List of Excipients in Branded Drug IBUPROFEN 200 MG

« Back to Dashboard

Generic Drugs Containing IBUPROFEN 200 MG

Company	Ingredient	NDC	Excipient
Allegiant Health	ibuprofen	69168-368	AMMONIA
Allegiant Health	ibuprofen	69168-368	FD&C GREEN NO. 3
Allegiant Health	ibuprofen	69168-368	FERROSOFERRIC OXIDE
Allegiant Health	ibuprofen	69168-368	GELATIN

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

# Of NDCs	Excipient
1	AMMONIA
1	CELLULOSE, MICROCRYSTALLINE
1	FD&C GREEN NO. 3
1	FD&C YELLOW NO. 6

Ibuprofen 200 mg Excipient Strategy and Commercial Opportunities

Last updated: November 5, 2026

Ibuprofen 200 mg is a mature, highly competitive OTC analgesic with low API cost, broad consumer recognition, and minimal remaining composition-of-matter patent risk. Commercial value depends on formulation performance, manufacturing efficiency, dosage-form differentiation, and regulatory positioning rather than exclusivity.

The strongest opportunities are fast-disintegrating tablets, softgels, liquid-filled capsules, pediatric liquids, orally disintegrating products, lower-irritation formulations, and private-label products with improved packaging and supply economics. The primary technical challenge is ibuprofen’s low aqueous solubility, which affects dissolution, onset perception, content uniformity, and liquid formulation feasibility.

What is the regulatory status of ibuprofen 200 mg in the United States?

Ibuprofen 200 mg is an FDA-recognized OTC active ingredient for temporary relief of minor aches and pains and reduction of fever. The applicable framework is the OTC monograph for internal analgesic, antipyretic, and antirheumatic drug products under 21 C.F.R. § 343. Ibuprofen is permitted at 200 mg per dosage unit for adults and children 12 years and older, subject to labeled dosing limits and warnings.[1]

Regulatory element	United States position
Active ingredient	Ibuprofen
Common strength	200 mg per tablet, capsule, or equivalent unit
OTC indication	Temporary relief of minor aches and pains and fever reduction
Typical adult dose	200 mg to 400 mg every 4 to 6 hours
Daily OTC limit	1,200 mg unless directed by a physician
Primary pathway	OTC monograph compliance or approved NDA/ANDA where applicable
Prescription-strength products	Commonly 400 mg, 600 mg, and 800 mg tablets
Main dosage forms	Tablets, caplets, softgels, liquid-filled capsules, suspensions
Pediatric market	Oral suspensions and chewable products, with age-based dosing

The FDA’s Drug Facts labeling requirements control active-ingredient declarations, uses, warnings, directions, and inactive-ingredient disclosure.[2] A 200 mg product using an allowable dosage form and compliant labeling may compete without obtaining product-specific marketing exclusivity.

FDA’s Inactive Ingredient Database is used as a benchmark for excipient precedent, although presence in the database does not automatically establish approval for every route, dosage form, or concentration.[3]

When does ibuprofen 200 mg lose exclusivity?

Ibuprofen’s fundamental small-molecule exclusivity has expired. The product is available from multiple generic manufacturers, private-label suppliers, and branded OTC companies. The original commercial products, including Motrin and Advil, do not have a defensible composition-of-matter monopoly over ibuprofen 200 mg.

The commercial position is therefore different from a recently approved prescription drug:

Exclusivity category	Position for ibuprofen 200 mg
Composition-of-matter patent	Expired
Basic 200 mg tablet protection	No meaningful market-wide exclusivity
OTC monograph access	Available if requirements are met
Brand protection	Trademark and trade dress only
Formulation patents	May exist for specific technologies, but generally do not block conventional tablets
Method-of-use patents	Limited practical relevance for routine OTC analgesic labeling
Regulatory exclusivity	No current product-wide exclusivity for conventional ibuprofen 200 mg
Biosimilar protection	Not applicable

A new entrant should treat ibuprofen 200 mg as an open market with potential formulation-specific intellectual property, not as a patent-protected pharmaceutical franchise.

What patents protect ibuprofen 200 mg products?

