Replies to post #16629 on Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

All I could find was that Teva's first notice delt with DR. Reddy. I'm not prevy to know how the fda sends out the Para IV notice. It would seem rather quick for the FDA to 'accept' both Mylan's and Momenta's filing one month later if they hadn't filed earlier.

I think being that both Mylan and Momenta happened to be accepted concurrently the FDA is telegraphing its intent.




Teva Comments on Receipt of First Paragraph IV Notice for COPAXONE® 40 mg/mL (glatiramer acetate injection) Formulation

August 07, 2014 12:04 PM Eastern Daylight Time

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE® 40 mg/mL product from Dr. Reddy’s Laboratories, Inc. Teva will continue to vigorously defend its COPAXONE® intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of FDA approval of Dr. Reddy’s ANDA.

COPAXONE® 40 mg/mL is protected by two Orange Book patents that expire in 2030.

http://www.businesswire.com/news/home/20140807005954/en/Teva-Comments-Receipt-Paragraph-IV-Notice-COPAXONE%C2%AE

[jbog]

alternatepatel,

Upon further research it looks like the FDA recieved its first submission much earlier, on Feb 26, 2014.

Glatiramer Acetate Injection 40 mg/mL,pre-filled syringe Copaxone 2/26/2014

That means that whoever filed it did not notify Teva at the same time. It looks like Reddy was the one who alerted Teva of it's intentions.

Maybe dew could explain while they didn't alert Teva back in Feb to start the 30 month clock.

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM293268.pdf