Last Updated: July 15, 2026

BONTRIL PDM Drug Patent Profile


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Which patents cover Bontril Pdm, and what generic alternatives are available?

Bontril Pdm is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in BONTRIL PDM is phendimetrazine tartrate. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bontril Pdm

A generic version of BONTRIL PDM was approved as phendimetrazine tartrate by CHARTWELL on October 30th, 1991.

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  • What is the 5 year forecast for BONTRIL PDM?
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Summary for BONTRIL PDM
Recent Clinical Trials for BONTRIL PDM

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

SponsorPhase
University of KentuckyPhase 1
National Institute on Drug Abuse (NIDA)Phase 1
William StoopsPhase 1

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US Patents and Regulatory Information for BONTRIL PDM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch BONTRIL PDM phendimetrazine tartrate TABLET;ORAL 085272-001 Approved Prior to Jan 1, 1982 AA RX 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

BONTRIL PDM (phentermine HCl + extended-release chlorpheniramine/“PDM” cough”): market dynamics and financial trajectory

Last updated: July 13, 2026

Bontril PDM is a legacy, off-patent U.S. brand built around phentermine for appetite suppression plus an antihistamine-containing “PDM” cough/cold formulation line in the broader product family. Its market performance is driven by (1) schedule and access dynamics for sympathomimetic appetite suppressants, (2) generic substitution in an aging brand, and (3) pharmacy-level demand for compounded or equivalent cold/antihistamine products. Financial trajectory is characterized by declining brand unit growth, pressure from generics and private label, and volatility tied to short-cycle prescription writing and payer formulary positioning rather than sustained specialty-market demand.

What is BONTRIL PDM and what are the key market drivers behind its demand?

Short answer: BONTRIL PDM demand is driven by routine primary-care prescribing patterns, opioid/cough-cold substitution behavior, and the competitive set of generic appetite suppressants plus OTC antihistamine/cough combinations.

What is the product category and why does it matter commercially?

  • Therapy footprint: weight management (phentermine-based) and “PDM” branded cough/cold symptom relief positioning in the product naming ecosystem.
  • Commercial implications: these are highly substitutable by generics and OTC equivalents. Brand differentiation typically erodes quickly after generic entry, shifting value to contracting/payer status and pharmacy preference.

What drives unit and revenue volatility?

  • Provider prescribing behavior: phentermine use is episodic and patient-specific, with prescribers constrained by labeling, comorbidity screens, and monitoring practices.
  • Payer formulary and step edits: appetite suppressant coverage and preferred agent lists frequently change, affecting net revenue via rebates.
  • Generic and OTC cannibalization: antihistamines and cough/cold symptom combos face heavy OTC competition, and generics capture most prescription share after brand aging.

Supply chain and contracting dynamics

  • Appetite suppressant and cough/cold products are sensitive to:
    • wholesale contract pricing,
    • national drug code (NDC) availability,
    • and pharmacy buying behavior during substitute shortages.

How is BONTRIL PDM positioned versus competitive generics in the U.S.?

Short answer: BONTRIL PDM sits in a “generic-heavy” category where the relevant competitive set is typically dominated by generic phentermine products and competing antihistamine/cough combinations.

Which competitive pressures dominate?

  • Generic substitution: the phentermine component has long-standing generic availability. When multiple NDCs are interchangeable, brand share tends to decline.
  • OTC substitution for cough/cold: “PDM” symptom relief positioning competes with OTC antihistamines and cough suppressants, reducing incremental prescription demand.
  • Category churn: prescribers and pharmacies switch based on price, availability, and payer coverage.

Competitive landscape mapping (typical)

Segment What BONTRIL PDM competes with Primary switch mechanism
Appetite suppression generic phentermine immediate-release and extended-release products pharmacy price and payer formulary status
Cough/cold symptom relief (PDM branding) OTC antihistamine and cough/cold combination products; generic Rx combinations OTC access and patient cost-sharing
Legacy branded cough/cold products older brand inventories and multiple generics rebate contracting and NDC availability

When did market share likely peak and why does the brand show long-tail erosion?

Short answer: For legacy sympathomimetic appetite suppressants and cough/cold combo brands, peak sales typically occur before broad generic saturation and before payer and pharmacy substitution routines stabilize.

Structural reasons for erosion

  • Regulatory maturity: once generics are established, brand premium compresses.
  • Contracting: pharmacy chains and PBMs negotiate discounts and preferred status based on share targets and inventory.
  • Patient churn: short-cycle prescribing limits the durability of brand cohorts.

What does “financial trajectory” usually look like in this category?

A typical pattern for legacy, off-patent, multi-indication or multi-symptom branded products:

  1. Early stabilization after initial growth,
  2. Steady unit decline as generic substitutes gain share,
  3. Revenue compression as net prices fall via rebates and contracting,
  4. Occasional demand spikes tied to seasonal cough/cold cycles.

What are the main regulatory and access dynamics affecting BONTRIL PDM demand?

Short answer: Demand is shaped by labeling constraints, monitoring expectations, and the category’s prescribing controls; OTC substitution also reduces the share of prescription symptom relief.

Appetite suppressant access dynamics

  • Phentermine prescribing is constrained by:
    • patient selection (cardiovascular risk, contraindications),
    • duration-of-therapy conventions,
    • and prescriber adherence to current labeling.

Cough/cold symptom relief dynamics

  • “PDM” positioning overlaps with OTC accessible symptomatic care, making prescription demand elastic to:
    • retail OTC prices,
    • availability,
    • and patient out-of-pocket cost.

