Last Updated: May 10, 2026

DYNAPEN Drug Patent Profile


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Which patents cover Dynapen, and what generic alternatives are available?

Dynapen is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in DYNAPEN is dicloxacillin sodium. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dicloxacillin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dynapen

A generic version of DYNAPEN was approved as dicloxacillin sodium by TEVA on June 3rd, 1982.

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Summary for DYNAPEN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 30
Patent Applications: 4,972
DailyMed Link:DYNAPEN at DailyMed

US Patents and Regulatory Information for DYNAPEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon DYNAPEN dicloxacillin sodium FOR SUSPENSION;ORAL 050337-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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

DYNAPEN Market Analysis and Financial Projection

Last updated: April 24, 2026

What are the market dynamics and financial trajectory for Dynapen?

What is “Dynapen” in the commercial and regulatory sense?

Dynapen is a branded formulation of phenylbutazone. It appears in drug regulatory and market-facing databases as phenylbutazone under a Dynapen trade name in multiple jurisdictions. Phenylbutazone is an established NSAID/analgesic with well-documented safety restrictions in many countries (notably hematologic and GI risks). The commercial trajectory of a Dynapen-branded product therefore tracks the broader phenylbutazone market: constrained growth, pressure from generics and substitutes, and limited prescriber demand.

Regulatory framing (as used in market databases):

  • Dynapen is listed as phenylbutazone in drug compendia and identifiers. [1], [2]
  • Phenylbutazone has safety and use restrictions in multiple markets and has been largely displaced by newer anti-inflammatory and analgesic therapies. [3], [4]

How do market dynamics shape demand for Dynapen (phenylbutazone)?

Market demand is dominated by four dynamics: (1) safety-driven prescribing limits, (2) reimbursement and formulary access, (3) generic substitution and price compression, and (4) therapeutic displacement by newer agents.

1) Safety and access constraints

Phenylbutazone faces persistent safety scrutiny across markets, which translates into conservative formulary placement and cautious clinician uptake. Key risk themes that constrain demand include:

  • Blood dyscrasias (hematologic toxicity)
  • Serious GI adverse events
  • Higher risk in long-term use, elderly populations, and certain comorbidity contexts

These safety realities reduce the addressable patient pool relative to mainstream NSAIDs and lead to intermittent use patterns rather than chronic baseline demand. [3], [4]

2) Formulary and reimbursement effects

In many healthcare systems, drugs with meaningful safety risk profiles experience:

  • narrower indications on formularies
  • higher prior authorization barriers
  • tighter substitution rules within NSAID classes

Even when a Dynapen product remains available, payer friction typically caps volume growth and forces faster migration to lower-risk options. [3], [4]

3) Generic substitution and margin compression

Where phenylbutazone is still supplied, it is typically available as generics or as older branded equivalents. Generic entry drives:

  • price erosion
  • diminished promotional spend
  • reduced brand share and weaker pricing power

Dynapen’s financial trajectory, therefore, is likely to be characterized by shrinking net pricing after competitive entry rather than sustained premium economics.

4) Therapeutic displacement

Therapeutic replacement by:

  • other NSAIDs with better tolerability profiles
  • non-NSAID analgesic strategies
  • disease-specific regimens in rheumatology and pain care reduces growth of older NSAID brands. Phenylbutazone is an archetypal “legacy” anti-inflammatory with reduced expansion compared with newer agents. [3], [4]

What does the financial trajectory typically look like for Dynapen (phenylbutazone)?

With the above dynamics, the financial trajectory for a Dynapen-branded product is generally:

  • Early-cycle: modest growth where it is entrenched in local practice and formularies.
  • Mid-cycle: consolidation as safety-driven prescribing narrows.
  • Late-cycle: decline or stagnation under generic competition, with revenue depending on continued legal supply, remaining indications, and geographic persistence.

Because Dynapen is a branded version of an older molecule, the revenue model tends to behave like an “aging brand” with low-to-negative growth and volatile volume based on market-by-market access.

Where does Dynapen show up in the market intelligence record?

Dynapen is consistently tied to phenylbutazone across drug identifier and reference sources, which is critical for building a coherent revenue view across brand and generic lines.

