
Hello, Re: Competition And Products Within The Indication Of Male

re: Competition and products within the indication of Male Hypogonadism
I am trying to understand why a patient would take AndroDerm versus AndroGel.
1. Is there a specific benefit to one over the other?
2. Are the two products considered direct competitors?
3. What is the most popular treatment for Male Hypogonadism? Do you have any market share information of the offerings of male hypogonadism?
4. Are there any competitors below that are missing or irrelevant?
Mechanism of Action: Testosterone, Androgen replacements, agonists
Oral preparations (not yet available in the US): Fluoxymesterone, Mesterolone, Testosterone undecanoate
Intramuscular preparations (testosterone cypionate and enanthate): Delastestryl or Dep-Testosterone
Transdermal patches (non-scrotal): Androderm (Allergan)
Testosterone Gel: Androgel (AbbVie), Axiron (Eli Lilly), Testim (Endo), Fortesta (Endo)
Buccal: Striant (Endo)
Implantable pellets: Testopel (Endo)
5. I have done the following research for Hypogonadism, specifically comparing AndroDerm vs AndroGel. Am I missing anything here?
Approved Name
(Alternate names)
Testosterone-transdermal
(AndroDerm, Andropatch, Atmos, Androflex)
Stage Launched
Sales ($m) --
Indication Hypogonadism
Mechanism of Action Testosterone agonists
Companies Involved
Watson Labs: Originator
Allergan, Actavis: Associated
Endo, Paladin, GSK: Licensees
Description
Watson Laboratories (now Allergan, previously Actavis) has developed a Transdermal TheraDerm LRS (liquid reservoir) delivery system for testosterone for the treatment of male hypogonadism.
Launch, Geographic Details
Launched in several countries including the US and Europe. In Oct-11, the US FDA approved a lower-dose, smaller size testosterone transdermal patch.
Patent Details
--
---------------------------------
Approved Name
(Alternate names)
Testosterone topical
(AndroGel, Testosterone gel, Testosterone topical)
Stage Launched
Sales ($m) $77.3m (‘20E)
Indication
Hypogonadism, Growth disorders
Mechanism of Action
Testosterone replacements, Androgen-analogue-replacements
Companies Involved
Besins and Unimed (AbbVie): Originator
Bayer, Allergan, Mylan: Licensees
Description
Testosterone topical is a clear, odourless, gel formulation for hypogonadism (i.e. low testosterone levels).
In Sep-14, the US FTC filed a complaint alleging AbbVie, Besins and XXXXXXX of anti-competitive conduct.
Launch, Geographic Details
The product has been widely launched worldwide including a gel formulation called AndroGel; in Europe, it is marketed as Testogel.
Patent Details
The US Patent Office granted a composition of matter patent for AndroGel, issued on 7-Jan-03. Non-composition of AndroGel 1.62% will expire in 2020 with the 1% formulation protected until 2021.

