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CIPLA AUSTRALIA PTY LTD

Home Clinical Trial Sponsors and OrganizationsCIPLA AUSTRALIA PTY LTD

CIPLA AUSTRALIA PTY LTD

L 1 132-136 ALBERT ROAD, South Melbourne, Victoria, Australia

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Clinical Trials

0

0 active

Approvals

977

Total approvals

Agencies

1

Regulatory bodies

Founded

N/A

Overview

Trial Phase Distribution

No trial phase data available

Trial Status Distribution

No trial data available

Clinical Trials

No trial data available

Approvals

Approvals by Agency

TGA

Therapeutic Goods Administration

977

Approvals

Recent Approvals

TERRYWHITE CHEMMART SALBUTAMOL INHALER salbutamol 100 microgram (as sulfate) pressurised inhaler metered dose (with counter) (474110)

XBIRA abiraterone acetate 500 mg tablet blister pack (444832)

CIP ABIRATERONE abiraterone acetate 500 mg tablet blister pack (444830)

CIPLA ABIRATERONE abiraterone acetate 500 mg tablet blister pack (444831)

CIP ABIRATERONE abiraterone acetate 500 mg tablet blister pack (444830)

CIPLA ABIRATERONE abiraterone acetate 500 mg tablet blister pack (444831)

XBIRA abiraterone acetate 500 mg tablet blister pack (444832)

XBIRA abiraterone acetate 250 mg tablet bottle (446770)

CIP ABIRATERONE abiraterone acetate 250 mg tablet bottle (443940)

CIPLA ABIRATERONE abiraterone acetate 250 mg tablet bottle (443941)

News

Australian Court Rules Formulation Patents Ineligible for Patent Term Extensions in Landmark Otsuka Decision

- The Full Court of the Federal Court of Australia ruled that only patents claiming active pharmaceutical ingredients are eligible for patent term extensions, not pharmaceutical formulations. - The decision in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd invalidates existing patent term extensions for formulation patents, creating "zombie PTEs" vulnerable to challenge. - Pharmaceutical companies must urgently review their patent portfolios as the ruling affects loss of exclusivity dates and may accelerate generic drug market entry across Australia.

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