Generic- Watsons Won't Be Out In Sept/2012

Endo expects to finish converting patients to the new formulation of Opana ER in 2Q12.
Generics/Patent: The patent on Opana ER has been challenged by many companies, namely, Sandoz
(Novartis), Impax Laboratories, Teva, Watson, Actavis, Roxane Laboratories and Ranbaxy. The company
has settled all disputes apart from the one associated with Ranbaxy which Endo has decided not to
challenge. Consequently, Ranbaxy can sell the generic versions of Opana ER from September 9, 2013.
Following the settlements with all other challengers, they have agreed not to challenge patents relating to
Opana ER. Actavis launched the generic version of non-tamper resistant formulation of Opana ER (7.5
and 15 mg dosages) on July 15, 2011. Impax can sell generic versions of Opana ER from January 1,
2013. Sandoz, Teva, Watson, Roxane and Actavis can sell all doses of the generic version of non-tamper
resistant Opana ER from July 1, 2013. Ranbaxy is expected to launch its generic version on
September 9, 2013.
In March 2012, Endo announced that it has acquired US patent 7,851,482 B2 for the key API in all
formulations of Opana from Johnson Matthey. Endo expects to enjoy additional protection for the
Opana franchise through 2029.
$ in million 2011A 2012E 2013E 2014E 2015E Est. Growth (11- 14)
Opana ER $385.7 $434.2 $405.3 $430.4 $474.5 3.7%
Frova (

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REPORT

pharmpro.com has an article on this from the Associated Press stating that WATSON can sell their generic in SEPTEMBER of 2012, It's already approved by the FDA.. so where did u get this b.s from?

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This is a article that was posted this year. The article about Watson Generic Opana is from Oct. 2010. Things have changed since then.


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Penwest Rallies As Impax, Sandoz To Sell Opana ER Generics

DOW JONES NEWSWIRES Endo Pharmaceuticals Holdings Inc. (ENDP) said it and Penwest Pharmaceuticals Co. (PPCO) have agreed to grant two separate licenses to sell generic Opana extended-release pain-relief tablets. Shares of Penwest, whose fortunes are significantly tied to Opana, jumped 21% to $3.35 as the deals eliminate uncertainty that has hung over the company for years. The stock is up 53% the past year, but traded above $20 in 2006. Impax gained 0.9% to $19.96 while Endo added 9 cents to $20.31. Opana ER has been a source of continuing patent litigation for the developers. Penwest in May said it settled a separate dispute with Barr Laboratories related to the drug. Sales for the Opana franchise generated $66 million for Endo in its latest quarter, a 25% increase from the year-earlier period, it said in April. On Tuesday, Endo said it and Penwest granted Novartis AG's (NOVN.VX) Sandoz Inc. unit a license to sell a generic version of Opana in September 2012. Impax Laboratories Inc. (IPXL) will get a similar license, effective at the start of 2013. Impax will have 180 days of exclusivity for tablets with several dosages of the drug, Endo said. Opana ER is used to relieve moderate to severe pain in patients requiring around-the-clock treatment for an extended period of time, according to a website for the drug. -By Matt Jarzemsky; Dow Jones Newswires.

Generic Opana - Topics - The People's Medicine Community: /topics/generic-opana/
10 posts - 4 authors - 3 days ago
generic- watsons won't be out in Sept/2012 Filed in Opana Endo expects to finish converting patients to the new formulation of Opana ... Consequently, Ranbaxy can sell the generic versions of Opana ER from September 9, 2013. ...

If you can show me something that is dated this year would be nice. I am going by what I read. Have you spoke to Watson about the generic Opana? I want the generic to come out. I was in a bad motorcycle wreck and have had 17 operations. Opana is the only pain meds that has helped me in years. The new doesn't work as well and I take it like it tells me too. The article also states it will be the non-which i guess it means the plastic meds. I have found articles in many places stating Opana ER generic won't be out in Sept. this year. Please, prove they are wrong.

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I also found this article where the old opana's have been placed in the Orange book which means it can no longer be produced.

Endo Completes Transition of OPANA® ER Franchise to New Formulation Designed to be Crush Resistant
Source Press Release
Company Endo Health Solutions, Grünenthal
Tags Withdrawn Post Marketing, USA, Central Nervous System
Date June 14, 2012

Endo Completes Transition of OPANA® ER Franchise to New Formulation Designed to be Crush Resistant

CHADDS FORD, Pa., June 14, 2012 /PRNewswire/ -- Endo Health Solutions (Nasdaq: ENDP), today announced the completion of the company's transition of its OPANA ER franchise to the new formulation designed to be crush resistant. In connection with the completion of this transition, the U.S. Food and Drug Administration (FDA) has moved the old formulation of OPANA ER to the Orange Book Discontinued List.