re: Competition and products within the indication of Male Hypogonadism
I am trying to understand why a patient would take AndroDerm versus AndroGel.
1. Is there a specific benefit to one over the other?
2. Are the two products considered direct competitors?
3. What is the most popular treatment for Male Hypogonadism? Do you have any market share information of the offerings of male hypogonadism?
4. Are there any competitors below that are missing or irrelevant?
Mechanism of Action: Testosterone, Androgen replacements, agonists
Oral preparations (not yet available in the US): Fluoxymesterone, Mesterolone, Testosterone undecanoate
Intramuscular preparations (testosterone cypionate and enanthate): Delastestryl or Dep-Testosterone
Transdermal patches (non-scrotal): Androderm (Allergan)
Testosterone Gel: Androgel (AbbVie), Axiron (Eli Lilly), Testim (Endo), Fortesta (Endo)
Buccal: Striant (Endo)
Implantable pellets: Testopel (Endo)
5. I have done the following research for Hypogonadism, specifically comparing AndroDerm vs AndroGel. Am I missing anything here?
Approved Name
(Alternate names)
Testosterone-transdermal
(AndroDerm, Andropatch, Atmos, Androflex)
Stage Launched
Sales ($m) --
Indication Hypogonadism
Mechanism of Action Testosterone agonists
Companies Involved
Watson Labs: Originator
Allergan, Actavis: Associated
Endo, Paladin, GSK: Licensees
Description
Watson Laboratories (now Allergan, previously Actavis) has developed a Transdermal TheraDerm LRS (liquid reservoir) delivery system for testosterone for the treatment of male hypogonadism.
Launch, Geographic Details
Launched in several countries including the US and Europe. In Oct-11, the US FDA approved a lower-dose, smaller size testosterone transdermal patch.
Patent Details
--
---------------------------------
Approved Name
(Alternate names)
Testosterone topical
(AndroGel, Testosterone gel, Testosterone topical)
Stage Launched
Sales ($m) $77.3m (‘20E)
Indication
Hypogonadism, Growth disorders
Mechanism of Action
Testosterone replacements, Androgen-analogue-replacements
Companies Involved
Besins and Unimed (AbbVie): Originator
Bayer, Allergan, Mylan: Licensees
Description
Testosterone topical is a clear, odourless, gel formulation for hypogonadism (i.e. low testosterone levels).
In Sep-14, the US FTC filed a complaint alleging AbbVie, Besins and XXXXXXX of anti-competitive conduct.
Launch, Geographic Details
The product has been widely launched worldwide including a gel formulation called AndroGel; in Europe, it is marketed as Testogel.
Patent Details
The US Patent Office granted a composition of matter patent for AndroGel, issued on 7-Jan-03. Non-composition of AndroGel 1.62% will expire in 2020 with the 1% formulation protected until 2021.
The 2 products are very similar.
Detailed Answer:
Hi
I have gone through your query and understood your concern.
treatements for male gonadism depends on the cause and whether you're concerned about fertility.
For hypogonadism caused by testicular faillure also called primary hypogonadism,it is recommended the testosteron replacement therapy or TRT.
TRT can ease the symptoms of hypogonadism,restore the muscle strength and prevent bone loss.
Testosteron replacement therapy is avaible in several forms.
I want to underline that all the forms can improve testosteron levels and have the same benefits for hypogonadism.
To conclude my answer :Androderm is a brand name of Testosteron Transdermal Patch.
Androgel is one of the brand names of Testosteron topical.
The two products contain testosteron.
The difference is in the way you do TRT and the cost.
Your best option of TRT depend on your medical needs as well as your lifestyle.
My advice for you is to discuss carefully with your treating doctor about the most appropriate TRT therapy for you.I m sure you will find your best option.
Hope this is hepful.
Best regards.

The 2 products are very similar.
Detailed Answer:
Hi
I have gone through your query and understood your concern.
treatements for male gonadism depends on the cause and whether you're concerned about fertility.
For hypogonadism caused by testicular faillure also called primary hypogonadism,it is recommended the testosteron replacement therapy or TRT.
TRT can ease the symptoms of hypogonadism,restore the muscle strength and prevent bone loss.
Testosteron replacement therapy is avaible in several forms.
I want to underline that all the forms can improve testosteron levels and have the same benefits for hypogonadism.
To conclude my answer :Androderm is a brand name of Testosteron Transdermal Patch.
Androgel is one of the brand names of Testosteron topical.
The two products contain testosteron.
The difference is in the way you do TRT and the cost.
Your best option of TRT depend on your medical needs as well as your lifestyle.
My advice for you is to discuss carefully with your treating doctor about the most appropriate TRT therapy for you.I m sure you will find your best option.
Hope this is hepful.
Best regards.


I thought your detailed answer for my question on hypogonadism was extremely helpful. Thank you! I have one follow-up please, if you can do the same it will be most appreciated.
re: Competition and products within the indication of Hypothyroidism
I am trying to understand why a patient would take Synthroid versus Armour Thyroid.
1. Is there a specific benefit to one over the other?
2. Are the two products considered direct competitors?
3. What is the most popular treatment for Hypothyroidism? Do you have any market share information of the offerings of Hypothyroidism?
4. Are there any competitors below that are missing or irrelevant?
Armour thyroid (Allergan)
Synthroid (AbbVie)
Unithroid (Jerome Stevens Pharmaceuticals)
Levoxyl (Pfizer)
Levothroid (Forest Laboratories)
Tirosint (IBSA)
Levothyroxine (generics; Mylan)
5. Are any products currently in the pipeline?
6. Are both products off-patent?
Approved Name
(Alternate names)
Armour Thyroid
(thyroid tablets, USP)
Stage Patent expired
Sales ($m) $209.8m
Indication
Hypothyroidism
Mechanism of Action
Unknown, DNA transcription and protein synthesis
Companies Involved
Allergan: Originator
Description
Armour Thyroid (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odour. (T3 liothyronine is approximately four times as potent as T4 levothyroxine).
Patent Details
-
-------------------------------------
Approved Name
(Alternate names)
Synthroid
(levothyroxine sodium tablets, USP)
Stage Patent expired
Sales ($m) $789.4m
Indication
Hypothyroidism and pituitary thyrotropin
Mechanism of Action
Thyroid hormone (T4) receptor agonists
Companies Involved
AbbVie: Originator
Description
Synthroid is levothyroxine sodium (T4) indicated for
• Hypothyroidism: As replacement therapy across all types of hypothyroidism
• Pituitary Thyrotropin suppression: As an adjunct to surgery and radioiodine therapy in management of thyrotropin-dependent well-differentiated thyroid cancer.
Patent Details
[off-patent??]
Thank you very much for your help.

