Share This Page
List of Excipients in Branded Drug BASIC CARE ACID REDUCER 75
✉ Email this page to a colleague
Generic Drugs Containing BASIC CARE ACID REDUCER 75
| Company | Ingredient | NDC | Excipient |
|---|---|---|---|
| L Perrigo Company | ranitidine | 0113-7876 | CELLULOSE, MICROCRYSTALLINE |
| L Perrigo Company | ranitidine | 0113-7876 | D&C YELLOW NO. 10 |
| L Perrigo Company | ranitidine | 0113-7876 | FD&C BLUE NO. 2 |
| L Perrigo Company | ranitidine | 0113-7876 | FD&C RED NO. 40 |
| L Perrigo Company | ranitidine | 0113-7876 | HYPROMELLOSES |
| L Perrigo Company | ranitidine | 0113-7876 | MAGNESIUM STEARATE |
| L Perrigo Company | ranitidine | 0113-7876 | TITANIUM DIOXIDE |
| >Company | >Ingredient | >NDC | >Excipient |
What are the Most Frequently-Used Excipients in BASIC CARE ACID REDUCER 75?
| # Of NDCs | Excipient |
|---|---|
| 1 | CELLULOSE, MICROCRYSTALLINE |
| 1 | D&C YELLOW NO. 10 |
| 1 | FD&C BLUE NO. 2 |
| 1 | FD&C RED NO. 40 |
| 1 | HYPROMELLOSES |
| 1 | MAGNESIUM STEARATE |
| 1 | TITANIUM DIOXIDE |
| ># Of NDCs | >Excipient |
Basic Care Acid Reducer 75: Excipient Strategy and Commercial Opportunities
Basic Care Acid Reducer 75 is a 75-tablet over-the-counter famotidine product, positioned as a low-cost acid reducer for occasional heartburn. The commercial opportunity is primarily in formulation robustness, swallowability, packaging, retailer economics, and differentiated delivery formats rather than in active-ingredient patent protection. Famotidine is an established H2-receptor antagonist with extensive generic and OTC competition.
What is Basic Care Acid Reducer 75?
Basic Care Acid Reducer 75 is generally marketed as famotidine acid reducer tablets in a 75-count package. The number "75" refers to the package count, not the famotidine dose.
| Attribute | Product characterization |
|---|---|
| Brand | Basic Care |
| Product type | OTC acid reducer |
| Likely active ingredient | Famotidine |
| Typical OTC strengths | 10 mg or 20 mg per tablet |
| Package configuration | 75 tablets |
| Therapeutic class | Histamine-2 receptor antagonist |
| Primary indication | Relief and prevention of heartburn |
| Dosage form | Immediate-release oral tablet |
| Commercial positioning | Store-brand or value-priced OTC product |
| Regulatory pathway | OTC labeling and applicable FDA monograph framework, depending on the marketed formulation |
The exact active strength and inactive-ingredient list should be confirmed against the product’s current Drug Facts label and National Drug Code listing before a formulation, substitution, or licensing decision.
What excipients are important in famotidine tablets?
The core excipient strategy for a conventional famotidine tablet is low-cost direct compression or wet granulation with sufficient mechanical strength, rapid disintegration, and acceptable taste.
Functional excipient categories
| Function | Candidate excipient classes | Commercial purpose |
|---|---|---|
| Diluent | Microcrystalline cellulose, lactose, dibasic calcium phosphate, mannitol | Controls tablet weight, flow, and compression |
| Binder | Pregelatinized starch, povidone, hydroxypropyl cellulose | Improves granule and tablet strength |
| Disintegrant | Croscarmellose sodium, crospovidone, sodium starch glycolate | Supports rapid breakup after ingestion |
| Lubricant | Magnesium stearate, sodium stearyl fumarate | Prevents sticking and improves ejection |
| Glidant | Colloidal silicon dioxide | Improves powder flow |
| Film former | Hypromellose, polyvinyl alcohol | Controls appearance, handling, and moisture exposure |
| Opacifier or colorant | Titanium dioxide alternatives, iron oxides, permitted FD&C colors | Supports product identification and branding |
| Sweetener or flavor | Sucralose, mannitol, flavor systems | Relevant to chewable or orally disintegrating products |
Famotidine is typically formulated as a low-dose immediate-release tablet. The formulation challenge is therefore less about loading a large quantity of active ingredient and more about content uniformity, powder flow, compactability, disintegration, and stability.
