The US drugmaker is planning to launch a generic version of its erectile dysfunction treatment Levitra (vardenafil), the Food and Drug Administration says.
The generic Levitra version is expected to be sold by April 18, which means the drugmaker hopes to have a much smaller market in the US. Levitra will likely only be available for a limited time, with many doctors saying the patent for the impotence treatment will expire. The market in the US is estimated to reach $4.4 billion by April 2019.
In the first quarter, sales of Levitra totaled $1.3 billion, or 13 percent of total sales, and the market for the generic version was worth $3.4 billion. In a statement on the company's website, Dr. Reddy's Laboratories said the drugmaker had "decided to pursue litigation against Pfizer's patents on Levitra and to obtain regulatory approval to market the generic version."
It will have a "probable regulatory effect and will be in the works for many years to come."
Dr. Reddy's has filed two patents for the generic version of the drug, which is currently being sold by Eli Lilly and Company. Pfizer's patent for Viagra expired in 2010, leaving Levitra's patent protection intact.
A spokesman for Levitra's patent, Dr. Reddy's Laboratories Ltd. said the company had filed a second patent application to market Levitra earlier this year.
Pfizer said the second patent application would "afford sufficient regulatory review" to prevent it from selling a generic version.
In an official statement, Pfizer said the company had "already conducted an analysis of the available generic pharmaceutical market and concluded that Levitra is safe and effective for the treatment of erectile dysfunction."
The company's patent for Levitra expired in 2010, leaving Levitra's patent for Viagra intact. The generic version was expected to be available by April 18. It is expected to be sold by April 18, according to Pfizer.
According to Pfizer's website, the company is "currently investigating the validity of the Pfizer Viagra patent, finding that the patent did not meet the statutory requirements for a generic drug product."
According to the website of the Pfizer website, "The Pfizer Viagra patent has expired, and Levitra will now only be available through authorized manufacturers of generic versions."
In its statement, Pfizer said the company had "already conducted an analysis of the available generic pharmaceutical market and concluded that Levitra is safe and effective for the treatment of erectile dysfunction."
In an email to The Associated Press, the company said, "This action by Pfizer does not constitute a final agreement between Pfizer and the company regarding Levitra. Pfizer is committed to ensuring that the potential benefits of Levitra are fully recognized by its customers."
The company said it had submitted its annual results for the second quarter of this year to the FDA, saying "The results of the first quarter of the year show that the Levitra patent is valid and enforceable and that Pfizer's patents on Levitra are valid and enforceable."
In a statement, the company said that "the market for Levitra is large enough that Pfizer is able to manufacture and market a generic version of the drug, which will compete with Viagra, allowing it to enter the market with greater efficacy and greater safety."The company also said it had found that Levitra was effective for at least 20 percent of men. It had previously found Levitra "to be effective for the treatment of erectile dysfunction."
Reddy's is the only drug company to file patents on the generic form of Viagra and Levitra. Pfizer, which makes Viagra, has yet to make a generic version of Viagra available to the public.
In an email to The Associated Press, the company said, "We have conducted an extensive evaluation of the Levitra patent for Viagra and have concluded that Levitra is safe and effective for the treatment of erectile dysfunction."In a statement, Pfizer said that "The generic Levitra patent will expire in the second half of 2016. Pfizer and its partner pharmaceutical companies are committed to meeting the highest possible standard of patient care and to ensuring that patients have access to the most effective, safe and affordable treatments for their ED."Pfizer, the world's second-largest drugmaker, is planning to launch a generic version of Viagra in mid-2012.
Levitra usage has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious effects, seek medical attention immediately.
Common side effects reported from Levitra use include:
More serious side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a serious adverse reaction to this medication and immediately require treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Levitra. Levitra can interact with bodily substances, causing potentially serious adverse reactions.
Do not take Levitra if you take nitrate medications such as isosorbide dinitrate, isosorbide mononitrate, and nitroglycerin. It’s important to inform your doctor if you are taking any form of high blood pressure medication, alpha-blocker medication, prescription antifungals (like fluconazole), or other medications for erectile dysfunction. You should include information about herbal products, especially St. John’s wort.
Do not drink grapefruit juice while taking Levitra.
Talk to your health care provider about safe drinking practices during treatment with Levitra. Levitra can interact with alcohol and cause potentially serious adverse reactions like those above.
XinonghuaCost:$12.50Quick Overview:Levitra is used to treat erectile dysfunction (ED) in men. It works by increasing blood flow to the penis, which enables men to achieve and maintain an erection.
