Generic- Watsons Won't Be Out In Sept/2012
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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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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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So my understanding is that Impax makes a generic Opana ER with the Impax company name, but the manufacture is Global and that these are the same as the Opana ER before the reformulation. Can they now can be prescribed by MDs? Are they at the pharmacies?

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Told you guys!!!! I been enjoying them for over a week now :)

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I don't know who wrote that last posting with No Name but it wasn't me. Someone used my user name. I was in bed sleeping when that was posted. I don't even have a computer at home to post anything or get online. I live out in the country where there is no internet available. I have to use a friends computer, so who ever used my name cut it out.
I just spoke to Impax and they just shipped to many distributors for the pharmacies today so they will be able to have it in their database and order generic next week. There is a picture online now what the generic opana looks like now. Its under oxymorphone and it has Impax generic company name.

Images & Information:
Oxymorphone hydrochloride extended-release 40 mg G74
Oxymorphone hydrochloride extended-release

Imprint: G74
Strength: 40 mg
Color: Orange
Shape: Round
Availability: Prescription only
Drug Class: Narcotic analgesics
Pregnancy Category: C - Risk cannot be ruled out
CSA Schedule: 2 - High potential for abuse
Manufacturer: Global Pharmaceuticals
Image: images.ddccdn.com/images/pills/custom/pill20400-1/oxymorphone-hydrochloride-extended-release.jpg

This is under Drugs.com

I don't know why people have to be hateful on this site and call people names just because you don't like something that was said. It would be nice if everyone could be understanding for a change.

I am changing my user name to DKS

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

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