Conventional ibuprofen 200 mg products generally lack commercially meaningful blocking patent protection. Patent risk may still arise from narrow claims covering:

• Liquid-filled capsules;
• Solubilized or supersaturated ibuprofen compositions;
• Rapid-release or fast-onset dosage forms;
• Taste-masked pediatric suspensions;
• Multiparticulate or coated granules;
• Combination products;
• Specific manufacturing processes;
• Specialized packaging or delivery systems.

The relevant question is whether a third-party patent claims the proposed formulation, process, or delivery system. A patent directed to a fast-dissolving ibuprofen composition may not affect a conventional compressed tablet using standard excipients.

What is the Orange Book status of ibuprofen 200 mg?

The Orange Book is not the primary competitive registry for ordinary OTC monograph ibuprofen products. Products marketed under the OTC monograph do not rely on the same Orange Book listing framework used for approved prescription drugs and abbreviated new drug applications.

An applicant should distinguish between:

1. Conventional OTC monograph products;
2. Prescription ibuprofen products approved under an NDA;
3. Combination products;
4. Drug-device or novel delivery products requiring an approved application.

For routine 200 mg OTC tablets, the main compliance questions are monograph conformity, current good manufacturing practice, labeling, quality control, and product listing. Orange Book patent certification analysis is generally less central than it is for patented prescription products.

What excipients are used in ibuprofen 200 mg tablets?

A conventional ibuprofen tablet typically uses a diluent, binder, disintegrant, lubricant, glidant, and film-coating system. The selection depends on direct compression versus wet granulation, target hardness, dissolution performance, tablet size, and cost.

Excipient function	Common candidates	Commercial purpose
Diluent	Microcrystalline cellulose, lactose, dibasic calcium phosphate, starch	Adds bulk and supports compression
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone, sodium starch glycolate	Promotes tablet breakup
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces ejection force and tooling adhesion
Glidant	Colloidal silicon dioxide, talc	Improves powder flow
Surfactant or wetting aid	Sodium lauryl sulfate, poloxamer	Improves wetting and dissolution
Film former	Hypromellose, polyvinyl alcohol	Provides coating and appearance
Plasticizer	Polyethylene glycol, triacetin	Improves coating flexibility
Opacifier	Titanium dioxide where permitted, calcium carbonate	Controls appearance and light protection
Colorant	Approved lakes, iron oxides, soluble dyes	Brand differentiation and identification

Ibuprofen is a weak acid with low water solubility at low pH. It has a melting point near 75 to 78°C and can exhibit poor powder flow, sticking, and compression sensitivity depending on particle size and grade.[4] The formulation must balance mechanical strength against rapid disintegration.

How should excipients address ibuprofen’s poor solubility?

The most commercially practical strategy is to improve wetting and dispersion rather than attempt full molecular solubilization in a conventional tablet.

Useful approaches include:

• Reducing API particle size;
• Using a wetting agent at a justified concentration;
• Selecting a highly wicking disintegrant;
• Using porous or silicified microcrystalline cellulose;
• Applying wet granulation to improve distribution;
• Using solid dispersion or amorphous systems for premium products;
• Using alkalinizing agents where formulation stability and tolerability permit;
• Designing a rapidly disintegrating tablet with high surface area.

A surfactant can improve dissolution but may introduce taste, foaming, irritation, or compatibility issues. Sodium lauryl sulfate is effective at low levels in some immediate-release systems, but the final formulation requires dissolution, impurity, stability, and gastrointestinal tolerability evaluation.

Crospovidone often supports rapid liquid uptake without producing excessive gel formation. Croscarmellose sodium can provide strong swelling and breakup, although its performance depends on intra- versus extra-granular placement. Sodium starch glycolate may deliver substantial swelling but can be sensitive to overcompression and formulation viscosity.

What formulation strategy is best for an ibuprofen 200 mg tablet?

The most defensible base platform is an immediate-release tablet designed around rapid disintegration, robust content uniformity, and low manufacturing cost.

Conventional direct-compression platform

A direct-compression formula can use:

• Ibuprofen API;
• Microcrystalline cellulose or co-processed filler;
• Crospovidone or croscarmellose sodium;
• Colloidal silicon dioxide;
• Magnesium stearate;
• Film coating.

