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Author Topic: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?  (Read 7575 times)

golfboy307

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[MODERATOR SPLIT FROM HERE: http://www.peaktestosterone.com/forum/index.php?topic=8120.0]

My insurance pays for three 10mg pills per month for a co pay of $60.  I split them in half, and 5 mg works fine for me most of the time.

I heard that the reason they are using Cialis to treat BPH was to extend the patent past 2017?  Any truth to that rumor?

There is no way the FDA should allow this drug over the counter.  I am all for convenience, but this is a powerful drug, especially at the higher doses.  Just wait until some 25 year old takes 50 mg and strokes out.  I am not a big FDA fan, but in this case I hope safety wins out.  Now, generic competition, I am all for that.
« Last Edit: September 15, 2015, 03:39:34 pm by PeakT »
Age 51, 5'10, 155 lbs
Cholesterol 162 (HDL 59, LDL 87, Trigs 88, LDL-P 850)
Fasting Glucose 65 (down from 97 pre TRT)
A1C:  5.0 (down from 5.7 per TRT)
Homocysteine:  12.4 > 11.0 > 10.2 > 8.9 using B vitamin therapy.  MTHFR positive 

BP  120/78 (using improved diet and 10 mg Lisinopril ACE Inhibitor)  145/90 prior to meds.

Current protocol:  60 mg Test Cyp IM every 5 days.  No AI.
2/15/17 labs:  Total T (peak day): 1169 (250 - 1100 ng/dl).  Free T 198 pg/ML (46-225).  Sensitive E2: 40 High.  Previously 32. PSA 0.2  Hemocrit 44.2. SHBG: 32
9/15/18 labs:  Total T (trough day):  598 (250 -1100 ng/dl)  Free T 73.9 (46-225) Sensitive E2: 21  Hemocrit 43.7  SHBG 34
2/20/19 labs:  Total T (mid point):  776 (250 -1100 ng/dl) Free T 115.6 (46 - 224 pg/ml) Sensitive E2 24 (<29), DHT 43 (16-79 ng), DHEA-s 244 (70-495 mcg/dl)


Supplements:  Multivitamin, plus additional B12, B6, C, D, K2, Red Yeast Rice, Magnesium, and Coq10  Evening:  Kyolic Garlic, 2mg Cialis, LEF Endothelial Protection

PeakT

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #1 on: September 15, 2015, 03:48:59 pm »
[MODERATOR SPLIT FROM HERE: http://www.peaktestosterone.com/forum/index.php?topic=8120.0]

My insurance pays for three 10mg pills per month for a co pay of $60.  I split them in half, and 5 mg works fine for me most of the time.

I heard that the reason they are using Cialis to treat BPH was to extend the patent past 2017?  Any truth to that rumor?

There is no way the FDA should allow this drug over the counter.  I am all for convenience, but this is a powerful drug, especially at the higher doses.  Just wait until some 25 year old takes 50 mg and strokes out.  I am not a big FDA fan, but in this case I hope safety wins out.  Now, generic competition, I am all for that.

Big changes in the PDE5 market coming up:

http://www.forbes.com/sites/investor/2013/12/20/pfizers-expiring-viagra-patent-adversely-affects-other-drugmakers-too/

"Owing to generic intrusion, the global market for branded erectile dysfunction drugs is forecast to decline at a compounded annual rate of 4.5% from 2013 to 2019."

"A recent report published by Transparency Market Research has cast a pall on the future profitability of the PDE5 inhibitor sex drug class, forecasting that annual sales of sexual dysfunction drugs will fall from $4.3 billion in 2012 to $3.4 billion in 2019. The study authors opine that the loss of Viagra’s patent exclusivity in Canada, Asia and Europe last year will weaken drug makers’ lock on pricing power in coming years."

