FENTORA Drug Patent Profile

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

Fentora is a drug marketed by Cephalon and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in FENTORA is fentanyl citrate. Five suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fentora

A generic version of FENTORA was approved as fentanyl citrate by HIKMA on July 11^th, 1984.

Summary for FENTORA

US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENTORA

Paragraph IV (Patent) Challenges for FENTORA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FENTORA	Buccal Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	021947	1	2007-11-13

US Patents and Regulatory Information for FENTORA

FENTORA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No			Y

International Patents for FENTORA

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

Country	Patent Number	Title	Estimated Expiration
Austria	350017
Austria	433745
Austria	434432
Austria	548028
Australia	4019400

Supplementary Protection Certificates for FENTORA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831

FENTORA (fentanyl buccal tablet) Investment Scenario and Patent/Regulatory Fundamentals (FDA, Exclusivity, Generics, Litigation, Revenue Exposure)

Last updated: July 29, 2026

FENTORA is a branded fentanyl buccal formulation for breakthrough cancer pain with FDA approval in 2006 and an established long-term commercialization record. The investment case hinges on (1) how quickly competing generic buccal fentanyl products replace branded share, (2) whether FENTORA retains meaningful exclusivity and formulation IP against generic substitution, and (3) regulatory and controlled-substance execution risks that affect channel fill and demand.

What matters most for investment: (a) patent and exclusivity posture in the Orange Book, (b) Paragraph IV and litigation outcomes driving generic entry timing, and (c) commercial durability relative to other transmucosal fentanyl products.

What patents protect FENTORA (fentanyl buccal tablet) in the US and how strong is the patent estate?

Direct answer: FENTORA’s US IP position depends on the Orange Book-listed patents tied to fentanyl buccal tablet approvals. Without the Orange Book patent list for FENTORA (patent numbers, listed claims, assignees, and expiration dates), a complete protection map cannot be produced to support an investment-grade “how strong is the estate” assessment.

What typically drives the strength of a fentanyl buccal tablet patent estate

• Drug product composition of matter: formulation composition and specific ratios.
• Methods of treatment: breakthrough cancer pain dosing regimens and titration steps.
• Manufacturing and delivery system: surface characteristics, tablet matrix features, and dissolution/adhesion properties for buccal absorption.
• Bioavailability/release control: patents around dissolution profile and conversion of buccal exposure to systemic fentanyl levels.

Investment implication

• If FENTORA’s Orange Book patents are primarily formulation and method-of-use, generic entry risk is usually faster than if composition-of-matter patents dominate.
• If remaining patents require proving equivalence to a specific release/dissolution feature, generic substitution can be slower, and litigation can extend exclusivity-to-market effects.

No definitive, patent-number-level coverage is provided here because the required Orange Book data for FENTORA is not included in the prompt and the response cannot be constructed from incomplete inputs.

When does FENTORA lose exclusivity and what are the key expiration dates investors track?

Direct answer: The exclusivity timeline and patent expiration dates for FENTORA are determined by FDA Orange Book listings (US patents) and FDA exclusivity classifications (if applicable). A precise schedule requires the Orange Book listing for FENTORA’s NDA and associated exclusivities.

What dates matter for the model (and the inputs needed)

• Orange Book patent expiration dates for drug product and listed claims
• Any pediatric exclusivity tied to patent or new clinical investigation
• Orphan drug exclusivity if applicable to the indication
• Any listed exclusivity affecting ANDA approvals
• Potential 30-month stay windows from Paragraph IV filings and HCC/ANDA litigation timing

Investment implication

• In transmucosal fentanyl, brand share usually erodes when ANDA products enter and physicians/payers switch based on formulary coverage, patient tolerability, and opioid stewardship controls.
• Investors typically underwrite a downside case that assumes accelerated generic uptake soon after the first legally permitted generic launch.

What patent litigation affects FENTORA and how does it influence generic entry risk?

Direct answer: Patent litigation outcomes are material for generic entry timing, but a complete analysis needs the docket-level litigation record (case numbers, asserted patents, ANDA applicants, outcomes, and settlement terms). That dataset is not present in the prompt.

What to watch in fentanyl buccal patent cases

• Paragraph IV challenges asserting invalidity/ non-infringement of Orange Book patents
• Section viii carve-outs tied to use/dosing limitations
• Consent decrees or settlement dates that define launch windows
• Design-around success via dissolution or excipient changes that avoid claim coverage

Investment implication

• If early-stage generic challenges settle with limited exclusivity or permitted launch triggers, the brand’s revenue durability compresses.
• If litigation extends through trial and appeal, the brand can retain a longer time window for supply contracts and payer negotiations.

What is the Orange Book status of FENTORA (and which ANDAs are relevant)?

Direct answer: Orange Book status is defined by FENTORA’s listed patents and any approved ANDAs/related supplements. The prompt does not include the Orange Book listing details required to state which patents are listed and which ANDA products are on the market or pending.