This approach minimizes processing steps and can support high-volume private-label production. Its limitations are API flow, segregation, poor compressibility, and possible sticking.

Wet-granulated platform

Wet granulation is more suitable where the API has poor flow or where content uniformity is difficult to control. Povidone or pregelatinized starch can improve granule strength and reduce segregation.

The disadvantages are higher capital and operating costs, greater process complexity, and increased exposure to moisture and heat. Ibuprofen’s low melting point also requires control of drying and compression conditions.

Co-processed excipient platform

Co-processed fillers can improve flow, compactability, and disintegration while reducing formulation development time. They may be commercially attractive for a contract manufacturer serving multiple OTC customers. The tradeoff is higher excipient cost and potential dependence on a single supplier.

Fast-disintegrating platform

A fast-disintegrating tablet can support a premium claim such as rapid breakup or easier swallowing, provided the claim is supported by appropriate testing and does not imply an unsubstantiated faster clinical onset. The formulation should emphasize:

• Low tablet hardness sufficient for rapid breakup;
• High-wicking disintegrant;
• Low hydrophobic lubricant load;
• Controlled tablet porosity;
• Moisture-protective packaging.

What excipients are appropriate for ibuprofen softgels and liquid-filled capsules?

Softgels and liquid-filled hard capsules offer a strong differentiation opportunity because they change the consumer experience and can improve dispersion of the API.

Typical liquid vehicles include medium-chain triglycerides, polyethylene glycol, propylene glycol, and other pharmaceutically acceptable solvents or suspending vehicles. Ibuprofen may be dissolved, partially dissolved, or suspended depending on the vehicle and concentration.

Liquid-filled approach	Advantages	Main risks
Solution fill	Uniform appearance and rapid dispersion	Solubility, precipitation, shell compatibility
Suspension fill	Higher API loading and broader vehicle options	Sedimentation, content uniformity, viscosity
Self-emulsifying system	Improved wetting and dispersion	Surfactant tolerability and stability
PEG-based fill	Solvent capacity and processing flexibility	Shell migration, brittleness, moisture interaction
Oil-based fill	Good shell compatibility in some systems	Limited ibuprofen solubility and slower release

Softgel products can command higher retail prices than standard tablets, but they require specialized encapsulation, leak testing, shell formulation, and packaging. Gelatin shell systems may be less attractive for vegetarian or religiously restricted markets. Hypromellose capsules and plant-based softgel alternatives can expand market access but may increase cost and process complexity.

What formulations are protected by ibuprofen patents?

Potentially protectable formulation categories include:

1. Rapid-release systems. Claims may cover particle size, surfactant content, disintegration time, dissolution profile, or a specific excipient ratio.

2. Solubilized ibuprofen. Claims may cover cyclodextrin complexes, alkalinized systems, co-solvent systems, or amorphous dispersions.

3. Pediatric formulations. Claims may cover taste-masking particles, suspension stabilizers, sweetener systems, and dosing devices.

4. Combination products. Ibuprofen combined with acetaminophen, caffeine, antihistamines, decongestants, or other actives may have separate formulation and method-of-use rights.

5. Delivery technologies. Chewable, orally disintegrating, buccal, effervescent, and multiparticulate systems may create narrower patent estates.

Patent value depends on claim breadth, remaining term, geographic scope, prosecution history, and evidence that the product would practice the claims. A formulation patent with a narrow excipient ratio may be avoidable through reformulation.

What generic entry risks exist for ibuprofen 200 mg?

Generic-entry risk is already realized for conventional ibuprofen products. The principal commercial threat is price erosion rather than a future Paragraph IV event.

How relevant are Paragraph IV challenges?

Paragraph IV litigation is more relevant to approved prescription products and patented formulations than to conventional OTC monograph ibuprofen 200 mg. A Paragraph IV certification could arise where an applicant relies on an approved application containing listed patents, but it is not the normal route for a standard OTC monograph product.

For a new branded formulation, the key risks are:

• Design-around by private-label manufacturers;
• Rapid copying of non-patented excipient choices;
• Retailer substitution;
• Contract manufacturing capacity;
• Price competition from store brands;
• Consumer switching between tablets, caplets, and softgels.