"Cialis and Levitra aren’t operating in a vacuum, as low-cost versions of Viagra will adversely affect their ability to raise drug prices going forward: generic firms plan to capture Viagra share by discounting their me-too versions of sildenafil up to 90% less per pill: in the U.K., the price for drugs containing sildenafil have fallen from approximately £10 ($15.30) for branded Viagra to about £1 ($1.53) per pill, according to the European Generic Medicines Association."

Interestingly, Lilly is already poising for the OTC version, but like you said there are some big hurdles imo:

http://www.wsj.com/articles/SB10001424052702304587704579588442314255198

"Cialis maker Eli Lilly & Co. has struck a licensing deal allowing French drug maker Sanofi SA to sell a nonprescription version of the pill in major markets if regulators approve—"

"But the OTC project could face hurdles, including safety concerns. Sanofi will have to demonstrate to government drug regulators that men can correctly decide whether to take the drug—and use it safely—without a doctor's guidance. Cialis, like Viagra, can cause a sudden drop in blood pressure if it is taken with certain heart and blood-pressure medications, causing fainting or even death, among other adverse events linked to the drugs."
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Peak Testosterone Forum

Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #1 on: September 15, 2015, 03:48:59 pm »


Regulus

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #2 on: September 15, 2015, 05:29:43 pm »
THe Forbes article is right on;   once any of these drugs goes generic, it's game over for the high priced name brands as a class.   

The drugmakers clearly believe the patent party is over.   That is the entire reason why Lilly wants Cialis to go OTC.   Their plan is clearly to make it up on volume.   (Pretty smart move I'd say.)

I'm sceptical about them being able to get the OTC approved, but stranger things have happened.  I think the strongest argument for going OTC is that the risk from people taking internet generics (of questionable provenance and quality) is greater than the risk of someone taking a legit pill who shouldn't (those warned side effects are rare.)   I completely buy that argument myself, but I just don't think the FDA will.

I don't see any way Lilly successfully extends the Cialis patent, and can't see why they'd want to at this point.   Once you can get Viagra for a buck a pill, the right to sell Cialis for $25 won't mean much.
Late 40's, on TRT since 2011.
Test cyp 50 mg twice per week
Vegan and loving it since late 2015

golfboy307

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #3 on: September 15, 2015, 06:48:06 pm »
Good info, thanks for splitting out the thread.  Good points Regulus.  Cialis in my experience has the effect of lasting much longer than Viagra.  24-48 hours for me, vs. 4-6 with Viagra.  The Cialis generic will take off I predict.  I still hope 2017 is the date, that will be nice.  I don't use it as much anymore, but it is nice to have around.
Age 51, 5'10, 155 lbs
Cholesterol 162 (HDL 59, LDL 87, Trigs 88, LDL-P 850)
Fasting Glucose 65 (down from 97 pre TRT)
A1C:  5.0 (down from 5.7 per TRT)
Homocysteine:  12.4 > 11.0 > 10.2 > 8.9 using B vitamin therapy.  MTHFR positive 

BP  120/78 (using improved diet and 10 mg Lisinopril ACE Inhibitor)  145/90 prior to meds.

Current protocol:  60 mg Test Cyp IM every 5 days.  No AI.
2/15/17 labs:  Total T (peak day): 1169 (250 - 1100 ng/dl).  Free T 198 pg/ML (46-225).  Sensitive E2: 40 High.  Previously 32. PSA 0.2  Hemocrit 44.2. SHBG: 32
9/15/18 labs:  Total T (trough day):  598 (250 -1100 ng/dl)  Free T 73.9 (46-225) Sensitive E2: 21  Hemocrit 43.7  SHBG 34
2/20/19 labs:  Total T (mid point):  776 (250 -1100 ng/dl) Free T 115.6 (46 - 224 pg/ml) Sensitive E2 24 (<29), DHT 43 (16-79 ng), DHEA-s 244 (70-495 mcg/dl)


Supplements:  Multivitamin, plus additional B12, B6, C, D, K2, Red Yeast Rice, Magnesium, and Coq10  Evening:  Kyolic Garlic, 2mg Cialis, LEF Endothelial Protection

Peak Testosterone Forum

Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #3 on: September 15, 2015, 06:48:06 pm »


PeakT

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #4 on: September 15, 2015, 08:35:00 pm »
THe Forbes article is right on;   once any of these drugs goes generic, it's game over for the high priced name brands as a class.   

