Eli Lily Patent particular form of tadalafil

Indian Patent Office (Chennai) has lately issued an Indian patent # 224314 (the ‘314 patent) to Lilly Icos LLC for Tadalafil particulate form and method of preparation thereof. The ‘314 patent is issued against the national phase application (PCT) # IN/PCT/2002/143/CHE claiming priority from US provisional application # 60/147,048 dated August 03, 1999 which later issued as US 6,821,975 and currently listed with the US FDA Orange Book. Marketed as Cialis by Eli Lilly, Tadalafil is one of the drug that was granted exclusive marketing right (EMR) in India against the application # 85/DEL/1995 (the 1995 application) which later got stayed by the Calcutta High Court after a petition made by Mumbai-based Ajanta Pharma.

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The 1995 application covered claims for Tadalafil per se and process of preparation thereof. Considering [pre-grant opposition] filed by Ajanta Pharma, the Indian Patent Office (Delhi) last year on March 22 rejected product claims for Tadalafil per se but allowed process claims. The product claims were found obvious over the US 3,917,599 (the ‘599 patent) issued to Central Drug Research Institute (CDRI). The ‘599 patent exemplified 2-substituted-1, 2, 3, 4, 6, 7, 12, 12a-octahydropyrazino [2’, 1’:6, 1] pyrido [3, 4-b] indoles which is the base structure of Tadalafil but never suggested to be useful for treatment of erectile dysfunction.

Tadalafil Approved for Benign prostatic hyperplasia

The US Food and Drug Administration (FDA) today approved tadalafil (Cialis, Eli Lilly), a phosphodiesterase-5 inhibitor, to also treat the signs and symptoms of benign prostatic hyperplasia (BPH) as well as a combination of BPH and erectile dysfunction (ED) when the conditions coincide.

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Men with BPH often experience sudden urges to urinate, difficulty in starting urination, a weak urine stream, and more frequent urination, including at night. In 2 clinical trials, men with BPH who took 5 mg of tadalafil daily experienced a significant improvement in these symptoms compared with men receiving a placebo. A third study showed that men who experienced both ED and BPH and who took 5 mg of tadalafil daily had improvement in both conditions compared with a placebo group.

Scott Monroe, MD, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said in a press release that both BPH and ED are common disorders among older men. "Cialis offers these men another treatment option," Dr. Monroe said.

Tadalafil joins a long list of other FDA-approved drugs for BPH symptoms: finasteride (Proscar), dutasteride (Avodart), dusasteride plus tamsulosin (Jalyn), and alpha-blockers terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax), alfuzosin (Uroxatral), and silodosin (Rapaflo). The agency approved tadalafil for treating ED in 2003.

The FDA advises clinicians that they should not prescribe tadalafil for men taking nitrates such as nitroglycerin because the combination may trigger an unsafe drop in blood pressure. Also, the agency does not recommend combining tadalafil with alpha-blockers for the treatment of BPH because the combo therapy has not been adequately studied, and it comes with a risk of lowering blood pressure.

Erectile Dysfunction Market report

Erectile Dysfunction Drugs Market - Growth, Share and Forecasts To 2022

The global erectile dysfunction drugs market is expected to reach USD 3.2 billion by 2022 according to a new report by Grand View Research Inc. Rising adoption of sedentary lifestyle and increasing prevalence of conditions causing erectile dysfunction such as stress, hypertension, and related medications are the key factors expected to widen the target population base for this market.

However, the market is estimated to witness decline in revenue over the forecast period. Expiration of key drugs from 2017 to 2019 is likely to curb revenue growth. On the other hand, the market is likely to open up new avenues for the generic manufacturers to capitalize on. The increasing risk of sexually transmitted diseases, narrowing of insurance coverage for erectile dysfunction treatment, growing threat from counterfeit drugs, and presence of social stigma in developing countries are some factors limiting penetration rates. 

