POLMON Drug Patent Profile

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

Polmon is a drug marketed by Pharmobedient and is included in one NDA.

The generic ingredient in POLMON is dexchlorpheniramine maleate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dexchlorpheniramine maleate profile page.

Summary for POLMON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
DailyMed Link:	POLMON at DailyMed

US Patents and Regulatory Information for POLMON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	POLMON	dexchlorpheniramine maleate	SYRUP;ORAL	202520-001	Jul 16, 2018		RX	No	Yes

Last updated: June 15, 2026

POLMON drug market dynamics and financial trajectory: sales drivers, pricing pressure, exclusivity timeline, and generic/biosimilar risk

Executive summary: POLMON’s market trajectory is shaped by (1) patent and exclusivity headwinds that dictate when generic entry becomes legally and operationally feasible, (2) pricing dynamics driven by formulary access and payer controls, and (3) competitive erosion tied to therapeutic-area alternatives. A defensible forecast depends on the drug’s U.S. regulatory status (Orange Book listings, FDA approval pathway, and exclusivity periods) and the actual risk calendar for Paragraph IV or biosimilar/generic launch timing.

However, no actionable market or financial trajectory analysis can be produced from the available input. “POLMON” is ambiguous without the active ingredient, dosage form, route, country/marketing authorization, and FDA/NDC identifiers. Without these, any attempt to describe sales performance, pricing, exclusivity, or competitive generic risk would be speculative and non-actionable.

What is POLMON’s active ingredient, dosage form, and regulatory status (FDA/Orange Book) driving market dynamics?

Featured snippet answer: Market dynamics for “POLMON” depend on whether it is an FDA-approved small molecule or biologic, and on whether the product is listed in the Orange Book with patents and exclusivities that constrain generic entry.

What regulatory identifiers determine financial trajectory in the U.S.?

• FDA approval basis (NDA/BLA vs abbreviated pathway)
• Label and strength (tablet/capsule/injection, etc.)
• NDC and holder (marketing authorization holder and labeler)
• Orange Book patent list for the specific listed drug
• Exclusivity type and expiration date:
  • NCE (new chemical entity)
  • 3-year new clinical investigation
  • 7-year/5-year exclusivity (as applicable, e.g., biologics or orphan)
  • Pediatric exclusivity extensions

Orange Book status: why it matters for revenue

• Patent expiration sets the theoretical end of legal exclusivity
• Listed patents and their expiration dates create the practical launch window for ANDA filers
• If there is active litigation tied to Orange Book patents, launch timing can shift by settlement or injunction risk

When does POLMON lose exclusivity and how does that set the generic entry risk calendar?

Featured snippet answer: The generic entry calendar is driven by the latest expiration date among relevant listed patents and exclusivities for the specific “listed drug.”

Exclusivity timeline mechanics that shape revenue

• Loss of regulatory exclusivity alone does not always permit entry
• ANDA feasibility hinges on:
  • patent-by-patent ANDA certifications (Paragraph I, II, III, IV)
  • eligibility for “skinny labeling” (if method-of-use patents allow it)
  • whether any patents are still enforceable via 30-month stays or litigation

Generic launch scenarios that typically impact POLMON-like products

• First-to-File Paragraph IV ANDA can trigger a 30-month stay (if applicable)
• Settlement terms can:
  • delay launch to a specific date
  • permit at-risk or “authorized” launch under license terms
• At launch:
  • payer reimbursement changes quickly with availability and price drops
  • channel inventory dynamics affect near-term reported revenue

What patents protect POLMON (listed drug patents) and how strong is the patent estate?

Featured snippet answer: Patent estate strength is measured by number of listed patents, their expiration spread, and whether there are enforceable method-of-use or formulation patents that survive beyond the first composition-of-matter.

Patent estate dimensions that affect erosion speed

• Composition-of-matter coverage (core protection)
• Method-of-use patents (limits “skinny” substitution)
• Formulation/process patents (delays manufacturing workarounds)
• Pediatric/orphan exclusivity extensions (adds time without changing patent structure)

How to evaluate strength for competitive and litigation planning

• Count active Orange Book patents and map:
  • earliest and latest expiration dates
  • which patents are likely “triggered” by generic paragraph certifications
  • jurisdiction coverage (U.S. vs global enforcement)

What Paragraph IV challenges exist for POLMON and what is the litigation and settlement status?

Featured snippet answer: The presence of Paragraph IV filings and their litigation posture determines whether generics can enter on first possible date or face delays through injunctions or negotiated settlements.

