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Differentiated product development
(505(b)(2)/EU Hybrid application

Driving patient-centered innovation with unique delivery technologies for differentiated products.

Product differentiation is a core business strategy for the big pharma organizations as much as it is for the smaller players, often giving those smaller pharma organizations a chance against larger rivals.

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Repositioning and repurposing of well established, commercially available drugs via the US 505(b)(2), the European 10(3) Hybrid and Canadian SRTD regulatory pathways is a growing trend as the cost of new drug development increases. Many of these repurposed drugs lack patent protection.

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We will use its patent protecting delivery technologies to design, formulate and develop differentiated, yet cost-effective new products, with extended patent protection in key markets like North America, Europe and Latin America.

Key steps involved in differentiated dosage forms:

  • Identifying the appropriate differentiation elements like patient compliance, ease of dosing and many more.

  • Creating design map to balance risk of failures and increase chances of success.

  • Studying IP landscape and creating own IP around it. 

  • Execution of strategy and assessing outcome at every stage gate.

  • Finetuning the next steps as per project to reach end goal. 

Differentiated dosage forms mainly being developed

  • Oral solids to oral Liquids

  • Taste masking

  • Enhancing Bioavailability

  • Immediate release to modified release

  • ​Lyo injections to ready to use injections

  • Injections to Oral delivery

  • New combinations for additive or synergistic effects

Why Concresco ?

Innovative Product Development

Dosage Form Proficiency

Global Expertise

ExperiencedLeadership Team

Extensive Industry Network

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