VOGELXO Drug Patent Profile

When do Vogelxo patents expire, and when can generic versions of Vogelxo launch?

Vogelxo is a drug marketed by Upsher Smith Labs and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vogelxo

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

Summary for VOGELXO

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	1
Patent Applications:	5,580
Drug Prices:	Drug price information for VOGELXO
What excipients (inactive ingredients) are in VOGELXO?	VOGELXO excipients list
DailyMed Link:	VOGELXO at DailyMed

See drug prices for VOGELXO

Recent Clinical Trials for VOGELXO

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

Sponsor	Phase
Upsher-Smith Laboratories	Phase 4

See all VOGELXO clinical trials

Pharmacology for VOGELXO

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists

US Patents and Regulatory Information for VOGELXO

VOGELXO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upsher Smith Labs	VOGELXO	testosterone	GEL, METERED;TRANSDERMAL	204399-003	Jun 4, 2014	BX	RX	No	No	8,785,426		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL;TRANSDERMAL	204399-002	Jun 4, 2014	AB2	RX	No	No	8,785,426		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL, METERED;TRANSDERMAL	204399-003	Jun 4, 2014	BX	RX	No	No	9,662,340		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL, METERED;TRANSDERMAL	204399-003	Jun 4, 2014	BX	RX	No	No	9,295,675		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL;TRANSDERMAL	204399-002	Jun 4, 2014	AB2	RX	No	No	9,295,675		Y
Upsher Smith Labs	VOGELXO	testosterone	GEL;TRANSDERMAL	204399-002	Jun 4, 2014	AB2	RX	No	No	9,662,340		Y

EU/EMA Drug Approvals for VOGELXO

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 VOGELXO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2857286
Taiwan	I608766
South Africa	201604587	TESTOSTERONE GEL COMPOSITIONS AND RELATED METHODS
Singapore	11201604788U	TESTOSTERONE GEL COMPOSITIONS AND RELATED METHODS
Australia	2014362275	Testosterone gel compositions and related methods
Hong Kong	1223852
Taiwan	201711535	Print circuit board and method for manufacturing same

Market Dynamics and Financial Trajectory for Vogelxo

Introduction

Vogelxo, a testosterone gel developed by Upsher-Smith Laboratories, is a significant player in the testosterone replacement therapy (TRT) market. Here, we will delve into the market dynamics and financial trajectory of Vogelxo, including its regulatory approvals, market positioning, and financial implications.

Regulatory Approvals and Therapeutic Equivalence

Vogelxo received an AB rating from the U.S. Food and Drug Administration (FDA), indicating that it is therapeutically equivalent to Testim (testosterone gel) by Auxilium. This rating means that Vogelxo can be substituted for Testim with the expectation of producing the same clinical effects and safety profile when used as directed[1][4].

Market Positioning

Vogelxo is uniquely positioned in the market due to its availability in three convenient configurations: unit-dose tubes, unit-dose packets, and a metered-dose pump. This versatility makes it the first and only generic transdermal testosterone replacement therapy available in these three forms, enhancing patient compliance and convenience[1][4].

Target Market and Indications

Vogelxo is indicated for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone. This includes hypogonadism, a condition characterized by low or no testosterone production. The drug provides continuous transdermal delivery of testosterone for 24 hours following a single application[3].

Competitive Landscape

The TRT market is highly competitive, with several products available, including Natesto (testosterone nasal gel) by AYTU Bioscience, which is the only testosterone replacement therapy delivered via a nasal gel. However, Vogelxo's diverse delivery options and its generic status make it a strong competitor in the $1.8 billion TRT market[2].

Safety and Side Effects

While Vogelxo offers significant benefits, it also comes with potential serious side effects. These include worsening of prostate symptoms, possible increased risk of prostate cancer, blood clots, and a potential decrease in sperm count with large doses. These factors must be carefully managed by healthcare providers to ensure patient safety[1][3].

Financial Implications

The financial trajectory of Vogelxo is influenced by several factors:

Revenue Generation

Given its therapeutic equivalence to Testim and its availability in multiple forms, Vogelxo has the potential to capture a significant share of the TRT market. The drug's launch and subsequent marketing efforts have contributed to revenue growth for Upsher-Smith Laboratories[1].

Cost and Affordability

As a generic product, Vogelxo is generally more affordable than its branded counterparts, making it more accessible to patients. This affordability can drive higher adoption rates and contribute to increased revenue[1].

Market Expansion

Upsher-Smith's strategy to bring high-quality, affordable medications to market aligns with the growing demand for TRT. The company's focus on expanding the commercialization of Vogelxo and its authorized generic version is expected to enhance its financial performance[1].

Business Strategy

Upsher-Smith's business strategy includes expanding the commercialization of Vogelxo through its direct sales force and distribution network. The company also aims to acquire additional marketed products and late-stage development assets to complement its existing portfolio, further enhancing its financial trajectory[1].

Market Statistics

The TRT market, in which Vogelxo operates, is substantial, with over 6.8 million prescriptions annually. This large market size provides a significant opportunity for revenue growth for Vogelxo and its authorized generic version[2].

Quotes from Industry Experts

Rusty Field, Chief Commercial Officer at Upsher-Smith, highlighted the company's commitment to bringing high-quality medications to market: "At Upsher-Smith, we strive to bring high-quality medications to market that are more affordable and accessible to patients."[1]

Illustrative Statistics

• Market Size: The TRT market accounts for over $1.8 billion annually.
• Prescriptions: Over 6.8 million prescriptions are filled each year in this market[2].
• Product Forms: Vogelxo is available in three forms, making it a versatile option for patients[1].

Key Takeaways

• Regulatory Approval: Vogelxo has received an AB rating from the FDA, indicating therapeutic equivalence to Testim.
• Market Positioning: Available in three convenient forms, making it a unique offering in the TRT market.
• Target Market: Indicated for adult males with conditions associated with low or no testosterone.
• Financial Implications: Potential for significant revenue generation due to its affordability and market demand.
• Business Strategy: Focus on expanding commercialization and acquiring complementary products.

FAQs

Q: What is Vogelxo used for? A: Vogelxo is used for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone.

Q: What forms is Vogelxo available in? A: Vogelxo is available in unit-dose tubes, unit-dose packets, and a metered-dose pump.

Q: Is Vogelxo therapeutically equivalent to any other product? A: Yes, Vogelxo is therapeutically equivalent to Testim (testosterone gel) by Auxilium.

Q: What are the potential serious side effects of Vogelxo? A: Potential serious side effects include worsening of prostate symptoms, possible increased risk of prostate cancer, blood clots, and a potential decrease in sperm count.

Q: How does Vogelxo contribute to the financial performance of Upsher-Smith Laboratories? A: Vogelxo contributes to revenue growth through its market positioning, affordability, and the company's strategic efforts to expand its commercialization.

Sources

1. Upsher-Smith Laboratories's Vogelxo (Testosterone) Gel 1% Receives AB Rating from FDA - PR Newswire
2. AYTU BIOSCIENCE, INC - Annual Reports - Annual Reports
3. Vogelxo (Testosterone Gel): Side Effects, Uses, Dosage, Interactions - RxList
4. FDA: Vogelxo Therapeutically Equivalent to Testim - eMPR.com