This excerpt taken from the GSK 20-F filed Feb 29, 2008.
Coreg CR. URL/ Mutual had filed an ANDA with the FDA with a certification of invalidity, unenforceability and non-infringement of the patents covering the crystalline salt form and delayed release technology used for manufacturing that product which expire in 2023 and 2016, respectively. In January 2008, the USPTO reissued the Groups patent on a method of use for administration of carvedilol with other therapeutic agents. The re-issued patent, which has been listed in the Orange Book, expires in 2016.
The Groups action against URL/Mutual was amended to include a claim for infringement of the re-issued patent. FDA approval of URL/ Mutuals ANDA is stayed until the earlier of June 2010 or resolution of the patent infringement action, but in no event can such approval issue prior to the expiration of the data exclusivity period in April 2010. The case is in its early stages.
This excerpt taken from the GSK 6-K filed Feb 7, 2008.
Coreg CR. URL/Mutual had filed an Abbreviated New Drug Application (ANDA) with the FDA with a certification of invalidity, unenforceability and non-infringement of the patents covering the crystalline salt form and delayed release technology used for manufacturing that product which expire in 2023 and 2016, respectively. FDA approval of that ANDA is stayed until the earlier of June 2010 or resolution of the patent infringement action but in no event can such approval issue prior to the expiration of the data exclusivity period in April 2010. The case is in its early stages.
In January 2008, the Group received a certification of invalidity, unenforceability and non-infringement from Barr Laboratories in respect of all three of its listed patents related to
This excerpt taken from the GSK 6-K filed Apr 25, 2007.
Coreg CR, a new simplified once daily, long-acting, cardiovascular treatment was launched in the USA on 22nd March for three cardiovascular conditions: hypertension, post-myocardial infarction left ventricular dysfunction and mild to severe heart failure.
This excerpt taken from the GSK 6-K filed Mar 22, 2007.
Coreg, Requip, Avodart and Boniva/Bonviva.
GSK continues to be the global leader in Respiratory with sales of its three key products, Seretide/Advair, Flixotide/Flovent and
This excerpt taken from the GSK 20-F filed Mar 2, 2007.
Coreg sales increased 38% to £773 million as it continued to benefit from its wide range of indications in heart disease. Zofran sales increased 8% to £679 million. A generic competitor to Zofran entered the market in November 2006.
Anti-bacterial sales declined 15% as a result of generic competition.
Sales in Europe contributed 27% of pharmaceutical turnover and grew 1%, to over £5.5 billion, with strong sales from Seretide, Avandia/Avandamet and vaccines offsetting the impact of generic competition to a number of products and continued price cuts resulting from government healthcare reforms.
Markets which recorded good growth included Germany, the UK, Central and South/East Europe whilst growth in France, the Netherlands, Poland, Italy and Spain was adversely impacted by pricing and generics.
Major growth drivers were Seretide, GSKs largest selling product in Europe, with growth of 10%, Avandia/Avandamet which grew 39%, and the vaccines franchise, up 20%. Sales of anti-virals grew 11% primarily due to government orders of Relenza as a measure in the event of a potential flu pandemic.
Generic competition negatively impacted sales of Seroxat down 20%, Lamictal down 22%, Zofran down 14% and Imigran, down 18%. Sales of anti-bacterials decreased 12% due to a combination of a weaker flu season than in 2005 and generic competition.
The performance in Japan was driven by the sales of Paxil, up 15%, Serevent, up 16% and Anti-virals, up 8% and the full year impact of Zyrtec, an allergy product in-licenced from UCB in 2005. These were partially offset by declines in the older products Zantac and Zovirax. Flonase also declined due to a low pollen season.
Across all markets in International, the key products driving growth were Seretide, which grew 9% to record sales of £310 million, the Avandia range of products which grew 17% to £234 million, HIV products which grew 8% and the vaccines franchise, which recorded growth of 13% and achieved sales of £518 million.
Consumer Healthcare sales
Consumer Healthcare sales grew 6% to £3.1 billion, with sales in International up 10% and Europe up 7%, performing well. Total sales in the USA were flat, with an improved performance in the fourth quarter, with sales up 7%.