RYBIX ODT Drug Patent Profile

Which patents cover Rybix Odt, and what generic alternatives are available?

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-two 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:	67
Patent Applications:	2,915
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
Hungary	0003691
Germany	69217191
China	1264299
France	2679451	COMPRIME MULTIPARTICULAIRE A DELITEMENT RAPIDE.
Israel	130339	Multiparticulate tablet with quick disintegration

Supplementary Protection Certificates for RYBIX ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	C300152	Netherlands		PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
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	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

RYBIX ODT market dynamics and financial trajectory: revenue exposure, competitive pressure, payer fit, and IP-driven launch risks

Last updated: June 9, 2026

RYBIX ODT is an orally disintegrating tablet (ODT) product with an active ingredient that is not provided here, and no FDA, Orange Book, pricing, or sales data are included in the input. Without the specific active ingredient and FDA product identifiers (NDC, NDA/BLA number) it is not possible to produce a complete, accurate market and financial trajectory assessment grounded in verifiable filings, exclusivity timelines, or competitive benchmarks.

What is RYBIX ODT and which active ingredient drives its market dynamics?

A market dynamics forecast for an ODT product depends on the active ingredient’s therapeutic category, line-of-therapy position, dosing frequency, safety profile, and formulation differentiation. None of these are stated.

Which therapeutic class does RYBIX ODT compete in?

ODT products typically differentiate on adherence and tolerability (e.g., nausea, dysphagia, pediatric or geriatric use). Market structure changes materially by whether the drug is:

• First-line chronic therapy vs. episodic use
• Generic-heavy commodity vs. protected branded specialty
• CNS vs. metabolic vs. infectious disease space (payer tactics differ)

No class or target indication is provided.

Does the ODT formulation change payer coverage or utilization management?

Formulation can affect step therapy, prior authorization criteria, and formulary tier placement. Payer behavior is highly indication- and ingredient-specific and requires FDA labeling, payer policy, and comparable product sets.

No labeling or comparable set is provided.

What is the FDA status of RYBIX ODT and what does Orange Book say about exclusivity?

Featured-snippet answer: A product’s competitive timing and generic risk come from the FDA Orange Book listings (patent/exclusivity codes) and the FDA approval history.

No FDA status, NDA number, Orange Book record, or exclusivity (regulatory or patent) is provided.

What is RYBIX ODT’s NDA and approval date?

Required to map:

• Brand launch year
• First commercial year
• Patent expiration window and 180-day generic exclusivity triggers

Not provided.

What patents are listed for RYBIX ODT on the Orange Book?

Required to estimate:

• Date-specific generic entry risk
• Strength of formulation, method-of-use, and polymorph/process coverage
• Litigation exposure for Paragraph IV filings

Not provided.

When does RYBIX ODT lose exclusivity and how does that affect revenue?

Exclusivity-driven revenue decline is typically modeled on:

• Patent expiration (lumpy)
• 30-month stay outcomes for Paragraph IV cases
• Loss of regulatory exclusivity (sooner if only exclusivity provided coverage)

No exclusivity timeline exists in the input.

How much generic competition risk is implied for RYBIX ODT?

Generic competition hinges on patent landscape and whether there are enforceable barriers to bioequivalence or formulation workarounds. Without the Orange Book and patent list, the risk cannot be stated.

Not provided.

How competitive is RYBIX ODT versus substitutes, and which products pressure pricing?

ODT products face price pressure from:

• Therapeutic equivalents (same active ingredient, alternative dosage forms)
• Brand-to-generic switching if patents expire
• Better-tolerated competitors if safety signals exist
• Payer-preferred generics or authorized generics

None of the competitor set, dosage forms, or active ingredient identity is provided.

What are the main substitutes (same MOA, same indication)?

Not provided.

Are there authorized generics or pharmacy benefit channel preferences?

Not provided.

What are the pricing, reimbursement, and payer dynamics for RYBIX ODT?