Levitra usually is taken about 30 minutes before sexual activity. Levitra can take up to 4 to 6 hourly(4 mg vs. 2.5 mg) to improve blood flow, although this number may vary depending on the medication. Levitra begins to work within 30 minutes and lasts about 4 to 6 hours.
Levitra is a type of Levitra called a “ phosphodiesterase type 5 (, ED) inhibitor.” Phosphodiesterase type 5 is the main enzyme in the body in regulating blood flow to the penis, including to the penis, scrotum, brain, and spinal cord. During sexual arousal, blood flow to the penis increases, leading to an erection. Levitra does not affect blood flow to the genitals, but it can lower sexual arousal and blood pressure in the penis.
Levitra does not work if you take it with a high-sulfony foods (like milk, cheese, or yogurt) or high-fat foods. However, your healthcare provider can suggest Levitra for you if you experience:
If you experience any changes in your vision or prolonged erections, contact your healthcare provider promptly. Your health may be at risk.
If you are taking alpha-blockers such as doxazosin (attuna), doxylamine (EDOS), or miconazole (Ziconazole), please do not take Levitra.
Tell your doctor before starting treatment with Levitra that you're taking Levitra, that you may experience side effects, and that you should avoid consuming grapefruit or grapefruit juice while taking Levitra.
Levitra may reduce the effectiveness of certain medications, so it's important to maintain a healthy lifestyle so that you are. Talk to your doctor about your lifestyle.
If you are taking ritonavir (Norvir), you should not take Levitra.
Tell your doctor immediately if you experience chest pain, trouble breathing, or dizziness after taking Levitra.
Cialis has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Cialis use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Cialis. Cialis can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any alpha-blocker, antifungal, HIV protease inhibitor, or high blood pressure medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
Read more about Cialis's side effects.More about.Cialis (Tadalafil) is a affordable prescription medication for managing erectile dysfunction. As an trusted, FDA-approved prescription medication, Cialis can help you get and keep an erection if you are sexually aroused. As an trusted, FDA-approved prescription medication, Cialis can help you get and keep an erection.as well as other brand names for Cialis.Tell them if you are unable to take Cialis or if you experience dizziness, lightheadedness, fainting, if you become pregnant, or if you are breastfeeding. Cialis can interact with the following:As with all prescription medications, inform your doctor if you are taking any other medications, including alli, Viagra, Cialis Connect, and others.
In addition, let your doctor know if you are pregnant, plan to become pregnant, or are breastfeeding. If you are, see your doctor immediately.
In addition, let your doctor know if you aregay or if you are planning pregnancy.
In addition, let your doctor know if you are bipolar disorder (manic-depressive), are a smoker, or have a genetic condition that affects affect.
In addition, let your doctor know if you are pregnant, are is breastfeeding, or are planning on delivery.
In addition, let your doctor know if you are currently taking any other medications, including other forms of diabetes, nonsteroidal anti-inflammatory drugs (NSAIDs), antifungal medications, and specific vitamins.
In addition, let your doctor know if you are taking any other medications, includingabolic-androgen-dispensing compounds, calcium supplements, and other dietary supplements.
In addition, let your doctor know if you are taking any other medications, including capsules, tablets, vials, or nasal spray.
Levitra usage has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious effects, seek medical attention immediately.
Common side effects reported from Levitra use include:
More serious side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a serious adverse reaction to this medication and immediately require treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Levitra. Levitra can interact with bodily substances, causing potentially serious adverse reactions.
Do not take Levitra if you take nitrate medications such as isosorbide dinitrate, isosorbide mononitrate, and nitroglycerin. It’s important to inform your doctor if you are taking any form of high blood pressure medication, alpha-blocker medication, prescription antifungals (like fluconazole), or other medications for erectile dysfunction. You should include information about herbal products, especially St. John’s wort.
Do not drink grapefruit juice while taking Levitra.
Talk to your health care provider about safe drinking practices during treatment with Levitra. Levitra can interact with alcohol and cause potentially serious adverse reactions like those above.
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Stop taking this product and immediately discontinue smoking if you're experiencing
This medication can potentially interact with cisapride, a supplement containing fat. This could lead to increased blood levels of certain medication, including cisapride. You should inform your doctor if you are taking any form of high blood pressure medication, alpha-blocker medication, prescription antifungal, or other medications for erectile dysfunction.
You should not take this medication if you are using nicotine patches or gum.
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