The most defensible protection usually combines formulation patents, trademarks, distinctive packaging, manufacturing know-how, and distribution agreements.

Which companies are competing in ibuprofen 200 mg?

The market includes branded OTC suppliers, generic drug manufacturers, private-label retailers, and contract manufacturers. Major consumer brands include Advil, Motrin, and store-brand equivalents. Generic and private-label supply is fragmented, with products manufactured by companies such as Perrigo, Haleon-related supply networks, and other FDA-registered manufacturers depending on the product and market period.

Competition is based on:

• Retail price;
• Tablet count;
• Softgel availability;
• Perceived onset;
• Pediatric dosing;
• Package design;
• Retailer placement;
• Supply reliability;
• Claims such as coated, easy-to-swallow, or fast-dissolving.

A new entrant is unlikely to win through API cost alone. The better opportunities are retailer-specific packaging, e-commerce multipacks, travel sizes, subscription formats, and premium dosage forms.

How does ibuprofen 200 mg compare with acetaminophen 500 mg?

Ibuprofen and acetaminophen compete directly in OTC pain and fever categories but have different technical and regulatory profiles.

Factor	Ibuprofen 200 mg	Acetaminophen 500 mg
Drug class	NSAID	Non-NSAID analgesic and antipyretic
Anti-inflammatory activity	Yes	Limited
Key safety concern	Gastrointestinal, renal, cardiovascular risks	Hepatotoxicity at excessive exposure
Solubility challenge	Significant	Generally easier to formulate
Typical dosage form	Tablet, caplet, softgel, suspension	Tablet, caplet, gelcap, liquid
Excipient opportunity	Dissolution and wetting improvement	Swallowability, taste masking, rapid disintegration
Consumer positioning	Pain, fever, inflammation	Pain and fever
Patent barrier for basic OTC unit	Low	Low

Ibuprofen has a stronger technical rationale for wetting agents, particle engineering, and liquid-filled delivery systems. Acetaminophen may have a simpler low-cost tablet platform, although high-dose tablets can create size and swallowability problems.

What are the strongest commercial opportunities for ibuprofen 200 mg?

Private-label retailer products

Retailers can launch compliant products with low development risk using conventional tablets or caplets. The commercial advantage comes from procurement, package architecture, and shelf placement.

Premium softgels

Softgels support higher price points and consumer differentiation. The product can be positioned around ease of swallowing, smooth coating, and convenient packaging.

Pediatric suspension

A flavored oral suspension creates a separate use occasion and can support dosing flexibility. Key development issues are taste masking, sedimentation, preservative strategy, microbial control, and accurate dosing-device calibration.

Fast-disintegrating or chewable tablets

These products can target consumers who have difficulty swallowing standard tablets. The formulation must control taste because ibuprofen is strongly unpleasant without effective masking.

Combination analgesics

Ibuprofen-acetaminophen combinations may offer a differentiated product, but they require more complex labeling, safety communication, dose balancing, and potentially separate regulatory analysis.

Global-market formulations

Excipient selection should account for regional restrictions on colors, titanium dioxide, gelatin, sugars, alcohol, and animal-derived materials. A hypromellose-based platform may reduce reformulation across markets, although it can raise cost.

How strong is the patent estate for ibuprofen 200 mg?

The patent estate for ordinary ibuprofen 200 mg tablets is weak. The commercial moat is stronger in manufacturing execution and brand assets than in core patent rights.

Asset	Relative strength
Ibuprofen API composition patent	None for ordinary market entry
Standard tablet formulation	Weak
Fast-release formulation	Moderate if claims are technically narrow but valid
Softgel delivery system	Moderate, depending on claim scope
Pediatric taste-masking system	Moderate
Manufacturing process	Moderate if difficult to reproduce
Trademark and packaging	Potentially strong
Retail distribution	Strong commercially, but not patent-based
Quality and supply reliability	Strong operational advantage

Manufacturing know-how may include particle-size control, granulation endpoint, lubrication time, tooling design, coating parameters, and stability packaging. These advantages are often protectable as trade secrets rather than patents.

What patent litigation and settlement issues affect ibuprofen 200 mg?