The drugmakers clearly believe the patent party is over.   That is the entire reason why Lilly wants Cialis to go OTC.   Their plan is clearly to make it up on volume.   (Pretty smart move I'd say.)

I'm sceptical about them being able to get the OTC approved, but stranger things have happened.  I think the strongest argument for going OTC is that the risk from people taking internet generics (of questionable provenance and quality) is greater than the risk of someone taking a legit pill who shouldn't (those warned side effects are rare.)   I completely buy that argument myself, but I just don't think the FDA will.

I don't see any way Lilly successfully extends the Cialis patent, and can't see why they'd want to at this point.   Once you can get Viagra for a buck a pill, the right to sell Cialis for $25 won't mean much.

Yes, but Cialis, assuming you are going to regularly take PDE5 inhibitors, is probably the best for a man's long term health imho:  it keeps the prostate under control and will help with 24 hour endothlial function.  In other words, just popping a Viagra three or four times per week isn't going to do that.
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Regulus

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #5 on: September 15, 2015, 09:33:43 pm »
THe Forbes article is right on;   once any of these drugs goes generic, it's game over for the high priced name brands as a class.   

The drugmakers clearly believe the patent party is over.   That is the entire reason why Lilly wants Cialis to go OTC.   Their plan is clearly to make it up on volume.   (Pretty smart move I'd say.)

I'm sceptical about them being able to get the OTC approved, but stranger things have happened.  I think the strongest argument for going OTC is that the risk from people taking internet generics (of questionable provenance and quality) is greater than the risk of someone taking a legit pill who shouldn't (those warned side effects are rare.)   I completely buy that argument myself, but I just don't think the FDA will.

I don't see any way Lilly successfully extends the Cialis patent, and can't see why they'd want to at this point.   Once you can get Viagra for a buck a pill, the right to sell Cialis for $25 won't mean much.

Yes, but Cialis, assuming you are going to regularly take PDE5 inhibitors, is probably the best for a man's long term health imho:  it keeps the prostate under control and will help with 24 hour endothlial function.  In other words, just popping a Viagra three or four times per week isn't going to do that.

Agreed, but prostate health isn't the reason guys are taking this stuff.  :-)    If Cialis is expensive and Viagra is cheap, and both produce the desired effect, you don't need an MBA to do that market analysis.    If Viagra's price drops 90%, Cialis has to drop comparably, which makes fighting for the patent not worthwhile.

(On the other hand, if Cialis is priced in the same ballpark and OTC, they clean up.  Which is why Lilly is smart to pursue the OTC strategy.    Pfizer actually tried to take Viagra OTC and failed, but then they got the patent extension;  had they not gotten it I think they would have fought harder for the OTC.)
Late 40's, on TRT since 2011.
Test cyp 50 mg twice per week
Vegan and loving it since late 2015

PeakT

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #6 on: September 15, 2015, 09:39:23 pm »
THe Forbes article is right on;   once any of these drugs goes generic, it's game over for the high priced name brands as a class.   

The drugmakers clearly believe the patent party is over.   That is the entire reason why Lilly wants Cialis to go OTC.   Their plan is clearly to make it up on volume.   (Pretty smart move I'd say.)

I'm sceptical about them being able to get the OTC approved, but stranger things have happened.  I think the strongest argument for going OTC is that the risk from people taking internet generics (of questionable provenance and quality) is greater than the risk of someone taking a legit pill who shouldn't (those warned side effects are rare.)   I completely buy that argument myself, but I just don't think the FDA will.

I don't see any way Lilly successfully extends the Cialis patent, and can't see why they'd want to at this point.   Once you can get Viagra for a buck a pill, the right to sell Cialis for $25 won't mean much.