How should an excipient strategy address famotidine stability?
Famotidine tablet development should prioritize moisture control, chemical compatibility, and reproducible dissolution.
Moisture management
Moisture-sensitive excipients and packaging choices can affect tablet hardness, disintegration, and assay stability. A formulation program should evaluate:
- Water activity and residual moisture after granulation
- Moisture uptake during accelerated stability testing
- Compatibility of famotidine with lactose, starches, and superdisintegrants
- Impact of coating systems on dissolution
- Bottle versus blister packaging
- Desiccant requirements for high-humidity markets
High-barrier blister packaging can support premium positioning, while a high-density polyethylene bottle with an induction seal is usually more compatible with low-cost 75-count retail packaging.
Compatibility screening
Early compatibility studies should compare famotidine with:
- Lactose and other reducing sugars
- Starch-based binders
- Cellulosic fillers
- Polyols such as mannitol
- Lubricants and glidants
- Colorants and coating polymers
Differential scanning calorimetry, infrared spectroscopy, powder X-ray diffraction, assay, related substances, dissolution, and moisture uptake testing can identify risks before scale-up.
Dissolution and disintegration
A conventional famotidine tablet should provide rapid disintegration and consistent dissolution across commercial batches. Excess lubricant, overcompression, excessive coating weight, or high binder concentration can delay release. The development target should be a robust operating range rather than a single laboratory result.
What formulation opportunities exist for Basic Care Acid Reducer 75?
The strongest commercial opportunities are dosage-form extensions that improve convenience without creating unnecessary regulatory or manufacturing complexity.
Chewable famotidine tablets
Chewable tablets could address consumers who prefer rapid administration without water. The formulation would require:
- Taste masking
- Reduced chalkiness
- Adequate chewability
- Controlled friability
- Sweetener and flavor compatibility
- Packaging that limits moisture and odor transfer
Mannitol, xylitol, sorbitol, or compressible sugar systems can support mouthfeel, but polyols may create gastrointestinal tolerability considerations at higher exposure. Taste-masking coatings or ion-exchange approaches may increase cost and process complexity.
Orally disintegrating tablets
An orally disintegrating tablet could differentiate the product through convenience. The main technical barriers are mechanical fragility, moisture sensitivity, packaging cost, and taste. Unit-dose blister packaging would likely be preferable to a multidose bottle.
This format could support a higher retail price, but the incremental value must offset:
- Specialized tablet tooling
- More stringent packaging
- Higher rejection risk from friability
- Taste-masking requirements
- Potentially slower manufacturing throughput
Film-coated tablets
A thin film coat can improve appearance, swallowability, product identification, and protection from handling damage. It is the lowest-risk extension of a standard immediate-release tablet.
The coating should not materially delay dissolution. Color and imprinting can support counterfeit deterrence and retailer brand differentiation.
Combination products
Combination acid-reducer products could pair famotidine with an antacid such as calcium carbonate or magnesium hydroxide. These products may provide distinct mechanisms, but they introduce additional formulation and regulatory constraints:
- Increased tablet size
- Mineral-active compatibility issues
- Different dissolution behavior
- More complex Drug Facts labeling
- Broader adverse-effect and interaction language
- Potentially higher manufacturing and testing costs
A combination product should be evaluated as a separate regulatory and commercial program rather than as a simple line extension.
What manufacturing and intellectual-property barriers affect the product?
