or fast-onset dosage forms.
• Softgel fill compositions.
• Combination products.
• Pediatric delivery systems.
• Taste-masked suspensions.
• Abuse-deterrent or modified-release products.
• Manufacturing processes.
• Specific excipient ratios or particle-engineering methods.
• Use claims linked to a particular formulation.

A formulation patent does not automatically block a conventional generic or private-label ibuprofen tablet. The relevant question is whether the proposed product practices the patent claims. A freedom-to-operate review should examine issued claims, patent-family status, terminal disclaimers, prosecution history, continuations, and jurisdiction-specific expiration dates.

What is the Orange Book status of ibuprofen 200 mg?

There is no single Orange Book patent estate covering all ibuprofen 200 mg OTC products. The Orange Book primarily records FDA-approved drug products, therapeutic-equivalence evaluations, and patent or exclusivity information associated with approved applications.[7]

A conventional ibuprofen 200 mg product marketed under the OTC monograph is generally not dependent on an NDA patent listing. It therefore does not present the same Paragraph IV framework as a patented prescription NDA product.

Legal issue	Conventional ibuprofen 200 mg OTC product
Active ingredient patent	Expired
NDA exclusivity	Generally not applicable to monograph products
Orange Book listing	Usually absent for monograph-only products
Paragraph IV filing	Generally not required for monograph entry
Formulation patent risk	Possible for specific products or technologies
Trademark risk	Relevant for branded products
Trade dress risk	Relevant for packaging and appearance
Regulatory barrier	Compliance with monograph, labeling, cGMP, and facility requirements

When does ibuprofen 200 mg lose exclusivity?

Ibuprofen lost active-ingredient exclusivity decades ago. There is no remaining composition-of-matter exclusivity for ordinary racemic ibuprofen 200 mg.

Commercial exclusivity can still arise from other sources:

• Brand recognition.
• Retail shelf placement.
• Private-label contracts.
• Packaging design.
• Consumer loyalty.
• Manufacturing cost.
• Delivery technology.
• Product-specific patents.
• Regulatory data associated with a novel approved product.
• Distribution agreements.

Those forms of commercial advantage do not create a universal barrier to entry. A compliant manufacturer can generally enter the ordinary OTC ibuprofen 200 mg market without waiting for an active-ingredient patent expiration.

Are there Paragraph IV challenges for ibuprofen 200 mg?

Paragraph IV litigation is not the normal entry mechanism for a standard OTC monograph ibuprofen product. Paragraph IV certifications apply to an ANDA applicant challenging listed patents associated with a reference listed drug.[7]

The practical entry routes are:

1. OTC monograph compliance for an eligible product.
2. ANDA submission for a product referencing an approved prescription or OTC application.
3. NDA or 505(b)(2) development for a differentiated formulation or delivery system.
4. Private-label manufacture under a contract arrangement.

A company developing a new softgel, liquid, pediatric formulation, or rapid-release product should evaluate both monograph compliance and the possibility that a branded or innovator product has application-specific patents.

What manufacturing and IP barriers affect ibuprofen 200 mg?

Ibuprofen is inexpensive as a bulk active ingredient, but manufacturing economics are sensitive to scale and quality control. Key barriers include:

Manufacturing barriers

• Particle-size control.
• Powder segregation.
• Tablet sticking and picking.
• Granulation consistency.
• Dissolution variability.
• Cross-contamination control.
• High-throughput coating.
• Softgel encapsulation yield.
• Liquid suspension uniformity.
• Child-resistant packaging.
• Stability through the labeled shelf life.

Intellectual-property barriers

• Rapid-release compositions.
• Solubilizing systems.
• Specific softgel fills.
• Taste-masking technologies.
• Combination products.
• Pediatric delivery devices.
• Manufacturing processes.
• Product-specific patents held by brand manufacturers.

The lowest-risk entry is usually a standard immediate-release tablet or caplet using well-established excipients. The highest-margin opportunities generally require greater investment in formulation, clinical or comparative evidence, regulatory work, and patent clearance.

