Last Updated: June 22, 2026

UNISOM Drug Patent Profile


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When do Unisom patents expire, and when can generic versions of Unisom launch?

Unisom is a drug marketed by Pfizer and Chattem and is included in two NDAs.

The generic ingredient in UNISOM is doxylamine succinate. There are fourteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the doxylamine succinate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Unisom

A generic version of UNISOM was approved as doxylamine succinate by PERRIGO on September 18th, 1996.

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Questions you can ask:
  • What is the 5 year forecast for UNISOM?
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Summary for UNISOM
Recent Clinical Trials for UNISOM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Hospira, now a wholly owned subsidiary of PfizerPhase 4
Hospira, Inc.Phase 4
University of PennsylvaniaPhase 4

See all UNISOM clinical trials

US Patents and Regulatory Information for UNISOM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer UNISOM doxylamine succinate CAPSULE;ORAL 019440-001 Feb 5, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chattem UNISOM doxylamine succinate TABLET;ORAL 018066-001 Approved Prior to Jan 1, 1982 OTC Yes 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

UNISOM: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is UNISOM in commercial terms?

UNISOM is a branded sleep-aid franchise marketed in the US under multiple product types. In practice, “UNISOM” functions as a consumer-facing brand umbrella for over-the-counter (OTC) sedative-hypnotic and related sleep products, with the dominant active ingredients varying by formulation (commonly doxylamine succinate for “nighttime” products).

Because UNISOM is an OTC brand, its financial trajectory is driven more by retail coverage, payer-like pharmacy-channel demand, trade spend, and competitive substitution than by patent-protected prescription dynamics.

What market dynamics govern UNISOM’s demand?

UNISOM’s market is shaped by recurring OTC sleep drivers:

  1. OTC category growth tied to sleep impairment awareness

    • Demand tracks consumer spending on sleep aids and seasonal patterns in self-medication for insomnia symptoms.
  2. Ingredient-level substitution

    • Consumer choice shifts between competing antihistamine sleep aids (same therapeutic class) based on price, availability, perceived onset duration, and side-effect profiles.
  3. Retail shelf and promotion intensity

    • OTC sleep sales are strongly influenced by:
      • Planogram placement (preferred shelf position)
      • Retail execution (in-stock rates)
      • Trade promotions (couponing, retailer-funded offers)
  4. Competitive pressure from other OTC sleep brands

    • UNISOM competes in a crowded shelf category against established sleep-aid brands, store brands, and generics (ingredient equivalence).
  5. Regulatory and labeling constraints

    • Label wording, dosing limits, warnings (sedation, next-day impairment), and age guidance constrain how brands can differentiate.

How does UNISOM monetize in the value chain?

UNISOM’s revenue is primarily monetized via:

  • Retail OTC sales
  • Wholesale distribution to pharmacy and mass channels
  • Private label and alternative-brand substitution risk
  • Marketing spend to sustain brand pull in a low-differentiation ingredient category

In OTC sleep, brand economics tend to compress when:

  • Retailers push house brands
  • Competitors run heavier price promotions
  • Ingredient-equivalent rivals maintain stronger trade terms

Who benefits most from UNISOM’s competitive setup?

From a market-structure standpoint, UNISOM’s brand value is realized when it achieves:

  • Higher retail velocity through stable availability
  • Strong consumer recognition and repeat purchase behavior
  • Effective trade terms that keep it competitive at the shelf level

If these conditions weaken, category dynamics shift toward commodity-like behavior at the ingredient level.

What is the financial trajectory for UNISOM?

A complete, citation-backed financial trajectory requires specific, brand-level revenue, operating income, or sales-unit data across time. The prompt does not include such figures, and UNISOM financials are typically reported only within larger corporate OTC segments unless a public disclosure exists with brand-level granularity.

Under the operational constraint to produce a complete and accurate response, no numeric financial trajectory (trend line, growth rates, margins, or channel splits) is stated here.

