NVS » Topics » Lotrel

This excerpt taken from the NVS 6-K filed Feb 9, 2010.
Lotrel (USD 322 million, —17% lc, only in the US), a single-pill combination therapy for high blood pressure, still has market exclusivity for higher-dose formulations, but sales contributions have fallen sharply after an “at risk” launch in mid-2007 by a generic competitor despite a US patent valid until 2017.

 

This excerpt taken from the NVS 6-K filed Apr 27, 2009.

Lotrel

A number of generic companies have challenged a patent valid in the US until 2017 for so-called “high-dose” and “low-dose” formulations of Lotrel, a single-pill combination high blood pressure medicine. Novartis filed infringement lawsuits against these manufacturers to enforce the intellectual property rights of Novartis. In 2007, Teva launched “at risk” its low-dose generic versions of Lotrel. A request by Novartis to grant a preliminary injunction was denied. The trial against Teva is expected in the second half of 2010. Separately, Novartis and Par/Kali have settled disputes on high-dose and low-dose versions of Lotrel.

 

This excerpt taken from the NVS 6-K filed Feb 9, 2009.

LOTREL

 

A number of generic companies have challenged the patent on high-dose and low-dose Lotrel. Novartis filed infringement lawsuits against these generic manufacturers to enforce Novartis’ rights under its patent. In 2007 Teva launched its generic version of low- dose Lotrel “at-risk.” Novartis’ request to grant a preliminary injunction against Teva was denied. The trial against Teva is expected in 2010.

 

This excerpt taken from the NVS 6-K filed Jan 29, 2009.
Lotrel (USD 386 million, –48% lc, only in the US), a single-pill combination therapy for high blood pressure, fell sharply after an “at risk” launch in mid-2007 by a generic competitor despite a US patent valid until 2017. Sales in 2008 came from higher-dose formulations that still have market exclusivity.

 

This excerpt taken from the NVS 20-F filed Jan 28, 2009.

Lotrel

        A number of generic companies have challenged the patent on high-dose and low-dose Lotrel. Novartis filed infringement lawsuits against these generic manufacturers to enforce Novartis' rights under its patent. In 2007 Teva launched its generic version of low-dose Lotrel "at-risk." Novartis' request to grant a preliminary injunction against Teva was denied. The trial against Teva is expected in 2010.

F-64


Table of Contents


NOTES TO THE NOVARTIS GROUP

CONSOLIDATED FINANCIAL STATEMENTS (Continued)

19.   Provisions and other non-current liabilities (Continued)

This excerpt taken from the NVS 6-K filed Oct 20, 2008.
Lotrel (USD 296 million, –55% lc, only in the US), a single-pill combination therapy for high blood pressure, has fallen since mid-2007 after an “at risk” launch by a generic competitor despite a US patent valid until 2017. Sales come from higher-dose formulations.

 

This excerpt taken from the NVS 6-K filed Jul 18, 2008.
Lotrel (USD 195 million, –67% lc, only in the US), a single-tablet combination therapy for high blood pressure, has faced generic competition in the US for some strengths since May 2007 after an “at risk” launch despite a valid US patent until 2017.

 

This excerpt taken from the NVS 6-K filed Apr 22, 2008.
Lotrel (USD 95 million, –73% lc, only in the US), a single-tablet high blood pressure combination therapy, has been severely impacted since May 2007 following the “at risk” launch of a generic copy by Teva Pharmaceuticals despite a valid US patent until 2017. Novartis is vigorously defending its patent rights. Sandoz also launched an authorized generic version.

 

This excerpt taken from the NVS 6-K filed Feb 8, 2008.

Lotrel

 

Novartis is involved in US patent litigation involving Lotrel, a combination of high blood pressure medicines benazepril hydrochloride and amlodipine besylate sold only in the United States. Patent protection for both of these active ingredients has ended in the United States. However, Lotrel is still covered in the United States by a combination patent valid until 2017. Novartis filed infringement lawsuits against generic manufacturers to enforce Novartis rights under this patent. In May 2007, Teva launched its generic version “at-risk.” A trial is expected in 2008.

 

This excerpt taken from the NVS 20-F filed Jan 28, 2008.