I thought your detailed answer for my question on hypogonadism was extremely helpful. Thank you! I have one follow-up please, if you can do the same it will be most appreciated.
re: Competition and products within the indication of Hypothyroidism
I am trying to understand why a patient would take Synthroid versus Armour Thyroid.
1. Is there a specific benefit to one over the other?
2. Are the two products considered direct competitors?
3. What is the most popular treatment for Hypothyroidism? Do you have any market share information of the offerings of Hypothyroidism?
4. Are there any competitors below that are missing or irrelevant?
Armour thyroid (Allergan)
Synthroid (AbbVie)
Unithroid (Jerome Stevens Pharmaceuticals)
Levoxyl (Pfizer)
Levothroid (Forest Laboratories)
Tirosint (IBSA)
Levothyroxine (generics; Mylan)
5. Are any products currently in the pipeline?
6. Are both products off-patent?
Approved Name
(Alternate names)
Armour Thyroid
(thyroid tablets, USP)
Stage Patent expired
Sales ($m) $209.8m
Indication
Hypothyroidism
Mechanism of Action
Unknown, DNA transcription and protein synthesis
Companies Involved
Allergan: Originator
Description
Armour Thyroid (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odour. (T3 liothyronine is approximately four times as potent as T4 levothyroxine).
Patent Details
-
-------------------------------------
Approved Name
(Alternate names)
Synthroid
(levothyroxine sodium tablets, USP)
Stage Patent expired
Sales ($m) $789.4m
Indication
Hypothyroidism and pituitary thyrotropin
Mechanism of Action
Thyroid hormone (T4) receptor agonists
Companies Involved
AbbVie: Originator
Description
Synthroid is levothyroxine sodium (T4) indicated for
• Hypothyroidism: As replacement therapy across all types of hypothyroidism
• Pituitary Thyrotropin suppression: As an adjunct to surgery and radioiodine therapy in management of thyrotropin-dependent well-differentiated thyroid cancer.
Patent Details
[off-patent??]
Thank you very much for your help.
The benefits and side effects are the same for the two medications.
Detailed Answer:
Hi and welcome back.
Synthroid and Armour Thyroid are used to treat hypothyroidism due to many causes.(thyroid hormone replacement therapy)
Synthroid is a synthetic compound(made in a laboratory) identical to T4 (levothyroxine) produced by the human thyroid gland and Armour Thyroid is a natural product made from animal thyroid glands and purified in a laboratory.
Synthroid contains T4 (thyroxine) only, whereas Armour contains both T4 and T3 (tri-iodothyronine).
Both these hormones can have similar benefits ,similar side effects profile and both will necessitate the need for the same exact lab tests to start and than to modify the dosis of treatement.
So,both Synthroid and Armor thyroid can help to normalise your thyroid test if you have hypothyroidism and help you feel better if you have symptoms of hypothyroidism.
In my opinion this is the most importat think.
Your treating doctor will give you all the info about your thyroid condition,your actual thyroid test result and he/she will decide the right treatement for you specific case.
The follow up with your local doctor is also very important because you may need dosis modification or (in rare cases ) even change of therapy accordingly to your symptoms.
Hope this is helpful.
Let me know if i can assist you further.
Regards.

The benefits and side effects are the same for the two medications.
Detailed Answer:
Hi and welcome back.
Synthroid and Armour Thyroid are used to treat hypothyroidism due to many causes.(thyroid hormone replacement therapy)
Synthroid is a synthetic compound(made in a laboratory) identical to T4 (levothyroxine) produced by the human thyroid gland and Armour Thyroid is a natural product made from animal thyroid glands and purified in a laboratory.
Synthroid contains T4 (thyroxine) only, whereas Armour contains both T4 and T3 (tri-iodothyronine).
Both these hormones can have similar benefits ,similar side effects profile and both will necessitate the need for the same exact lab tests to start and than to modify the dosis of treatement.
So,both Synthroid and Armor thyroid can help to normalise your thyroid test if you have hypothyroidism and help you feel better if you have symptoms of hypothyroidism.
In my opinion this is the most importat think.
Your treating doctor will give you all the info about your thyroid condition,your actual thyroid test result and he/she will decide the right treatement for you specific case.
The follow up with your local doctor is also very important because you may need dosis modification or (in rare cases ) even change of therapy accordingly to your symptoms.
Hope this is helpful.
Let me know if i can assist you further.
Regards.

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