ALLZITAL Drug Patent Profile
When do Allzital patents expire, and when can generic versions of Allzital launch?
Allzital is a drug marketed by Pharmobedient and is included in one NDA.
The generic ingredient in ALLZITAL is acetaminophen; butalbital. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
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Questions you can ask:
- What is the 5 year forecast for ALLZITAL?
- What are the global sales for ALLZITAL?
- What is Average Wholesale Price for ALLZITAL?
Summary for ALLZITAL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Patent Applications: | 7 |
| Drug Prices: | Drug price information for ALLZITAL |
| DailyMed Link: | ALLZITAL at DailyMed |
Pharmacology for ALLZITAL
| Drug Class | Barbiturate |
US Patents and Regulatory Information for ALLZITAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmobedient | ALLZITAL | acetaminophen; butalbital | TABLET;ORAL | 203484-001 | Dec 4, 2015 | AA | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
ALLZITAL Market Dynamics, Patent Position, and Financial Trajectory
ALLZITAL is a mature prescription combination of butalbital 25 mg, acetaminophen 325 mg, and caffeine 50 mg used for tension or muscle-contraction headaches. Its commercial position is shaped by generic competition, controlled-substance restrictions, low product differentiation, and limited public financial disclosure. The product does not have the characteristics of a protected growth asset: publicly available FDA materials do not indicate meaningful remaining market exclusivity, an active patent barrier, or a distinct biologic or delivery technology. Revenue data for ALLZITAL are not separately reported by its manufacturer.
What is ALLZITAL and who manufactures it?
ALLZITAL is an oral tablet containing:
| Component | Amount per tablet | Commercial role |
|---|---|---|
| Butalbital | 25 mg | Barbiturate muscle relaxant |
| Acetaminophen | 325 mg | Analgesic |
| Caffeine | 50 mg | Analgesic adjuvant |
The product is marketed as a prescription drug for the relief of the symptom complex of tension, or muscle-contraction, headache. The FDA labeling identifies the product as an immediate-release tablet and carries warnings associated with butalbital, acetaminophen exposure, medication-overuse headache, dependence, and withdrawal.[1]
ALLZITAL has been associated with Mikart, Inc., a U.S. pharmaceutical manufacturer and contract-development and manufacturing company. Public product materials do not establish a separately reported ALLZITAL business unit or a publicly disclosed revenue figure.
The drug is pharmacologically similar to other butalbital combination products, including Fioricet and generic butalbital, acetaminophen, and caffeine products. Its 25/325/50 mg strength differs from the commonly recognized Fioricet formulation, which generally contains butalbital 50 mg, acetaminophen 300 mg, and caffeine 40 mg.
What is the FDA regulatory status of ALLZITAL?
ALLZITAL is an FDA-approved prescription tablet listed under NDA 022208 in FDA product databases.[2] It is not a biologic, injectable drug, controlled-release formulation, or combination product dependent on a device.
FDA regulatory characteristics
| Regulatory attribute | ALLZITAL status |
|---|---|
| FDA pathway | New Drug Application |
| Dosage form | Immediate-release tablet |
| Route | Oral |
| Prescription status | Prescription only |
| Active ingredient | Butalbital, acetaminophen, caffeine |
| Biologic exclusivity | Not applicable |
| Biosimilar pathway | Not applicable |
| Generic pathway | ANDA or other applicable small-molecule pathway |
| Controlled-substance considerations | Butalbital combination products may be subject to Schedule III controls under federal law, depending on formulation and applicable classification |
The principal regulatory constraints are safety-related rather than approval-related. Butalbital creates risks of sedation, dependence, misuse, and withdrawal. Acetaminophen creates dose-related hepatotoxicity risk, especially when patients use multiple acetaminophen-containing products. These risks can restrict prescribing and reduce the product's attractiveness relative to non-barbiturate migraine therapies.
What patents protect ALLZITAL?
