POSIMIR Drug Patent Profile

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

Posimir is a drug marketed by Innocoll and is included in one NDA. There are two patents protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in POSIMIR is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.

DrugPatentWatch^® Generic Entry Outlook for Posimir

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 12, 2041. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for POSIMIR

International Patents:	7
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	5,288
What excipients (inactive ingredients) are in POSIMIR?	POSIMIR excipients list
DailyMed Link:	POSIMIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for POSIMIR

Constraining patent/regulatory exclusivity:

11,400,019

NDA:

204803

Dosage:

SOLUTION;INFILTRATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for POSIMIR

POSIMIR is protected by two US patents.

This potential generic entry date is based on patent 11,400,019.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		DISCN	Yes	No	11,771,624
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		DISCN	Yes	No	11,400,019		Y

Expired US Patents for POSIMIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,846,072
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,153,149
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,753,665
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021	8,153,661

EU/EMA Drug Approvals for POSIMIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Ireland Limited	Exparel liposomal	bupivacaine	EMEA/H/C/004586Exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain.in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.	Authorised	no	no	no	2020-11-16

International Patents for POSIMIR

When does loss-of-exclusivity occur for POSIMIR?

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

Brazil

Canada

China

European Patent Office

Japan

South Korea

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 POSIMIR around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112022013784	SISTEMAS DE DISTRIBUIÇÃO DE FÁRMACOS DE LIBERAÇÃO PROLONGADA COM IMPUREZAS REDUZIDAS E MÉTODOS RELACIONADOS
Canada	3167217	SYSTEMES D'ADMINISTRATION DE MEDICAMENT A LIBERATION PROLONGEE AVEC IMPURETES REDUITES ET PROCEDES ASSOCIES (SUSTAINED RELEASE DRUG DELIVERY SYSTEMS WITH REDUCED IMPURITIES AND RELATED METHODS)
China	115666621	具有减少的杂质的持续释放药物递送系统及相关方法 (Sustained release drug delivery systems with reduced impurities and related methods)
European Patent Office	4090353	SYSTÈMES D'ADMINISTRATION DE MÉDICAMENT À LIBÉRATION PROLONGÉE AVEC IMPURETÉS RÉDUITES ET PROCÉDÉS ASSOCIÉS (SUSTAINED RELEASE DRUG DELIVERY SYSTEMS WITH REDUCED IMPURITIES AND RELATED METHODS)
Japan	2023515918	不純物が低減された徐放性薬物送達システム及び関連の方法

POSIMIR market dynamics and financial trajectory: revenue drivers, payer positioning, pricing pressure, and exclusivity-linked risk

Last updated: June 8, 2026

POSIMIR is an FDA-approved prescription product with a defined commercial window tied to its reference and exclusivity environment, but its market impact is shaped primarily by: (1) hospital and ambulatory uptake for opioid-sparing post-surgical pain management, (2) payer reimbursement and formulary inclusion, and (3) near-to-mid-term competitive entry risk from generics/biosimilars only if POSIMIR’s active ingredient and/or formulation protections permit cheaper substitutes. Without the underlying FDA approval date, NDC-level sales, and Orange Book listings for POSIMIR’s specific strengths and dosage forms, a complete financial trajectory with quantified revenue milestones cannot be produced.

What is POSIMIR and what market is it competing in?

POSIMIR is marketed for post-operative pain. The product’s commercial relevance typically depends on how it is positioned against standard-of-care multimodal analgesia regimens in inpatient and ambulatory surgery settings, including oral, IV, and other local/regional analgesic approaches.

Which pain-management alternatives does POSIMIR compete against?

POSIMIR’s competitive set generally includes:

• Opioid-based discharge and in-hospital regimens
• Non-opioid systemic analgesics (NSAIDs, acetaminophen combinations)
• Local analgesics and topical or device-based approaches (where used)
• Other perioperative multimodal products

How does the purchase channel shape POSIMIR adoption?

Commercial outcomes track with:

• Pharmacy procurement in hospitals (group purchasing organization dynamics, contract pricing, and formulary placement)
• Ambulatory surgery center purchasing (tendering, preference cards, and bundled procedure economics)
• Specialty pharmacy distribution only if the product’s utilization model supports it (many perioperative products remain institutionally driven)

How strong is POSIMIR’s exclusivity protection and why does it matter for revenue?

POSIMIR’s financial trajectory depends on whether its protections cover:

• The active ingredient (composition of matter)
• A specific formulation or delivery mechanism (formulation/process patents)
• A specific method of use (indication, dosing regimen, or patient-selection claims)
• Label scope that supports reimbursement coding and clinical pathway adoption

What patents protect POSIMIR and how long do they last?

A revenue-impact assessment requires Orange Book patent identifiers for POSIMIR (US patents listed against the approved NDA/ANDA) and their stated expiration dates. Those specific listings are not provided here, so a protection-duration forecast cannot be quantified.

When does POSIMIR lose exclusivity?

Exclusivity loss is typically driven by:

• Patent expiration (composition, formulation, or method-of-use)
• Regulatory exclusivities (if any) connected to the approval pathway
• De facto label narrowing if entrants can launch “skinny-label” versions

A timeline requires exact Orange Book exclusivity and expiration dates for POSIMIR’s listed patents. Those dates are not available in the input.

What is the Orange Book status of POSIMIR (NDC, patents, exclusivities)?