Famotidine itself is generic and widely available. The principal barriers are operational rather than patent-based.
Manufacturing barriers
A commercial manufacturer must control:
- Active-ingredient particle-size distribution
- Blend uniformity
- Tablet weight and hardness
- Disintegration and dissolution
- Lubrication time
- Coating uniformity
- Packaging-line performance
- Stability under retail distribution conditions
A 75-count bottle is operationally attractive because it fits standard OTC packaging equipment and supports a value proposition between small travel packs and larger family-size packages.
Intellectual-property position
Basic Care Acid Reducer 75 is unlikely to depend on a blocking composition-of-matter patent for famotidine. Potentially protectable elements could include:
- A novel taste-masking system
- A specific chewable matrix
- A moisture-protective dosage form
- A manufacturing process
- A specialized combination formulation
- Packaging or dispensing technology
Routine use of common tablet excipients is unlikely to create meaningful patent exclusivity. Any new formulation patent would need claims that distinguish over the extensive famotidine generic and OTC prior art.
What is the FDA and Orange Book status of Basic Care Acid Reducer 75?
Famotidine OTC products are generally marketed under FDA OTC requirements rather than through a product-specific exclusivity strategy. OTC monograph products do not receive the same Orange Book patent-listing framework as prescription NDA products.
The relevant compliance issues are:
- Use of the permitted active ingredient and dosage
- Compliant Drug Facts labeling
- Required warnings and directions
- Manufacturing under current good manufacturing practice
- Product listing and NDC obligations
- Stability and quality-system controls
- Advertising claims consistent with the authorized labeling
The product’s specific regulatory status depends on its active strength, manufacturer, label version, and current FDA listing. Retailer private-label status does not itself create regulatory exclusivity.
How strong is the patent estate for famotidine?
The patent estate for ordinary immediate-release famotidine tablets is commercially weak because the active ingredient and basic dosage form are mature and broadly available.
| Patent category | Likely commercial strength |
|---|---|
| Famotidine composition of matter | Low for new entrants because the molecule is long established |
| Conventional immediate-release tablet | Low |
| Standard film coating | Low |
| Common excipient combination | Low |
| Novel chewable formulation | Moderate if supported by unexpected performance |
| Taste-masked formulation | Moderate, depending on claim breadth and prior art |
| Orally disintegrating formulation | Moderate to potentially strong if technically differentiated |
| Combination acid reducer | Variable |
| Manufacturing process | Moderate if process-specific and difficult to design around |
| Packaging system | Usually low unless the system has a specific technical function |
Freedom-to-operate work should focus on formulation patents, process patents, and branded combination products rather than on basic famotidine composition claims.
What generic launch risks exist for Basic Care Acid Reducer 75?
The product has low conventional generic-entry risk because it is already positioned as an OTC store-brand product. Its main commercial risks are price erosion, retailer replacement, supply interruption, and private-label competition.
Key competitive pressures
- National brands such as Pepcid
- Retailer-owned famotidine products
- Amazon and e-commerce private labels
- Pharmacy-chain store brands
- Club-store multipacks
- Chewable and combination acid reducers
- Proton-pump inhibitor products for longer-duration acid control
A competing manufacturer can usually enter with a conventional famotidine tablet using established excipients and contract manufacturing capacity. Differentiation must therefore come from price, availability, packaging, dosage form, or retailer-specific execution.
What licensing and commercial opportunities exist?
The most practical opportunities are contract manufacturing, private-label supply, formulation licensing, and packaging differentiation.
Contract manufacturing
A manufacturer with existing OTC tablet capacity could supply:
- 10 mg famotidine tablets
- 20 mg famotidine tablets
- 75-count bottles
- Blister packs
- Club-size packages
- Retailer-specific colors and imprints
The value proposition depends on low conversion cost, validated cleaning procedures, reliable API supply, and the ability to meet retailer service levels.
