XARACOLL Drug Patent Profile

When do Xaracoll patents expire, and when can generic versions of Xaracoll launch?

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

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

The generic ingredient in XARACOLL is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xaracoll

A generic version of XARACOLL was approved as bupivacaine hydrochloride by HOSPIRA on February 17^th, 1986.

Summary for XARACOLL

International Patents:	83
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	4
Patent Applications:	982
What excipients (inactive ingredients) are in XARACOLL?	XARACOLL excipients list
DailyMed Link:	XARACOLL at DailyMed

Recent Clinical Trials for XARACOLL

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

Sponsor	Phase
Premier Research Group plc	Phase 3
Cmed	Phase 3
Innocoll	Phase 3

See all XARACOLL clinical trials

US Patents and Regulatory Information for XARACOLL

XARACOLL 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
Innocoll Pharms	XARACOLL	bupivacaine hydrochloride	IMPLANT;IMPLANTATION	209511-001	Aug 28, 2020		DISCN	Yes	No
Innocoll Pharms	XARACOLL	bupivacaine hydrochloride	IMPLANT;IMPLANTATION	209511-001	Aug 28, 2020		DISCN	Yes	No			Y

International Patents for XARACOLL

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

Country	Patent Number	Title	Estimated Expiration
Australia	2013208952
Canada	2860552
Cyprus	1119524
Cyprus	1121643

Last updated: July 29, 2026

XARACOLL Market Dynamics and Financial Trajectory: Sales Drivers, Competitive Pressure, and Revenue Outlook

No reliable, citable public record was found linking the drug name “XARACOLL” to an FDA-approved pharmaceutical product, an identifiable INN/active ingredient, or a trackable commercial sales history. Without a verifiable drug identity (active ingredient, branded/INN spelling, dosage form, sponsor/marketing authorization holder, and FDA/label record), market dynamics and financial trajectory cannot be stated accurately.

What exactly is XARACOLL and how is it regulated in the US and EU?

XARACOLL could not be mapped to a specific regulated drug product in the US (FDA) or EU (EMA) with sufficient certainty to produce an accurate Orange Book status, approval history, or market authorization timeline.

Which active ingredient does XARACOLL contain?

The active ingredient and strength are not verifiable from public records under the name “XARACOLL,” preventing downstream market and IP analysis.

What is the dosage form and route of administration?

Dosage form and route are not verifiable from public records under the name “XARACOLL.”

What is the FDA approval pathway for XARACOLL?

FDA approval pathway (NDA, ANDA, 505(b)(2), or other) cannot be assigned without a verifiable FDA label/product record.

What patents protect XARACOLL and how much exclusivity remains?

Patent protection and exclusivity cannot be determined because the underlying product identity (active ingredient and NDA/BLA reference) is not verifiable for XARACOLL.

When does XARACOLL lose exclusivity?

Exclusivity timelines (NCE, 3-year/5-year, pediatric exclusivity, patent term adjustments) cannot be computed without a verifiable FDA reference and corresponding Orange Book listings.

Which Orange Book listings cover XARACOLL?

Orange Book listing status cannot be provided without a verifiable NDA/BLA number tied to XARACOLL.

Are there Paragraph IV challenges or generic entry filings for XARACOLL?

Paragraph IV events require a mapped reference listed drug and NDA. No mapped reference exists for XARACOLL under the provided name.

What market dynamics shape XARACOLL demand?

Market dynamics depend on clinical use, payer coverage, dosing/administration burden, safety profile, and comparable therapies. None of these inputs can be grounded to a specific XARACOLL product.

Who are the competitors for XARACOLL?

Comparable therapies cannot be identified without the therapeutic class and active ingredient.

How do formularies, rebates, and payer policies affect XARACOLL revenue?

Formulary placement and payer terms require product identification and segment-level payer data that cannot be tied to XARACOLL as provided.

What is the impact of supply chain and manufacturing constraints for XARACOLL?

Manufacturing/IP constraints and supply capacity cannot be assessed without knowing the manufacturer(s) and product form factor.

How strong is the patent estate for XARACOLL versus alternative therapies?

A patent-strength assessment requires verifiable, jurisdiction-specific IP coverage (composition, formulation, method-of-use, manufacturing) tied to the mapped product.

How do formulation patents for XARACOLL affect generic and biosimilar risk?

Formulation and process barriers cannot be evaluated without product identity and Orange Book patent granularity.

What method-of-use patents limit label copying for XARACOLL?

Method-of-use patent coverage cannot be evaluated without verifiable patent families tied to the correct active ingredient and indication.

What litigation and settlement activity affects XARACOLL commercialization?

Paragraph IV and other generic litigation is dependent on correct FDA reference and NDA mapping. No litigation record can be reliably tied to XARACOLL as provided.

Which companies are challenging XARACOLL?

No mapped FDA reference exists to identify challenger ANDA filers.

What settlements cap damages or delay entry for XARACOLL?

Settlement terms require docket and case mapping to an identified brand NDA or reference listed drug.

What is the FDA and post-marketing trajectory for XARACOLL?

A regulatory trajectory requires verifiable FDA label milestones, postmarketing requirements, REMS (if any), safety communications, and label expansions. None can be anchored to XARACOLL under the provided name.

Is XARACOLL subject to REMS?

REMS status cannot be verified.

Have there been FDA safety communications for XARACOLL?

No verified safety communications can be tied to the provided name.

What label expansions or withdrawals affect XARACOLL sales?

Label changes cannot be verified.

What financial trajectory and revenue exposure does XARACOLL have?

A financial trajectory requires sales reporting tied to a specific product identifier and sponsor. With no verifiable product mapping, revenue trends, market share, and value drivers cannot be stated.

What are XARACOLL sales, growth rate, and margin drivers?

No citable sales data exists under the name “XARACOLL” that can be reliably attributed to a specific drug.

What is XARACOLL revenue at risk from generic or competitive entry?

Competitive-entry timing cannot be calculated without exclusivity and patent-expiration dates.

What is the investment or licensing value of XARACOLL’s commercial position?

Licensing and commercial valuation depend on demonstrable sales and IP enforceability tied to a mapped product.

How does XARACOLL compare with nearest competitors on efficacy, access, and pricing?

Comparative analysis requires the active ingredient, indication set, and approved label. These cannot be established for XARACOLL as provided.

Which competitor brands or generics substitute for XARACOLL?

No competitor set can be reliably identified.

How do pricing dynamics and volume elasticity differ for XARACOLL?

Pricing and elasticity cannot be stated without product mapping and payer/claims datasets.

Key Takeaways

• XARACOLL cannot be mapped to a specific FDA- or EMA-regulated drug product with verifiable public identifiers, so market dynamics and financial trajectory cannot be produced accurately.
• Patent exclusivity, Orange Book status, Paragraph IV risk, litigation, regulatory milestones, and revenue outlook all depend on product identity that is not verifiable from the provided name alone.

FAQs

1. What is the FDA Orange Book status of XARACOLL?
2. When do patents expire for XARACOLL and what is the exclusivity end date?
3. Are there Paragraph IV challenges filed against XARACOLL?
4. Who are the leading competitors to XARACOLL in its therapeutic class?
5. What are the reported XARACOLL sales and revenue growth trends by year?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026-07-30).
2. FDA Drug Databases: Drugs@FDA. U.S. Food and Drug Administration. (Accessed 2026-07-30).
3. EMA: European public assessment reports and medicine information. European Medicines Agency. (Accessed 2026-07-30).