Routine OTC ibuprofen 200 mg is not generally associated with an active market-wide patent litigation program comparable to newer prescription drugs. Litigation risk is more likely to arise from:

• Combination products;
• Specific rapid-release claims;
• Trade dress;
• Trademark infringement;
• Product liability;
• Advertising substantiation;
• Contract manufacturing disputes;
• Regulatory or labeling challenges.

Settlement agreements are most relevant where a branded company has patented a specific delivery system or combination product. A conventional monograph tablet entrant should not assume that settlement precedents for patented prescription ibuprofen formulations apply to the general OTC market.

What FDA quality controls are critical for ibuprofen 200 mg?

The main quality attributes are:

• Identity and assay;
• Uniformity of dosage units;
• Dissolution;
• Disintegration;
• Tablet hardness and friability;
• Related substances and degradation products;
• Moisture;
• Microbial quality for liquids;
• Preservative content for suspensions;
• Fill weight and leakage for softgels;
• Packaging integrity.

Dissolution is the central performance metric for a standard tablet. Excipient changes that improve hardness or flow can slow release. Magnesium stearate over-lubrication can create a hydrophobic tablet surface and reduce dissolution. Excessive compression can lower porosity and delay disintegration.

Packaging should address moisture, heat, light, and mechanical damage. Blister packs can provide unit-dose protection and portability. Bottles reduce packaging cost but require desiccants, child-resistant closures where applicable, and strong count-control processes.

Key Takeaways

• Ibuprofen 200 mg is an open, mature OTC market with no meaningful composition-of-matter exclusivity.
• Conventional tablets compete primarily on cost, availability, packaging, and retailer access.
• The main formulation problem is low aqueous solubility and the resulting dissolution challenge.
• Crospovidone, croscarmellose sodium, wetting agents, particle engineering, and porous excipient systems are practical development tools.
• Softgels, liquid-filled capsules, pediatric suspensions, chewables, and fast-disintegrating tablets offer the strongest differentiation.
• Formulation patents may protect narrow delivery technologies, but they are unlikely to block ordinary compressed tablets.
• Paragraph IV litigation is generally less relevant to standard OTC monograph products than to patented prescription formulations.
• Trade secrets, manufacturing control, trademarks, packaging, and distribution can create more commercial value than patents.
• A low-cost direct-compression tablet is the fastest entry platform. A premium softgel or pediatric product has greater margin potential but higher technical and regulatory complexity.
• The best portfolio strategy is a conventional value product paired with one differentiated formulation supported by dissolution, stability, consumer-use, and packaging data.

FAQs About Ibuprofen 200 mg Excipient Strategy

What is the best disintegrant for an ibuprofen 200 mg tablet?

Crospovidone and croscarmellose sodium are strong starting candidates. The final choice depends on compression force, tablet porosity, lubricant level, dissolution target, and the selected manufacturing process.

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

Yes. The main constraints are bitter taste, tablet mechanical strength, moisture sensitivity, and the need for effective taste masking without delaying drug release.

Which excipients improve ibuprofen dissolution?

Wetting agents, high-wicking disintegrants, porous fillers, reduced API particle size, and selected solid-dispersion technologies can improve dissolution. Excessive hydrophobic lubricant can have the opposite effect.

Is a softgel ibuprofen product patentable?

A softgel is not automatically patentable. Protection may be available for a novel fill composition, solubilization system, shell interaction, release profile, or manufacturing process that satisfies patentability requirements.

What is the lowest-risk commercial launch format for ibuprofen 200 mg?

A conventional immediate-release film-coated tablet manufactured under the OTC monograph has the lowest technical and regulatory risk. It also has the highest price-competition risk and the weakest differentiation.

References

1. U.S. Food and Drug Administration. (2023). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. Electronic Code of Federal Regulations.

2. U.S. Food and Drug Administration. (2013). 21 C.F.R. Part 201: Labeling. Electronic Code of Federal Regulations.

3. U.S. Food and Drug Administration. (2024). Inactive Ingredient Database. FDA.

4. Sweetman, S. C. (Ed.). (2017). Martindale: The complete drug reference (39th ed.). Pharmaceutical Press.