How the Orange Book status is used in an investment model

• Build a patent ladder (earliest expiry across composition, formulation, method-of-use)
• Identify independent claim families most likely to be challenged
• Map each ANDA’s Paragraph IV-to-specific-patents footprint
• Link to projected market share transitions from:
  • payer formulary inclusion timing
  • pharmacy channel stocking
  • prescriber adoption cycles

How many patents cover FENTORA formulations and what formulations are protected?

Direct answer: The number and scope of formulation-protecting patents for FENTORA cannot be quantified without the Orange Book patent list and claim descriptions for the NDA.

Typical formulation-protection elements relevant to buccal tablets

• Matrix composition driving dissolution and buccal absorption
• Tablet structural attributes influencing erosion and fentanyl release
• Adhesion and wetting characteristics affecting transmucosal uptake
• Stability and packaging that preserve product performance

Investment implication

• Strong formulation coverage can delay generic “design-around” and reduce price erosion speed.
• If patents focus on specific release curves, generic applicants may need reformulation and additional bridging studies, slowing entry.

What generic entry risks exist for FENTORA (Paragraph IV, 30-month stays, settlement pathways)?

Direct answer: Generic entry risk depends on (1) whether ANDA applicants filed Paragraph IV certifications to FENTORA’s Orange Book patents, (2) whether they received a 30-month stay via litigation timing, and (3) whether settlements permit launch at specific dates.

A quantitative entry-risk assessment requires the Orange Book patent list, Paragraph IV certifications, and litigation/settlement dates, none of which are included in the prompt.

How does FENTORA compare with other transmucosal fentanyl products (Subsys, Lazanda, Abstral, Ionsys) on competitive and IP fronts?

Direct answer: Competitive pressure in transmucosal fentanyl comes from both formulary switching and perceived ease-of-use. A precise IP comparison requires the Orange Book and litigation status for each comparator product, which is not included in the prompt.

What typically differentiates brands in payer adoption

• Dosing flexibility and titration simplicity
• Insurance coverage and rebate structures
• Patient adherence based on route of use (buccal vs intranasal)
• Safety signals and REMS execution in real-world practice

Investment implication

• If FENTORA faces substitution from multiple established competitors with favorable payer access, margin dilution can occur even before generics fully eliminate brand demand.

What FDA regulatory pathway and post-marketing constraints shape FENTORA demand?

Direct answer: FENTORA is a controlled opioid product and is subject to controlled-substance regulations, opioid risk management expectations, and labeling controls consistent with FDA-approved use. A full regulatory risk model needs the REMS and post-marketing commitments status for the specific product.

What investors usually model in opioids

• Manufacturing continuity and quality systems for solid-dose buccal formulations
• Distribution constraints that can affect channel fill and backorders
• Label adherence to breakthrough cancer pain criteria
• Risk controls that can influence prescriber behavior and patient selection

Commercial fundamentals: pricing, volume sensitivity, payer access, and channel dynamics for FENTORA

Direct answer: The commercial fundamentals are determined by (1) brand share versus peers, (2) reimbursement and rebate dynamics, and (3) generic substitution timing and penetration. The prompt does not include revenue, volume, or payer share data needed for a quantified fundamentals view.

What typically drives FENTORA’s revenue trajectory

• Oncology patient funnel: incidence of breakthrough cancer pain management and oncologist prescribing patterns
• Formulary access: how many plans prefer FENTORA vs competing transmucosal fentanyl products
• Competitor substitution: intranasal or other buccal formulations with preferred coverage
• Generic availability: timing of first legally marketed ANDA and subsequent uptake by pharmacies

Key licensing and supply-chain considerations for investors in FENTORA

Direct answer: A licensing/supply-chain investment view requires the corporate ownership and any licensing agreements that govern manufacturing rights, distribution rights, and IP enforcement. The prompt does not provide the rights map needed to produce actionable deal terms.

What matters for underwriting

• Manufacturing concentration risk and single-site dependencies
• Contractual rebate and wholesaler terms
• Enforcement strategy for IP and controlled-substance compliance

Key Takeaways

• FENTORA’s investment profile is dominated by patent and exclusivity timing, Paragraph IV litigation outcomes, and generic substitution speed in transmucosal fentanyl.
• A complete, decision-grade assessment of the patent estate, exclusivity end dates, and generic entry risks requires Orange Book-listed patents/exclusivities and Paragraph IV/litigation/settlement records, which are not provided in the prompt.
• Commercial durability will be determined by payer formulary access, competitor substitution, and controlled-substance execution that affects channel availability.

FAQs

1. How do investors model generic substitution risk for transmucosal fentanyl buccal tablets?
2. What factors drive payer formulary switching between fentanyl buccal and intranasal fentanyl products?
3. How do Paragraph IV filings typically affect branded opioid revenue before generic launch?
4. What regulatory and compliance issues most often disrupt opioid supply continuity?
5. Which patent claim types in buccal fentanyl programs are most frequently challenged in ANDA litigation?

References

No sources were cited because the prompt did not include FENTORA-specific Orange Book, litigation, FDA exclusivity, or financial data necessary to produce an accurate, citation-backed analysis.