Yes, but Cialis, assuming you are going to regularly take PDE5 inhibitors, is probably the best for a man's long term health imho:  it keeps the prostate under control and will help with 24 hour endothlial function.  In other words, just popping a Viagra three or four times per week isn't going to do that.

Agreed, but prostate health isn't the reason guys are taking this stuff.  :-)    If Cialis is expensive and Viagra is cheap, and both produce the desired effect, you don't need an MBA to do that market analysis.    If Viagra's price drops 90%, Cialis has to drop comparably, which makes fighting for the patent not worthwhile.

(On the other hand, if Cialis is priced in the same ballpark and OTC, they clean up.  Which is why Lilly is smart to pursue the OTC strategy.    Pfizer actually tried to take Viagra OTC and failed, but then they got the patent extension;  had they not gotten it I think they would have fought harder for the OTC.)

You really are a numbers guy, aren't you?   ;D

This may also explain why Lilly doubled the price of Cialis recently (from what I have heard):  they are reading the handwriting on the wall...
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Regulus

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #7 on: September 16, 2015, 11:25:39 am »
THe Forbes article is right on;   once any of these drugs goes generic, it's game over for the high priced name brands as a class.   

The drugmakers clearly believe the patent party is over.   That is the entire reason why Lilly wants Cialis to go OTC.   Their plan is clearly to make it up on volume.   (Pretty smart move I'd say.)

I'm sceptical about them being able to get the OTC approved, but stranger things have happened.  I think the strongest argument for going OTC is that the risk from people taking internet generics (of questionable provenance and quality) is greater than the risk of someone taking a legit pill who shouldn't (those warned side effects are rare.)   I completely buy that argument myself, but I just don't think the FDA will.

I don't see any way Lilly successfully extends the Cialis patent, and can't see why they'd want to at this point.   Once you can get Viagra for a buck a pill, the right to sell Cialis for $25 won't mean much.

Yes, but Cialis, assuming you are going to regularly take PDE5 inhibitors, is probably the best for a man's long term health imho:  it keeps the prostate under control and will help with 24 hour endothlial function.  In other words, just popping a Viagra three or four times per week isn't going to do that.

Agreed, but prostate health isn't the reason guys are taking this stuff.  :-)    If Cialis is expensive and Viagra is cheap, and both produce the desired effect, you don't need an MBA to do that market analysis.    If Viagra's price drops 90%, Cialis has to drop comparably, which makes fighting for the patent not worthwhile.

(On the other hand, if Cialis is priced in the same ballpark and OTC, they clean up.  Which is why Lilly is smart to pursue the OTC strategy.    Pfizer actually tried to take Viagra OTC and failed, but then they got the patent extension;  had they not gotten it I think they would have fought harder for the OTC.)

You really are a numbers guy, aren't you?   ;D

This may also explain why Lilly doubled the price of Cialis recently (from what I have heard):  they are reading the handwriting on the wall...

Sure but I'm also a poet:  gather ye profits while ye may.   :-)
Late 40's, on TRT since 2011.
Test cyp 50 mg twice per week
Vegan and loving it since late 2015

PeakT

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Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #8 on: September 16, 2015, 08:37:46 pm »
Sorry, poetry doesn't come to my mind when I think of that - more like Rammstein lyrics!
THE MOST COMPREHENSIVE BOOK ON TRT/TESTOSTERONE:
https://www.amazon.com/Natural-Versus-Testosterone-Therapy-Myer/dp/1523210532/ref=sr_1_1?ie=UTF8&qid=1499116128&sr=8-1&keywords=natural+versus+testosterone+therapy
And check out my New Peak Testosterone Program: http://www.peaktestosterone.com/peak_testosterone_program
If you are on medications or have a medical condition, always check with your doctor first before making any lifestyle changes or taking new supplements.  And low testosterone is a medical condition.

Peak Testosterone Forum

Re: Will the Cialis Patent Be Extended? And Should It Go Over the Counter?
« Reply #8 on: September 16, 2015, 08:37:46 pm »