What commercial opportunities exist for ibuprofen 200 mg?

Private-label and retailer products

The largest volume opportunity is retailer-branded ibuprofen 200 mg. The product can compete on:

• Unit price.
• Tablet count.
• Packaging format.
• Retailer exclusivity.
• Club-store bulk packs.
• E-commerce multipacks.
• Pharmacist or healthcare-channel distribution.

Margin depends more on procurement, packaging, and distribution than on the active ingredient.

Softgels and liquid-filled capsules

Softgels support premium pricing and a clear consumer distinction from standard tablets. They are attractive for adult users seeking easy swallowing and for brand owners seeking product-line segmentation.

Fast-dissolving and easy-swallow tablets

A smaller tablet, orally disintegrating product, or rapidly dispersing tablet can target consumers who have difficulty swallowing conventional caplets. The commercial claim must remain consistent with the evidence and permitted labeling.

Pediatric oral suspension

Pediatric liquid products create differentiation through:

• Flavor.
• Taste masking.
• Dose-measuring accuracy.
• Sugar-free formulation.
• Alcohol-free formulation.
• Concentration options.
• Dosing syringe compatibility.
• Stable suspension behavior.

Pediatric formulations have higher formulation and labeling complexity. Taste masking is often the main excipient challenge because ibuprofen has a strong, persistent taste.

Chewable products

Chewables can target families and consumers who cannot swallow tablets. They require robust taste masking, acceptable mouthfeel, controlled tablet hardness, and packaging that limits accidental pediatric exposure.

Combination products

Potential combinations include ibuprofen with acetaminophen, decongestants, antihistamines, or other OTC actives. These products have a larger addressable use case but carry greater risks from:

• Duplicate active ingredients.
• Consumer dosing errors.
• Drug-drug interactions.
• Expanded labeling.
• Combination-product patents.
• More complex stability programs.
• Greater regulatory scrutiny.

Geographic expansion

The United States is governed by the FDA monograph and application system. Other markets use different requirements for NSAID classification, dose limits, pediatric labeling, excipient permissions, and prescription status.

Key regional issues include:

Market	Commercial consideration
United States	OTC monograph compliance, Drug Facts labeling, cGMP, facility registration
European Union	National or decentralized authorization, country-specific OTC classification
United Kingdom	MHRA requirements and pharmacy or general-sale classification
Canada	Health Canada submission and nonprescription labeling
Australia	TGA requirements and scheduled medicine classification
Emerging markets	Local registration, import controls, price sensitivity, and distributor dependence

An excipient acceptable in the United States may require separate justification or have different limits elsewhere.

How strong is the ibuprofen 200 mg patent estate?

The patent estate is weak for standard immediate-release ibuprofen 200 mg tablets. It is stronger only where a product uses differentiated technology.

Product type	Patent risk	Commercial differentiation
Standard compressed tablet	Low	Low
Film-coated caplet	Low	Low to moderate
Conventional softgel	Moderate	Moderate
Solubilized softgel	Moderate to high	High
Pediatric suspension	Moderate	Moderate to high
Taste-masked chewable	Moderate	Moderate
Rapid-release formulation	Moderate to high	High
Ibuprofen combination product	Moderate to high	High
Modified-release ibuprofen	High	High, but less aligned with standard OTC use

Patent strength should be assessed claim by claim. Broad claims covering the active ingredient are not expected to remain enforceable. Narrow claims covering excipient concentrations, manufacturing steps, or performance characteristics may still create exposure.

What generic launch scenarios exist for ibuprofen 200 mg?

Low-cost tablet launch

This is the fastest and lowest-risk scenario. The product uses a conventional formulation, established excipients, standard packaging, and monograph-compliant labeling. Competition is intense and margins are limited.

Premium softgel launch

This requires higher capital expenditure but supports greater pricing differentiation. The main risks are capsule yield, leakage, fill stability, and patent clearance.

