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[e-drug] Generic heat stable lopinavir/ritonavir launched in India

  • From: "E-Drug" <e-drug@healthnet.org>
  • Date: Mon, 09 Apr 2007 14:19:24 +0200

E-DRUG: Generic heat stable lopinavir/ritonavir launched in India
[E-drug normally does not post commercial messages but this one by Cipla has
public health relevance. The heat-stable version of the original lop/r
(Aluvia by Abbott) does now have generic competition from India. See Cipla's
press release below. The advantages compared to the "old" lop/r (which had
to remain refrigerated in the warehouse) are obvious for tropical climates.
The generic price (USD 1560/year) is still more than what Abbott charges in
subsaharan Africa (USD 500/year) but seems competitive with Abbott's price
in the 45 middle income countries where it charges USD 2200/year. In the
"rich" countries the original product might even cost USD 7740/year.

Generic lop/r will be interesting for Thailand which recently issued a
compulsory license for the original product by Abbott.

E-drug also welcomes messages from middle-income countries whether generic
Lopi/r can be registered there, and whether compulsory licenses are needed
to import generic lopi/r from India. WB]


On 1st March 2007, CIPLA launched a new heat stable tablet formulation of an
antiretroviral drug Lopimune containing in combination, two potent protease
inhibitors, Lopinavir and Ritonavir, 200 mg and 50 mg, respectively per
tablet. This allows adult patients to take fewer pills with or without food
as part of their treatment regimen. Additionally, there will be no
refrigeration requirements for the tablets. These advantages are not
available with the Lopimune soft gelatin capsules also manufactured by

As per the Indian ARV guidelines, Lopimune is a recommended second line
option for treatment after patients have used a first line regimen
containing efavirenz or nevirapine.

Some Western countries recommend that the lopinavir / ritonavir combination
may also be used as a first line option for initiating therapy.

The major benefits of CIPLA¹s Lopimune tablets include:

* Lopimune tablets ­ fewer daily dosing
While the total daily dose of lopinavir/ritonavir in Lopimune is unchanged,
the number of Lopimune tablets that adult patients need to take is reduced
from 6 soft gel capsules to four tablets per day. Thus, the patient takes
fewer doses per day as part of an ongoing treatment regiment in adults.

* Lopimune tablets ­ independent of food effect
Whereas the Lopimune soft gel capsules needed to be taken after meals,
Lopimune tablets can be taken before or after meals. This certainly greatly
enhances patient adherence.

* Lopimune tablets - does not require refrigeration
Lopimune tablets do not require refrigeration, unlike the soft gel capsule
formulation. This improves convenience, especially in resource-limited
countries, where access to refrigeration and continuous cold-chain
facilities may not always be possible.

The current monthly cost of Lopimune tablets therapy in India (monthly pack
of 120 tablets) at the maximum retail price level is about Rs 5800/- (US$
130), whereas in the USA, the monthly cost of similar tablets is well in
excess of $ 645 per month.

Thus, the introduction of Lopimune tablets represents another major
patient-friendly advance in HIV therapy by CIPLA, both in India and