Sanofi's formulation patents on multibillion-dollar Lantus are Invalidated by US PTE16 Dec 2018
Mylan achieves key milestone to provide US diabetes patients with more affordable generic version of Sanofi's Lantus insulin glargine vials.
Mylan has announced that the US Patent and Trademark Appeal Board (PTAB) has ruled in favor of Mylan in its inter partes review (IPR) proceedings and found all claims of Sanofi's Lantus (insulin glargine 100 Units/mL) formulation patents (US Patent Nos. 7,476,652 and 7,713,930) unpatentable.
Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes for the control of high blood sugar. Sanofi sells the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR). Mylan's 505(b)(2) New Drug Application (NDA) for generic versions of Lantus and Lantus SoloSTAR, co-developed with Biocon, is under active review by the FDA.
Mylan CEO Heather Bresch commented: "For years, Mylan has been investing in the development of a more affordable generic to insulin glargine for diabetes patients. The PTAB's favorable ruling that invalidates two Sanofi Lantus formulation patents is an important step forward in our journey to help address the needs of nearly 30 million Americans living with diabetes. We take seriously the responsibility to improve insulin access and are honored to be a part of the solution that will bring much-needed competition to this critical market."
In October 2017, Sanofi initiated patent infringement litigation against Mylan's NDA in the United States District Court for the District of New Jersey that includes these two formulation patents listed as covering Lantus as well as other patents listed as covering the Lantus SoloSTAR injection pen. That litigation is pending, and no trial date has been set.
Sanofi's total IQVIA sales for the 12 months ending Oct. 31, 2018, were approximately $2.14 billion for Lantus 100 Units/mL and about $4.39 billion for Lantus SoloSTAR.
Specialist API CDMO acquired by GHO Capital
16 Mar 2019
Future plan is to extend Sterling’s international presence to meet increasing demand from customers worldwide.Read more
Bringing next generation single-use sensor technologies to the life science market
14 Mar 2019
Pall and Broadley-James’ combined expertise proves complementary in addressing critical customer pain points in modern bioprocessing.Read more
Third Sartorius Research Xchange Forum 2019 focuses on CAR-T cell therapy
13 Mar 2019
Event for experts from academia and industry, including talks, live demo sessions, and panel discussion.Read more
TraceLink submits an interoperable blockchain network solution for FDA DSCSA Pilot Project Program
12 Mar 2019
Trace Histories is a purpose-built distributed ledger solution for ensuring patient safety by 2023 DSCSA deadline.Read more
Overcoming lyophilization challenges at Interphex 2019
10 Mar 2019
Line of Sight approach to freeze-drying enables organizations to bring pharmaceutical products safely and quickly to market.Read more
Catalent invests over $27 million to commercialize Zydis Ultra
7 Mar 2019
Zydis Ultra allows a patented and innovative drug coating to be introduced during a product’s formulation, enabling the dosage of active ingredient to be up to four times higher than a conventional Zydis ODT.Read more
Novel systems for membrane chromatography
6 Mar 2019
Optimally run membrane chromatography processes will provide higher productivity, smaller-scale operations and increased robustness.Read more
Lilly to introduce lower-priced insulin
5 Mar 2019
Authorized generic version of Humalog will be available in US pharmacies at 50% lower list price.Read more
Biogen acquisition boosts its ophthalmology pipeline
4 Mar 2019
Nightstar Therapeutics has two potentially first-in-class mid- to late-stage clinical assets as well as preclinical programs.Read more
Uniqsis expands LED photoreactor range
3 Mar 2019
The availability of three new alternative switchable LED configurations provides chemists with the unique ability to optimally undertake almost any photochemistry reaction.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation