BUNAVAIL Drug Patent Profile

When do Bunavail patents expire, and what generic alternatives are available?

Bunavail is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-three patent family members in twenty-six countries.

The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bunavail

A generic version of BUNAVAIL was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22^nd, 2013.

Summary for BUNAVAIL

International Patents:	83
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	2
Patent Applications:	343
Drug Prices:	Drug price information for BUNAVAIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUNAVAIL
What excipients (inactive ingredients) are in BUNAVAIL?	BUNAVAIL excipients list
DailyMed Link:	BUNAVAIL at DailyMed

See drug prices for BUNAVAIL

Recent Clinical Trials for BUNAVAIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indivior Inc.	Phase 4
BioDelivery Sciences International	Phase 3

See all BUNAVAIL clinical trials

Paragraph IV (Patent) Challenges for BUNAVAIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	2.1 mg/0.3 mg and 4.2 mg/0.7 mg	205637	1	2016-11-23
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	6.3 mg/1 mg	205637	1	2015-12-21

US Patents and Regulatory Information for BUNAVAIL

BUNAVAIL is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No	9,655,843		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No	9,522,188		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No	8,703,177		Y

Expired US Patents for BUNAVAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014	6,159,498
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	6,159,498
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014	7,579,019

International Patents for BUNAVAIL

When does loss-of-exclusivity occur for BUNAVAIL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BUNAVAIL around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	229322
Austria	288743
Australia	3892401

Last updated: June 25, 2026

Bunavail (buprenorphine/naloxone) Market Dynamics and Financial Trajectory: Sales, Uptake Drivers, Competitive Pressures, and Exclusivity Timeline

Bunavail (buprenorphine/naloxone) is an opioid use disorder (OUD) treatment in an established drug class where market share is concentrated among sublingual and film formulations and where competitive share gains depend on pharmacy channel placement, payer coverage, and adverse-event or discontinuation rates. Financial trajectory is constrained by long-running competition within buprenorphine/naloxone products and by the continued shift of prescribers toward formulations with broad formulary access and simpler patient management. Near-term revenue protection is driven more by formulation-specific patent and brand coverage than by primary compound exclusivity; longer-term erosion risk increases as product-level barriers weaken.

---

What is Bunavail and how does it fit into the OUD buprenorphine/naloxone market?

Bunavail is a buprenorphine/naloxone product for OUD maintenance and is differentiated by its delivery form. The commercial question for payers and prescribers is whether Bunavail improves adherence, reduces dosing friction, and fits patient tolerability compared with competing buprenorphine/naloxone formats (sublingual tablets and films, including generic and branded alternatives).

Where does Bunavail sit versus branded and generic buprenorphine/naloxone products?

Competitive set (category-level):

• Branded and branded generics in buprenorphine/naloxone maintenance.
• Off-formulary and non-preferred alternatives when payers impose prior authorization (PA) or step therapy.

Key market dynamic: Within OUD, formulary preference and patient retention matter more than incremental clinical differentiation because OUD dosing is chronic and switching introduces risk of destabilization, missed doses, and follow-on counseling burden. That makes pharmacy benefit design a first-order driver.

---

How has Bunavail sales performed and what do the financial trajectory indicators imply?

No complete, verifiable sales dataset is provided in the prompt. Without market-reported revenue figures, channel data, or company filings specific to Bunavail, a quantified sales trajectory cannot be stated accurately.

What financial trajectory signals are most relevant in OUD?

• Payer coverage breadth: Preferred status in Medicaid and commercial formularies.
• Utilization growth vs. share shift: Whether the product grows by expanding total treated population or by taking share from competitors.
• Net revenue pressure: Rebates and discounts tied to contracting and competitive bid cycles.
• Switching dynamics: If pharmacy managers push generic substitution or equivalent formulations, brand net revenue typically compresses.

---

What drives Bunavail market share: payer coverage, step therapy, or patient adherence?

Payer design dominates. For OUD maintenance, insurers and pharmacy benefit managers aim to minimize cost per treated member while maintaining adherence enough to reduce relapse and downstream utilization. That favors agents that achieve high formulary acceptance with acceptable tolerability.

Payer levers that determine volume

• Formulary placement: Preferred vs non-preferred tiering.
• PA and step edits: Common in chronic OUD drugs.
• Quantity limits: Less common for established buprenorphine/naloxone but can be used to manage cost.
• Generic substitution rules: If equivalent generics are widely available, brand retention depends on negotiated discounts.

Adherence levers that determine persistence

• Dosing friction and administration time
• Taste and mucosal tolerability
• Real-world discontinuation risk (driven by nausea, headache, oral discomfort, insomnia, and opioid withdrawal symptoms if dosing is inconsistent)

---

What patents protect Bunavail and what is the exclusivity timeline?

No patent-by-patent or FDA Orange Book listing detail is included in the prompt. Without specific Orange Book entries, expiry dates, and listed patent numbers for Bunavail, an accurate exclusivity and patent expiration timeline cannot be produced.

How OUD product estates usually map to revenue protection

For combination buprenorphine/naloxone products, the revenue “shield” typically comes from:

• Formulation and dosing regimen patents specific to the dosage form
• Manufacturing process patents
• Method-of-use patents (less common than formulation)
• Data exclusivity windows only when relevant new clinical submissions are tied to the product
• Patent life that can extend beyond compound-level coverage

---

When does Bunavail lose exclusivity and what generic entry risks exist?

A generic entry assessment requires:

• The exact Orange Book patent list for Bunavail
• Patent expiration and any listed regulatory exclusivities
• Any Paragraph IV filings and litigation/settlement status

Those inputs are not present, so a grounded “when” and “how big” risk profile cannot be stated.

---

What patent litigation affects Bunavail and what settlement terms matter for generic launch timing?

A litigation and settlement-driven timeline requires:

• Court dockets and case numbers tied to Bunavail
• Stated settlement dates and launch commitments
• Country-by-country settlement or carve-outs

No such litigation record is provided.

---

What is the Orange Book status of Bunavail and what patents are listed?

No Orange Book entry data is provided in the prompt. A correct Orange Book table must include:

• Patent numbers
• Expiration dates
• Proprietary names and active ingredients
• Dosage forms covered
• Patent claims scope (if available in the Orange Book record)

This cannot be generated accurately without the source dataset.

---

How does Bunavail compare with competing buprenorphine/naloxone formulations on commercial risk?

A robust comparison requires product-level information on:

• Form factor availability (tablet vs film vs other delivery systems)
• Branded vs generic share within the same payer segments
• Contracting discounts and formulary placement

No such dataset is included.

Commercial risk map (category logic)

• Higher risk: Brands with weaker formulary placement versus generic alternatives.
• Lower risk: Brands that retain preferred status with strong rebates and demonstrate acceptable persistence.
• Switching sensitivity: Patients stabilized on a formulation can resist switching, but payers can drive switches through coverage edits.

---

What regulatory milestones and FDA pathway factors influence Bunavail’s commercial trajectory?

A credible regulatory commercial analysis requires:

• FDA approval history for Bunavail
• Supplement history affecting labeling and dosing
• Any REMS obligations or safety communications
• Changes to manufacturing or bioequivalence that affect market access

None of these are supplied in the prompt.

---

Who manufactures Bunavail and how does supply chain or manufacturing change market stability?

Manufacturing stability impacts:

• Ability to sustain contracted pharmacy demand
• Backorder and fulfillment reliability
• Any product recalls or quality issues that shift prescriber behavior

No manufacturer, site, or quality event data is provided.

---

Which companies are challenging Bunavail and what does that imply for revenue exposure?

Paragraph IV filers, generic entrants, and authorized generic arrangements drive near-term revenue compression. Without identified challengers and timing, revenue exposure cannot be quantified.

---

How strong is the patent estate for Bunavail versus the buprenorphine/naloxone category?

Patent strength depends on:

• Count and breadth of composition/formulation/manufacturing patents
• Claim scope and remaining life
• Litigation validity posture

No patent estate inventory is provided.

---

Key Takeaways

• Bunavail competes in a mature OUD buprenorphine/naloxone category where payer contracting and formulary placement are primary determinants of volume and net revenue.
• Financial trajectory is most sensitive to generic/brand competitive dynamics and to patient persistence, which depends on dosing friction and tolerability in real-world use.
• Accurate exclusivity timing, Paragraph IV risk, and litigation-driven launch scenarios require Bunavail’s Orange Book patent list and any associated FDA litigation record; these inputs are not provided, so no dates or case outcomes can be stated.
• Near-term commercial defensibility typically comes from dosage-form specific IP and negotiated payer access rather than from sole reliance on compound-level exclusivity.

---

FAQs

1. How do payer step edits and prior authorization policies typically affect utilization of buprenorphine/naloxone products like Bunavail?
2. What real-world factors most often cause discontinuation in buprenorphine/naloxone maintenance therapies?
3. How do pharmacy benefit manager contracting dynamics change net revenue for OUD brands during generic competition?
4. What Orange Book patent categories (formulation, method-of-use, manufacturing) most commonly delay generic entry for buprenorphine/naloxone products?
5. How do patient switching costs in OUD influence brand persistence after generic or authorized generic launches?

---

References (APA)

No sources are cited because no Bunavail-specific Orange Book, FDA, litigation, or sales/financial datasets were provided in the prompt.