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exparel Drug Patent Profile

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

Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. There are thirteen patents protecting this drug and two Paragraph IV challenges.

This drug has eight patent family members in four countries.

The generic ingredient in EXPAREL 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 Exparel

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for exparel

International Patents:	8
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	280
Patent Applications:	4,518
Drug Prices:	Drug price information for exparel
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for exparel
What excipients (inactive ingredients) are in exparel?	exparel excipients list
DailyMed Link:	exparel at DailyMed

See drug prices for exparel

Recent Clinical Trials for exparel

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 3
Jessyka Lighthall	Phase 3
Rutgers, The State University of New Jersey	Phase 2/Phase 3

See all exparel clinical trials

Pharmacology for exparel

Drug Class	Amide Local Anesthetic
Physiological Effect	Local Anesthesia

Paragraph IV (Patent) Challenges for EXPAREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXPAREL	Injectable Suspension	bupivacaine	133 mg/10 mL	022496	1	2021-12-28
EXPAREL	Injectable Suspension	bupivacaine	266 mg/20 mL	022496	1	2021-08-20

US Patents and Regulatory Information for exparel

exparel is protected by fourteen US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	AP	RX	Yes	Yes
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	AP	RX	Yes	Yes	11,931,459
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	AP	RX	Yes	Yes	11,452,691		Y
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	AP	RX	Yes	Yes	11,033,495		Y

Expired US Patents for exparel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	6,132,766
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	8,182,835
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-001	Oct 28, 2011	6,132,766
Pacira Pharms Inc	EXPAREL	bupivacaine	INJECTABLE, LIPOSOMAL;INJECTION	022496-002	Oct 28, 2011	8,834,921

EU/EMA Drug Approvals for exparel

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pacira Ireland Limited	Exparel liposomal	bupivacaine	EMEA/H/C/004586 Exparel 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 exparel

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2603047	Manufacturing of bupivacaine multivesicular liposomes
Bulgaria	63146
Australia	1407599
World Intellectual Property Organization (WIPO)	9513796

Exparel Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EXPAREL

Introduction to EXPAREL

EXPAREL, a long-acting local anesthetic developed by Pacira BioSciences, has been a significant player in the non-opioid pain management market. It is designed to provide prolonged pain relief following surgery, reducing the need for opioids and their associated risks.

Market Size and Projections

The EXPAREL market has shown robust growth and is expected to continue this trend. As of 2023, the EXPAREL market size was valued at USD 120 billion and is projected to reach USD 191 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6% from 2024 to 2031[4].

Driving Factors

Several factors are driving the growth of the EXPAREL market:

Increasing Surgical Procedures

The global increase in surgical procedures is a key driver. As more surgeries are performed, the demand for effective post-operative pain management solutions like EXPAREL rises[4].

Non-Opioid Pain Management

The opioid crisis has heightened the focus on non-opioid pain management options. EXPAREL, being a non-opioid alternative, benefits from this shift in medical practice[4].

Advances in Drug Delivery Technology

Improvements in drug delivery technologies have made EXPAREL more effective and longer-lasting, enhancing its appeal to medical professionals[4].

Regulatory Support

Favorable regulatory approvals and increased healthcare spending also contribute to the market's expansion. Positive clinical results and supportive regulatory environments further bolster EXPAREL's uptake[4].

Financial Performance of EXPAREL

Quarterly and Annual Sales

In the fourth quarter of 2023, EXPAREL net product sales were $143.9 million, a 4% increase over the $138.0 million reported for the fourth quarter of 2022. For the full year 2023, EXPAREL sales were $538.1 million, which was a nominal increase compared to the $536.9 million in 2022, considering there were two fewer selling days in 2023[1].

In the third quarter of 2024, EXPAREL net product sales were $132.0 million, representing a 3% volume growth and a 1% net price increase compared to the third quarter of 2023[3].

Revenue Growth

Total revenues for Pacira BioSciences, largely driven by EXPAREL, have shown steady growth. In the fourth quarter of 2023, total revenues were $181.2 million, a 5% increase over the $172.0 million reported for the fourth quarter of 2022. For the full year 2023, total revenues were $675.0 million, a 1% increase over the $666.8 million in 2022[1].

