RYBIX ODT Drug Patent Profile

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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. 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

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

International Patents for RYBIX ODT

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

Country	Patent Number	Title	Estimated Expiration
Austria	148339
Australia	2417192
Australia	666666
Canada	2092074	TABLETTE MULTIPARTICULEE A DESINTEGRATION RAPIDE (RAPIDLY DISINTEGRATABLE MULTIPARTICULATE TABLET)
Germany	69217191

Supplementary Protection Certificates for RYBIX ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
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

Last updated: July 22, 2026

Executive summary

RYBIX ODT’s commercial and investment fundamentals can’t be analyzed from a patent-and-exclusivity standpoint because “RYBIX ODT” is not uniquely identifiable to an active ingredient, brand-to-INA/USAN mapping, FDA product record, Orange Book listing, or a patent estate. Without that anchor, no defensible conclusions can be produced on: FDA status, exclusivity timelines, patent expiration dates, Paragraph IV risk, generic or biosimilar launch probability, licensing leverage, or litigation posture.

No actionable investment scenario can be issued under these constraints.

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What is RYBIX ODT (active ingredient) and what FDA record does it map to?

No reliable identification is possible from the provided name alone. “RYBIX ODT” could correspond to different actives across markets, and investment-grade analysis requires the exact FDA application/product (NDA/BLA/ANDA), strength, dosage form, and label route.

What must be true to build an investment model

• Active ingredient and strength
• FDA application number (NDA/BLA) and supplement history
• Labeling route (oral, buccal/sublingual), dosing schedule, and indication set
• FDA regulatory classification (505(b)(1), 505(b)(2), 505(j), 351(a)/(k) pathways)

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What patents protect RYBIX ODT and how strong is the patent estate?

A patent estate assessment requires at least one of:

• FDA Orange Book patent listings tied to the specific NDA/BLA product code; or
• Known patents covering the specific active ingredient and formulation (e.g., ODT composition, polymorphs, particle size, disintegrant matrix, process) and methods of use tied to the labeled indications.

No Orange Book-patent mapping is possible without the drug’s correct FDA record.

What a complete patent estate review would include (but can’t be populated here)

• Composition of matter patents on the API
• Formulation patents specific to ODT (including manufacturing/process claims)
• Method-of-use patents by indication
• Regulatory exclusivities driving “real” exclusivity beyond patent terms (NCE, 3/5/7-year rules)
• Any terminal disclaimers that compress effective protection

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When does RYBIX ODT lose exclusivity and what are the key expiration dates?

No exclusivity timeline can be stated without:

• NDA/BLA approval date(s)
• Reference product status (if applicable)
• Orange Book “drug substance” and “drug product” patent expiry dates
• Paediatric exclusivity, if any
• Pediatric post-marketing requirements or granted paediatric exclusivity periods

What the timeline would normally show

• Earliest patent expiration (composition of matter)
• Latest patent expiration (formulation/process/indication)
• Any market exclusivity end date (data exclusivity)
• Any 30-month stay triggers if Paragraph IV challenges exist

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Are there Paragraph IV challenges or generic entry risks for RYBIX ODT?

Paragraph IV risk requires:

• Identifying the ANDA(s) filed against the specific RLD with Paragraph IV certifications
• Reading the FDA “Patent Certifications” and “Notice of Paragraph IV” records
• Confirming litigation/settlement entries linked to those certifications

No ANDA/Orange Book record can be connected to “RYBIX ODT” without active ingredient and FDA product identity.

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What is the Orange Book status of RYBIX ODT?

Orange Book status is product-code specific (drug product, dosage form, strength). A defensible listing review requires:

• Orange Book publication details
• Listed patents (numbers, patent types: 1, 2, 3, 4 categories)
• Patentee/assignee and expiration dates
• Patent linkage to specific dosage-form entries

No Orange Book data can be generated without the exact FDA identifier.

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What formulations are protected for RYBIX ODT (ODT-specific IP)?

ODT-specific IP analysis requires access to:

• Listed formulation patents for that product code
• Independent claim scope for matrix/disintegrant/binder systems
• Any disclosed manufacturing steps that would be relevant to ANDA design-around

Without the active ingredient and product identity, no formulation IP can be accurately tied to RYBIX ODT.

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What method-of-use patents cover RYBIX ODT’s labeled indications?

Method-of-use patent review requires:

• Labeled indications and dosing regimen
• Listed “use” patents on the Orange Book
• Claim charts or at least claim construction summaries from litigation/filings

No indication-to-patent mapping is possible without FDA label identity.

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What patent litigation affects RYBIX ODT and what settlements exist?

Litigation and settlements require a verified link to:

• Case filings (Delaware/SDNY/other federal venues or ITC if applicable)
• Parties (ANDA filers vs brand NDA holders)
• Settlement agreement dates and scope (authorized generic timing, launch date carve-outs)

No case list can be created without identifying the brand sponsor and NDA number.

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How does RYBIX ODT compare with competing ODT drugs by exclusivity, pricing power, and patent moat?

A competition model needs:

• Comparable products in the same therapeutic class and dosage-form niche
• Their Orange Book expiry schedules and litigation status
• Market share and price-per-unit, at least at a tracked market level

No reliable competitive set can be chosen from “RYBIX ODT” alone.

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Investment scenario: what does the upside/downside depend on for RYBIX ODT?

A credible investment scenario normally depends on:

• Patent-guarded cash flows and the probability-weighted generic entry date
• Litigation outcome and settlement terms
• Reimbursement and formulary position
• Supply and manufacturing continuity risk (ODT manufacturing complexity can matter)
• Pipeline or lifecycle moves (new strengths, new indications, line extensions)

None of these levers can be quantified without the exact RYBIX ODT identity, its regulatory status, and its linked patent/exclusivity data.

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Key Takeaways

• A complete patent, exclusivity, and generic-entry investment analysis for “RYBIX ODT” cannot be produced from the provided input because the drug is not uniquely identifiable to an FDA product record and Orange Book patent estate.
• No defensible expiration dates, Paragraph IV risk assessment, litigation map, or competitive moat can be stated.
• Any investment scenario would be speculative and non-actionable under an IP fundamentals framework.

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FAQs

1) Is RYBIX ODT protected by composition-of-matter patents or only by formulation patents?

No answer can be provided without the Orange Book drug product listing tied to the correct FDA application and product code.

2) What is the earliest possible generic launch date for an ANDA against RYBIX ODT?

Not determinable without Orange Book patent expiry dates and any active Paragraph IV certifications/30-month stays.

3) Does RYBIX ODT have 505(b)(2) or 351(k) pathway relevance?

Not determinable without the FDA application type and reference product identity.

4) Are there ODT manufacturing-process patents that could block ANDA design-around?

Not determinable without listed formulation/process patents and claim scope.

5) Which companies are likely competitors for RYBIX ODT at time of generic entry?

Not determinable without identifying the active ingredient, therapeutic class, and the FDA-linked RLD entry that attracts ANDA filers.

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References (APA)

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-22)