"While the original formulation of OPANA ER was deemed by FDA to be safe and effective when taken according to the prescribing information, the original formulation was subject to both intentional and inadvertent abuse and misuse," said Dr. Ivan Gergel, chief scientific officer of Endo. "Patient safety is our top concern and addressing appropriate use of opioids is a responsibility that we take very seriously. We firmly believe that the new formulation of OPANA ER, coupled with our long-term commitment to awareness and education around appropriate use of opioids will benefit patients, physicians and payers."

As a result of the FDA placing OPANA ER (NDA 21-610) in the Orange Book Discontinued List, all strengths of the original formulation of OPANA ER are now on the Discontinued List. The OPANA ER (NDA 21-610) 7.5 mg and 15 mg dosage strengths were moved to the Discontinued List previously. The new formulation of OPANA ER designed to be crush resistant (under NDA 201655) remains on the approved prescription drug product list as it is the only currently available formulation.

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I printed out the paper.. I'll type out the exact page that tells me from the Associated Press that Watson will be putting their generic version out in September OF THIS YEAR.

pharmpro.com/News/FeedsAP/2010/10/watson-pharma-can-launch-generic-opana-er-in-2012/

Good luck

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I am not trying to be picky but that was from 2010. The articles I am reading now are from 2012.
things have changed. I want Watson to have generic Opana out in Sept. of this year. It will make it easier for me to pay for it.

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I dont think it matters man.. Read the source, read where the info is coming from.. Looks legit to me... Where's the info you are reading coming from?

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If the FDA approves it.. Why in the world would they not put it out?? They don't like to make money?

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I think everyone wants the same thing: a less costly and hopefully a better working product! My insurance company has Opana ER as a "non preferred" formulation, which means I pay a $45 copay per month. When a generic is out, it will only cost me $10 per month! So, I'm confused when they will be available, but the sooner, the better! Does anyone have a concrete date when this will happen...not opinions, but published hard facts? It'sg important, as the $35 difference may not sound like much to some, but I may have to switch to another medication because of it. I would rather not switch and adjust, only to then learn that the generic was now available! Thank you for your assistance in this matter, and god bless you fellow pain sufferers!

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Watson will not be making generic opana ER until JUNE OF 2013. Sad but true. I called Watson to find out for myself last week because I heard via online it was going to be September of this year. The only thing people can do is call ENDO and complain to a pharmacist about adverse effects, one of the pharm. told me if enough people complain they will change the formula. The generic news is sad and disappointing.

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I have called Watson and Impax concerning the release date of the generic Opana. Neither one has a date of release. Does anyone know the correct answer for this question? There are so many things on the internet but when you call these companies nothing seems the truth. Impax said they are working on the generic product but no date of release. Is it the old Opana's or the new ones? People have a right to know when they spend so much money on their meds for their health. If I could I would quit taking every single med I have but I don't want to die yet or be in terrible pain that I can't live my life. Everyone needs to get together and stand up for their rights when it comes to their health.

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RIGHTS!??? What rights? They don't owe you any explanation, unless you are a stockholder...and then probably not! Endo gets the money you spend on Opana, and believe me, they spend part of it on making sure that a generic doesn't come out! Look at what happened with Oxycontin, and how they spent millions to delay anyone else from making a generic...It's all about money with drug companies!
And these rights you speak of when it comes to health care...well, they don't exist in this case! We are only guaranteed life, liberty and the PURSUIT of happiness...not happiness, but the pursuit of it!

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I just found this on the internet today. Endo is trying to block generic Opana from being produce.

« Latest News From "The Pink Sheet" DAILY - Sequestration Would Cut $319 Million From FDA Budget | Main
September 17, 2012
Coming In Tuesday's "The Pink Sheet" DAILY - Endo Seeks To Block Generic Versions Of Opana ER

Endo Pharmaceuticals filed a citizen petition with FDA seeking to block approval of generic versions of its discontinued, non-crush resistant Opana ER (oxymorphone). FDA approved Endo’s new formulation that resists crushing in December 2011.

