March and April have proved to be busy months for the India-based firm, Glenmark Generics. On 11th April, Glenmark reported that it had settled pending patent litigation with GlaxoSmithKline regarding Glenmark's generic equivalent of the pharmaceutical giant's atovaquone and proguanil hydrochloride product, Malarone. Glenmark believes it is the first company to file an ANDA with a Paragraph IV certification for this product, and so will be entitled to the 180-days marketing exclusivity allowed under the Hatch-Waxman Act, once approval for its version is given. The patent litigation commenced in August 2009 in the US District Court for the District of Delaware; the settlement will enable Glenmark to launch its version in the third quarter of 2011, well before the expiration of the three patents in the FDA's Orange Book covering the product. All three expire on 25th November 2013, but all three have additional paediatric exclusivity periods until 25th May 2014. A paediatric dosage version of the product forms part of GlaxoSmithKline's NDA, but Glenmark is not challenging this version. Following on from its US approval for ropinirole in February 2010, on 7th April 2010, Glenmark announced that it had gained UK approval for the drug. The product, a generic equivalent of GlaxoSmithKline's Requip, is indicated for the treatment of restless legs syndrome.
Asides from its entanglements with GlaxoSmithKline, Glenmark has also had two other ANDAs approved in March and April in the US. On 26th March, its ANDA for 0.005% calcipotriene ointment was approved. The product, a generic equivalent of Leo Pharmaceuticals' Dovonex ointment, is indicated for the treatment of plaque psoriasis in adults. Leo's version is no longer marketed in the US, having been discontinued for reasons of commercial viability in April 2007. Glenmark appears to have the only marketed ointment version of the drug in the US; however, the fact that the branded version was discontinued for commercial reasons raises questions. Leo currently markets topical cream and solution variants of Dovonex; three generic versions of the topical solution variant are also marketed, by Tolmar, Hi-Tech Pharmacal and Nycomed. A few days later, on 1st April, Glenmark announced FDA approval for its 7.5 mg and 15 mg moexipril hydrochloride tablets. The product is a generic version of Schwarz Pharmaceuticals' Univasc, used in the treatment of hypertension. Branded revenues for the drug appear to be relatively small, and Glenmark's version joins long-established versions marketed by Teva Pharmaceutical Industries, Paddock Laboratories and Apotex. Glenmark noted that this approval complemented an approval for moexipril hydrochloride and hydrochlorothiazide, which was gained on 17th March 2010. On 31st March, Glenmark reported that NDAs for oxycodone hydrochloride capsules and liquid solution had been submitted by its partner, Lehigh Valley Technologies, to the FDA. The FDA has now begun reviewing the applications. Plenty of versions, both branded and generic, of oxycodone are currently marketed in the US, but these appear to all be in tablet form, which would perhaps explain why Lehigh has filed an NDA rather than an ANDA. Glenmark's partnership with Lehigh goes back to 2006, with an agreement covering two unnamed liquid generic pharmaceutical products. This was then extended some months later with an agreement covering another seven products for the US market.
However, the period has not been all plain sailing for Glenmark. On 16th March 2010, the FDA announced that it had ordered the firm to stop marketing unapproved nitroglycerin tablets. The FDA sent a warning letter requiring the tablets to be removed as part of the FDA's Unapproved Drugs Initiative, and gave Glenmark 15 days to respond with a discontinuation plan, and 90 days from the date of the letter to cease manufacturing. It is likely that Glenmark's ultimate response will be to file an ANDA for its version, in order to be able to bring it back to the market.
Ian Platts – Editor, World Generic Markets
Friday, April 23, 2010
Friday, April 9, 2010
AstraZeneca enters generics agreement with Torrent Pharmaceuticals
AstraZeneca has announced that it has entered into a licence and supply agreement with India's Torrent Pharmaceuticals. The firm has been vague on details, but said that the agreement would cover 18 products in nine countries, with the option to expand the agreement to cover more products and more countries. The countries are described as being emerging markets, which AstraZeneca believes will contribute around 70% of pharmaceutical industry growth in the next five years. The firm added that branded generics in these markets account for around 50% by value. The agreement will see Torrent manufacture and supply a portfolio of generics to AstraZeneca for which Torrent already has licences.
