Small-Molecule Loss-of-Exclusivity Strategy
Authorized-generic, brand-retention, pricing, channel and erosion-scenario decisions for products approaching loss of exclusivity.
PSS helps leadership evaluate product-specific LoE alternatives, quantify erosion and portfolio implications, sequence pricing and channel responses, assess external partners and establish decision gates and implementation governance.
Brand-retention (also called brand-for-generic) strategy refers to the innovator continuing to market and support the brand alongside a generic or authorized-generic entrant, rather than exiting the market at loss of exclusivity.
What We Do
Lifecycle & Erosion Planning
Authorized generic strategy
Brand-for-generic launches
Erosion modeling
Lifecycle extension planning
Pricing & Market Access
Pricing response planning
Rebate and contracting response
Payer response planning
Trade & Commercialization
Channel strategy
Trade and distribution strategy
Retail vs specialty channel planning
Wholesaler strategy
Commercialization sequencing
Execution & Governance
Launch governance
External partner coordination
Who This Is For
Strategic Planning
Commercial leadership preparing for LoE or competitive entry
Brand teams evaluating authorized generics or brand-for-generic launches
Operational Execution
Market access and pricing teams requiring scenario-based planning
Teams managing complex trade and distribution sequencing
Typical Deliverables
Strategic Roadmaps
Lifecycle roadmap, milestones, and decision points
Partner landscape and selection shortlists
Financial & Access Models
Erosion scenario pack (base/downside/upside assumptions)
Pricing response and contracting strategy frameworks
Typical Engagement Structure
Strategy & Operating Model Alignment — 4–8 weeks
Commercialization Coordination & Execution Support — Variable based on scope and implementation complexity
Partner Ecosystem (as needed)
Market access and contracting specialists
Trade and channel operations specialists
Commercial analytics and forecasting support
Distribution and logistics providers (external)
Labeling and packaging vendors (external)
Legal and compliance advisors (client-led or introduced)
Frequently Asked Questions
- How far ahead of loss of exclusivity should this work start?
Most engagements begin 12–24 months ahead of the anticipated loss-of-exclusivity date, giving enough runway to evaluate scenarios, align stakeholders, and prepare an operating plan before erosion begins.
- Do you model authorized-generic timing and erosion scenarios?
Yes. PSS builds scenario models covering authorized-generic timing, expected erosion curves, and channel dynamics to support a decision-ready view of the available options.
- How do you approach brand retention without overstating what can realistically be preserved?
PSS evaluates and seeks to preserve portfolio economics where realistic, using conservative, evidence-based assumptions rather than promising outcomes that depend on factors outside the client’s control.
What We Do Not Do
We do not provide manufacturing services or FDA establishment registration.
We do not operate as legal counsel.
We do not operate distribution, laboratory, hub, or 3PL functions.
We coordinate qualified external partners where appropriate.
Regulatory ownership remains with the sponsor and its designated regulatory partners.
LoE Erosion Strategy & Pricing Response Planning
An innovator brand team engaged PSS to develop a multi-year loss-of-exclusivity (LoE) strategy for a primary care asset. PSS delivered comprehensive erosion modeling and a scenario-based pricing framework to evaluate authorized generic and brand-for-generic partnership models. The strategy included channel-specific response plans and trade/distribution adjustments to evaluate and seek to preserve portfolio economics post-LoE. PSS translated strategic recommendations into a decision-ready roadmap, coordinating internal stakeholders to ensure operational alignment ahead of competitive entry.
Discuss a product-specific loss-of-exclusivity decision
Call:
Email:
Schedule a Meeting:
Please fill out our contact form to request a meeting, and we’ll follow up with our availability.
Upload Securely:
*Do not upload PHI or sensitive personal data. Do not upload confidential information unless an NDA is in place.
LinkedIn: