SOLODYN Drug Patent Profile

When do Solodyn patents expire, and what generic alternatives are available?

Solodyn is a drug marketed by Bausch and is included in one NDA. There are eight patents protecting this drug and four Paragraph IV challenges.

This drug has twelve patent family members in nine countries.

The generic ingredient in SOLODYN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Solodyn

A generic version of SOLODYN was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for SOLODYN

International Patents:	12
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	19
Patent Applications:	2,938
Drug Prices:	Drug price information for SOLODYN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOLODYN
What excipients (inactive ingredients) are in SOLODYN?	SOLODYN excipients list
DailyMed Link:	SOLODYN at DailyMed

See drug prices for SOLODYN

See drug sales revenues for SOLODYN

Recent Clinical Trials for SOLODYN

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

Sponsor	Phase
Journey Medical Corporation	Phase 1
Dr. Reddy's Laboratories Limited	Phase 1
National Jewish Health	Phase 2

See all SOLODYN clinical trials

Paragraph IV (Patent) Challenges for SOLODYN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOLODYN	Extended-release Tablet	minocycline hydrochloride	105 mg	050808	1	2010-12-13
SOLODYN	Extended-release Tablet	minocycline hydrochloride	55 mg	050808	1	2010-12-02
SOLODYN	Extended-release Tablet	minocycline hydrochloride	80 mg	050808	1	2010-10-27
SOLODYN	Extended-release Tablet	minocycline hydrochloride	65 mg and 115 mg	050808	1	2009-11-19

US Patents and Regulatory Information for SOLODYN

SOLODYN is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009		DISCN	Yes	No	7,790,705
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010		DISCN	Yes	No	7,790,705
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009		DISCN	Yes	No	8,252,776
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010		DISCN	Yes	No	8,252,776

Expired US Patents for SOLODYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-004	Jul 23, 2009	5,908,838
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-008	Aug 27, 2010	5,908,838
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-001	May 8, 2006	5,908,838
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009	5,908,838

International Patents for SOLODYN

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010017310
World Intellectual Property Organization (WIPO)	2007001961
China	101208097	Method for the treatment of acne
Australia	2006262428	Method for the treatment of acne

SOLODYN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Solodyn

Introduction

Solodyn, a minocycline hydrochloride extended-release tablet, is a key product in the dermatological pharmaceutical market, particularly for the treatment of acne. Developed by Medicis Pharmaceutical Corporation, now part of Galderma, Solodyn has faced various market and financial challenges that have significantly impacted its trajectory.

Market Position and Competition

Solodyn was a flagship product for Medicis, dominating the acne treatment market for several years. However, its market position has been threatened by generic competition and strategic maneuvers by other pharmaceutical companies.

Generic Competition

The entry of generic versions of Solodyn has been a significant challenge. Despite efforts by Medicis to delay generic entry through legal and strategic means, such as "product hopping" (changing the strengths of the drug to avoid generic competition), several generic drug companies have successfully entered the market. For instance, three generic drug companies briefly launched their versions of Solodyn in 2009 and 2010 before settling with Medicis[1].

Competitive Landscape

Allergan, a major competitor, has been poised to capitalize on any weaknesses in Solodyn's market position. The potential approval of generic versions of Solodyn by competitors like Impax further intensified the competitive pressure, leading to concerns about the sustainability of Solodyn's market share[5].

Financial Performance and Challenges

The financial performance of Solodyn has been impacted by several factors, including accounting errors, generic competition, and market dynamics.

Accounting Errors and Investor Confidence

In 2008, Medicis announced an accounting error that led to a restatement of six years of financial numbers. This error, although relatively minor in terms of financial impact, led to a significant loss of investor confidence. The market's reaction was more driven by concerns over Solodyn's patent status and potential generic competition rather than the accounting issue itself[5].

Revenue Impact

The introduction of generic versions and the loss of patent exclusivity have directly affected Solodyn's revenue. Companies like Journey Medical Corporation, which face similar challenges with their own products, have reported declines in revenue due to generic competition. For example, Journey Medical saw a 9% decline in revenue in the fourth quarter of 2022 compared to the previous year, primarily due to generic competition for one of their products, Targadox[2].

Strategic Maneuvers: Product Hopping

To mitigate the impact of generic competition, Medicis employed a strategy known as "product hopping." This involved withdrawing certain strengths of Solodyn from the market and introducing new strengths, making it more difficult for generic manufacturers to enter the market with identical products. This tactic, while temporarily effective, did not completely prevent generic entry[1].

Legal and Regulatory Challenges

Solodyn has been involved in several legal battles, particularly antitrust litigation. The core allegation in the In re: Solodyn Antitrust Litigation was that Medicis made payments to generic manufacturers to delay their entry into the market. These legal challenges have added to the financial and operational complexities faced by the company[1].

Market Trends and Future Outlook

The dermatological pharmaceutical market, including products like Solodyn, is subject to various trends and factors that influence its future outlook.

Growing Demand for Dermatological Treatments

The demand for dermatological treatments, including acne medications, is increasing. This is driven by rising awareness and the growing prevalence of skin conditions. However, this growth is also attracting more competitors, including generic manufacturers[4].

Impact of COVID-19

The COVID-19 pandemic has had a noticeable impact on the pharmaceutical industry, including the market for Solodyn. The pandemic led to disruptions in supply chains and manufacturing, affecting the demand and supply of pharmaceutical products. This has been a temporary setback but highlights the resilience needed in the industry[4].

Key Takeaways

• Generic Competition: The entry of generic versions of Solodyn has significantly impacted its market share and revenue.
• Strategic Maneuvers: Medicis used "product hopping" to delay generic competition, but this strategy had limited success.
• Financial Impact: Accounting errors and legal challenges have added to the financial complexities faced by the company.
• Market Trends: The growing demand for dermatological treatments and the impact of COVID-19 are key factors influencing the market.
• Competitive Landscape: Allergan and other competitors have capitalized on Solodyn's weaknesses, further intensifying market competition.

FAQs

What is Solodyn used for?

Solodyn is a minocycline hydrochloride extended-release tablet used primarily for the treatment of acne.

How has generic competition affected Solodyn?

Generic competition has significantly reduced Solodyn's market share and revenue, despite Medicis' efforts to delay generic entry through legal and strategic means.

What is "product hopping" in the context of Solodyn?

"Product hopping" refers to the strategy of withdrawing certain strengths of Solodyn from the market and introducing new strengths to make it more difficult for generic manufacturers to enter the market with identical products.

How did accounting errors impact Medicis?

An accounting error in 2008 led to a restatement of six years of financial numbers, resulting in a loss of investor confidence and highlighting concerns over Solodyn's patent status and generic competition.

What is the current market outlook for Solodyn?

The market outlook for Solodyn is challenging due to ongoing generic competition, legal battles, and the impact of COVID-19 on the pharmaceutical industry.

Sources

1. In re: Solodyn Antitrust Litigation: Lessons From a "Big Stakes" Reverse-Payment Pharmaceutical Trial - California Lawyers for the Arts.
2. Journey Medical Corporation Reports Full-Year 2022 Financial Results and Recent Corporate Highlights - Journey Medical Corporation.
3. VALEANT PHARMACEUTICALS INTERNATIONAL, INC. 2016 Annual Report - Valeant Pharmaceuticals International, Inc.
4. Minocycline Hydrochloride Market Size Report, 2022-2027 - IndustryARC.
5. Medicis' Accounting Error Puts Spotlight on Solodyn Weakness - CBS News.