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PCRX Receives New Patent for Lead Pain Drug Exparel in the US
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Pacira BioSciences (PCRX - Free Report) announced the reception of the ‘940 patent from the U.S. Patent and Trademark Office that protects the chemical composition of Exparel (bupivacaine liposome injectable suspension), ensuring protection against generics in the market through 2044. The ‘940 patent is the first from a new family of patents related to Exparel produced by Pacira’s enhanced large-scale manufacturing process in San Diego, which received FDA approval in February 2024.
Exparel is Pacira’s flagship pain-management product, which was launched in 2012. The drug is indicated for postsurgical local analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.
Pacira plans to list the ‘940 patent in the FDA's Orange Book, which includes patents covering the active ingredient, drug formulation, or approved usage methods. The company is also pursuing additional patent applications and expects more patents to be granted in the future.
In the past three months, shares of Pacira have gained 13.6% against the industry’s 6.4% decline.
Image Source: Zacks Investment Research
PCRX to Sue 3 Companies for Exparel Patent Infringement
In the same press release, Pacira shared plans to sue Jiangsu Hengrui Pharmaceuticals and its U.S. distributor, Fresenius Kabi, for infringing the newly issued ‘940 patent.
Separately, it is pursuing legal action against eVenus Pharmaceutical Laboratories, Jiangsu Hengrui and Fresenius for violating the ‘574 patent in a New Jersey federal court. Additionally, Pacira is appealing the court decision in August 2024 that invalidated its ‘495 patent. To succeed in the market, the defendants must overcome PCRX’s robust patent protections.
The multi-layered patent protection for Exparel ensures the drug’s exclusivity in the pain management market, thereby preventing generic erosion.
Exparel – The Primary Growth Driver for PCRX
Exparel is the major contributor to Pacira’s revenues. It has been witnessing strong demand, primarily driven bygrowth within existing accounts, along with increasing acceptance by major hospitals and orthopedic centers, as it continues to be used in orthopedic procedures. It is also ticking the interest among oral and maxillofacial surgeons, fueled by a partnership announced in September 2022 between Pacira and Sevaredent to provide expanded access to Exparel for patients undergoing oral and maxillofacial procedures.
In the first nine months of 2024, the drug generated revenues worth $401.3 million, representing year-over-year growth of 1.8%.
Pacira is also looking to further expand Exparel’s label to treat younger age groups. In 2024, the company initiated an early-stage pharmacokinetic study of Exparel as a single-dose post-surgical infiltration administration in patients under six years of age.
Subject to the success of this study, Pacira plans to initiate a phase III registration study to support regulatory filings seeking label expansions in the United States, the U.K. and the EU. Potential approval will further boost sales by increasing its patient eligibility criteria. The company is also currently exchanging dialogues with several regulatory bodies to align on the regulatory pathway for Exparel administered as a nerve block in the pediatric setting.
Besides Exparel, Pacira also markets Zilretta, approved as an extended-release intra-articular therapy providing relief to osteoarthritis patients with knee pain and the iovera drug delivery system, which generates incremental revenues for the company.
Over the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 7.8% in the past three months.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
In the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 10.3% in the past three months.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 17.4% in the past three months.
Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.
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PCRX Receives New Patent for Lead Pain Drug Exparel in the US
Pacira BioSciences (PCRX - Free Report) announced the reception of the ‘940 patent from the U.S. Patent and Trademark Office that protects the chemical composition of Exparel (bupivacaine liposome injectable suspension), ensuring protection against generics in the market through 2044. The ‘940 patent is the first from a new family of patents related to Exparel produced by Pacira’s enhanced large-scale manufacturing process in San Diego, which received FDA approval in February 2024.
Exparel is Pacira’s flagship pain-management product, which was launched in 2012. The drug is indicated for postsurgical local analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.
Pacira plans to list the ‘940 patent in the FDA's Orange Book, which includes patents covering the active ingredient, drug formulation, or approved usage methods. The company is also pursuing additional patent applications and expects more patents to be granted in the future.
In the past three months, shares of Pacira have gained 13.6% against the industry’s 6.4% decline.
Image Source: Zacks Investment Research
PCRX to Sue 3 Companies for Exparel Patent Infringement
In the same press release, Pacira shared plans to sue Jiangsu Hengrui Pharmaceuticals and its U.S. distributor, Fresenius Kabi, for infringing the newly issued ‘940 patent.
Separately, it is pursuing legal action against eVenus Pharmaceutical Laboratories, Jiangsu Hengrui and Fresenius for violating the ‘574 patent in a New Jersey federal court. Additionally, Pacira is appealing the court decision in August 2024 that invalidated its ‘495 patent. To succeed in the market, the defendants must overcome PCRX’s robust patent protections.
The multi-layered patent protection for Exparel ensures the drug’s exclusivity in the pain management market, thereby preventing generic erosion.
Exparel – The Primary Growth Driver for PCRX
Exparel is the major contributor to Pacira’s revenues. It has been witnessing strong demand, primarily driven bygrowth within existing accounts, along with increasing acceptance by major hospitals and orthopedic centers, as it continues to be used in orthopedic procedures. It is also ticking the interest among oral and maxillofacial surgeons, fueled by a partnership announced in September 2022 between Pacira and Sevaredent to provide expanded access to Exparel for patients undergoing oral and maxillofacial procedures.
In the first nine months of 2024, the drug generated revenues worth $401.3 million, representing year-over-year growth of 1.8%.
Pacira is also looking to further expand Exparel’s label to treat younger age groups. In 2024, the company initiated an early-stage pharmacokinetic study of Exparel as a single-dose post-surgical infiltration administration in patients under six years of age.
Subject to the success of this study, Pacira plans to initiate a phase III registration study to support regulatory filings seeking label expansions in the United States, the U.K. and the EU. Potential approval will further boost sales by increasing its patient eligibility criteria. The company is also currently exchanging dialogues with several regulatory bodies to align on the regulatory pathway for Exparel administered as a nerve block in the pediatric setting.
Besides Exparel, Pacira also markets Zilretta, approved as an extended-release intra-articular therapy providing relief to osteoarthritis patients with knee pain and the iovera drug delivery system, which generates incremental revenues for the company.
Pacira BioSciences, Inc. Price and Consensus
Pacira BioSciences, Inc. price-consensus-chart | Pacira BioSciences, Inc. Quote
PCRX’s Zacks Rank & Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold).
Some better-ranked pharma stocks are Allogene Therapeutics (ALLO - Free Report) , Pfizer (PFE - Free Report) and Gilead Sciences (GILD - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, Allogene Therapeutics’ estimates for loss per share have narrowed from $1.40 to $1.35 for 2024, and that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 7.8% in the past three months.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
In the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 10.3% in the past three months.
Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.
In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 17.4% in the past three months.
Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.