Dr Reddy's Tussles with Pfizer


Code : COM0020

Year :

Industry : Health Care

Region : India

Teaching Note:Not Available

Structured Assignment :Not Available

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Abstract: Dr Reddy's Laboratories are a leading Indian pharmaceutical company and a well-established player in the global generics and bulk drug manufacturing business.

It was the first Indian pharmaceutical company that received approval from the US Food and Drug Administration (FDA) to market a generic version of Eli Lilly's drug, Prozac, under a 180-day marketing exclusivity.

However, in 2002, Pfizer challenged Dr Reddy's intentions to market its yet-to-launch branded generic version of Norvasc (for example AmVaz of Dr Reddy's) in US courts.

Pedagogical Objectives:

  • To discuss Dr Reddy's defense against Pfizer's challenges.
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    Keywords : Dr Reddy's Laboratories Limited; Pfizer Inc; US Food and Drug Administration (FDA); Branded generics; Competitive Strategies Case Study; Abbreviated New Drug Application (ANDA); Patent challenges; Indian pharmaceutical industry; United States Court of Appeals for the Federal Circuit; 505 (b) (2) application process, paragraph IV filing; American pharmaceutical industry; Exclusive marketing rights; Generic drug manufacturers; Business strategy; Norvasc, Amlodipine Besylate, Amlodipine Maleate; Off-patent drugs

    Contents :
    Dr. Reddy's US Battle
    The Road Ahead for Dr. Reddy's

    Case Introduction >>

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