How do patent and exclusivity realities affect UNISOM’s pricing power?

UNISOM is not defined by long-duration patent exclusivity in the way prescription products are. The competitive baseline in OTC sedative ingredients is usually ingredient-generic parity over time, which shifts financial outcomes toward:

  • Brand-driven demand persistence
  • Promotion intensity management
  • Trade negotiations
  • Formulation-level differentiation (timing, dose units, combination products)

That structure typically limits long-term sustained price premium unless brand execution outperforms substitution.

What indicators best map to UNISOM’s near-term performance?

For OTC sleep brands, investors and operators typically track:

  • Channel velocity: sell-through at retail and re-order rates through wholesalers
  • Promotion-to-baseline ratio: frequency and depth of discounting
  • Net sales per unit: discounting pressure and pack-mix changes
  • Share stability: relative shelf share versus antihistamine sleep competitors
  • Store brand encroachment: evidence of unit migration to retailer equivalents

These indicators connect directly to how UNISOM’s financial trajectory evolves quarter to quarter in OTC.

Scenario analysis: what changes would most alter UNISOM’s financial path?

Even without numeric forecasts, the directionality in OTC sleep is usually driven by these variables:

Upside levers

  • Increased retail distribution and planogram improvements
  • Higher-performing formulations within the UNISOM line
  • Reduced promotional intensity while holding volume
  • Stronger consumer retention via brand trust and repeat use

Downside levers

  • Intensified competition from entrenched sleep brands with aggressive trade spend
  • Store brand substitution and sharper price competition at key retailers
  • Disruptions in supply or increased out-of-stocks reducing velocity
  • Tighter category labeling norms limiting messaging differentiation

Investment or R&D relevance: what matters for UNISOM’s future competitiveness?

UNISOM’s long-run business relevance depends less on patent-led innovation and more on:

  • Formulation strategy: dose timing, tablet vs. gelcap format preferences, and compliance-oriented packaging
  • Portfolio extension: variants that preserve brand umbrella demand
  • Retail execution: merchandising that maintains distinctiveness in a commodity environment
  • Regulatory-safe claims: keeping labeling compliant while maintaining consumer clarity

Market outlook (directional): where OTC sleep tends to go

OTC sleep is generally supported by:

  • Aging demographics and chronic insomnia symptom prevalence
  • Ongoing consumer education
  • Persistent demand for non-prescription symptom relief

Financial outcomes still hinge on competitive promo intensity and substitution rates.

Key Takeaways

  • UNISOM is an OTC sleep-aid brand whose market dynamics are dominated by retail execution, ingredient-level substitution, and trade promotion intensity rather than patent exclusivity.
  • UNISOM’s financial trajectory in OTC typically follows category velocity and net price pressure, with share stability dependent on merchandising and brand pull.
  • A numeric brand-level financial trend cannot be stated from the information provided.
  • The most decision-relevant performance indicators for UNISOM are sell-through velocity, promotion depth, net sales per unit, share stability, and store brand encroachment.

FAQs

1) Is UNISOM prescription or OTC?

UNISOM is an OTC consumer sleep-aid brand.

2) What primarily drives UNISOM demand?

Consumer need for OTC sleep symptom relief, retail availability, and promotional competitiveness in the antihistamine sleep category.

3) What is the biggest financial risk for an OTC sleep brand like UNISOM?

Substitution to ingredient-equivalent competitors and retailer private label driven by price and shelf execution.

4) Does UNISOM have patent-led pricing power like prescription drugs?

OTC sleep-aid ingredients generally face generic and substitution dynamics that limit long-duration patent-style pricing power.

5) What metrics should be monitored to track UNISOM’s trajectory?

Net sales per unit, promotion frequency and depth, unit velocity, share vs. key competitors, and store-brand displacement.


References

[1] APA (7th ed.). Publication Manual of the American Psychological Association. American Psychological Association.
[2] US FDA. Over-the-Counter (OTC) Drug Products. U.S. Food and Drug Administration.

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