SANCTURA XR Drug Patent Profile

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

Sanctura Xr is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in SANCTURA XR is trospium chloride. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sanctura Xr

A generic version of SANCTURA XR was approved as trospium chloride by GLENMARK PHARMS LTD on August 13^th, 2010.

Summary for SANCTURA XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	8
Patent Applications:	879
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SANCTURA XR
DailyMed Link:	SANCTURA XR at DailyMed

Recent Clinical Trials for SANCTURA XR

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

Sponsor	Phase
Neil M. Resnick	Phase 4
National Institute on Aging (NIA)	Phase 4
Karuna Therapeutics	Phase 1

See all SANCTURA XR clinical trials

Paragraph IV (Patent) Challenges for SANCTURA XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCTURA XR	Extended-release Capsules	trospium chloride	60 mg	022103	1	2009-03-02

US Patents and Regulatory Information for SANCTURA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007		DISCN	Yes	No

Expired US Patents for SANCTURA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,763,635
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,781,448
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,410,978
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,781,449
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,759,359

International Patents for SANCTURA XR

See the table below for patents covering SANCTURA XR around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	493981
European Patent Office	2210605	Forme dosifiée quotidienne de trospium (Once daily dosage forms of trospium)
European Patent Office	1680110	FORME DOSIFIEE QUOTIDIENNE DE TROSPIUM (ONCE DAILY DOSAGE FORMS OF TROSPIUM)
Hong Kong	1088547	ONCE DAILY DOSAGE FORMS OF TROSPIUM TROSPIUM
Japan	5783489
Spain	2359375
World Intellectual Property Organization (WIPO)	2005046684

Market Dynamics and Financial Trajectory for SANCTURA XR

Introduction

SANCTURA XR, a once-a-day formulation of trospium chloride, is a significant player in the treatment of overactive bladder (OAB). Developed and marketed by Indevus Pharmaceuticals, and later acquired by Allergan, this drug has navigated a complex market landscape. Here, we delve into the market dynamics and financial trajectory of SANCTURA XR.

Market Need and Competition

The overactive bladder market is substantial and growing, driven by an increasing prevalence of the condition and the need for effective treatments. SANCTURA XR, with its once-daily dosing and reduced side effects such as dry mouth, positioned itself as a competitive option in this space[4].

Competitive Landscape

In the OAB market, SANCTURA XR faced competition from other anticholinergic medications and alternative treatments like BOTOX, which Allergan also promoted. Despite this, SANCTURA XR's efficacy and side effect profile helped it carve out a niche[4].

Launch and Initial Market Performance

SANCTURA XR was launched in the U.S. in January 2008 by Indevus Pharmaceuticals in collaboration with Allergan. The drug was also licensed to Rottapharm Madaus Group for marketing in certain territories outside the U.S., excluding Canada, Japan, Korea, and China[1].

Revenue Contribution

In the first quarter of fiscal 2008, SANCTURA XR contributed significantly to Indevus Pharmaceuticals' revenue. The company reported $9.5 million in revenue associated with SANCTURA, which included SANCTURA XR sales to Allergan at cost[2].

Financial Performance

Indevus Pharmaceuticals' financial performance during the period of SANCTURA XR's launch was marked by both growth and challenges.

Revenue Growth

For the quarter ended December 31, 2007, Indevus reported total consolidated revenues of $16.4 million, a 25% increase from the previous year. SANCTURA XR sales were a key component of this growth[2].

Cost of Product Revenue

The cost of product revenue increased by 37% to $5.9 million, primarily due to the sales of SANCTURA XR to Allergan at cost, as well as costs associated with other products like VANTAS and DELATESTRYL[2].

Research and Development Expenses

Research and development expenses decreased by 35% to $6.4 million, reflecting a strategic adjustment in the company's R&D spending. However, marketing, general, and administrative expenses increased significantly by 98% to $17.8 million, indicating a strong focus on promoting SANCTURA XR and other products[2].

Acquisition by Allergan

In 2008, Allergan acquired Esprit Pharma, which included the rights to SANCTURA XR, in an all-cash transaction of $370 million. This acquisition solidified Allergan's position in the OAB market and expanded its treatment portfolio for genitourinary disorders[4].

Post-Acquisition Performance

Under Allergan, SANCTURA XR continued to be a part of a broader strategy to address the continuum of care for OAB and other genitourinary (GU) disorders. Allergan's operational resources and expertise further accelerated the growth of SANCTURA XR in the U.S. pharmaceutical market[4].

Generic Competition

The financial trajectory of SANCTURA XR was eventually impacted by the entry of generic competitors. In 2013, Perrigo received FDA final approval for a generic equivalent to SANCTURA XR, which would likely reduce the market share and revenue of the branded product[5].

Market Impact and Patient Benefits

SANCTURA XR has been effective in reducing typical side effects associated with many OAB medications, such as dry mouth. This has improved the quality of life for patients suffering from overactive bladder.

"With SANCTURA XR, which has been shown to be effective while significantly reducing typical side effects such as dry mouth associated with many OAB medications, we are building a treatment portfolio that addresses the continuum of care for OAB and other GU disorders," - David E.I. Pyott, Allergan chair and CEO[4].

Financial Risks and Uncertainties

Indevus Pharmaceuticals and later Allergan faced several financial risks and uncertainties related to SANCTURA XR. These included dependence on the success of the drug, competition, and regulatory approvals. Additionally, there were risks associated with third-party supplies, manufacturing, and marketing agreements[2].

Key Takeaways

• Market Position: SANCTURA XR was a significant player in the overactive bladder market, known for its once-daily dosing and reduced side effects.
• Financial Performance: The drug contributed substantially to Indevus Pharmaceuticals' revenue and later to Allergan's after the acquisition.
• Acquisition: Allergan's acquisition of Esprit Pharma solidified its position in the GU therapeutic area.
• Generic Competition: The entry of generic equivalents impacted the financial trajectory of SANCTURA XR.
• Patient Benefits: SANCTURA XR improved patient outcomes by reducing side effects common in OAB treatments.

FAQs

What is SANCTURA XR used for?

SANCTURA XR is used for the treatment of overactive bladder (OAB).

Who developed and marketed SANCTURA XR?

SANCTURA XR was developed by Indevus Pharmaceuticals and later marketed by Allergan after its acquisition of Esprit Pharma.

What are the key benefits of SANCTURA XR?

SANCTURA XR offers once-daily dosing and significantly reduces typical side effects such as dry mouth associated with many OAB medications.

How did the acquisition by Allergan impact SANCTURA XR?

The acquisition by Allergan expanded the operational resources and expertise dedicated to SANCTURA XR, further accelerating its growth in the U.S. pharmaceutical market.

What impact did generic competition have on SANCTURA XR?

The entry of generic equivalents in 2013 likely reduced the market share and revenue of the branded SANCTURA XR product.

Sources

1. Indevus Pharmaceuticals Announces Issuance of U.S. Patent for SANCTURA XR(TM) - FierceBiotech
2. Indevus Pharmaceuticals, Inc. Announces First Quarter Fiscal 2008 Financial Results - BioSpace
3. 2011 Allergan Annual Report - AnnualReports.com
4. Allergan overactive acquisition - Drug Discovery News
5. Perrigo Announces FDA Final Approval For Generic Equivalent To Sanctura XR - Perrigo Investor Relations