FDA’s Vaccines and Related Biological Products Advisory Committee will discuss the parameters for using emerging technologies to look for known and novel adventitious agents in vaccines produced with novel cell substrates, including those derived from human tumors, at its Sept. 19 meeting.

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They are companies that are still trying to get generic Opana approved. ThoRx and Ranbaxy. They filed this month. Also everyone should look at the Hatch-Waxman Act. It was when Pres. Bush was in office.
FYI-
OxyContin Without Safety Features could Return to Pharmacies
By StopOxy

A national organization that fights prescription drug abuse is sounding the alarm about the possibility of pain pills without safety features being released to pharmacies across the nation. The nonprofit Center for Lawful Access and Abuse Deterrence (CLAAD) is urging the FDA to prevent the return of crushable versions of OxyContin and Opana.

This Org is Raising the Alarm about Abusable Painkillers

Under government pressure, the makers of these powerful opioid drugs reformulated their products to prevent abuse. The new versions of the drugs are resistant to crushing, making it impossible to smoke, snort or inject the drugs in order to circumvent their time-release formula. Studies have shown that prescription drug abusers and dealers are less interested in the new versions of the drugs because of their tamper-resistant features.

The Generics Might Not Be Safeguarded

Despite evidence that reformulation of painkillers has reduced abuse, several drug companies have requested FDA approval for generic versions of these drugs. The generic pills, which would have no abuse-deterrent features, could be released to pharmacies early in 2013.
CLAAD recently sent a letter to the FDA urging the agency to halt the marketing of generic versions of OxyContin and other opiate drugs without abuse-deterrent features. The letter was co-signed by several other public health organizations, including the American Academy of Pain Management and The Partnership at DrugFree.org. A bill that is currently before the U.S. House of Representatives would require drug manufacturers to use tamper-resistant formulas for all opioid painkillers, including the generic versions of OxyContin and Vicodin. The bill is not expected to be approved before the expected release of the generic formulas.FYI-
Posted on November 28, 2012 by Erin Marie Daly

The Canadian government has given the stamp of approval to six generic versions of the widely abused painkiller OxyContin, despite urgings from some of the country’s leading pain doctors and researchers to hold off, according to this article.

The green light from Health Canada came just after the expiration of the patent held by Purdue Pharma for its long-acting formulation of oxycodone, the active ingredient in OxyContin, the article says.

OxyContin in Canada was phased out earlier this year by Purdue and replaced by an abuse-resistant version known as OxyNEO. But the newly-approved generics will use the same older formulation in the now discontinued Oxy-Contin, the article notes. FYI- ThoRx filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Opana®ER with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from FDA that ThoRx’s ANDA had been accepted for filing, ThoRx notified the New Drug Application holder and patent owner of its paragraph IV certification.

On November 14, 2012, Endo Pharmaceuticals Inc. and Grunenthal GMBH filed suit for patent infringement against ThoRx Laboratories, Inc. and Impax Laboratories, Inc. in the United States District Court for the Southern District of New York. This action formally initiates the patent challenge process under the Hatch-Waxman Act.

Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, intends to commercialize the product.

Opana® ER is indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time. According to Wolters Kluwer Health, U.S. sales of Opana® ER were approximately $90 million for the three-month period ending September 2012.

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To Silver:
Thank you for the posting... The information was quite helpful and very concise!

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Is the generic impax version of opana going to be non tamper or is any pharmacy co going to make them with out timerx

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They are planing in making them without tamper abuse properties. Endo pharmaceuticals owns the release system. Of course they might use another method... no one knows... plus they whole thing is held Up in litigation...

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I thought it comes out Jan 1st by impax. Read the legal info they won and it's out jan 1.

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The generic opana is the old opana but later things could change. Bottom line is people need to quit abusing them. Take them the correct way. They do help the pain more than the new ones just taken by mouth. FDA has just came out with the memo below wanting to make all pain meds abuse proof.
FYI:

FDA NEWS RELEASE

For Immediate Release: Jan. 9, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397; [email protected]
Consumer Inquiries: 888-INFO-FDA
FDA issues draft guidance on abuse-deterrent opioids

The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,†explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.

“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation,†said FDA Commissioner Margaret A. Hamburg, M.D. “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.â€

Opioids can be abused in a number of ways. Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation. The science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. In working with industry, the FDA will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.

“While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States,†said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.â€

The FDA continues to encourage the development of abuse-deterrent formulations of opioids and believes that these products have promise to help reduce prescription drug abuse. At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics.

This draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy’s (ONDCP) Prescription Drug Abuse Prevention Plan.

“Our nation is in the midst of a prescription drug abuse epidemic,†said Gil Kerlikowske, director of National Drug Control Policy. “While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic. This guidance is a vitalcomponent of the Administration’s comprehensive effort to reduce prescription drug abuse in America, and we commend the FDA for its commitment to this challenge.â€

FDA is seeking public comment on the draft guidance for 60 days and encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies. Instructions on how to submit comments will be announced in an upcoming Federal Register notice. The FDA will also hold a public meeting to discuss and receive feedback on the draft guidance. In finalizing the guidance document, the agency will consider the information received from the public.

FDA: Draft Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling
ONDCP: Prescription Drug Abuse

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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"abuse-deterrent properties" is pretty vague! Whom is going to fecide if a drug has those properties, what ever they decide they are to be!?!?! It's a government agency, it will take forever for them to get anything done about this... and when/if they do... there will be many loopholes for the makers!

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To pain sucks:
Your right... They are out now, although my pharmacy didn't have them yet. They said they will on my next visit, which is Feb. 5th.

To no name "also":
Nobody likes a smart a**

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New generic opana is still not available at my pharmacy... and the pharmacist said that she is having trouble getting the branded Opana... says their is another major shortage due to drug company slowing down production because of expected lower need due to generic being out!!! @&*#$% If it wasn't such a pain, it would be funny!

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hi im in tennesse,does any one no of a pharmacy here that has these? im so happy they got approved!! i dont abuse them but the trf ones sucked bad didnt help at all.thanks for the help!!

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Try a independent pharmacy. I know someone who went to a mom and pop pharmacy and they ordered it for him. He received it 3 days later. This wasn't in Ohio. I don't know what is going on that so many people can't get their scripts filled. Every state is different. Some places have it others don't. Call Global. Its Impax generic company that process the generic. Maybe they can tell you where to find it. You can go online to find their number.

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Also if anybody knows a place in the Cincinnati Ohio area where I can find these please let me know.

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I tried a specialty compounding pharmacy they also were out. My local pharmacy said they could order it if they could find a WIC number not the NDC number. They could not explain what is stood for, just that it was needed to order it. Do you know what the WIC number is? By any chance could somebody who is getting this medication find this information out from their pharmacy? Thank you for your help.

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I use a specialty compounding pharmacy...
They cater to hospices and home bound patients...
Look in the phone book or online for these types of pharmacies, and then call to see if they have them in stock!
Hope this helps! Oh, they can order meds also...mine can get most drugs in one to two days...

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My MD wrote a script for the Oxymorphone Hydrocholoride ER 40 MG. I went to all the pharms around here and nobody has it or says it does not exist. I am having problems finding it, I did find one pharm that is looking into it and see if they can special order it.. What locations are people finding it in? Thank you for insight into this issue.

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There are different problems going on at doctors and pharmacies. Some pharmacies are saying that Opana don't have a generic and some do. In pill finder online it states this: Professional Monograph (FDA)
Generic Name: oxymorphone hydrochloride Dosage Form: tablet, extended release 1 INDICATIONS AND USAGE Opana ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.
I don't see how pharmacies can say it isn't the generic of Opana. In Florida Publix's won't fill the script unless it is wrote out for the oxymorphone and they are doing this only because 1 pharmacist said thats what it should be so he called other Publix's pharmacist in his town and told them that because of a doctor he spoke too. I have a friend that has cancer and he is taking Opana. Publix's called him an told him the generic came in and come pick it up when it is time. Two days before he was to pick it up they called him an told him they had to give him the brand because Opana ER doesn't have generic, that his doctor had to write oxymorphone hydrochloride ER. Because of everything that has happened with people abusing the old opana's and all the press doctor's won't write it for that. This patient doesn't have any record of abuse of drugs. He has cancer. He just got out of the hospital from being sick again. His medical bills are so high and he doesn't have the money to get the real care he should. It doesn't help the people who write on these forums and brag on how they abuse them. So if you live in Florida, don't go to Publix's pharmacies. All the others will fill Opana ER with the new generic.

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How should the script read. I talked to my pharmacy and asked if they have oxymorphone ER they stated they only had opana ER no generic am I asking for wrong thing? Please advise. Thank you

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yes just tell ur MD to prescribe as a generic and you're golden

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