| Mumbai-based drug major Sun Pharmaceutical Industries got a major breakthrough in the US drug market following the decision by Wyeth Pharmaceuticals not to sue Sun Pharma for infringing the patent on Wyeth’s top-selling drug Effexor XR - which is also the world’s best-selling antidepressant.
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| Sun Pharma had challenged the patents on three strengths of Effexor (venlafaxine) in 37.5 mg, 75 mg and 150 mg, based on an innovative technology for extended release tablets. These strengths have annual sales of approximately $ 2.6 billion in the US.
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| The company today announced that it received a ‘Covenant Not to Sue’ (a legal term in which an aggrieved party agrees not to sue the party liable to such action) from Wyeth over Sun Pharma’s Abbreviated New Drug Application for generic venlafaxine extended release tablets with multiple para IV certifications.
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| Para IV certifications filed with the US Food and Drug Administration indicates the challenge on patents and the innovator has to sue the challenger, according to the US rules on generic drugs.
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| “This development means we can launch the product on expiry of the patent, which we will decide later” said a Sun Pharma spokesperson.
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| She declined to comment whether the company would enter into a settlement agreement with Wyeth, citing legal reasons.
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| Wyeth already has an out-of-court settlement with Teva Pharmaceuticals of the US for the same product in capsule form.
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| As per the terms of the settlement, Wyeth allowed Teva to sell Effexor XR in 2010, seven years ahead of its patent expiration. In return, Teva has to pay Wyeth a percentage of profits from sales.
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However, Wyeth chose to sue other challengers such as Lupin Pharmaceuticals, Impax Laboratories, Anchen Pharmaceuticals and Alsa Corporation (a subsidiary of Johnson & Johnson) in the case of Effexor XR.
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| US BREATHER
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Sun Pharma had challenged the patents on three strengths of Effexor, based on an innovative technology for extended release tablets
The company today said that it received a ‘Covenant Not to Sue’ (a legal term in which an aggrieved party agrees not to sue the party liable to such action) from Wyeth
Sun can launch the product on expiry of the patent |
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