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Further key findings from the report suggest:

• Viagra accounted for over 47.0% of the total revenue in 2014. It is generally considered as the first line of treatment for erectile dysfunction. Brand loyalty and advantages associated with this drug such as high efficacy, and effectiveness are the major factors attributing for its large market share.
• Cialis (tadalafil) from Eli Lilly & Co. and Levitra (vardenafil) from Bayer AG are known to be the competitors for Viagra globally. Cialis (tadalafil) was approved in 2003 by the U.S. FDA, as a prescription drug in the U.S. Cialis is also known as “The Weekend Pill” owing to its 36-hour effectiveness.
• After the patent expiration of key drugs such as Cialis (tadalafil) in 2017 and Levitra (vardenafil) in 2018, other drugs such as Stendra/Spedra, Zydena (udenafil), and Vitaros (Alprostadil Cream) are expected to capture the market share during the forecasts period.
• North America constituted the largest share of approximately 55.0% in 2013 of the total erectile dysfunction market. Extension of patent exclusivity rights for Viagra (sildenafil citrate) in the U.S. till 2019 along with introduction of new erectile dysfunction drugs such as Zydena (udenafil) and Stendra/Spedra (avanafil) will be the major factors responsible for market growth during the forecasts period.
• Asia Pacific accounted for a revenue share of over 16.5% in 2012 owing to the presence of a lucrative market for generic drugs, untapped opportunities, and increasing awareness related to erectile dysfunction in this region
• Apricus Biosciences Inc., Cristalia Produtos Quimicos Farmaceuticos Ltd., Bayer AG, Dong-A Pharmaceutical Co. Ltd., Meda Pharmaceuticals, Inc., Eli Lilly and Company, Pfizer, Inc., S.K. Chemicals Co. Ltd., and Vivus, Inc. are some major players of this market
• Extensive R&D carried out by companies and high unmet needs in developing economies are expected to boost industrial growth. Key manufacturers are targeting regions with unmet clinical needs by entering into agreement with local manufacturers and distributors. Key players are constantly engaged in developing novel drugs in an attempt to improve the presence and ensure sustainability.

Tadalafil Vs Ayurveda

Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection.

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Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder.

This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more detail

Tadalafil is an effective medication used to treat Erectile dysfunction in males. Even though, it is a highly effective medication, it has several side effects.

Ayurveda provides the natural and safest alternative to Tadalafi & Sidenafil for Erectile Dysfunction. Some of the best Ayurveda products for  Erectile Dysfunction are;

Royal Tantex (Himalaya)

Vita Ex Gold (Baidyanath)

Spark Capsules (Vasu)

Promactil gel caps (KAL)

Vanari kalpha (Sandu)

Pallrywyn tabs (charak)

CountPlus (Nagarjuna)

Most of these products ingredients are herbal based. 

Court of Appeal finds CIALIS dosage regimen patent obvious

Unpredictable. Through the ages, humans and Kats have had to deal with the unpredictable, random and the volatile nature of life and, in particular, human behavior.  After the events of 2016/7, many of us may instituted more robust psychological tools to deal with unpredictable times - with varying degrees of success.  But an area where you cannot employ such tools is in patent litigation, where the fate of your patent or your defence depends on an inherently unpredictable fictional character/s - the skilled person/team - viewed through the prism of expert evidence and weighted with the perception of whatever judge you are before.  The Court of Appeal's decision last week in Actavis v ICOS [2017] EWCA Civ 1671 is a reminder that the uncertainty that can plague this and the resulting outcome of a court hearing, may not extend to the skilled team embarking on a routine clinical trial program.

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The Court of Appeal consisting of Lord Justice Kitchin, Lord Justice Floyd and Lord Justice Lewison overturned Mr Justice Birss' first instance decision (handed down last August - see here) that the '181 Patent was valid and infringed.  The '181 Patent covers the dosage regimen for tadalafil - a PDE5 inhibitor - sold under the brand name CIALIS (for male erectile dysfunction) and ADCIRCA (for pulmonary arterial hypertension).  The 2014 market for CIALIS in the UK amounted to $99 million and ADRICA amounted to $1 million.  Actavis and Teva appealed the decision on the '181 Patent on five grounds - construction/infringement, lack of entitlement to priority, added matter, novelty and obviousness. The Court of Appeal held that the '181 Patent was invalid for obviousness.  Birss J had held that the other patent at issue in the first instance proceedings - the '092 Patent - which covered the formulation was invalid.  ICOS (patent owner)/Lilly (exclusive licencee) did not appeal that decision.

