Mylan Launches Paroxetine Hydrochloride Extended-Release Tablets

Armen Hareyan's picture

Mylan Pharmaceuticals has launched Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GlaxoSmithKline's (GSK) Paxil CR. As the first company to successfully file an abbreviated new drug application (ANDA) containing a paragraph IV certification for the 12.5 mg and 25 mg tablets, Mylan has earned 180 days of marketing exclusivity for these two strengths. Reflecting a supply and distribution agreement with GSK, Mylan also has the right to market the 37.5 mg strength. Mylan is not aware of any other ANDA filers with paragraph IV certifications for this product.


"As another first-to-file opportunity, Paroxetine HCl ER reflects Mylan's continued dynamic speed-to-market capabilities," says Robert J. Coury, Mylan's vice chairman and CEO. "Because this product also belongs in the 'difficult- to-manufacture' category, it is yet another example of our historically strong R&D process, through which we're able to deliver affordable versions of important complex therapies. Our settlement with GSK is consistent with our commitment to monetize opportunities when it benefits both patients and our shareholders."

Paroxetine HCl ER Tablets had U.S. sales of approximately $301 million for the 12 months ending March 31, 2008, for all three strengths.

In October 2007, Mylan announced the settlement of patent litigation involving Paroxetine HCl ER. At that time, Mylan stated that the settlement would provide the company with patent licenses and the right to market all three strengths beginning no later than Oct. 1, 2008. As part of the settlement agreement, which remains confidential, Mylan has been provided with the patent licenses needed to distribute the product immediately.



My wife has been dianosed wtih severe depression. She has taken numerous different anti-depressants and anti-pshycotic medications over the past 3 years since her attempted suicide. Paxil was working well at getting her stable and feeling better. A little over a month ago, the insurance required that we use generic. We were given Paroxetine Hydrochloride Extended Release and were told that it was no different than Paxil CR. After about 2 to 3 weeks on the generic, my wife has started to reverse -- she gets into crying fits, over scared that someone is out to get her family, sleeps over 14 hours every day and had basically relasped. The only change in medication has been the paroxetine hydrochloride instead of Paxil. My question is, Is this common and do the symtoms reversse themselves. I spoke with the phsyciatrist this eveniong and he indicated that while the main ingredient is the same, generics may not be as effective as the brand name. SInce you are the maker of Paroxetine Hydrochloride, do you have the same opinion. I fear for my wife's safety since she has attempted suicide in the past and she seems to be getting worse as each day passes.
I do not understand how Mylan as well as doctors and pharmacists claim that the generic version works just as well as the brand name Paxil CR. I have been taking Paxil for 9 years now and Paxil CR ever since its release. Because of this so called Generic version, my insuance does not pay for the brand name so I have been forced to take this immitation. The outcome: I have been suffering extreme headaches, nausea, elevated anxiety, dizziness, loss of appetite, and very vivid nightmares. How come after several years on Paxil that I did not have these symptoms but somehow with the generic formula I do. I plan to take action against Mylan
I have been on the brand Paxil Cr for over 6 years last month I was given the Mylan Paroxetine Cr and took for about 3 weeks... I am currently back on the original brand Paxil Cr because my anxiety level came back worse than ever and I was having suicidal thoughts and uncontrollable rage and crying spells not to mention twitching and shaking uncontrollably... I called the doctor and he said to go back to the brand.. funny i did pay extra for it but it was well worth it as from the first pill I am now getting back to normal... You can actually get the doctor to declare to the insurance company that you must take the brand and they will comply with a higher copay but a few dollars more is better than feeling like you would like to die!