INTANGIBLE ASSETS, NET

12 Months Ended

Dec. 31, 2020

Goodwill and Intangible Assets Disclosure [Abstract]

INTANGIBLE ASSETS, NET

NOTE 6 – INTANGIBLE ASSETS, NET

The following table sets forth the gross carrying amount, accumulated amortization and net carrying amount of our intangible assets as of December 31, 2020 and 2019:

	December 31, 2020
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
Approved hormone therapy drug candidate patents	$	4,044,552	$	(748,627	)	$	3,295,925		12
Hormone therapy drug candidate patents (pending)		1,628,457		—			1,628,457		n/a
Non-amortizable intangible assets:
Multiple trademarks		323,341		—			323,341		indefinite
TOTAL	$	5,996,350	$	(748,627	)	$	5,247,723

	December 31, 2019
	Gross Carrying Amount		Accumulated Amortization			Net Amount		Weighted- Average Remaining Amortization Period (yrs.)
Amortizable intangible assets:
Approved hormone therapy drug candidate patents	$	3,463,082	$	(478,983	)	$	2,984,099		13
Hormone therapy drug candidate patents (pending)		1,979,299		—			1,979,299		n/a
Non-amortizable intangible assets:
Multiple trademarks		294,813		—			294,813		indefinite
TOTAL	$	5,737,194	$	(478,983	)	$	5,258,211

We capitalize external costs, consisting primarily of legal costs, related to securing our patents and trademarks. Once a patent is granted, we amortize the approved hormone therapy drug candidate patents using the straight-line method over the estimated useful life of approximately 20 years, which is the life of intellectual property patents. If the patent is not granted, we write-off any capitalized patent costs at that time. Trademarks are perpetual and are not amortized. During the years ended December 31, 2020 and 2019, we wrote off $1,131,776 and $78,864, respectively, in costs related to trademarks and patents. There was no impairment of intangible assets during the year ended December 31, 2018.

As of December 31, 2020, we had 38 issued domestic patents and 39 issued foreign patents, including:

● 15 domestic patents and nine foreign patents that relate to BIJUVA as well as three domestic patents that relate to estradiol and progesterone product candidates. These patents establish an important intellectual property foundation and are owned by us. The domestic patents will expire in 2032. The foreign patents will expire no earlier than 2032. In addition, we have pending patent applications relating to BIJUVA in the U.S., Argentina, Australia, Brazil, Canada, China, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea;

● 12 domestic patents (ten utility and two design) and 18 foreign patents (eight utility and ten design) that relate to IMVEXXY. These patents establish an important intellectual property foundation for IMVEXXY and are owned by us. The domestic patents will expire in 2032 or 2033. The foreign utility patents will expire no earlier than 2033. The foreign design patents provide protection expiring no earlier than 2025. In certain countries, the foreign design patents provide protection through at least 2037. In addition, we have pending patent applications related to IMVEXXY in the U.S., Argentina, Australia, Brazil, Canada, Europe, Israel, Japan, Mexico, New Zealand, Russia, South Africa, and South Korea;

● One domestic utility patent that relates to our topical-cream candidates, which is owned by us. The domestic patent will expire in 2035;

● One domestic utility patent and eight foreign patents that relate to our transdermal-patch candidates, which are owned by us. The domestic utility patent will expire in 2032. The foreign patents will expire no earlier than 2033. We have a pending patent application with respect to our transdermal-patch candidates in Brazil;

● Three domestic utility patents that relate to TX-009HR, a progesterone and estradiol product candidate, which are owned by us and will expire in 2037;

● Two domestic and four foreign patents that relate to formulations containing progesterone, which are owned by us. The domestic patents will expire between 2032 and 2036. The foreign patents will expire no earlier than 2033. In addition, we have pending patent applications with respect formulations containing progesterone in the U.S., Australia, Canada, Europe, and Mexico; and

● One domestic utility patent that relates to our OPERA information-technology platform, which is owned by us and will expire in 2031.

Amortization expense was $269,546, $197,593, and $112,474 for the years ended December 31, 2020, 2019, and 2018, respectively.

Estimated amortization expense, based on current patent cost being amortized, for the next five years is as follows:

Year Ending December 31,	Estimated Amortization
2021	$	274,669
2022	$	274,669
2023	$	274,669
2024	$	274,669
2025	$	274,669