Publicly available FDA Orange Book information does not indicate a commercially meaningful patent estate protecting ALLZITAL's active ingredients, tablet composition, or clinical use.[3]
The product uses long-established active ingredients. Butalbital, acetaminophen, and caffeine are not novel molecular entities. The commercial formulation is a conventional immediate-release tablet rather than a complex drug-delivery system.
| Patent category | Commercial significance for ALLZITAL |
|---|---|
| Composition-of-matter patent | No meaningful remaining protection expected |
| Formulation patent | No publicly identified blocking formulation estate |
| Method-of-use patent | No publicly identified blocking method-of-use patent |
| Manufacturing patent | No publicly identified barrier to conventional manufacture |
| Pediatric exclusivity | Not identified as a current commercial barrier |
| Orphan-drug exclusivity | Not applicable |
| New chemical entity exclusivity | Not applicable |
The absence of a meaningful patent estate limits the ability of a product sponsor to prevent competing butalbital combination products. Product differentiation therefore depends on supply reliability, wholesaler access, pricing, labeling, and prescriber familiarity.
When does ALLZITAL lose exclusivity?
ALLZITAL's commercial protection is effectively mature. The product does not appear to depend on a remaining period of NCE exclusivity or a blocking patent term. Any historical approval exclusivity associated with the original NDA would have expired long before the current market period.
The practical exclusivity timeline is therefore:
| Milestone | Commercial effect |
|---|---|
| Original NDA approval | Established regulatory authorization |
| Initial approval exclusivity | Historical protection only |
| Patent term | No current blocking patent protection identified |
| Current market position | Mature branded-generic product |
| Future entry risk | Primarily generic and substitute-product competition |
This structure differs from a branded drug approaching patent expiry. ALLZITAL is already exposed to competition based on product substitution and alternative therapy selection.
How many patents cover ALLZITAL?
No material number of active Orange Book patents has been identified as protecting ALLZITAL's marketed product. The relevant commercial conclusion is that the product has no visible patent-based barrier comparable to a branded small-molecule medicine with listed formulation or method-of-use patents.
This does not eliminate all intellectual-property risk. A manufacturer could hold manufacturing know-how, private formulation information, trademarks, packaging rights, or non-Orange Book intellectual property. Those rights would not normally prevent a qualified competitor from marketing a therapeutically equivalent oral tablet.
Are there Paragraph IV challenges to ALLZITAL?
A significant Paragraph IV litigation program has not been publicly associated with ALLZITAL. That outcome is consistent with the product's mature market, limited patent position, and relatively low commercial value.
Paragraph IV litigation is most economically attractive when a challenger expects substantial sales before the listed patents expire. ALLZITAL does not present that profile. A generic applicant would more likely pursue an ordinary approval pathway without litigation if no blocking patent is listed.
The principal competitive threat is therefore not a high-value patent challenge. It is substitution by existing or newly approved products, distributor purchasing decisions, and reduced prescribing.
What generic products compete with ALLZITAL?
ALLZITAL competes across several layers:
Direct butalbital combination competition
The nearest substitutes are products containing butalbital, acetaminophen, and caffeine. These may differ in strength, tablet design, labeling, supplier, and reimbursement treatment. Therapeutic substitution can occur even when the strengths are not identical, subject to prescriber and pharmacist practices.
Fioricet and generic Fioricet products
Fioricet established the commercial category for butalbital, acetaminophen, and caffeine headache products. Generic versions have created a broad low-price alternative base. The existence of these products limits the pricing power of ALLZITAL.
Fiorinal and related products
Butalbital combinations containing aspirin and caffeine compete for some of the same headache prescriptions. Their suitability differs because of aspirin-related bleeding and gastrointestinal risks.
Non-barbiturate headache treatments
Triptans, NSAIDs, acetaminophen products, gepants, ditans, preventive CGRP therapies, and behavioral or nonpharmacologic approaches compete for headache treatment. These products can reduce use of butalbital combinations because clinical guidelines and stewardship programs often discourage routine barbiturate use for recurrent headache.
How strong is the ALLZITAL patent estate?