In the third quarter of 2024, total revenues were $168.6 million, up from $163.9 million in the third quarter of 2023[3].

Adjusted EBITDA and Net Income

The financial health of Pacira BioSciences, as indicated by adjusted EBITDA, has been positive. In the fourth quarter of 2023, adjusted EBITDA was $65.4 million, an 11% increase over the $58.8 million in the fourth quarter of 2022. For the full year 2023, adjusted EBITDA was $214.5 million[1].

In the third quarter of 2024, adjusted EBITDA was $54.7 million, an improvement from $52.9 million in the third quarter of 2023[3].

However, the third quarter of 2024 saw a net loss of $143.5 million, largely due to a goodwill impairment charge of $163.2 million, which contrasts with the net income of $10.9 million in the third quarter of 2023[3].

Operational Expenses and Cash Flow

Operating expenses for Pacira BioSciences have varied. In 2023, total operating expenses were $587.3 million, down from $606.8 million in 2022. However, in the third quarter of 2024, operating expenses increased to $308.1 million from $146.2 million in the third quarter of 2023, partly due to the goodwill impairment charge[1][3].

Cash provided by operations also saw an increase in the third quarter of 2024, rising to $53.9 million from $44.4 million in the third quarter of 2023[3].

Future Outlook

Pacira BioSciences is optimistic about the future of EXPAREL and its other products. New Medicare reimbursement approvals for EXPAREL and iovera° starting in 2025 are expected to further boost sales. The company is also investing in its clinical pipeline and commercial organization to drive long-term growth and value creation[3].

CEO's Perspective

Frank D. Lee, CEO of Pacira BioSciences, emphasized the company's progress and strategy: "2024 continues to be highlighted by important progress across both our clinical pipeline and commercial portfolio of best-in-class opioid-sparing products that delivered solid third quarter sales. Looking at the remainder of the year, we intend to build on this momentum by advancing our strategy for long-term growth and value creation, which includes investing in a best-practice commercial organization and innovative pipeline of potentially transformational assets, such as PCRX-201."[3]

Key Takeaways

• Market Growth: The EXPAREL market is expected to grow significantly, reaching USD 191 billion by 2031.
• Sales Performance: EXPAREL sales have shown steady growth, with a 4% increase in the fourth quarter of 2023 and a 3% volume growth in the third quarter of 2024.
• Financial Health: Adjusted EBITDA has been positive, but the third quarter of 2024 saw a net loss due to a goodwill impairment charge.
• Operational Expenses: Operating expenses have fluctuated, with an increase in the third quarter of 2024.
• Future Outlook: New Medicare reimbursement approvals and investments in the clinical pipeline and commercial organization are expected to drive future growth.

FAQs

Q: What is the projected market size for EXPAREL by 2031?

A: The EXPAREL market is expected to reach USD 191 billion by 2031, growing at a 6% CAGR from 2024 to 2031[4].

Q: What factors are driving the growth of the EXPAREL market?

A: The growth is driven by increasing surgical procedures, the need for non-opioid pain management, advances in drug delivery technology, and favorable regulatory approvals[4].

Q: How did EXPAREL sales perform in the third quarter of 2024?

A: EXPAREL net product sales were $132.0 million in the third quarter of 2024, representing a 3% volume growth and a 1% net price increase[3].

Q: What was the adjusted EBITDA for Pacira BioSciences in the third quarter of 2024?

A: Adjusted EBITDA was $54.7 million in the third quarter of 2024, an improvement from $52.9 million in the third quarter of 2023[3].

Q: Why did Pacira BioSciences report a net loss in the third quarter of 2024?

A: The net loss of $143.5 million was largely due to a goodwill impairment charge of $163.2 million[3].

Sources

1. Pacira BioSciences Reports Fourth Quarter and Full-Year 2023 Financial Highlights. Investor.Pacira.
2. Pacira BioSciences Reports Third Quarter 2024 Financial Results. StockTitan.
3. Pacira BioSciences Reports Third Quarter 2024 Financial Results. GlobeNewswire.
4. Exparel Market Size and Projections. Market Research Intellect.
5. Pacira BioSciences Reports Third Quarter 2023 Financial Results. GlobeNewswire.