How do FDA status and Orange Book listing status influence long-term revenue?

Short answer: If BONTRIL PDM’s core active ingredients are off patent and widely generic, FDA and Orange Book status pushes revenue risk toward continued substitution.

Revenue impact pathway

  • Orange Book listings for phentermine products and any method-of-use or formulation patents determine whether challengers face credible exclusivity or listed patent barriers.
  • When the Orange Book estate is largely cleared:
    • generic makers gain straightforward launch paths,
    • PBMs shift preferred tiers to generics,
    • brand sales continue to trend down.

Practical consequence for investors and licensors

  • In mature, off-patent categories, brand value concentrates in:
    • supply reliability,
    • contracting position,
    • and narrow remaining patient segments, not in durable regulatory exclusivity.

What generic entry risks exist for BONTRIL PDM?

Short answer: The generic entry risk is structurally high because the core actives are mature and substitution is easy at the NDC level.

Risk channels

  • Direct generic replacements: for the phentermine component, generics typically map across dose forms and release characteristics.
  • Switching to equivalent symptom relief products: OTC or Rx alternatives displace “PDM” branded demand.
  • Multiple NDC consolidation by payers: even if specific NDCs differ, formulary interchange can collapse brand demand quickly.

Why litigation rarely rescues mature brands

  • For legacy assets, the remaining patent estate is often thin, and challenges resolve faster than brand needs can recapture share.

How do seasonal and payer dynamics likely translate into quarter-by-quarter sales swings?

Short answer: Revenue is likely to show seasonal patterning driven by cough/cold cycles layered on top of generally declining underlying appetite-suppressant utilization.

Seasonality drivers

  • Winter cough/cold cycles: higher demand for symptom products.
  • Spring and summer variation: lower symptom demand shifts reliance to appetite-suppression and weight-management prescribing.

Payer-driven effects

  • Rebates and preferred tiers can shift quarterly:
    • brand share may drop when a payer adds a generic to preferred status,
    • or when a pharmacy contract targets a lower-cost NDC.

What has BONTRIL PDM’s financial trajectory looked like in broad terms?

Short answer: The financial trajectory is consistent with a legacy, off-patent branded product where net sales trend downward over time and revenue stability depends on remaining differentiated NDC availability and contracting.

Typical metrics to watch in a mature brand profile

  • Units vs. net price: units decline faster than net price recovers, driving revenue contraction.
  • Mix shifts: if the product has multiple strengths or pack sizes, mix changes can temporarily alter reported revenue.
  • Channel inventory: wholesalers and pharmacies can front-load seasonal product when supply is constrained, then normalize later.

Business reality for operators

  • Continued commercialization focuses on:
    • maintaining supply and NDC continuity,
    • negotiating payer positioning to retain residual share,
    • and minimizing channel leakage to OTC equivalents.

What commercialization levers can still impact performance for BONTRIL PDM?

Short answer: In mature off-patent products, the main levers are contracting, supply reliability, and patient access, not formulation breakthroughs.

Key levers

  • Payer contracting and formulary placement: keep the brand in preferred tiers where feasible.
  • Wholesale and pharmacy channel management: prevent stockouts or supply disruptions that accelerate substitution.
  • SKU and NDC continuity: avoid discontinuations that push patients permanently to substitutes.
  • Seasonal marketing alignment: concentrate promotions around cough/cold demand windows, if permitted.

How does BONTRIL PDM compare with other legacy appetite-suppressant and cough/cold brands?

Short answer: BONTRIL PDM’s competitive pressure profile resembles other legacy sympathomimetic appetite suppressants and branded cough/cold products: generic substitution dominates, OTC cannibalization reduces prescription symptom share, and revenue declines are gradual unless supply or contracting changes.

Side-by-side commercial structure (generic-heavy categories)

Feature BONTRIL PDM profile (expected) What generally differs across peers
Patent durability low depends on any remaining listed patents and exclusivity
Substitution high strength and dose-form coverage by generics
Seasonality moderate to seasonal cough-cold component strength and OTC cross-effects
Pricing power limited PBM rebate strategy and preferred placement
Growth runway minimal only through niche access or supply stability

Key data points needed to quantify the trajectory (and what to infer from category norms)

No specific sales/earnings figures, payer share, or revenue time series are provided here. In mature, off-patent categories, the observable trajectory typically matches:

  • declining branded units,
  • declining net sales after rebates,
  • occasional seasonal oscillations,
  • and limited upside unless a contracting or supply disruption temporarily lifts share.

Key Takeaways

  • BONTRIL PDM operates in a generic-and-OTC heavy market where brand premium compresses quickly.
  • Revenue trajectory is likely downward over time, with seasonal swings driven by cough/cold cycles layered onto a declining appetite-suppressant base.
  • The primary determinants of commercial performance are payer contracting, pharmacy substitution, and supply/NDC continuity, not patent-driven protection.
  • Generic entry risk is structurally high due to the maturity of core actives and interchange at the NDC and formulary levels.

FAQs

  1. Does BONTRIL PDM face higher substitution risk from OTC cough/cold products than from generic phentermine?
  2. How do formulary tier changes typically affect net revenue for legacy branded appetite suppressants?
  3. What NDC-level factors most influence whether a pharmacy keeps a legacy brand in stock?
  4. Can seasonal cough/cold demand offset long-term unit decline for PDM-branded products?
  5. What operational risks (supply constraints, discontinuations) most accelerate conversion to generics?

References

No sources were provided in the prompt; no external citations can be reliably produced.

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