When a branded therapy loses exclusivity, generics capture over 90% of prescriptions within months. Oral thin films offer a strategic path forward, extending product life by 3-7 years, improving bioavailability by up to 200%, and simplifying administration.
Download the guide to see how leading pharma companies are using OTF platforms to protect market share and build stronger pipelines.
DOWNLOAD THE GUIDE
How formulation and manufacturing process patents extend market exclusivity 3-7 years beyond API expiration, creating barriers to generic entry.
Patent extension strategies
A STRATEGIC RESOURE FOR PHARMACEUTICAL AND BIOTECH DECISION-MAKERS
The Oral Thin Film Edge explores how leading companies use oral thin film (OTF) platforms to defend market share, enhance therapeutic performance, and reach patient populations that conventional tablets can’t serve. Drawing on ARx’s experience supporting four FDA approvals and producing over 100 million units annually, this guide offers practical frameworks for assessing feasibility, regulatory pathways, and development timelines.
Inside, you’ll discover:
Acting now helps your team de-risk development and build a stronger, more competitive pipeline, positioning your therapies for lasting impact.
Bioavailability optimization
Accelerated development timelines
Platform selection frameworks
Real-world development processes
How the 505(b)(2) regulatory pathway compresses traditional development from 6-8 years to 24-36 months.
Why sublingual and buccal delivery achieve 40–200% improvements in systemic exposure versus oral tablets, enabling lower doses and better safety profiles.
Decision tools to align buccal, sublingual, and lingual film formats with PK requirements, patient preferences, and commercial goals.
Real-world development processes
Platform selection frameworks
ARx’s stage-gate model from feasibility through commercialization, including investment ranges, validation steps, and regulatory checkpoints.
When a branded therapy loses exclusivity, generics capture over 90% of prescriptions within months. Oral thin films offer a strategic path forward, extending product life by 3-7 years, improving bioavailability by up to 200%, and simplifying administration.
Download the guide to see how leading pharma companies are using OTF platforms to protect market share and build stronger pipelines.