AXIRON Drug Patent Profile

Which patents cover Axiron, and when can generic versions of Axiron launch?

Axiron is a drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in AXIRON is testosterone. There are sixty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Axiron

A generic version of AXIRON was approved as testosterone by ACTAVIS LABS UT INC on January 27^th, 2006.

Summary for AXIRON

International Patents:	37
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	9
Patent Applications:	4,269
Drug Prices:	Drug price information for AXIRON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AXIRON
What excipients (inactive ingredients) are in AXIRON?	AXIRON excipients list
DailyMed Link:	AXIRON at DailyMed

See drug prices for AXIRON

See drug sales revenues for AXIRON

Recent Clinical Trials for AXIRON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
INC Research	Phase 3
Clarus Therapeutics, Inc.	Phase 3
Syneos Health	Phase 3

See all AXIRON clinical trials

Paragraph IV (Patent) Challenges for AXIRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXIRON	Topical Solution	testosterone	30 mg/1.5 mL	022504	1	2013-01-29

US Patents and Regulatory Information for AXIRON

AXIRON is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,435,944
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,993,520
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	9,180,194
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No	8,807,861		Y

Expired US Patents for AXIRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	8,784,878
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	6,299,900
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	8,071,075
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010	6,923,983

EU/EMA Drug Approvals for AXIRON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Warner Chilcott UK Ltd.	Intrinsa	testosterone	EMEA/H/C/000634 Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28
Warner Chilcott  Deutschland GmbH	Livensa	testosterone	EMEA/H/C/000630 Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.	Withdrawn	no	no	no	2006-07-28

International Patents for AXIRON

See the table below for patents covering AXIRON around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013237690	METHOD AND COMPOSITION FOR TRANSDERMAL DRUG DELIVERY
Germany	69739037
European Patent Office	1534235	COMMANDE DE DEBIT D'APPORT TRANSDERMIQUE UTILISANT DES COMPOSITIONS PHARMACEUTIQUES AMORPHES (TRANSDERMAL DELIVERY RATE CONTROL USING AMORPHOUS PHARMACEUTICAL COMPOSITIONS)
China	101636194	Spreading implement

Supplementary Protection Certificates for AXIRON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1769785	CA 2012 00012	Denmark

AXIRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Axiron

Introduction

Axiron, a topical testosterone replacement therapy developed by Acrux, has been a significant player in the men's health market since its approval by the FDA in 2010. Here, we delve into the market dynamics and the financial trajectory of Axiron, highlighting its launch, growth, and the challenges it faced.

Market Context: Testosterone Replacement Therapy

The global market for testosterone therapies has been growing steadily, driven by increasing awareness and diagnosis of hypogonadism, a condition characterized by low testosterone levels. As of 2010, the global sales of testosterone therapies exceeded $1 billion annually, with testosterone gels in the US market alone generating $700 million in sales[4].

FDA Approval and Initial Launch

Axiron was approved by the FDA in 2010, just ten months after Acrux submitted the marketing application. This approval was a milestone for Acrux, resulting in a $87 million payment from Eli Lilly, which had acquired the worldwide rights to commercialize Axiron[1].

Market Performance in the US

Upon its launch, Axiron quickly gained traction in the US market. The US testosterone therapy market, particularly the transdermal segment, was growing rapidly, with a compound annual growth rate of 19% over five years leading up to 2010. Axiron competed directly with other popular products like Androgel and Testim, and by 2012, it had captured a significant share of the market, becoming the second-largest product in the transdermal testosterone gel therapy segment[3].

Global Expansion

Beyond the US, Axiron was launched in several key markets, including Canada, Australia, Brazil, and Germany. These launches were facilitated by Eli Lilly's extensive global distribution network and regulatory approvals in these territories. By 2014, Axiron had been approved and launched in multiple ex-US markets, which were seen as crucial for its long-term growth[2][3].

Financial Performance

Revenue and Milestones

The financial performance of Axiron was robust in its initial years. In 2010/11, Acrux reported a profit after tax of $57 million, largely due to the $87 million milestone payment from Eli Lilly. In the following years, Axiron continued to generate significant revenue. For the half-year to December 2013, Acrux reported revenue of $43.7 million, with $42.5 million attributed to Axiron sales and milestone payments[2].