The patent estate is weak from a market-exclusivity perspective. The product's commercial defensibility depends on execution rather than patent rights.
| Strength factor | Assessment |
|---|---|
| Molecular novelty | Low |
| Formulation complexity | Low |
| Patent blocking power | Low |
| Regulatory switching barriers | Moderate |
| Prescriber familiarity | Potentially moderate |
| Supply-chain importance | Variable |
| Pricing power | Low |
| Substitution exposure | High |
A mature branded-generic can retain demand despite weak patents when it has reliable manufacturing, established distribution, and a recognizable product name. Those advantages are vulnerable to price competition and supply interruptions.
What is the Orange Book status of ALLZITAL?
ALLZITAL is an FDA-listed prescription product associated with an NDA rather than a conventional generic-only product.[2] The Orange Book's commercial relevance is limited if no active patent listings prevent ANDA approval.
An NDA listing does not by itself create durable market exclusivity. The product's continuing commercial value depends on FDA approval status, manufacturing compliance, wholesaler supply, and demand for its specific strength.
The key Orange Book questions for commercial diligence are:
- Whether the NDA remains active.
- Whether the product is listed as currently marketed.
- Whether any patents or exclusivities are listed.
- Whether therapeutically equivalent products are available.
- Whether supply has been interrupted or the product has been discontinued.
What manufacturing and intellectual-property barriers exist?
Manufacturing barriers are limited. ALLZITAL is an immediate-release tablet made from established active ingredients using conventional solid-dose manufacturing processes.
Potential operational barriers include:
- Controlled-substance handling and recordkeeping for butalbital products.
- Acetaminophen content uniformity and impurity control.
- Reliable sourcing of active pharmaceutical ingredients.
- FDA current good manufacturing practice compliance.
- Packaging and labeling controls.
- Wholesale and pharmacy distribution access.
- Management of product-specific demand at a relatively small scale.
These requirements can create operational friction, but they do not amount to a strong exclusionary IP position. A capable generic manufacturer could generally reproduce the product's dosage form and analytical profile through the applicable FDA approval process.
What is the financial trajectory for ALLZITAL?
No standalone public revenue series is available for ALLZITAL. The manufacturer does not report the product as a separately listed public-company revenue segment, and prescription claims data are not equivalent to net sales.
The financially supportable trajectory is therefore qualitative:
| Period | Likely commercial condition |
|---|---|
| Launch and early commercialization | Brand recognition and differentiated strength |
| Mature period | Increasing substitution and price pressure |
| Current market | Low-growth or declining unit economics |
| Forward outlook | Stable niche demand with limited pricing expansion |
ALLZITAL's revenue potential is constrained by five factors:
- The active ingredients are old and widely available.
- Competing butalbital combinations are established.
- The product has limited patent protection.
- Clinical practice is moving away from barbiturate-containing headache products.
- Payers and pharmacies generally favor lower-cost equivalents.
The product can still generate recurring revenue if it maintains distribution and retains prescriber use. Its financial profile is more consistent with a niche mature-product franchise than with a growth pharmaceutical asset.
Which licensing deals affect ALLZITAL?
No major publicly disclosed licensing transaction has been identified as a material driver of ALLZITAL's market value. The product's commercial structure appears to rely on manufacturer ownership, distribution arrangements, or ordinary supply relationships rather than a high-value co-development or territorial licensing model.
A licensing transaction would have limited strategic value unless it included manufacturing access, distribution scale, or a broader portfolio of headache products. The underlying molecule and formulation do not provide a strong basis for a premium royalty stream.
What patent litigation affects ALLZITAL?
No high-value patent litigation involving ALLZITAL has been publicly identified as a current market driver. That is consistent with the absence of a visible blocking patent estate and the product's relatively modest commercial scale.
The more relevant legal risks are product liability, controlled-substance compliance, manufacturing compliance, labeling, and potential enforcement involving opioid-like prescribing or medication-overuse concerns. Those risks are distinct from patent litigation and could affect availability or commercial reputation without creating generic-entry protection.
What generic launch risks exist?
Generic-entry risk is high in structural terms, even if a specific near-term launch cannot be quantified from public data.
Price erosion
Any therapeutically equivalent entrant can pressure wholesale acquisition cost, reimbursement, and pharmacy purchasing terms.
