PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: GenericsWeb Pty Ltd | Ark Patent Intelligence

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Novartis’ Blockbuster Zoledronic Acid – Overview of IP Situation and Litigation - GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching generic versions of Zoledronic Acid
Novartis’ Blockbuster Zoledronic Acid – Overview of IP Situation and Litigation

 

NewswireToday - /newswire/ - Sydney, New South Wales, Australia, 2011/09/27 - GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching generic versions of Zoledronic Acid.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Marketed by Novartis, Zoledronic Acid is indicated for the treatment of oncology-related bone conditions (Zometa®) and non-oncology related bone conditions (Reclast®/Aclasta®) with reported global sales of USD $1.5bn and USD $580m in 2010 respectively.

The article by GenericsWeb highlights the following observations in relation to generic Zoledronic Acid:

• Zometa (4mg/5mL) and Aclasta (5mg/100mL) are currently available for intravenous (IV) administration, the frequency of administration depending on the indicated bone condition under treatment.
• Both Boehringer Mannheim/Roche and Novartis are the registered patentees of two patent families which protect the Zoledronic Acid molecule with over three months between their respective priority applications.
• Molecule protection for the earlier Boehringer Mannheim patent family remains in force in Europe via Supplementary Protection Certificates (SPCs) and a national patent term extension in Australia until July 2012, and early 2014 in Canada. Equivalent protection has already expired in the US.
• In most major European territories, SPCs also protect the Zoledronic Acid molecule in Novartis’ later molecule patent family with SPCs expiring in November 2012. Novartis has successfully complied with the measures in agreed paediatric investigation plans (PIP) and has been awarded 6 month extensions to the terms of the SPCs, giving an expiry of May 2013. National patent term extensions have also been granted in Australia and the US with expiries of November 2012 and May 2013 respectively.
• In all major territories where Zoledronic Acid has been marketed, the data and marketing exclusivity have already expired and are not a factor for generic competition.
• In the US, tentative FDA approvals for generic Zoledronic Acid have been granted to Apotex, Bedford, Emcure, Hospira, Pharmaceuticals International, Pharmaforce, Sun and Teva.
• Paragraph IV filings have been identified relating to generic Zometa and Reclast however litigation was resolved after Teva discontinued a patent challenge and agreed to not launch Zoledronic Acid in the US until expiry of Novartis’ molecule patent.
• Generics company Teva appears in the top five applicants for patents relating to Zoledronic Acid.

GenericsWeb notes that: “In summary, Novartis’ protection remains in force for the Zoledronic Acid molecule in Europe as a result of SPCs and extended patents in other major territories and as such represents a barrier to generic competition. Considering the global sales of Zoledronic Acid the expiry of this molecule protection means that generic competition will undoubtedly be very strong once molecule protection expires, provided later filed patents are not granted in a manner where the claims cannot be circumvented.”

About GENERICSWEB – THE SEARCH IS OVER

GenericsWeb (genericsweb.com), the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: GenericsWeb Pty Ltd | Ark Patent Intelligence

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


Novartis’ Blockbuster Zoledronic Acid – Overview of IP Situation and Litigation

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Yoann Bretonnet - GenericsWeb.com 
+61(2) 9262 7696 y.bretonnet[.]genericsweb.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any GenericsWeb Pty Ltd | Ark Patent Intelligence securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From GenericsWeb Pty Ltd | Ark Patent Intelligence / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

Greenphire Sponsors Second Annual Clinical Trial Agreements, Investigator Payments and Fair Market Value Meeting
Genentech’s Gazyva Helped People with Previously Untreated Follicular Lymphoma Live Significantly Longer
BD Announces Adoption of Windows 10 ‘Internet of Things’ for the Pyxis™ ES System
Greenphire Named to Deloitte 2016 Technology Fast 500™
Genentech Showcases New Clinical Data Across a Variety of Blood Diseases at American Society of Hematology 2016 Annual Meeting
BD Collaborates with JDRF to Focus on Extended Wear Innovations for Insulin Infusion Delivery
BD Launches First Syringe Designed for Use with Humulin® R U-500 Insulin
MDxHealth Announces Unique CPT Code Awarded for ConfirmMDx from the American Medical Association
BD MAX™ Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Greenphire Receives EU-US Privacy Shield Certification
The 2016 Georges Mathé Prize Recognizes Research on the Immunological Determinants of the Response to Breast Cancer Treatment
MDxHealth Announces Agreement with HIFU CLINIC Prostate Cancer Center for Distribution of SelectMDx in Poland
First Patient in Malaysia Receives TheraSphere™ Radioembolisation Therapy
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) Prefilled Syringe
BTG and Mirada Medical Announce CE Mark Certification for Simplicit90Y Dosimetry Software in Europe

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  La Bella Bakery Artisan Bakery Arizona

Visit  JobsWare.com





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)