Wrays’ Life Sciences Team Making an Impact on the World Pharmaceutical Market

Australia is producing impressive results on the world pharmaceutical stage. To date, Australia has developed 13 drugs that have received approval from the United States Food and Drug Administration (FDA). Of these 13, 5 were patented by the services provided by Wrays, including FDA approved drugs from iCeutica and Sarepta.

Wrays’ Chairman Gary Cox said “We congratulate our clients iCeutica and Sarepta for the major achievement of receiving FDA approval for their products. They are great examples of world-class intellectual property being developed in Australia and making a real impact on the world pharmaceuticals market. Receiving FDA approval requires all parties to integrate seamlessly, achieving a balance of scientific and technical understanding, and strategic IP proficiency.”

Achieving FDA approval requires rigorous assessment against strict safety, effectiveness and patent criteria. In 2019, only 48 new drugs were approved by the FDA, putting into perspective the significance of this remarkable achievement.

Approved drugs are included in the FDA’s so-called ‘Orange Book’. Used by Medical Professionals and researchers worldwide, the Orange Book is the gold standard reference for identifying generic equivalents to brand name drugs, drug patents, and drug exclusivity. It also helps in making important intellectual property decisions and strategies for pharmaceutical companies.

Driven by local innovation and investment, Australia’s thriving biotechnology research industry has numerous other drugs in late-stage development and we look forward to seeing more Australian-developed products achieve their own FDA approval.

More information about Wrays’ Life Sciences Team can be found on our industry page.

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