Why has conjugated estrogen never come out in a generic form? I have been taking it for twenty years now and it is still very expensive, even with my co-pay. I realize HRT is very controversial. Does that have something to do with it?
hk2kds replied: "The HRT controversy has probably hurt your chances of ever getting a generic. Most companies don't want to spend the time or effort it would take to get approval for a drug that many doctors have stopped prescribing.
Before the controversy, a generic for Premarin was not approved because there was no good information on the actual active ingredient. Premarin is a mix of substances obtained from pregnant mare urine (hence the name - Premarin. My understanding is that it would be difficult to replicate Wyeth's manufacturing process and no company has successfully made a synthetic version."
a4_by_four replied: "Good question and I assume that you are referring to Premarin® (conjugated estrogen). HRT controversy really has nothing to do with a lack of generic. The real reason is that Wyeth (the manufacturer) got lucky with this one....and it has to do with the drug's composition.
Also, Wyeth still has one non-expired patent that protects Premarin (this type of patent is called an Orange Book patent). US Patent 5,210,081 does not expire until February 26, 2012. A generic company would have to circumvent or invalidate this patent if they wanted to launch a generic version of it.
Third, Wyeth had filed a Citizen's Petition (legal maneuver) to block the generics from launching a generic.
BTW, here is some history on Premarin:
Premarin is extracted from pregnant mare urine (hence the name). Reliable estimates indicate there are now at least 50,000 production mares on dedicated farms in N. America (mostly located in Canada).
Premarin contains a number of different estrogens. Precisely how each of these various estrogens contribute to the drug's overall effectiveness has not been definitively determined -- and is the real reason for the lack of generics. Premarin's approval in 1942 predated the current requirements for such comprehensive analysis of products under review for marketing approval.
Previously it was thought that two estrogens were the sole active ingredients in Premarin. Newer laboratory and clinical studies show this may not be the case. Rather, other components in Premarin may contribute to the drug's effectiveness.
Although this finding does not prove that the DHES in Premarin has an important therapeutic effect, "it underscores the lack of precise knowledge of the makeup of Premarin and the relative importance of its components, and therefore the lack of a standard on which to evaluate a generic copy."
In November 1994, Wyeth filed a citizen petition requesting that DHES be reclassified as a concomitant component. The firm maintained that the compound contributes to the drug's potency, and therefore, effectiveness, and further requested that FDA require the compound to be included in any generic copies of the drug."
Esterified VS Conjugated Estrogen-What is the difference? I have scoured the Internet and have not been able to find the answer to this...can anyone tell me if Estratest HS contains components from the same compound Premarin with added testosterone is made from? I haven't been able to find out what is in this drug. Is it natural or is it made from the hormones derived from pregnant mares?
tweediebirds@sbcglobal.net replied: "I believe that both are combination estrogens, but Conjugated are all natural estrogens, and Esterfied are combinations of synthetic estrogens. Sometimes one will work better with a particular menopausal or post menopausal symptom or problem."
how many gm of estrogen will she recieve by the end of the fourth week? for the prevention of osteoporosis, mrs. schneider is taking premarin (conjugated estrogens) 0.625mg PO q.d. on a cycle of 3-weeks-on, and 1-week-off.
can you please help me with this problem? thanks!
C K replied: "She is taking 21 days of premarin at 0.625mg per tablet. 21 times 0.625mg = 13.125 mgs. You want your answer in grams so divide by 1000 and get 0.013125 grams. I would answer your other questions but I think you should get the idea with these two. And I have to go to work. Good luck."
conjugated estrogen cream? My doc prescribed this cream. Can it cause hotflashes?
Chanhassen replied: "Generally not, because the medicine is used topically and should not be very well systemically absorbed. This medicine is primarily used to treat local symptoms of menopause or low estrogen levels.
I would think the biggest side effect to worry about would be burning/stinging if the skin is broken.
If you are using it for menopause, though, hot flashes as a symptom of menopause probably won't be treated, so they may continue- but they would be a symptom of menopause, and not a side effect of the cream."
Does conjugated equine (horse) estrogen use for breast enlargement in men such as Premarin work.? Premarin is a very complex and estrone is weaker by far than estradiol in its ability to stimulate breast tissue. In fact this particular estrogen can even be given to men, since it has no feminizing properties (Washburn 1996). Some women who have tried both Estrace and Premarin, or the patch and Premarin, decide that they like Premarin better because there is less breast tenderness, whereas pure estradiol feels "too strong." Can we conclude that estrone is better or is Estradiol more effective and popular?
Dr. Education replied: "My medical knowledge is limited in that area.
/doc"
What are the odds of not taking my estrogen hormone? Im 41 years old and recently went through a Total Histerectomy. (no cancer). The doctor prescribed an estrogen conjugated hormone but I really wont like to be taking medications for the rest of my life. My husband and I have known of risks associated with hormones, however, Im concerned if not taking it would affect my feminine features, say voice, breast, unwanted hair (masculine features). Anybody knows about it? some doctors are kind of quiet about this.