Formulation licensing
A licensable technology would need to offer a measurable advantage, such as:
- Better taste masking
- Faster disintegration
- Improved humidity stability
- Smaller tablet size
- Reduced coating cost
- Improved chewability
- Lower packaging requirements
A patent license is more defensible when the technology produces a performance benefit that can be verified in comparative dissolution, stability, sensory, or manufacturing studies.
Packaging opportunities
Packaging can create commercial differentiation without changing the active ingredient:
- Child-resistant easy-open bottles
- Unit-dose travel blisters
- High-barrier packs for humid climates
- Senior-friendly large-print labeling
- Recyclable packaging
- Multi-pack formats for e-commerce
- Tamper-evident dispensing systems
Packaging changes may require label, component, stability, and production-line validation but generally present less formulation risk than a new dosage form.
How does Basic Care Acid Reducer 75 compare with competing products?
| Product segment | Primary advantage | Main limitation | Excipient opportunity |
|---|---|---|---|
| Standard famotidine tablet | Lowest cost and simple manufacturing | Limited differentiation | Optimize compression, disintegration, and coating |
| Branded famotidine | Consumer recognition | Higher price | Match quality at lower cost |
| Chewable famotidine | Convenience and no-water use | Taste and texture challenges | Flavor, sweetener, and mouthfeel design |
| Combination antacid/famotidine | Multiple mechanisms | Larger formulation and label burden | Compatibility and dissolution control |
| Proton-pump inhibitor | Longer acid suppression | Different onset and use profile | Capsule, granule, or enteric systems |
| Blister-pack famotidine | Portability and dose protection | Higher packaging cost | Barrier films and retail-ready design |
Key Takeaways
- Basic Care Acid Reducer 75 is a value-oriented 75-tablet famotidine product.
- The principal opportunity is formulation and packaging optimization, not active-ingredient patent exclusivity.
- Conventional immediate-release tablets have low barriers to entry.
- Chewable and orally disintegrating formats offer the clearest differentiation but require taste, moisture, and mechanical-strength solutions.
- A robust excipient system should balance rapid disintegration, content uniformity, tablet strength, low cost, and stability.
- Commercial success depends on retailer economics, reliable supply, packaging efficiency, and price positioning.
- Any licensing strategy should focus on demonstrable formulation or manufacturing advantages rather than routine excipient combinations.
FAQs
Is Basic Care Acid Reducer 75 a prescription drug?
No. It is marketed as an OTC famotidine acid-reducer product.
Does the number 75 indicate a 75 mg famotidine dose?
No. The number generally indicates 75 tablets in the package. The active strength must be confirmed from the current Drug Facts label.
Can a manufacturer substitute excipients in the product?
A manufacturer may develop an alternative excipient system, but it must demonstrate that the finished product meets applicable identity, strength, quality, stability, dissolution, labeling, and manufacturing requirements.
Are famotidine tablets protected by active pharmaceutical ingredient patents?
Ordinary famotidine tablets are generally not protected by commercially significant new-molecule patent exclusivity. New formulation, process, or combination-product claims may create narrower protection.
What is the highest-value formulation opportunity?
A taste-masked chewable or orally disintegrating famotidine product has the strongest potential for differentiation, provided the added manufacturing and packaging costs are supported by a higher retail price or stronger retailer placement.
References
-
U.S. Food and Drug Administration. (n.d.). Drug Facts labeling for over-the-counter human drug products. FDA.
-
U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.
-
U.S. Food and Drug Administration. (n.d.). Current good manufacturing practice regulations for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. FDA.
-
U.S. Food and Drug Administration. (n.d.). Famotidine OTC labeling and product listing information. FDA.
More… ↓
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
Visit the Subscription Options page for details on plans and pricing.
ISSN: 2162-2639

Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Generic Entry Opportunies 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Access the Complete Database
Deeper Knowledge, Faster
- Analyze global market entry opportunities
- Uncover prior art in expired and abandoned patents
- Obtain formulation and manufacturing information