Product substitution
Pharmacists and prescribers may substitute among butalbital combination products, especially where the clinical objective is relief of tension headache rather than use of a unique delivery system.
Demand migration
Patients may migrate to migraine-specific treatments or non-barbiturate therapies, reducing the addressable market for ALLZITAL.
Supply disruption
Because the market is mature and relatively small, manufacturers may discontinue products when margins fall below the cost of controlled-substance compliance, quality systems, and inventory management.
Regulatory scrutiny
FDA and state regulators may scrutinize labeling, prescribing, dispensing, and promotional practices involving butalbital products. This can raise compliance costs and constrain promotional activity.
How does ALLZITAL compare with Fioricet?
| Attribute | ALLZITAL | Fioricet and generic equivalents |
|---|---|---|
| Butalbital strength | 25 mg | Commonly 50 mg |
| Acetaminophen strength | 325 mg | Commonly 300 mg |
| Caffeine strength | 50 mg | Commonly 40 mg |
| Market maturity | Mature | Mature and broadly established |
| Patent protection | No material current estate identified | No meaningful remaining pioneer protection |
| Competition | High | High |
| Differentiation | Strength and product identity | Brand recognition and broad generic supply |
| Financial outlook | Niche, low-growth | Larger category with persistent price pressure |
ALLZITAL's principal commercial distinction is its lower butalbital strength and different ingredient ratio. That distinction may support prescribing for selected patients, but it is not a strong barrier to therapeutic substitution.
What is the outlook for ALLZITAL revenue?
The base-case outlook is flat to declining revenue, with volatility caused by supply and distribution conditions rather than patent events. Upside would require expanded prescriber adoption, improved distribution, or a broader headache-product portfolio. Durable pricing growth is unlikely without a new formulation, clinical differentiation, or meaningful market consolidation.
The principal downside scenario is product discontinuation or reduced availability if manufacturing and compliance costs exceed the product's contribution margin. The principal stability scenario is continued niche demand from prescribers familiar with the lower-dose formulation.
Key Takeaways
- ALLZITAL is a mature immediate-release tablet containing butalbital, acetaminophen, and caffeine.
- Its commercial position is based on an established prescription niche, not patent exclusivity.
- No material active Orange Book patent estate or major Paragraph IV litigation program has been identified.
- Generic and therapeutic competition is high.
- The product is exposed to clinical movement away from barbiturate-containing headache treatments.
- Public financial filings do not provide standalone ALLZITAL revenue or profit data.
- The likely financial trajectory is stable to declining, with supply continuity and distribution more important than patent expiry.
- Biosimilar risk is not applicable because ALLZITAL is a small-molecule oral tablet.
- Manufacturing is technically conventional, although controlled-substance and quality-compliance requirements remain relevant.
- The product has limited potential for premium pricing or strategic licensing absent a reformulation or broader portfolio transaction.
FAQs
Is ALLZITAL still available?
Availability depends on the manufacturer, wholesaler inventory, pharmacy purchasing, and the product's current FDA marketing status. An NDA listing alone does not guarantee continuous commercial supply.
Is ALLZITAL a generic drug?
ALLZITAL is an NDA-listed branded product, but it competes in a market dominated by generic and therapeutically similar butalbital combinations.
Does ALLZITAL have an exclusivity period?
Any historical approval exclusivity is no longer a meaningful commercial barrier. No current NCE or patent exclusivity has been identified as protecting the product.
Is ALLZITAL covered by Medicare or commercial insurance?
Coverage varies by plan, formulary, state, and product availability. Payers commonly apply generic substitution and prior-authorization policies to butalbital combinations.
Is ALLZITAL a controlled substance?
Butalbital combination products may be regulated as Schedule III controlled substances under federal law and may face additional state-level requirements. The applicable classification depends on the precise formulation and governing regulations.
References
- DailyMed. (n.d.). ALLZITAL: Butalbital, acetaminophen, and caffeine tablet, prescribing information. U.S. National Library of Medicine.
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs, ALLZITAL, NDA 022208.
- U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
- U.S. Drug Enforcement Administration. (2024). Controlled substance schedules. U.S. Department of Justice.
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