RYBIX ODT Drug Patent Profile

Which patents cover Rybix Odt, and when can generic versions of Rybix Odt launch?

Rybix Odt is a drug marketed by Shionogi Inc and is included in one NDA.

The generic ingredient in RYBIX ODT is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rybix Odt

A generic version of RYBIX ODT was approved as tramadol hydrochloride by SUN PHARM INDS INC on June 19^th, 2002.

Summary for RYBIX ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	94
Patent Applications:	2,442
DailyMed Link:	RYBIX ODT at DailyMed

US Patents and Regulatory Information for RYBIX ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005		DISCN	No	No

Expired US Patents for RYBIX ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005
Shionogi Inc	RYBIX ODT	tramadol hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021693-001	May 5, 2005

International Patents for RYBIX ODT

See the table below for patents covering RYBIX ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	208616
France	2766089	COMPRIME MULTIPARTICULAIRE PERFECTIONNE A DELITEMENT RAPIDE
Hong Kong	1007414

Supplementary Protection Certificates for RYBIX ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488169	C202330042	Spain		PRODUCT NAME: COCRISTAL DE TRAMADOL, OPCIONALMENTE EN FORMA DE UNA SAL FISIOLOGICAMENTE ACEPTABLE, Y CELECOXIB; NATIONAL AUTHORISATION NUMBER: 89051; DATE OF AUTHORISATION: 20230925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 89051; DATE OF FIRST AUTHORISATION IN EEA: 20230925
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

Market Dynamics and Financial Trajectory for RYBIX ODT

Introduction to RYBIX ODT

RYBIX ODT, or tramadol hydrochloride orally disintegrating tablets, is a medication indicated for the management of moderate to moderately severe pain in adults. This drug is part of the broader orally disintegrating tablet (ODT) market, which is experiencing significant growth due to its convenience and ease of administration.

Market Size and Growth

The ODT market, within which RYBIX ODT operates, is projected to grow substantially. By 2033, the ODT market is expected to be worth around USD 29.0 billion, up from USD 13.2 billion in 2023, growing at a CAGR of 8.2% during the forecast period from 2024 to 2033[1].

Drug Class and Market Share

RYBIX ODT falls under the category of Anti-Psychotics and other pain management drugs, although it is specifically classified as an opioid analgesic. While Anti-Psychotics dominate the ODT market with a 42% market share, the demand for pain management medications like RYBIX ODT is also on the rise. This is driven by the growing need for effective pain therapeutics, particularly in the treatment of chronic pain[1][3].

Disease Indication and Demand

The primary disease indication for RYBIX ODT is pain management, which aligns with the broader trend in the ODT market where Central Nervous System (CNS) diseases account for a substantial 44% market share. The increasing prevalence of chronic pain and the need for convenient, effective treatments contribute to the demand for medications like RYBIX ODT[1].

Distribution Channels

RYBIX ODT is distributed through various channels, including Hospital Pharmacies, Online Pharmacies, Retail Pharmacies, and Drug Stores. Hospital Pharmacies currently hold a significant 33% market share in the ODT market, indicating a strong presence in clinical settings where pain management is a critical concern[1].

Regional Analysis

North America is a dominant region for the ODT market, holding a 36% market share and generating USD 8.1 billion in revenue in 2023. This region's strong healthcare infrastructure and high acceptance of advanced pharmaceutical products, including ODTs, bode well for the financial trajectory of RYBIX ODT[1].

Opportunities and Challenges

Expanding Geriatric Population

The aging global population presents a significant opportunity for RYBIX ODT. Geriatric patients often face difficulties swallowing traditional tablets, making ODTs like RYBIX ODT a preferred choice. As the elderly population grows, the demand for such medications is expected to increase[1].

Global Market Expansion

The ODT market, including RYBIX ODT, has the potential to expand into emerging markets where healthcare trends favor convenient and accessible medications. This expansion could drive further growth and revenue for RYBIX ODT[1].

Regulatory and Safety Considerations

While RYBIX ODT offers several benefits, it also comes with regulatory and safety considerations. The drug is part of the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program due to its potential for misuse and overdose. Additionally, it carries risks such as seizures, especially when used with other medications that reduce the seizure threshold[2][4].

Financial Trajectory

Given the growth projections of the ODT market and the specific demand for pain management medications, RYBIX ODT is likely to see a positive financial trajectory. Here are some key financial indicators:

• Market Growth: The overall ODT market is growing at a CAGR of 8.2%, which suggests a robust financial outlook for RYBIX ODT.
• Revenue Potential: As part of a market expected to reach USD 29.0 billion by 2033, RYBIX ODT stands to benefit from this significant revenue potential.
• Regional Performance: With North America leading in market share and revenue, RYBIX ODT can leverage this strong regional performance to drive its financial growth.

Competitive Landscape

The ODT market is diverse, featuring both established pharmaceutical giants and emerging companies. RYBIX ODT competes in a landscape that includes other major players like AstraZeneca plc., Mylan N.V., and Pfizer. The competitive nature of this market drives innovation and could further enhance the financial performance of RYBIX ODT[1].

Key Takeaways

• The ODT market, including RYBIX ODT, is projected to grow significantly, reaching USD 29.0 billion by 2033.
• RYBIX ODT benefits from the growing demand for pain management medications and the convenience of ODTs.
• The drug faces regulatory and safety challenges but has strong potential in expanding geriatric and global markets.
• North America's dominance in the ODT market is a positive indicator for RYBIX ODT's financial trajectory.

FAQs

What is RYBIX ODT used for?

RYBIX ODT is used for the management of moderate to moderately severe pain in adults.

What is the projected growth rate of the ODT market?

The ODT market is expected to grow at a CAGR of 8.2% from 2024 to 2033.

Which region dominates the ODT market?

North America dominates the ODT market, holding a 36% market share and generating significant revenue.

What are the key distribution channels for RYBIX ODT?

RYBIX ODT is distributed through Hospital Pharmacies, Online Pharmacies, Retail Pharmacies, and Drug Stores.

What are the potential risks associated with RYBIX ODT?

RYBIX ODT carries risks such as seizures, especially when used with other medications that reduce the seizure threshold, and is part of the Opioid Analgesic REMS program due to its potential for misuse and overdose.

Cited Sources:

1. Market.us: Orally Disintegrating Tablet Market Outlook | CAGR of 8.2%
2. Mayo Clinic: Tramadol (oral route) - Mayo Clinic
3. Maximize Market Research: Opioids Drugs Market- Global Industry Analysis and Forecast (2023 ...
4. RxList: Rybix ODT (Tramadol Hydrochloride Orally Disintegrating Tablets)