Approval of generic Buprenorphine/Naloxone combination/part 2

Actavis' Generic Suboxone® Receives FDA Approval

PARSIPPANY, N.J., Feb. 25, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone®.

Actavis intends to begin shipping the product immediately. Suboxone® is indicated for maintenance treatment of opioid dependence.

For the 12 months ending December 31, 2012, Suboxone® tablets had total U.S. sales of approximately $625 million, according to IMS Health data.

About Actavis

Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland.

Actavis is the world's third-largest generics prescription drug manufacturer. Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. The Company is ranked in the top 3 in 12 global markets, the top 5 in 16 global markets, and in the top 10 in 33 global markets. Actavis Pharma also develops and out-licenses generic pharmaceutical products outside the U.S. through its Medis third-party business, the world's largest generic pharmaceutical out-licensing business. Medis has more than 300 customers globally, and offers a broad portfolio of more than 200 products.

Actavis Specialty Brands is the Company's global branded specialty pharmaceutical business, which develops and markets a portfolio of approximately 40 products principally in the United States and Canada that are focused in the Urology and Women's Health therapeutic categories. Actavis Specialty Brands is committed to developing and marketing biosimilars products in Women's Health, Oncology and other therapeutic categories, and currently has a portfolio of 5 biosimilar products in development.

Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, with a capacity of approximately 44 billion units annually. Actavis Global Operations also includes Anda, Inc., the fourth-largest U.S. generic pharmaceutical product distributor in the United States.

For press release and other company information, visit Actavis' Web site at http://www.actavis.com.

Forward-Looking Statement

Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing information as of the date of this release. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actual results may differ materially from Actavis' current expectations depending upon a number of factors, risks and uncertainties affecting Actavis' business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Actavis and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and Actavis' Annual Report on Form 10-K for the year ended December 31, 2011 (such periodic public filings having been filed under the "Watson Pharmaceuticals, Inc." name). Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Suboxone® is a registered trademark of Reckitt Benckiser Healthcare (UK) Ltd.
source:
Actavis.com

Guest

That is great!! Thanks for sharing this Dee! I'm sure this will help a lot of people! Smile

Hope you're doing well!
Sorry I haven't been around much. Cooper has been sick.

Anyone know or found out what type of price tag this generic will have? Wonder when we will be able to get it prescribed? My doctors appointment is next week, I am definitely bringing this up because he said that the new generics was coming out soon and when they did, he would write it. Its nice that this has Naloxone in it, so they cant give me this crap bullshit line about no naloxone and people abuse it. He said that he would be honest with me and for me to be honest with him, if he dont write it then I will find another doctor end of story.
I have to save some money on the script if nothing else.

I haven't heard anything on how much it will cost and according to both companies who are making it they say they are shipping immediately so I would call around to find out.
If the doctor told you he would write for it when it was available then he probably will. It takes nothing out of his pocket to write for either prescription.
Give him a chance to come through for you.
I would be careful though when it comes to changing doctors and pharmacies. I don't want to make you angry but at the same time I don't want you to be accused of doctor shopping or anything else like it.

Oh no hun, I know what you mean. I just get a little wound up at times LOL. I will be so happy to find out the price of it, I seen somewhere that Amneal's product will be available early March. Im having a hard time typing. my pinky finger on my left hand is numb completely. Not sure if its a pinched nerve or if its my carpel tunnel syndrome acting up. its annoying thats for sure. so i figured out that my pinky finger is the shift key, so my sentences might not be capitalized like they are supposed to i apologize.

ive got my pharmacy talking with their supplier about the new generic. if i can find out a price, as soon as i do i will post it for you guys. i apologize i cant use my pinky finger still, its still numb.

sorry to hear about your finger. It does sound something like carpal tunnel, take care. Once you find out the cost in your area please do post it I'd like to compare it to others.
Hope you feel better.

It finally got the feeling back in it yesterday evening. There is a little numb spot in the pad of it but its small and atleast I can type with it now. Its my shift key holder and I play MMO games so I use that button ALOT. I need to add a new picture to my avatar, I got my hair done the other day. My husband and I did it, its half purple and half pink. Yes, Im nutty that way LOL. It looks so good, the colors really compliment each other well.
Anyways, I have been calling pharmacies pretty much everyday and no words yet. The day that I find out prices, I will post them here. Im not sure if the prices will be global, or if it will differ from state to state. I will do as much as I can to find out though. Yall are awesome, I love coming here and reading people's stories and experiences.

» Approval of generic Buprenorphine/Naloxone combination/part 1
» FDA approves another new Buprenorphine/Naloxone combination medication
» Is Generic Buprenorphine Approval a Blunder? Another opinion
» Is there a Generic Suboxone on the way?
» FDA Approval for Buprenorphine Pain Patch