How Viagra Works ?

How Viagra Works

Since the debut of the erectile dysfunction drug Viagra (sildenafil) in 1998, millions of men have discovered how this medication can help treat the symptoms of erectile dysfunction. But while countless men around the world (and their partners) have experienced the clear benefits of Viagra in their sex lives, there’s not as much awareness of how the “little blue pill” actually works. What does Viagra really do in the human body? How fast does it work, and how long does it last? We decided to dig deeper and find out. If you’ve ever been curious about what Viagra can do, read on – you might be surprised at what you discover.

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The manufacturers of Viagra recommend taking Viagra one hour before having sex. However, studies have suggested that it could start working even sooner than that. Some men were able to achieve an erection just 12 minutes after taking Viagra, although this wasn’t conclusively proven to be due to Viagra. And while the maximum concentration of sildenafil in the blood isn’t reached until about an hour after taking it (and is potentially delayed by an additional hour if taken with food), it took a median of 27 minutes (with a range of 12–70 minutes) for men taking sildenafil to begin experiencing erections. This was 23 minutes sooner than the median time of 50 minutes experienced by those who took a placebo.

The half-life of Viagra in the body is about four hours, meaning that every four hours after taking it, there’s only half as much of the drug left. However, even 10 to 12 hours after taking Viagra, men could still often achieve erections hard enough for penetration, though of a shorter duration. By 24 hours, all traces of Viagra in the blood are practically gone.

We’ve seen how quickly Viagra can work – but once it starts working, how long do erections typically last? In one study, an hour after taking Viagra, men reported being able to achieve erections lasting an average of 33 minutes. After eight hours, this decreased to 23 minutes, and by 12 hours, the mean duration of erections was reported to be 16 minutes. In comparison, men who took a placebo found that they experienced erections lasting an average of seven minutes – less than half as long as among men who had taken Viagra 12 hours ago. Even long after the window of 30 minutes to four hours recommended by the manufacturers of Viagra, the drug clearly still has possible beneficial effects on erectile function.

Dangers of Daily Viagra use

Men have been turning to the little blue pill to treat their erectile dysfunction (ED) for nearly 20 years. Since Viagra (sildenafil) first came on the scene, in 1998, the number of men diagnosed with ED has shot up by 250 percent.

It’s safe to say the drug has given millions of men a convenient and effective option for improving their sex lives. But taking Viagra or other meds such as Cialis (tadalafil) or Levitra (vardenafil), when you don’t have erectile dysfunction can be dangerous.

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Men who don’t have problems getting an erection may still want to up their game.

“There are certainly plenty of examples of men trying to get their hands on Viagra when they don’t necessarily have ED,” says Dr. Eisenberg. “In some cases, it might just be to enhance performance or to perform better sexually.”

Some use Viagra not for ED but because they’ve heard it can enhance athletic performance. For other men, it’s all about convenience and cost. They want the drug without the hassle of getting a prescription.

“Most of us live busy lives, and some men might find it hard to see their doctor,” says Eisenberg. “Also, there’s a stigma about ED. Many younger men might be embarrassed about getting help.”

Buying Viagra from an unreliable source can be risky. Drugs sold online may be fake, contaminated, or expired.

According to press statements, in 2011, Pfizer Global Security looked at 22 websites that appeared in the top search results for the phrase “buy Viagra.” They found that about 80 percent of these pills were counterfeit. These fake Viagra pills did contain the active ingredient sildenafil, but only about 30 percent to 50 percent of the amount advertised.

“With the internet, you really never know what you’re getting,” Eisenberg says.