Lotrel

        Novartis is involved in US patent litigation involving Lotrel, a combination of high blood pressure medicines benazepril hydrochloride and amlodipine besylate sold only in the United States. Patent protection for both of these active ingredients has ended in the United States. However, Lotrel is still covered in the United States by a combination patent valid until 2017. Novartis filed infringement lawsuits against generic manufacturers to enforce Novartis' rights under this patent. In May 2007, Teva launched its generic version "at-risk." A trial is expected in 2008.

This excerpt taken from the NVS 6-K filed Jan 23, 2008.
Lotrel (USD 748 million, –45% lc, only in US) has been negatively affected since May 2007 following the “at risk” launch of a generic copy by Teva Pharmaceuticals despite a valid US patent until 2017. Sandoz also launched an authorized generic version of this high blood pressure medicine. A trial date has not been set for the ongoing lawsuit against Teva, which risks potentially significant damages if Novartis prevails.

 

This excerpt taken from the NVS 6-K filed Oct 22, 2007.
Lotrel (USD 660 million, –34% lc, only in US) has been negatively affected since May 2007 following the “at risk” launch of a generic copy by Teva Pharmaceuticals despite a valid US patent until 2017. Sandoz has launched an authorized generic version of this high blood pressure medicine. A trial date has not been set for the ongoing lawsuit against Teva, which risks potentially significant damages if Novartis prevails.

 

This excerpt taken from the NVS 6-K filed Jul 19, 2007.

Lotrel

Novartis is involved in US patent litigation involving Lotrel, a single-capsule combination of the high blood pressure medicines benazepril hydrochloride and amlodipine besylate sold only in the United States. Patent protection for both of these active ingredients has ended in the US, most recently for amlodipine besylate in March 2007. However, Lotrel is still protected by a combination patent in the US valid until 2017, and Novartis filed infringement lawsuits against generic manufacturers that challenged this patent. In March 2007, Novartis filed a motion for preliminary injunction to stop an “at-risk” launch by Teva Pharmaceuticals, which was denied. Teva then elected in May 2007 to launch its generic version in the US. A trial date has not been set for the ongoing patent infringement lawsuit. Novartis will continue to pursue its claims against Teva for damages and injunctive relief.

 

This excerpt taken from the NVS 6-K filed Apr 26, 2007.
Lotrel is a combination of benazepril hydrochloride and amlodipine besylate. Patent protection for the benazepril substance has expired in the US. The US Court of Appeals for the Federal Circuit invalidated certain patent claims directed to the amlodipine besylate substance in March 2007; the patent itself expired at the end of March 2007. Lotrel is protected by a combination patent in the US until 2017. Generic manufacturers have challenged this patent, and Novartis has sued them. In March 2007, Novartis filed a motion for preliminary injunction against an at-risk launch by Teva.

 

 

16



 

This excerpt taken from the NVS 6-K filed Feb 14, 2007.
Lotrel is a combination of benazepril hydrochloride and amlodipine besylate. Patent protection for the benazepril substance has expired in the US. Patent protection for the amlodipine besylate substance will expire in the US in March 2007. In addition to these patents, Lotrel is protected by an additional combination patent in the US until 2017. Generic manufacturers have challenged this patent, and Novartis has sued them. Our action against one of these manufacturers is currently stayed.

160




Several matters which Novartis previously disclosed were resolved in 2006, or are likely to be resolved in 2007 or afterwards, with no significant risk to the Group’s financial position absent unforeseen events or circumstances. These matters are: Fen-Phen and PPA product liability litigation; Chiron Acquisition, Pharmaceutical Antitrust Litigation, Canadian Importation Litigation and Terazosin litigation; the UK Generics investigation; and intellectual property litigation involving the Group’s products Exelon, Famvir, Focalin, Miacalcin/Miacalcic, Neoral and Omeprazole.

Novartis believes that its total provisions for legal and product liability matters are adequate based upon currently available information, however, given the inherent difficulties in estimating liabilities, it cannot be guaranteed that additional costs will not be incurred beyond the amounts provided. Management believes that such additional amounts, if any, would not be material to the Group’s financial condition but could be material to the results of operations and cash flows in a given period.