Royalties and Dividends

Acrux received royalties on worldwide sales of Axiron and was eligible for up to $195 million in sales milestone payments. The company declared several dividends, including a special unfranked dividend of 60 cents per share in 2011 and a 12 cents per share dividend in 2014, reflecting the strong financial performance driven by Axiron sales[1][2].

Market Share and Competition

Axiron's market share grew steadily, particularly among primary care physicians and urologists/endocrinologists. By 2013, Axiron had overtaken Testim to become the second-largest product in the transdermal testosterone gel therapy segment, with a market share of 14%[3].

Challenges and Decline

Despite its initial success, Axiron faced significant challenges in later years. The introduction of generic competition and the termination of the licensing agreement with Eli Lilly led to a decline in global sales. By 2018, Axiron's royalty revenue had dropped by 90.4% due to these factors, resulting in a non-cash impairment loss of $5.6 million for Acrux[5].

Regulatory and Legal Issues

Acrux also faced legal challenges related to the Axiron patent. The company incurred non-recurring legal fees associated with patent appeal litigation, which further impacted its financial performance[5].

Clinical Trials and Marketing Efforts

Eli Lilly invested substantially in clinical trials and marketing efforts to support Axiron. These included studies on the product's impact on sex drive, energy levels, and ejaculatory dysfunction, as well as national direct-to-consumer advertising campaigns. These efforts helped maintain and grow Axiron's market presence despite increasing competition[3].

Healthcare Plan Coverage

Lilly's efforts to expand healthcare plan formulary coverage for Axiron were successful, with 87% of all commercially insured lives having access to Axiron by 2014. This increased coverage was crucial for maintaining market share and revenue[3].

Conclusion

Axiron's journey from its FDA approval in 2010 to its subsequent global launches and financial highs and lows provides a comprehensive view of the dynamics in the testosterone replacement therapy market. Here are the key takeaways:

• Strong Initial Performance: Axiron achieved significant revenue and market share growth following its launch.
• Global Expansion: Successful launches in multiple ex-US markets contributed to its global presence.
• Financial Milestones: Acrux benefited from substantial milestone payments and royalties.
• Challenges: Generic competition and the termination of the licensing agreement with Eli Lilly led to a decline in sales and revenue.
• Regulatory and Legal Issues: Patent appeal litigation added to the financial burdens.
• Marketing and Clinical Efforts: Substantial investments by Eli Lilly in marketing and clinical trials supported Axiron's market position.

Key Takeaways

• Axiron was a significant player in the growing testosterone replacement therapy market.
• Its success was driven by strong initial sales, global expansion, and substantial financial milestones.
• The product faced challenges from generic competition and legal issues.
• Marketing and clinical efforts were crucial in maintaining its market presence.

FAQs

Q: What was the significance of Axiron's FDA approval in 2010? A: The FDA approval of Axiron in 2010 was a milestone for Acrux, resulting in a $87 million payment from Eli Lilly and paving the way for its launch in the US market.

Q: How did Axiron perform in the global market? A: Axiron was launched in several key markets including Canada, Australia, Brazil, and Germany, contributing to its global presence and revenue growth.

Q: What were the main challenges faced by Axiron? A: Axiron faced significant challenges from generic competition and the termination of the licensing agreement with Eli Lilly, leading to a decline in sales and revenue.

Q: How did Eli Lilly support Axiron's market presence? A: Eli Lilly invested in clinical trials and marketing efforts, including national direct-to-consumer advertising campaigns, to support Axiron and expand its healthcare plan formulary coverage.

Q: What was the impact of regulatory and legal issues on Acrux? A: Acrux incurred non-recurring legal fees associated with patent appeal litigation, which further impacted its financial performance and resulted in a non-cash impairment loss.

Sources

1. Acrux - Annual Reports. Annual Reports.
2. For personal use only - ASX. ASX Announcements.
3. View Annual Report. Annual Reports.
4. Lilly to Acquire Global License to AXIRON Testosterone Solution. PR Newswire.
5. INVESTING IN OUR CORE STRENGTH - Annual Reports. Annual Reports.