It’s also important to know that Viagra can cause side effects, such as:

• Headache
• Upset stomach or diarrhea
• Dizziness
• Heartburn
• Runny or stuffy nose
• Nosebleeds
• Flushing
• Difficulty sleeping
• Muscle or back pain
• Numbness or tingling in the hands, arms, feet, or legs
• Sensitivity to light or vision changes

Using Viagra can lead to serious risks, too, if you have an underlying medical condition. For instance, men with heart disease who take drugs known as nitrates can develop dangerously low blood pressure if they take Viagra.

What is Viagra and How does it work ?

Some of most commonly prescribed and abused drugs in America belong to a drug family called the phosphodiesterase 5 inhibitors. But you probably know them better as Viagra (sildenafil), Cialis, and Levitra. Unless you never watch TV, it's almost impossible to miss their commercials.

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Viagra and the other phosphodiesterase 5 inhibitors are meant to be taken only by men who have erectile dysfunction (ED). Since Viagra was introduced in 1998, the number of men diagnosed with ED has gone up by 250 percent.

Risk factors for ED include older age, obesity, diabetes, heart disease, and high blood pressure. The problem is that men without issues are using these medications. "We are seeing more and more young men without any risk factors for ED asking for ED drugs. They look a lot like the young men dancing around in the TV advertisements, probably too healthy to have ED,” said Rowena DeSouza, MD, associate professor of surgery at the University of Texas Health Science Center at Houston and director of urology at Lyndon B. Johnson Hospital.

Reports of dangers from ED drug abuse run the gamut from unsafe sex practices and a heightened sexually transmitted infection (STI) risk to fatal drug interactions. They include these specifics:

• A five-fold increase in unsafe sex among men who have sex with men
• A two-fold increase in STIs
• Dangerous and potentially fatal mixing of ED drugs with club drugs such as ketamine and amyl nitrite

A 2011 survey on recreational use of ED medications published in the journal Archives of Sexual Behavior included responses from 1,994 men attending 497 colleges across the country. Four percent of these men admitted to using ED drugs recreationally. A majority of the recreational users mixed ED drugs with illegal drugs and engaged in risky sexual behaviors. Recreational use was associated with substance abuse and a higher number of sex partners.

Dapoxetine 90 Mg - Uses, Side effects, Dosage

Where can you buy Dapoxetine 90 Mg ?
What is Dapoxetine and how is it useful in premature ejaculation ?

Dapoxetine is a short acting selective serotonin reuptake inhibitor (SSRI) used specifically for the treatment of premature ejaculation in men aged between 18 and 64 years. This medicine should not be taken by men who are not diagnosed with premature ejaculation (PE).

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Uses of Dapoxetine

What is it prescribed for?

Premature ejaculation

SHOW MORE

Side effects

Major & minor side effects for Dapoxetine

Dizziness and lightheadedness

Nervousness and confusion

Excessive sweating

Headache

Diarrhea

Sleeplessness

Decreased libido

Blurred vision

Ringing or buzzing in the ears

Fast/irregular heart beatSEVERE

Increase in blood pressure

Excessive tiredness

Dry mouth

SHOW MORE

Highlights

Commonly asked questions for Dapoxetine

Onset of action

The effect of this medicine can be observed within 1-3 hours of administration.

Duration of effect

The effect of this medicine lasts for an average duration of 1-2 hours.

Safe with alcohol?

MODERATE

Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of serious adverse effects such as drowsiness, dizziness, impaired thinking, and loss of consciousness.

Is it habit forming?

No habit forming tendencies were reported.

Usage in pregnancy?

This medicine is not recommended for use in women.

Usage while breast-feeding?

This medicine is not recommended for use in women.

Generic Cialis or Cialis daily ? What should you take ?

Erectile dysfunction (ED) is an incredibly common condition, it is thought to affect half of all men between the ages of 40 and 70. In some cases, it can be mild or only occur infrequently; in other cases, it can be an indication of an underlying health condition like high blood pressure, diabetes or an overactive thyroid.