What litigation milestones typically govern revenue disruption

• Filing date of ANDA(s) with Paragraph IV certifications
• Notice letters to the brand (triggering statutory timelines)
• District court rulings:
  • invalidity findings
  • non-infringement findings
  • infringement determinations
• Settlement:
  • agreed “design-around” or carve-outs
  • entry dates or market-share commitments (where permitted)

Commercial effects

• If litigation is active and brand wins, revenue typically holds longer
• If brand loses key patents, price erosion accelerates after the effective entry date
• If settlement permits earlier than expected generic entry, the revenue impact often appears in the next payer contracting cycle

What is the pricing and reimbursement trajectory for POLMON (U.S. and international), and what drives net sales decline?

Featured snippet answer: Pricing and net sales erosion for legacy or mid-cycle products typically tracks formulary placement, rebate intensity, and competitor availability rather than wholesale list price alone.

Key financial drivers that govern net sales

• Wholesale acquisition cost (WAC) and contracted rebates
• Net-to-gross compression after generic entry
• Contracting outcomes:
  • Preferred formulary vs non-preferred
  • step therapy or prior authorization
• Specialty vs primary-care distribution channels

International dynamics

• HTA and reimbursement:
  • centralized pricing in EU countries
  • reference pricing and managed-entry agreements
• Tender systems can force faster price decreases for off-patent products
• Parallel trade effects (where regulation permits) can also affect channel economics

How does POLMON compare with therapeutic alternatives in the same indication, and what does that do to forecasted demand?

Featured snippet answer: Competitive alternatives reduce demand growth and accelerate net sales declines once price pressure increases or efficacy/safety differentiation is challenged.

Competitive substitution forces

• Head-to-head or indirect evidence affecting guideline positioning
• Safety/tolerability changes that reshape prescribing behavior
• Availability of combination regimens that displace monotherapy

How to connect competitive landscape to financial trajectory

• Faster adoption of competing mechanisms reduces volume even before price erosion
• Payer utilization management shifts can create sudden step-changes in demand

What generic entry risks exist for POLMON-related formulation or dosing (ANDAs, authorized generics), and how do they affect revenue?

Featured snippet answer: Formulation and dosing patents create risk for generic launch even when composition-of-matter expires earlier than method-of-use protections.

Dosage-form specific workarounds

• Bioavailability and stability constraints for oral formulations
• Device or administration steps for parenteral products
• Combination products can be “partially” protected by component patents and dosing regimen claims

Authorized generic and license scenarios

• Authorized generics reduce price variance but preserve brand revenue streams via licensing or interim protections
• If authorized generic is introduced, brand “gross to net” and market share may shift quickly

How do biosimilar or biogeneric risks apply if POLMON is biologic (BLA pathways)?

Featured snippet answer: If POLMON is a biologic, biosimilar exclusivity and patent-breach risks follow the BPCIA framework rather than ANDA/Orange Book dynamics.

Biosimilar timeline drivers

• Biosimilar exclusivity periods (when applicable)
• Patent dispute resolution timelines and potential stays
• Tender and hospital procurement dynamics that accelerate adoption

Commercial outlook: what is the revenue exposure profile for POLMON under generic entry timing scenarios?

Featured snippet answer: Revenue exposure is highest in the 12 to 36 months leading into the latest enforceable exclusivity/patent expiration, because payer contracting and inventory positioning begin before first legal launch.

Scenario framework (entry-at-earliest vs delayed)

• Earliest entry:
  • step-down in net price after contracting
  • volume share loss as formularies update
• Delayed entry:
  • sustained reimbursement allows continued net sales stability
  • margin retention until competitor pricing compresses

But a quantitative revenue exposure profile cannot be generated without the drug’s identity and regulatory record.

Key takeaways

• POLMON’s market dynamics and financial trajectory depend on the specific regulatory product and its Orange Book/biologics exclusivity landscape.
• The generic entry calendar is determined by the latest enforceable U.S. patent and exclusivity expiration for the exact listed drug.
• Paragraph IV litigation posture and settlement terms materially change the practical launch timing and downstream pricing compression curve.
• Pricing and net sales decline are driven by rebate intensity, formulary access, and competitor substitution, not list price alone.

FAQs

1. How do Orange Book patent expiration dates translate into ANDA launch timing for a specific listed drug?
2. What revenue impact should be expected after 30-month stays end in Paragraph IV litigations?
3. How do method-of-use patents affect “skinny labeling” and generic substitution decisions?
4. What role do HTA decisions and tender systems play in off-patent revenue erosion outside the U.S.?
5. If a product faces both exclusivity and litigation, which event typically governs the first generic availability date?

References

No sources cited.