Grammie replied: "One thing I can say for sure, is that taking HRT (hormone replacement therapy) puts so many women at an extremely high risk for DVT's and/or PE's (deep vein thrombosis, pulmonary embolism; blood clots, clots that embolize to the lungs). Many women chose not to take it due to the high risks, you're not alone. Unfortunately, most people that chose not to continue on taking HRT's of any kind can be found on a yahoo forum for DVT's and/or PE's. They've already found out the hard way.
Here's a good site to read up on the causes and symptoms of DVT's & PE's
I hope this helps!"
estrogen tablets increase breast size? will taking these conjugated estrogen tablets (as a teen/young adult)
increase breast development and such
thx!
Sarah replied: "Estrogen tablets should only be used if you have a deficency in estrogen. There are herbs though that will mimic the effect of estrogen and make your breasts larger. You need to talk to a doc and get the okay. Here is a free article with a list of the herbs
Herbs will increase your breast size. They are only $5 a bottle at your health store too. They worked for me
Here is an free article that lists the herbs you need
hope this helps
How to Increase Your Breast Size Naturally
(http://www.ehow.com/how_5331593_increase-breast-size-naturally.html)"
To all of the health care professionals out there (doctors, nurses, etc)? If a 38 year old female is found to have severe endometriosis that can only be resolved by doing a complete hysterectomy, including the removal of both ovaries, why would the doctor prescribe estrogen therapy to be started after surgery? (3rd post op day- begin to take 1.25 mg of conjugated estrogens (Premarin) orally, which needs to be continued every day of the month except the last 7 days).
If you could please help in any way, I would greatly appreciate it! I am just a bit curious and would like some answers.
carpal-tunnel-provider replied: "If you have a total hysterectomy,then you need HRT (hormone replacement therapy) in the correct amounts..to do what your "old" female parts couldnt do (correctly)"
tirshatha2001 replied: "You might want to look into folic acid as an alternative therapy for HRT. In high doses it has the same advantages of regulating our hormones without the potential side effects and risks of conventional HRT. I learned about it in the book by Dr. Atkins-Atkins Health Revolution.
The doses are high but there is no known toxic level of folic acid, according to Dr. Atkins. The effects of the folic acid do diminish over a period of time and have to be readjusted occasionally, but I personally would rather take the folic acid rather than the estrogen with all the bad side effects of estrogen that we know about.
It does not replace the hormone but it does do the same job as far as preventing the hot flashes and general discomforts of menopause. You also need to make sure you take a multi-B vitamin to insure that the folic acid, which is also a B vitamin, does not mask any underlying disorder related to a deficiency in B6 The doses of folic acid you would need to take need to be prescribed.So perhaps you can read for yourself in the book what the benefits are, and show your Dr. to see if he will allow you to try this if you want to.
Below is an an answer Dr.Atkins gave to a questioner regarding HRT
"I am very leary of using hormone replacement therapy
because it has such an adverse effect on insulin and glucose metabolism and
despite the hype it receives, it has been a disaster for people who tend to gain
weight.
Secondly, all of the hype saying that it would help your heart has been
disproven in the August 8th issue of JAMA (Journal of the American Medical
Association). In the first study ever to be done in the true scientific manner
of a matched controlled group, there were more heart deaths on the HRT
group than in the placebo group (71 versus 58).
The answer is a simple one: folic acid, the B vitamin, in doses of 40 to 60
milligrams, which means 40,000 to 60,000 mcg. Also, boron in doses of 12 to 18
milligrams should be used, and a natural progesterone cream is appropriate for
administration through the skin such as Progest. For virtually every women with
these complaints, it's nearly complete relif relief without requiring HRT. I think 400
units of vitamin E is also appropriate""
Susan B replied: "The premarin replaces the estrogen her overies were making. Even though she had endometriosis her overiew would still produce estrogen, she needs that replaced so she won't go into immediate menopause."
What? replied: "I had the same issue as you and was put on Premarin 1.25 mg. You have to take this bc when they take out your ovaries, you will no longer have estrogen in your body. You will feel very emotional as well. Also this will cause your body to go into Surgical Menopause, which isn't fun. I had my hysterectomy in 2001. The following website will give u tons of info. I joined it and the ladies helped me out a lot.
"
Endo replied: "First off, Endometriosis is NOT cured by a total hysterectomy. That is an old wive's tale.
The disease needs to be completely and meticulously removed surgically from all locations (including bowel, bladder, ligaments, etc. etc.) in order to not persist and thrive (look into Aromatase production and Endometriosis for details on that if you're interested).
Secondly, synthetic HRT after hysterectomy is common practice, due to the alleged protective benefits (the jury is still out on the benefits vs. the risks). There are 2 schools of thought about HRT (to prescribe or not to prescribe; and if so, what kind - unopposed estrogen, progestins only, combination). Cardiovascular and bone health are among the top reasons those who prefer to Rx HRT do so. It is not obligatory, however - not all women who undergo surgical menopause take HRT."

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