Orange Book status determines:

• Which entries are listed per dosage form/strength
• What patent numbers and expiry dates block ANDA or 505(b)(2) entry
• Whether there are listed “use” patents that constrain label design for generics

Which Orange Book listings exist for POSIMIR?

No NDC-level Orange Book listing data is included, so the number of patents, their expiration dates, and exclusivity periods cannot be stated.

Do Paragraph IV generic challenges threaten POSIMIR’s revenue?

Paragraph IV challenges drive:

• Legal leverage that can delay generic entry
• Settlement-based launch dates
• Early-loss risk when an infringer enters at risk and then wins narrow or design-around permission

What generic entry risks exist for POSIMIR?

A credible entry-risk profile requires:

• Any active or resolved Paragraph IV filings against POSIMIR’s NDA
• Whether the challenger is seeking generic substitution (ANDA) or 505(b)(2) with bridging data
• Litigation docket details and settlement terms

No such filing or docket information is provided.

What patent litigation affects POSIMIR commercialization and settlement outcomes?

Patent litigation impacts POSIMIR’s financial trajectory by:

• Creating periods of market uncertainty that pressure pricing and contracting
• Increasing discounting risk when payers anticipate cheaper alternatives
• Allowing challengers to delay or accelerate launches based on court rulings

Is there active POSIMIR patent litigation or past settlements?

Litigation status and settlement dates are not included, so the impact on revenue cannot be mapped to measurable post-event effects.

How does POSIMIR’s FDA regulatory status influence adoption and reimbursement?

Regulatory status affects commercialization through:

• Labeling specificity (dosing, patient populations)
• Safety communications that influence uptake
• Pathway-driven differentiation (e.g., 505(b)(2) may set expectations for follow-on competitors)

What FDA pathway and approval milestones define POSIMIR’s launch window?

A financial trajectory typically aligns sales ramps to:

• Initial approval launch
• Label expansions or restriction changes
• Post-approval safety communications affecting prescribing behavior

The FDA approval date and any major label changes are not provided here.

How is POSIMIR priced, reimbursed, and contracted in the US market?

POSIMIR revenue performance is driven by:

• Net price after rebates and chargebacks
• Contracting intensity in hospitals and ASC networks
• Reimbursement codes and payer policy that determine patient-level accessibility
• Competitive price compression if therapeutics with overlapping use cases appear

What pricing pressure and formulary dynamics should be modeled?

A forward model generally includes:

• Uptake curves based on formulary inclusion or pathway standardization
• Bid-season changes in GPO and hospital contracts
• Multimodal analgesia pathway standardization that can lock-in usage
• Generic substitute risk if patent and regulatory barriers clear

Quantified pricing trajectory cannot be provided without historical net sales, ASP/WAC data, and payer coverage changes.

How does POSIMIR compare with competing perioperative analgesics on market size and adoption mechanics?

For perioperative pain products, the adoption driver is rarely “therapeutic superiority” alone. It is the fit with:

• Clinical protocols (ERAS-like pathways)
• Operational workflow (pre-op/post-op processes)
• Nursing and anesthesia buy-in
• Pharmacy availability and inventory management

What competitive comparisons matter most for POSIMIR?

Competitors that can compress POSIMIR pricing or take share include:

• Similar route local/systemic analgesics
• Other hospital-preferred multimodal standards
• Lower-cost alternatives when budget constraints rise

A ranking requires market share or sales data for POSIMIR and peers, which is not in the prompt.

What is the financial trajectory outlook for POSIMIR across the next 5 years?

A financial trajectory needs at minimum:

• Historical US sales by quarter or year (NDC/NDA)
• International expansion status (if any)
• Cost-to-serve and contracting structure
• Exclusivity and competitor pipeline that can trigger share loss
• Litigation and generic risk timing

With none of those POSIMIR-specific inputs present, the only defensible statement is that POSIMIR’s long-run revenue depends on exclusivity duration and the timing of any market entry enabled by Orange Book and patent expiry, not on general category demand growth alone.

Key drivers that will determine POSIMIR revenue growth or decline

Even without quantified numbers, the direction of financial performance will be controlled by:

• Contracting and formulary inclusion in hospitals and ASCs
• Product-level differentiation in perioperative workflows
• Clinical guideline alignment for post-operative pain protocols
• Discounting and rebate pressure as competitors target the same utilization cohorts
• The presence or absence of generic substitutes tied to POSIMIR’s patent estate and regulatory exclusivity

Key Takeaways

• POSIMIR’s market dynamics are primarily shaped by institutional purchasing behavior, payer contracting, and perioperative protocol adoption.
• Revenue trajectory is exclusivity-driven: patent expiration, listed Orange Book barriers, and any Paragraph IV/litigation outcomes determine the timing of generic or follow-on competitive pressure.
• Quantified sales ramp, peak, and decline cannot be determined from the provided information because POSIMIR’s Orange Book listings, FDA approval/label milestones, and historical/forward sales data are not included.

FAQs

1. What drives POSIMIR adoption in hospitals versus ASCs?
2. How do Orange Book patent listings affect POSIMIR generic substitution risk by dosage form?
3. What settlement scenarios typically change POSIMIR launch timing for potential generic competitors?
4. How does net pricing (rebates and chargebacks) usually impact perioperative product revenue trajectories?
5. What clinical pathway changes most often shift demand for post-operative pain products like POSIMIR?

References (APA)

No sources were provided in the prompt.