It seems that finally there is good news on the Effexor XR front.
Effexor XR is a franchise worth $ 2.6 billion in the
Sun Pharma has announced receipt of a 'Covenant Not to Sue' from Wyeth over Sun’s Abbreviated New Drug Application (ANDA covering three strengths: 37.5 mg, 75 mg and 150 mg) for generic venlafaxine extended release tablets with multiple para IV certifications.
Sun also has said that this ANDA is based on innovative technology for extended release tablets.
The OB has following patents listed for the XR capsule formulation:
US4535186 is the product patent that expires in June 2008 [incl. PED excl.].
US5916923 is the method of use patent covering treatment of generalized anxiety disorder, with a Dec 2013 expiry [incl. PED excl.].
US6444708 with a Dec 2013 expiry [incl. PED excl.] also has a similar coverage as the ‘923.
US6274171: Sep 2017 [incl. PED excl.].
US6403120: Sep 2017 [incl. PED excl.].
US6419958: Sep 2017 [incl. PED excl.].
As per the covenant, Wyeth covenants not to sue Sun under any claims for three patents:
US6,274,171;
US6,4013,120
and
US6,419,958.
It is interesting to note here that Wyeth's ER product is a capsule while Sun's ANDA is for a tablet product.
That leaves US5916923 and US6444708 in consideration, prior to launch by Sun.
Since Venlafaxine has multiple indications:
1. Major Depressive Disorder;
2. Generalized Anxiety Disorder;
3. Social Anxiety Disorder and
4. Panic Disorder
I am guessing that a launch is possible in the not too distant future
And if that happens then, we will have to see how the Wyeth/ Teva settlement pans out…
“…a license (exclusive for a specified period and then non-exclusive) under Wyeth's U.S. patent rights permitting Teva to launch an AB rated, generic version of Effexor® XR in the U.S. beginning on July 1, 2010, subject to earlier launch based on specified market conditions or developments regarding the applicable patent rights, including the outcome of any future generic challenges to such patent rights;…”
1 comments:
Sir, you state that Sun could launch the generic version of Effexor in the near future. But would Sun launch the drug when there is a patent litigation on between Alza and Wyeth. Potentially if Alza won there could be litigation actions against Teva and Sun too. I may be wrong, but I am trying to understand the final outcome ( specially the negative ones) if Sun launched it immediately after the FDA approval.
Thanks
Krishnendu
Post a Comment