Financial trajectory depends on:

• Net price vs. WAC and rebate structure
• Medicaid vs. commercial mix
• Prior authorization and step therapy constraints
• MAC pricing and PBM formulary placement

No net pricing, WAC, channel mix, or PBM data is provided.

Does the ODT format drive higher net pricing or tighter rebate demands?

ODT can support differentiation but also may increase payer scrutiny if clinical value is unclear. This requires reimbursement and utilization evidence not included here.

Not provided.

What financial trajectory does RYBIX ODT show: sales ramp, peak, and decline?

A credible financial trajectory needs at least one of:

• Public sales figures (company filings, investor presentations)
• Paid data benchmarks (IQVIA/Endpoint/Symphony) not included
• Regulatory milestone-linked commercialization data

No sales, revenue, or guidance figures are provided.

What patent litigation affects RYBIX ODT’s launch economics and revenue runway?

Paragraph IV dynamics can compress peak revenue and extend exclusivity through settlements or litigation stays. This requires:

• Case caption, court, filing date
• Asserted patents
• Settlement terms (if any)
• Generic entrant and agreed launch dates

No litigation records are provided.

Are there Paragraph IV challenges against RYBIX ODT?

Not provided.

Have there been settlements or consent judgments?

Not provided.

How strong is the patent estate for RYBIX ODT, including formulations and method-of-use?

Patent strength is typically evaluated by:

• Number of listed patents and their expiration dates
• Claim coverage types (composition, formulation, polymorph, process, method-of-use)
• Whether patents are early or late in term and how many are “likely blocking”

No patent list is provided.

Which patent types typically protect ODTs (and what should be checked)?

Common ODT coverage includes:

• Formulation compositions (excipients, superdisintegrants, flavor/sweetener systems)
• Manufacturing processes (compression parameters, granulation)
• Polymorph/crystal form or solid-state properties
• Method-of-use (if tied to patient population)

No RYBIX ODT patent details are provided.

What generic entry risks exist for RYBIX ODT in the US, and what about biosimilar risk?

Biosimilar risk is irrelevant if the product is not a biologic, but the input does not state the product type. For a small-molecule ODT, biosimilar risk is not applicable; generic risk is applicable and depends on Orange Book patents and FDA approvals.

Not provided.

What is the likely generic launch scenario if exclusivity ends?

A launch scenario is typically:

• At expiration with immediate generic filing readiness
• Or after a 30-month stay and possible settlement launch date
• Or delayed due to formulation/process patent block

No applicable timelines or patents are provided.

What is the commercial size and revenue exposure for RYBIX ODT under different market share outcomes?

Revenue exposure modeling requires:

• Addressable patient population
• Dosing regimen (tablets/day, duration)
• Historical market share or uptake curve
• Competitor penetration and switching behavior

No patient numbers, dosing, or uptake data is provided.

Sensitivity drivers to model (required inputs not supplied)

• Net price elasticity after generic entry
• PBM formulary tier changes
• Rebate pressure and wholesaler channel inventory cycles
• Market size changes in indication expansions or label restrictions

Not provided.

Key takeaways

No complete market and financial trajectory can be produced from the provided information. The analysis requires the active ingredient, FDA regulatory identifiers (NDA number and Orange Book record), and any available sales/pricing data to map exclusivity loss, generic entry risk, competitive pricing pressure, and revenue trajectory.

FAQs

1. What Orange Book patents and exclusivity periods govern an ODT product like RYBIX ODT in the US?
2. How do Paragraph IV filings and 30-month stays change revenue timing for branded tablet products?
3. How does ODT formulation affect payer coverage, PA rules, and net pricing versus conventional tablets?
4. What indicators best predict sales ramp and peak for small-molecule prescription brands entering a generic-heavy market?
5. How should investors size revenue downside risk from generic competition after patent expiration for a branded product?

References

No sources were provided or can be cited from the input.