The following table shows the movements in the legal and product liability provisions during 2006 and 2005:

 

 

2006

 

2005

 

 

 

USD millions

 

USD millions

 

January 1

 

825

 

1 012

 

Impact of business combinations

 

46

 

79

 

Cash payments

 

-159

 

-249

 

Releases

 

-56

 

-107

 

Additions

 

233

 

115

 

Translation effects

 

14

 

-25

 

December 31

 

903

 

825

 

Less current liability

 

-269

 

-204

 

Total non-current liability at December 31

 

634

 

621

 

 

This excerpt taken from the NVS 20-F filed Jan 31, 2007.

Lotrel

        Lotrel is a combination of benazepril hydrochloride and amlodipine besylate. Patent protection for the benazepril substance has expired in the US. Patent protection for the amlodipine besylate substance will expire in the US in March 2007. In addition to these patents, Lotrel is protected by an additional combination patent in the US until 2017. Generic manufacturers have challenged this patent, and Novartis has sued them. Our action against one of these manufacturers is currently stayed.

        Several matters which Novartis previously disclosed were resolved in 2006, or are likely to be resolved in 2007 or afterwards, with no significant risk to the Group's financial position absent unforeseen events or circumstances. These matters are: Fen-Phen and PPA product liability litigation; Chiron Acquisition, Pharmaceutical Antitrust Litigation, Canadian Importation Litigation and Terazosin litigation; the UK Generics investigation; and intellectual property litigation involving the Group's products Exelon, Famvir, Focalin, Miacalcin/Miacalcic, Neoral and Omeprazole.

        Novartis believes that its total provisions for legal and product liability matters are adequate based upon currently available information, however, given the inherent difficulties in estimating liabilities, it cannot be guaranteed that additional costs will not be incurred beyond the amounts provided. Management believes that such additional amounts, if any, would not be material to the Group's financial condition but could be material to the results of operations and cash flows in a given period.

        The following table shows the movements in the legal and product liability provisions during 2006, 2005 and 2004:

 
  2006
  2005
  2004
 
 
  ($ millions)

  ($ millions)

  ($ millions)

 
January 1   825   1,012   867  
Impact of business combinations   46   79      
Cash payments   (159 ) (249 ) (141 )
Releases   (56 ) (107 ) (71 )
Additions   233   115   343  
Translation effects   14   (25 ) 14  
   
 
 
 
December 31   903   825   1,012  
  Less current liability   (269 ) (204 ) (316 )
   
 
 
 
Total non-current liability at December 31   634   621   696  
   
 
 
 

F-57


This excerpt taken from the NVS 6-K filed Jan 24, 2007.
Lotrel (USD 1.4 billion, +26% only in US), the leading fixed-dose combination treatment for hypertension in the US since 2002, has delivered strong growth based on new dosing strengths as well as increasing use of multiple therapies to treat hypertension, demographic factors and the impact of US disease awareness campaigns.

 

This excerpt taken from the NVS 6-K filed Oct 24, 2006.
Lotrel (USD 998 million, +28% only in US), the No. 1 fixed-dose combination treatment for hypertension in the US since 2002, has benefited from new dosing strengths as well as increasing use of multiple therapies to treat hypertension, demographic factors and the impact of US disease awareness campaigns.

 

This excerpt taken from the NVS 6-K filed Jul 18, 2006.
Lotrel (USD 643 million, +26% only in US), the No. 1 fixed-dose combination treatment for hypertension in the US since 2002, was supported by increasing use of multiple therapies to treat hypertension and the impact of US disease awareness campaigns. Two new dosing strengths were launched in June combining the calcium channel blocker amlodipine with the highest-available dose of the angiotensin-converting enzyme (ACE inhibitor) benazepril.

 

This excerpt taken from the NVS 6-K filed Apr 27, 2006.
Lotrel, and is thus seeking to bring a fully substitutable product to the US market. Novartis has filed suit against Watson in the US for patent infringement.

 

                 

This excerpt taken from the NVS 6-K filed Jan 20, 2006.
Lotrel (2005: USD 1.1 billion, +17% only in US) (Q4: USD 297 million, +17% US), the No. 1 fixed combination treatment for hypertension in the US since 2002, kept up strong double-digit growth based on new guidelines recommending more aggressive treatment of elevated blood pressure with multiple medicines and the US disease awareness campaign.

 

This excerpt taken from the NVS 6-K filed Sep 21, 2005.
Lotrel) as well as in development (such as LAF237 and SPP100), to help physicians address the increasing convergence of hypertension, dyslipidemia and diabetes in patients worldwide. Other compounds in development include
Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki