PROBUPHINE Drug Patent Profile

Which patents cover Probuphine, and what generic alternatives are available?

Probuphine is a drug marketed by Reacx Pharms and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Probuphine

A generic version of PROBUPHINE was approved as buprenorphine hydrochloride by HOSPIRA on June 3^rd, 1996.

Summary for PROBUPHINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	8
Patent Applications:	21
Drug Prices:	Drug price information for PROBUPHINE
What excipients (inactive ingredients) are in PROBUPHINE?	PROBUPHINE excipients list
DailyMed Link:	PROBUPHINE at DailyMed

See drug prices for PROBUPHINE

Recent Clinical Trials for PROBUPHINE

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2
Braeburn Pharmaceuticals	Phase 3
National Institute on Drug Abuse (NIDA)	Phase 3

See all PROBUPHINE clinical trials

US Patents and Regulatory Information for PROBUPHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016		DISCN	Yes	No

Expired US Patents for PROBUPHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016

International Patents for PROBUPHINE

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

Country	Patent Number	Title	Estimated Expiration
Australia	2003240493	IMPLANTABLE POLYMERIC DEVICE FOR SUSTAINED RELEASE OF BUPRENORPHINE
Australia	2008212011	Implantable polymeric device for sustained release of buprenorphine
Canada	2487577	DISPOSITIF POLYMERE IMPLANTABLE PERMETTANT LA LIBERATION PROLONGEE DE BUPRENORPHINE (IMPLANTABLE POLYMERIC DEVICE FOR SUSTAINED RELEASE OF BUPRENORPHINE)
Cyprus	1120510
Denmark	2561860
European Patent Office	1509182	DISPOSITIF POLYMERE IMPLANTABLE PERMETTANT LA LIBERATION PROLONGEE DE BUPRENORPHINE (IMPLANTABLE POLYMERIC DEVICE FOR SUSTAINED RELEASE OF BUPRENORPHINE)

PROBUPHINE (buprenorphine) Market Dynamics and Financial Trajectory: Revenue Trends, Exclusivity, Competitive Pressure, and Generic/Biosimilar Risk

Last updated: June 15, 2026

PROBUPHINE is a long-acting, surgically implanted buprenorphine depot for maintenance treatment of opioid use disorder (OUD). Commercial performance is shaped by (1) uptake and persistence of implant-treated patients, (2) payer coverage for implant vs. off-formulary oral/transdermal buprenorphine options, (3) prescribing friction tied to insertion and removal procedures, and (4) patent and exclusivity timing that determines when generic competition becomes a factor.

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What is PROBUPHINE and what drives its market demand?

PROBUPHINE (buprenorphine) is delivered via a subdermal implant indicated for maintenance treatment of OUD in patients who have been medically managed with buprenorphine and are considered stable. Market demand is driven less by “new-to-therapy” OUD initiation than by conversion of stable patients from oral buprenorphine products into implant delivery to improve adherence and reduce diversion risk.

Key demand drivers

• Adherence and diversion control: The implant is designed for sustained buprenorphine exposure without daily dosing.
• Clinician workflow: Demand is capped by the implant prescriber base and the capacity of clinics that can perform insertion/removal.
• Payer management: Coverage decisions and formulary placement strongly affect patient access.
• Patient selection: Conversion tends to be higher for stable patients rather than for induction-naïve populations.

Key demand constraints

• Procedure friction: Insertion and removal are barriers to switching compared with tablets/films.
• Therapeutic alternatives: Oral buprenorphine, buccal films, and sublingual regimens remain the default in many systems.
• Local practice patterns: Adoption varies by region due to clinician experience and office infrastructure.

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How have PROBUPHINE revenues and financial performance trended over time?

PROBUPHINE’s financial trajectory depends on the scale-up of implant penetration and retention of patients on the depot. The implant model usually produces:

• Front-loaded commercialization risk (patient acquisition and provider training)
• Steadier repeat demand if patients remain on therapy and implants are replaced on schedule
• Sharp revenue impact when competitors gain formulary access or when payer restrictions tighten

What typically determines whether revenue scales or stagnates

• Conversion rate from oral/transdermal to implant
• Treatment persistence and timely reinsertion cycles
• National payer coverage expansion vs. carve-out restrictions
• Reimbursement rates for insertion/removal and drug acquisition cost pass-through

Financial trajectory markers used by market participants

• Net sales growth vs. flatlining: Indicates whether patient conversion and persistence are expanding.
• Gross-to-net pressure: Rebates and utilization management can erode revenue even when demand holds.
• Manufacturing and supply stability: Implant products can face slower ramps due to procedural bottlenecks.

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What patents protect PROBUPHINE and how do they map to competitive entry risk?

The primary legal/competitive vector for PROBUPHINE is whether it remains protected from generic substitution in the U.S. at the time challengers file and win Paragraph IV disputes (if applicable). Patent estate strength also affects whether authorized generics or non-substitutable entry strategies emerge.

How to evaluate PROBUPHINE patent protection in practice

• Orange Book-listed patents (drug product, composition, method of use, and formulation where applicable)
• Method-of-use coverage that can block “skinny” generic carve-outs
• Device and implantation method protection (if claimed)
• Exclusivity overlays (regulatory exclusivity in addition to patents)

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What is the Orange Book status of PROBUPHINE?

No Orange Book listing data is included here because this response is constrained by the absence of cited, source-backed listing content in the provided information set.

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When does PROBUPHINE lose exclusivity in the U.S.?

No exclusivity calendar is provided here because the response cannot be completed with accurate, cited expiration dates for patents and regulatory exclusivities.

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How many patents cover PROBUPHINE and which assignees hold them?

No patent count or assignee table is provided here because the response requires verified patent-document inputs (numbers, application families, assignees, and expiration dates) that are not present in the provided information set.

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What patent litigation affects PROBUPHINE, including Paragraph IV challenges and settlements?

No litigation docket or settlement detail is provided here because the response cannot be completed with accurate, cited facts about case filings, outcomes, or settlement terms.

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What generic entry risks exist for PROBUPHINE and when could they materialize?

Generic risk is a function of:

• Whether an ANDA is filed for a substitutable product at the time of regulatory “entry eligibility”
• Whether Orange Book patents are challenged via Paragraph IV
• Whether exclusivity and injunction risks delay launch
• Whether formulation or method-of-use barriers block substitution

No launch-window assessment is included here because it would require verified entry dates tied to patent expiration and litigation outcomes.

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How does PROBUPHINE compare with other buprenorphine OUD options in payer and market access?

PROBUPHINE competes against:

• Oral buprenorphine formulations (tablet/sublingual)
• Buprenorphine buccal/sub-lingual film products
• Extended-release injectables (where available as alternatives in specific formularies)
• Transmucosal options depending on payer contracting

Comparative commercialization dynamics

• Payer preference often favors flexibility: oral and film regimens can be titrated with lower procedural friction.
• Implant economics depend on total cost and reimbursement structure: payer coverage can shift based on whether implant reduces downstream utilization (missed visits, relapse management, diversion).
• Clinician adoption is path dependent: once a clinic installs an implantation workflow, ongoing reinsertion can improve persistence.

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Which companies are challenging PROBUPHINE and what is the competitive landscape?

No challenger identities or competitive landscape data is provided here due to the absence of source-cited litigation and regulatory filings.

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What formulations and delivery systems are protected for PROBUPHINE?

Implant products can have protection spanning:

• Drug formulation inside the implant matrix
• Implant design and dose delivery kinetics
• Method-of-use claims tied to stable patients and clinical conversion

No protected-formulation and delivery-system claim mapping is provided here because claim-level details are not available in the provided information set.

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What manufacturing and IP barriers exist for generic or “authorized” implant entry?

For depot implant products, barriers commonly include:

• Implant production controls for uniform drug loading and release characteristics
• Insertion procedure standardization for safe dosing and patient tolerance
• Quality system and device-drug integration requirements

No product-specific manufacturing/IP barriers are provided here because those require cited details tied to PROBUPHINE-specific patents, manufacturing disclosures, and regulatory review documents.

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Regulatory pathway impact: How do FDA review outcomes affect PROBUPHINE competition?

Competition timing depends on:

• Approval status of generic/abbreviated submissions
• Patent certification outcomes
• Whether the product is eligible for substitution under the relevant pathway rules

No FDA pathway status details are provided here beyond the general concept because specific PROBUPHINE regulatory milestones and any relevant ANDA/505(b)(2) status are not available in the provided information set.

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Revenue exposure model: What share of OUD maintenance could PROBUPHINE capture and how does that translate to money at risk?

A practical exposure model for implant buprenorphine typically builds from:

• Total addressable patient base treated for OUD with buprenorphine
• Penetration into stable, eligible patients
• Persistence rate on implant therapy (implant replacement cadence)
• Net price realized after rebates and payer contracting
• Competitive substitution when generic entry occurs

No quantitative revenue model is provided here because the response requires PROBUPHINE net sales figures, market size estimates, and payer-mix data that are not present in the provided information set.

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Key Takeaways

• PROBUPHINE demand is primarily driven by conversion and persistence among stable OUD patients, with procedure capacity and payer coverage determining the ceiling for adoption.
• Its financial trajectory is sensitive to gross-to-net dynamics, the rate of patient retention, and whether implant prescribing expands beyond early adopters.
• Competitive risk hinges on Orange Book patent scope and exclusivity timelines tied to generic eligibility and litigation outcomes.
• This response does not include patent dates, litigation particulars, Orange Book listings, or revenue numbers because the necessary source-backed inputs are not available in the provided information set.

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FAQs

1. How does payer formulary placement typically affect implant buprenorphine adoption versus oral buprenorphine?
2. What patient and clinician factors most strongly predict persistence on PROBUPHINE therapy?
3. How do Paragraph IV disputes generally shape the launch timing for buprenorphine generics?
4. What non-patent barriers can delay generic competition for depot implant products?
5. How do rebates and utilization management commonly impact net sales for long-acting OUD drugs?

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References

1. (No sources were provided in the prompt; no cited materials are included.)