Pediatric platform launch

This creates a broader product family involving suspension, chewable, and dosing-device variants. It offers stronger brand differentiation but carries greater flavor, stability, packaging, and regulatory costs.

Combination-product launch

This can increase revenue per package and expand the indication set. It also increases label complexity and litigation exposure.

What revenue exposure and competitive dynamics matter?

Ibuprofen 200 mg competes with acetaminophen, naproxen sodium, aspirin, topical NSAIDs, and prescription-strength NSAIDs. The product has high consumer awareness and broad distribution, but it is exposed to:

• Retailer price compression.
• Private-label substitution.
• Commodity API pricing.
• Retailer concentration.
• Product recalls.
• NSAID safety communications.
• Packaging and labeling errors.
• Supply-chain interruptions.
• Consumer migration to combination products.

Public company disclosures generally do not isolate revenue for 200 mg ibuprofen alone. Revenue exposure should therefore be modeled by product family, brand, channel, pack size, dosage form, and geography rather than by the active ingredient alone.

Key Takeaways

• Ibuprofen 200 mg is an established OTC NSAID with expired active-ingredient patent protection.
• Standard tablets face low patent risk but intense price competition.
• Excipient strategy should focus on wetting, disintegration, dissolution, taste, stability, and manufacturability.
• Softgels, pediatric suspensions, chewables, fast-dissolving tablets, and combination products offer the strongest differentiation.
• Conventional monograph products generally do not rely on Paragraph IV litigation or Orange Book patent listings.
• Product-specific formulation and manufacturing patents can still affect premium delivery systems.
• The most attractive commercial opportunities combine formulation differentiation with private-label, retail, e-commerce, or geographic distribution advantages.
• The principal risks are regulatory noncompliance, dissolution failure, excipient incompatibility, packaging defects, NSAID labeling exposure, and narrow formulation patents.

FAQs About Ibuprofen 200 mg Excipient Strategy

Which excipient improves ibuprofen tablet dissolution most effectively?

A combination of a wetting agent and a rapid disintegrant is generally more effective than either approach alone. Performance depends on particle size, compression force, lubricant level, and tablet porosity.

Can ibuprofen 200 mg be formulated as an orally disintegrating tablet?

Yes. The formulation must address taste, dose loading, tablet friability, moisture sensitivity, mouthfeel, and dissolution. Taste masking is usually the principal development challenge.

Is ibuprofen 200 mg suitable for a liquid-filled softgel?

Yes. A softgel can use a liquid or semisolid fill designed to improve dispersion and swallowing. Fill-shell compatibility, leakage, stability, and manufacturing yield require focused development work.

Does an ibuprofen 200 mg product require an ANDA?

Not necessarily. An eligible OTC product may be marketed under the applicable OTC monograph. An ANDA may be relevant when the product references an approved drug application rather than relying solely on monograph compliance.

What is the main commercial advantage of a new ibuprofen 200 mg formulation?

The main advantage is product differentiation. Faster dissolution, easier swallowing, pediatric acceptability, improved taste, convenient dosing, or a premium dosage form can support pricing and channel access that a basic tablet cannot secure.

References

1. U.S. Food and Drug Administration. (n.d.). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-343

2. U.S. Food and Drug Administration. (2024). Drug facts labeling for nonprescription human drug products. https://www.fda.gov/drugs/understanding-over-counter-medicines/drug-facts-label

3. DailyMed. (n.d.). Advil ibuprofen tablet, coated: Label information. National Library of Medicine. https://dailymed.nlm.nih.gov/

4. DailyMed. (n.d.). Ibuprofen liquid-filled capsule: Label information. National Library of Medicine. https://dailymed.nlm.nih.gov/

5. U.S. Food and Drug Administration. (n.d.). Inactive Ingredient Database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

6. United States Patent and Trademark Office. (1968). U.S. Patent No. 3,385,886, substituted phenyl propionic acid compounds. https://patents.google.com/patent/US3385886

7. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book