Exactly which countries AstraZeneca is referring to as emerging markets is open to debate, but Torrent claims a presence in a number of markets around the world. Included in these are African operations, including Zimbabwe, Kenya, Uganda, Nigeria, Ghana and South Africa. The firm claims it has 355 product registrations covering 14 countries in Africa, where it has seen revenues double since 1999/2000. Torrent also has made inroads into the Middle East, entering an agreement with a local producer in Saudi Arabia, and gaining approvals in Kuwait, Oman and Libya. The firm also has an eye on other markets in the Middle East, including Egypt, Syria and Jordan. Operations in Asia include a presence in Sri Lanka, Vietnam, Burma and the Philippines. Torrent also has a subsidiary in Brazil. Clearly, Torrent has developed a strategy of establishing commercial operations in the parts of the world that can be considered as emerging markets, which AstraZeneca will be well placed to exploit.
In making this agreement with Torrent, AstraZeneca is following in the footsteps of other large multinational innovator companies. Most notable in recent months has been Pfizer, which has entered into a series of agreements with Indian generic firms, similarly to AstraZeneca's tie-up with Torrent. Pfizer's agreements are the result of something of a change of heart for the firm, which until recently has been staunchly anti-generic in its outlook, despite the generally down-played existence of its Greenstone subsidiary, which produces generics. The firm has developed an Established Products Business Unit, specifically set up to exploit the international demand for generics; the shift in Pfizer's thinking perhaps underscoring the financial difficulties being faced by large innovator firms during globally economically constrained times.
Perhaps this is also the basis for AstraZeneca's similar change of heart. AstraZeneca has a stated aim to increase its penetration of emerging markets, although this is not specifically through generics. As with Pfizer, AstraZeneca's relationship with the generic industry has been somewhat fraught up until now. The firm's bitterly-fought battle to keep generic omeprazole off the global markets for as long as possible at the turn of the current century was something of a case study in aggressive legal tactics and market manipulation, and AstraZeneca was able to stave off the inevitable, and prolong its monopoly on the drug for some time past the expiration of the basic patents. The firm has not had a generics subsidiary, but has often reached settlements with generic firms in patent challenges, and in recent years has also fought generic competition by entering into authorised generic agreements, taking advantage of an issue that has split the generics industry in the United States. This latest agreement, linking the firm with a generic manufacturer, coupled with Pfizer's similar recent moves, perhaps reveals a sea-change in outlook for the branded industry.
Ian Platts – Editor, World Generic Markets
Exactly which countries AstraZeneca is referring to as emerging markets is open to debate, but Torrent claims a presence in a number of markets around the world. Included in these are African operations, including Zimbabwe, Kenya, Uganda, Nigeria, Ghana and South Africa. The firm claims it has 355 product registrations covering 14 countries in Africa, where it has seen revenues double since 1999/2000. Torrent also has made inroads into the Middle East, entering an agreement with a local producer in Saudi Arabia, and gaining approvals in Kuwait, Oman and Libya. The firm also has an eye on other markets in the Middle East, including Egypt, Syria and Jordan. Operations in Asia include a presence in Sri Lanka, Vietnam, Burma and the Philippines. Torrent also has a subsidiary in Brazil. Clearly, Torrent has developed a strategy of establishing commercial operations in the parts of the world that can be considered as emerging markets, which AstraZeneca will be well placed to exploit.
In making this agreement with Torrent, AstraZeneca is following in the footsteps of other large multinational innovator companies. Most notable in recent months has been Pfizer, which has entered into a series of agreements with Indian generic firms, similarly to AstraZeneca's tie-up with Torrent. Pfizer's agreements are the result of something of a change of heart for the firm, which until recently has been staunchly anti-generic in its outlook, despite the generally down-played existence of its Greenstone subsidiary, which produces generics. The firm has developed an Established Products Business Unit, specifically set up to exploit the international demand for generics; the shift in Pfizer's thinking perhaps underscoring the financial difficulties being faced by large innovator firms during globally economically constrained times.
Perhaps this is also the basis for AstraZeneca's similar change of heart. AstraZeneca has a stated aim to increase its penetration of emerging markets, although this is not specifically through generics. As with Pfizer, AstraZeneca's relationship with the generic industry has been somewhat fraught up until now. The firm's bitterly-fought battle to keep generic omeprazole off the global markets for as long as possible at the turn of the current century was something of a case study in aggressive legal tactics and market manipulation, and AstraZeneca was able to stave off the inevitable, and prolong its monopoly on the drug for some time past the expiration of the basic patents. The firm has not had a generics subsidiary, but has often reached settlements with generic firms in patent challenges, and in recent years has also fought generic competition by entering into authorised generic agreements, taking advantage of an issue that has split the generics industry in the United States. This latest agreement, linking the firm with a generic manufacturer, coupled with Pfizer's similar recent moves, perhaps reveals a sea-change in outlook for the branded industry.
Ian Platts – Editor, World Generic Markets
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