RIMSO-50 Drug Patent Profile

Which patents cover Rimso-50, and what generic alternatives are available?

Rimso-50 is a drug marketed by Mylan Institutional and is included in one NDA.

The generic ingredient in RIMSO-50 is dimethyl sulfoxide. There are seventy-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dimethyl sulfoxide profile page.

Summary for RIMSO-50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	302
Patent Applications:	2,912
Drug Prices:	Drug price information for RIMSO-50
What excipients (inactive ingredients) are in RIMSO-50?	RIMSO-50 excipients list
DailyMed Link:	RIMSO-50 at DailyMed

See drug prices for RIMSO-50

US Patents and Regulatory Information for RIMSO-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	RIMSO-50	dimethyl sulfoxide	SOLUTION;INTRAVESICAL	017788-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for RIMSO-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Institutional	RIMSO-50	dimethyl sulfoxide	SOLUTION;INTRAVESICAL	017788-001	Approved Prior to Jan 1, 1982	3,549,770

International Patents for RIMSO-50

See the table below for patents covering RIMSO-50 around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	6465161
France	1492774	Procédé de traitement des dialkylsulfoxydes et produits ainsi obtenus
Luxembourg	47554
Netherlands	6414292
Sweden	331768

Supplementary Protection Certificates for RIMSO-50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2653873	2023C/501	Belgium		PRODUCT NAME: FUMARATE DE DIMETHYLE; AUTHORISATION NUMBER AND DATE: EU/1/13/837 20140203
1131065	39/2014	Austria		PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537	CA 2014 00035	Denmark		PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
0300652	SPC/GB03/005	United Kingdom		PRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830
2137537	SPC/GB14/046	United Kingdom		PRODUCT NAME: DIMETHYL FUMARATE; REGISTERED: UK EU/1/13/837 20140203

Market Dynamics and Financial Trajectory for RIMSO-50

Overview of RIMSO-50

RIMSO-50, also known as dimethyl sulfoxide (DMSO), is a prescription drug approved by the FDA for the symptomatic relief of interstitial cystitis (IC), a chronic and debilitating bladder condition characterized by symptoms such as urinary urgency, frequency, pelvic pain, and nocturia[5].

Market Size and Growth

The global interstitial cystitis drugs market, which includes RIMSO-50, is projected to grow significantly. From 2024 to 2028, the market is expected to expand by USD 385.4 million, with a Compound Annual Growth Rate (CAGR) of 5.85%[1].

Key Drivers of Market Growth

Increasing Diagnosed Cases

The market for IC drugs, including RIMSO-50, is driven by the increasing number of diagnosed cases of interstitial cystitis. As awareness and diagnostic capabilities improve, more patients are being identified and treated, leading to higher demand for therapeutic options[1].

Need for Effective Treatments

There is a significant need for innovative and effective treatments for IC, as current therapies primarily offer symptomatic relief without a cure. RIMSO-50, as an intravesical agent, fills this gap by providing relief directly to the bladder, making it a valuable option for patients[1].

Lack of Generic Alternatives

RIMSO-50 does not have a generic equivalent available in the United States, which can contribute to its market stability and pricing power. The absence of a generic version helps maintain its market share and revenue[4].

Challenges and Limitations

High Cost and Limited Access

One of the major challenges facing RIMSO-50 and other IC drugs is their high cost. This can limit access for many patients, leading them to seek off-label treatments or alternative therapies. The high expense of RIMSO-50 and other approved drugs like ELMIRON is a significant barrier to market expansion[1].

Side Effects and Safety Concerns

RIMSO-50 can have side effects, including hypersensitivity reactions, changes in the refractive index and lens opacities in animals, and potential interactions with other medications. These safety concerns require careful monitoring and can affect patient compliance and market growth[5].

Weak Pipeline

The pipeline for new IC drugs is weak, with most clinical trials in early stages and few drugs expected to enter the market during the forecast period. The failure of Phase III drugs further hinders the growth potential of the market[1].

Market Segmentation

Type of Therapy

The IC drugs market, including RIMSO-50, can be segmented by type of therapy into oral and intravesical therapies. RIMSO-50 falls under the intravesical therapy category, which involves direct instillation into the bladder[1].

Distribution Channels

The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. RIMSO-50 is typically administered in a clinical setting, making hospital pharmacies a key distribution channel[1].

Geographical Analysis

The global IC drugs market, including RIMSO-50, spans across North America, Europe, Asia, and the Rest of the World (ROW). The geographical distribution of the market is influenced by factors such as healthcare infrastructure, regulatory environments, and patient demographics[1].

Key Players

Major pharmaceutical companies like AstraZeneca, Pfizer, and Merck are key players in the IC drugs market. While RIMSO-50 is manufactured by Mylan Institutional LLC, these companies influence the market landscape with their own offerings and research initiatives[1].

Financial Trajectory

Revenue and Growth

Given the projected growth of the IC drugs market, RIMSO-50 is likely to contribute significantly to the revenue of its manufacturer. The market's CAGR of 5.85% from 2024 to 2028 indicates a steady financial trajectory for drugs like RIMSO-50, despite the challenges mentioned[1].

Pricing and Access

The high cost of RIMSO-50 and the lack of generic alternatives will continue to impact its financial performance. However, the absence of generic competition helps maintain pricing stability, which is crucial for the drug's revenue stream[4].

Conclusion

RIMSO-50 operates within a complex market landscape characterized by growing demand for effective IC treatments, high costs, and limited access to approved therapies. Despite these challenges, the drug's unique position as an intravesical agent and the lack of generic alternatives contribute to its financial stability and growth potential.

Key Takeaways

• Market Growth: The IC drugs market, including RIMSO-50, is expected to grow by USD 385.4 million from 2024 to 2028.
• Increasing Demand: The market is driven by increasing diagnosed cases of interstitial cystitis and the need for effective treatments.
• High Cost: RIMSO-50's high cost limits access for many patients, leading to off-label treatments.
• Lack of Generic Alternatives: No generic version of RIMSO-50 is available, maintaining its market share and revenue.
• Side Effects and Safety Concerns: RIMSO-50 has potential side effects and safety concerns that require careful monitoring.
• Geographical Distribution: The market spans across North America, Europe, Asia, and the Rest of the World.

FAQs

Q: What is RIMSO-50 used for?

RIMSO-50 is used for the symptomatic relief of patients with interstitial cystitis (IC), a chronic bladder condition.

Q: Is there a generic version of RIMSO-50 available?

No, there is currently no therapeutically equivalent generic version of RIMSO-50 available in the United States[4].

Q: What are the common side effects of RIMSO-50?

Common side effects include hypersensitivity reactions, a garlic-like taste, and potential changes in the refractive index and lens opacities. Patients may also experience discomfort during administration[5].

Q: How is RIMSO-50 administered?

RIMSO-50 is administered intravesically, meaning it is instilled directly into the bladder, typically in a clinical setting[5].

Q: What are the key drivers of the IC drugs market growth?

The key drivers include the increasing number of diagnosed IC cases, the need for effective treatments, and the lack of generic alternatives for drugs like RIMSO-50[1].

Sources

1. Technavio: Interstitial Cystitis Drugs Market size is set to grow by USD 385.4 million from 2024-2028[1].
2. Mayo Clinic: Dimethyl sulfoxide (intravesical route)[2].
3. IQVIA: Drug Expenditure Dynamics 1995-2020[3].
4. Drugs.com: Generic Rimso-50 Availability[4].
5. DailyMed: RIMSO-50- dimethyl sulfoxide irrigant[5].