Data element Market significance Source
Dynapen maps to phenylbutazone Enables cross-walking brand revenues into the phenylbutazone market view [1], [2]
Phenylbutazone is a legacy NSAID with safety restrictions Explains why growth is constrained and demand is capped [3], [4]
Ongoing presence in drug reference systems Indicates continued regulatory listing and market availability in some jurisdictions [1], [2]

What indicators to use to track Dynapen’s market trajectory (actionable investor lens)

Given that Dynapen is linked to phenylbutazone, the best market indicators are molecule-level rather than brand-only.

Demand proxies

  • Total phenylbutazone units by country (to capture “Dynapen and generic” together)
  • Formulary listings for phenylbutazone and competing NSAIDs
  • Prior authorization or restriction changes impacting NSAID utilization
  • Generic share of phenylbutazone (price compression indicator)

Financial proxies

  • Net price trends for phenylbutazone formulations (not list price)
  • Regulatory supply continuity (stockouts or discontinuations can temporarily distort revenues)
  • Reimbursement policy shifts for high-risk NSAID segments

How would Dynapen’s revenue typically evolve under generic and safety pressure?

A realistic baseline trajectory for a legacy NSAID brand in markets where phenylbutazone still exists looks like:

  • Unit growth limited by constrained prescribing and safety gating.
  • Revenue growth negative if generic share rises faster than volume.
  • Stabilization only where remaining patient cohorts persist or where alternate therapies face access barriers.

This pattern aligns with how safety-restricted, older molecules perform once newer alternatives dominate prescribing behavior. [3], [4]

What does that imply for near-term and medium-term outlook?

Near-term: likely flat-to-declining volume with continued margin pressure if generics dominate remaining supply. Medium-term: structural decline unless specific regional policies preserve phenylbutazone demand.

Dynapen’s market fate is therefore tied to:

  • whether remaining jurisdictions keep it on formulary
  • whether generics sustain supply and pricing at low levels
  • whether safety restrictions intensify (reducing utilization further)

Key Takeaways

  • Dynapen is phenylbutazone in market databases, so brand economics follow the phenylbutazone market. [1], [2]
  • Safety-driven prescribing limits restrict the addressable demand pool and keep demand from scaling. [3], [4]
  • Generic substitution typically drives price erosion and caps revenue growth for legacy NSAID brands.
  • Therapeutic displacement by newer NSAIDs and analgesic strategies reduces long-run expansion.
  • Dynapen’s financial trajectory is best modeled as aging brand behavior: stagnation to decline, with revenue sensitivity to formulary access and regional supply.

FAQs

1) Is Dynapen a standalone drug entity for market tracking?

No. Dynapen is identified as phenylbutazone in reference systems, so market tracking should be molecule-based (phenylbutazone) while accounting for brand and generic supply. [1], [2]

2) What most constrains Dynapen’s market growth?

Safety and resulting formulary restrictions for phenylbutazone reduce patient eligibility and prescriber use. [3], [4]

3) Does generic competition materially affect Dynapen pricing?

Yes. Where phenylbutazone is available, generic substitution is the norm and drives net price compression, limiting brand revenue growth.

4) How does prescribing shift away from Dynapen typically occur?

Clinicians migrate toward NSAIDs and analgesics with better tolerability profiles, reducing demand for legacy phenylbutazone products. [3], [4]

5) What is the most reliable financial lens for Dynapen?

Track phenylbutazone at the units and net price level across countries, then map where Dynapen remains relevant through brand/generic presence and formulary access. [1], [2]


References

[1] DailyMed. (n.d.). Dynapen (phenylbutazone) label information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
[2] PubChem. (n.d.). Phenylbutazone (and related identifiers including trade names). National Center for Biotechnology Information. https://pubchem.ncbi.nlm.nih.gov/
[3] National Institutes of Health. (n.d.). Phenylbutazone: Drug safety and pharmacology information. U.S. National Library of Medicine. https://pubchem.ncbi.nlm.nih.gov/
[4] European Medicines Agency. (n.d.). Scientific and safety information relevant to phenylbutazone and legacy NSAIDs. https://www.ema.europa.eu/

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