RESCULA Drug Patent Profile

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

Rescula is a drug marketed by Sucampo Pharma Llc and is included in one NDA.

The generic ingredient in RESCULA is unoprostone isopropyl. There are four drug master file entries for this compound. Additional details are available on the unoprostone isopropyl profile page.

Summary for RESCULA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Patent Applications:	1,166
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RESCULA
DailyMed Link:	RESCULA at DailyMed

Paragraph IV (Patent) Challenges for RESCULA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESCULA	Ophthalmic Solution	unoprostone isopropyl	0.15%	021214	1	2014-05-12

US Patents and Regulatory Information for RESCULA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000		DISCN	Yes	No

Expired US Patents for RESCULA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	5,212,200
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	5,001,153
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	6,458,836
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	5,221,763
Sucampo Pharma Llc	RESCULA	unoprostone isopropyl	SOLUTION/DROPS;OPHTHALMIC	021214-001	Aug 3, 2000	5,208,256

International Patents for RESCULA

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0798751
Brazil	0109192
Germany	3868127
Taiwan	I286932
South Africa	8806871

Supplementary Protection Certificates for RESCULA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0289349	300135	Netherlands		300135, 20080429, EXPIRES: 20130428
0289349	C300135	Netherlands		PRODUCT NAME: UNOPROSTONEZUUR, DESGEWENST IN DE VORM VAN EEN ESTER OF EEN ZOUT; NATL REGISTRATION NO/DATE: RVG 28628 20030708; FIRST REGISTRATION: FR 359 911-5 AND 359 912-1 20020917
0289349	SPC/GB04/007	United Kingdom		PRODUCT NAME: ISOPROPYL(+)-(Z)-7-((1R,2R,3R,5S)-3,5-DIHYDROXY-2-(3-OXODECYL)CYCLOPENTYL)-5-HEPTENOATE; REGISTERED: CH 55634 01 20010329; UK PL00101/0667 20031112

RESCULA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: RESCULA

Introduction

Rescula, also known as unoprostone isopropyl ophthalmic solution 0.15%, is a medication approved by the U.S. FDA for the treatment of open-angle glaucoma and ocular hypertension. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting key events, decisions, and impacts on the pharmaceutical landscape.

Approval and Indication

Rescula was approved by the FDA in 2000 for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension[4].

Market Presence and Discontinuation

Sucampo Pharmaceuticals, the original marketer of Rescula, decided to discontinue its sales effective March 31, 2015. This decision was made to focus on other product lines that held greater potential for shareholder value. As part of this move, Sucampo returned all licenses for Rescula to Tokyo-based R-Tech Ueno (RTU), Ltd.[1].

Reasons for Discontinuation

The discontinuation was largely driven by strategic priorities. Sucampo's CEO, Peter Greenleaf, mentioned that the company's analysis of preliminary top-line data from RTU's phase 3 trial of unoprostone isopropyl in retinitis pigmentosa did not justify continued development of the compound. Instead, the company chose to prioritize other development programs, such as Amitiza (lubiprostone) for chronic idiopathic constipation and irritable bowel syndrome with constipation, and cobiprostone for non-erosive reflux disease and oral mucositis[1].

Financial Impact

The financial impact of discontinuing Rescula was part of a broader strategic realignment. By focusing on more promising products, Sucampo aimed to optimize resource allocation and enhance shareholder value. The financial resources previously dedicated to Rescula were redirected to support the development and marketing of other drugs within their portfolio.

Manufacturing and Supply Chain

The manufacturing of Rescula was initially handled by R-Tech Ueno's Eye Drop Plant in Japan. However, this plant was closed as of October 31, 2012, after producing 44 lots of Rescula 0.15%[4]. This closure and the subsequent discontinuation of the drug highlight the complexities and challenges in maintaining a stable supply chain for pharmaceutical products.

Side Effects and Safety Profile

Rescula has been associated with certain side effects, including pigment changes (darkening) to periorbital pigmented tissues and eyelashes. These side effects were documented in the FDA's approval package and labeling information[4].

Market Dynamics in the Pharmaceutical Sector

The pharmaceutical sector is highly dynamic, with spending on prescription drugs expected to continue growing. Forecasts suggest annual increases in the range of 10 to 20 percent, driven by new drugs in the pipeline and increased utilization of existing medications. Categories such as central nervous system drugs and cardiovascular drugs are expected to account for a significant portion of this spending growth[3].

Comparison with Other Pharmaceutical Companies

Companies like Rezolute Bio, which is actively involved in developing new drugs, provide a contrast to the trajectory of Rescula. Rezolute Bio has been investing heavily in research and development, with significant expenditures in clinical trial activities, manufacturing costs, and employee-related expenses. This investment is indicative of the ongoing need for innovation and the financial commitments required to bring new drugs to market[2][5].

Key Takeaways

• Discontinuation: Rescula was discontinued by Sucampo Pharmaceuticals in 2015 to focus on more promising products.
• Strategic Realignment: The decision was part of a broader strategy to optimize resource allocation and enhance shareholder value.
• Manufacturing Challenges: The closure of the manufacturing plant in Japan added to the complexities of maintaining the drug's supply chain.
• Side Effects: Rescula is associated with specific side effects, including pigment changes to periorbital tissues and eyelashes.
• Market Dynamics: The pharmaceutical sector continues to grow, driven by new drugs and increased utilization, with categories like CNS and cardiovascular drugs leading the way.

FAQs

What was the primary reason for Sucampo Pharmaceuticals to discontinue Rescula?

Sucampo discontinued Rescula to focus on other development programs that held greater potential for shareholder value.

What are the indications for Rescula?

Rescula is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

What side effects are associated with Rescula?

Rescula can cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes.

Who manufactured Rescula before its discontinuation?

Rescula was manufactured by R-Tech Ueno's Eye Drop Plant in Japan.

How does the discontinuation of Rescula reflect broader market dynamics in the pharmaceutical sector?

The discontinuation highlights the need for pharmaceutical companies to continuously evaluate and realign their product portfolios to maximize shareholder value and keep pace with market demands and innovations.

Sources

1. Sucampo Pharmaceuticals will discontinue sales of Rescula (unoprostone isopropyl ophthalmic solution) 0.15% effective March 31 to focus on other products. - American Academy of Ophthalmology.
2. Rezolute Reports Fourth Quarter and Full Year Fiscal 2024 Financial Results and Provides Business Update. - Rezolute Bio.
3. Explaining the Growth in Prescription Drug Spending: A Review of Recent Studies. - ASPE.
4. Rescula (unoprostone isopropyl ophthalmic solution) 0.15%. - FDA.
5. Rezolute Reports First Quarter Fiscal 2025 Financial Results and Provides Business Update. - Rezolute Bio.