For many men, ED becomes more of a problem as they age. The good news is that tablets known as PDE-5 inhibitors can be prescribed; these tablets contain medicine that temporarily increases blood flow to the penis, allowing you to attain and maintain an erection sufficient for sex.

There are several PDE-5 inhibitors available but one of the most popular is Cialis, which comes in two varieties: Cialis prescribed for one-off use and Cialis Daily taken every day.

If you’re suffering from erectile dysfunction and considering treatment, read on to learn more about the differences between Cialis, Cialis Daily and the other ED tablets on the market.

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What are the side effects?

Cialis Daily

Cialis Daily comes in tablet sizes of 2.5mg and 5mg, and can cause nausea, vomiting, diarrhoea, an allergic rash, facial flushing, headache and back pain. These side effects are uncommon and usually resolve within a few days. More known side effects are an erection that does not go away and can cause damage to the penis. Addtionally, a sudden decrease in vision and hearing may occur although these side effects are very uncommon. A full list of side effects can be found in the infomation leaflet.

Cialis 

Cialis is available in tablet sizes of 10mg and 20mg and is associated with the same side effects as Cialis Daily. However, because it is prescribed in higher dosages than Cialis Daily, these side effects can be stronger.

What does it do?

Cialis Daily

Cialis Daily enables an erection in men who suffer from ED, and is designed to allow for spontaneous sex. When you take it every day, you should be able to get erections and have sex whenever you want to.

Cialis

Cialis enables an erection in men with ED but it is designed for one-off use. To get an erection with regular Cialis you will have to take one tablet 30-60 minutes before you plan to have sex.

Who’s it for?

Cialis Daily

Cialis Daily is suited to men who have sex three or more times a week. It can be particularly helpful for men in long-term relationships who would like to have spontaneous sex with their partner.

Cialis

Cialis is suited to men who have sex on a less regular basis, or whose ED comes and goes.

When do I take it?

Cialis Daily

Cialis Daily must be taken once every 24 hours, with or without food. It’s best to get into a routine and take it at the same time each day, as you should never take more than one tablet in a 24-hour period.

Cialis

Cialis should be taken 30-60 minutes before you plan to have sex.

How quickly does it work, and how long does it last?

Cialis Daily

When taken correctly (see above), Cialis Daily should begin to work within 3-5 days. After this point, you should be able to achieve erections whenever you want them – bearing in mind that you will only get an erection if you are sexually aroused. Cialis Daily should continue to be effective for as long as you take it.

Cialis

When taken correctly, Cialis should begin to work within 30-60 minutes. The effects of one Cialis tablet can last up to 36 hours; however during this period you will only achieve an erection if you become sexually aroused. 

What are tthe side effects of Cialis 80Mg

What are the side effects of Cialis 80 Mg ? Cialis 80 Mg is a high dosage tadalafil medication used to treat erectile dysfunction.

Cialis (tadalafil) is a phosphodiesterase inhibitor used for treating impotence (erectile dysfunction, or ED). Common side effects of Cialis include:

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Given below are some of the side effects of Cialis 80 Mg.

• flushing (redness or warmth of the face, neck, or chest),
• headaches,
• stomach upset,
• diarrhea,
• flu-like symptoms (such as stuffy nose, sneezing, or sore throat),
• memory problems,
• muscle or back pain,
• nausea,
• low blood pressure,
• dizziness,
• blurred vision and changes in color vision,
• abnormal ejaculation, and
• prolonged erections (priapism).

Tell your doctor if you have rare but serious side effects of Cialis including:

• a painful or prolonged erection lasting 4 or more hours;
• sudden decreased vision (including permanent blindness, in one or both eyes);
• a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness.

The recommended dose of Cialis is 5-20 mg per day taken before sexual activity. Cialis may interact with rifamycins, antibiotics, antifungals, antidepressants, barbiturates, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, HIV or AIDS medications or seizure medications. Tell your doctor all medications and supplements you use. Cialis is not approved for use in women and has not been evaluated in women who are breastfeeding.

Our Cialis Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.