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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 six patents protecting this drug.

This drug has sixty-one patent family members in twenty-nine 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

Indicators of Generic Entry

Summary for POSIMIR

International Patents:	61
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	4,778
What excipients (inactive ingredients) are in POSIMIR?	POSIMIR excipients list
DailyMed Link:	POSIMIR at DailyMed

US Patents and Regulatory Information for POSIMIR

POSIMIR is protected by six US patents and one FDA Regulatory Exclusivity.

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		RX	Yes	Yes			Y
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes
Innocoll	POSIMIR	bupivacaine	SOLUTION;INFILTRATION	204803-001	Feb 1, 2021		RX	Yes	Yes			Y

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/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 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
Russian Federation	2007114291	СИСТЕМА КОНТРОЛИРУЕМОЙ ДОСТАВКИ
Poland	2415484
Portugal	2767292
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)

POSIMIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for POSIMIR

Introduction

POSIMIR, a non-opioid, sustained-release local analgesic developed by DURECT Corporation, has been making significant strides in the pharmaceutical market, particularly in the treatment of post-surgical pain. Here, we will delve into the market dynamics and financial trajectory of POSIMIR.

Market Need and Demand

The demand for non-opioid pain relief solutions is on the rise, driven by the opioid epidemic and the need for safer alternatives. According to the Centers for Disease Control, prescription pain medications cause nearly 50% of all U.S. opioid overdoses, highlighting the critical need for drugs like POSIMIR[4].

FDA Approval and Commercial Launch

POSIMIR received FDA approval for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery. The commercial launch in the U.S. was announced in collaboration with Innocoll Pharmaceuticals Limited, marking a significant milestone for DURECT[3].

Technology and Efficacy

POSIMIR utilizes DURECT's innovative SABER® platform technology, enabling continuous sustained delivery of bupivacaine over 3 days. This technology allows for the administration of a higher dose of bupivacaine than any other approved single-dose sustained-release bupivacaine product, providing effective post-surgical analgesia for up to 72 hours[3].

Commercial Agreements and Milestones

DURECT has secured several lucrative agreements for POSIMIR. The collaboration with Innocoll includes a $2 million payment triggered by the first commercial sale, an $8 million milestone payment for the extension of U.S. patent coverage, and a $4 million upfront license fee. Additionally, DURECT is entitled to tiered royalties ranging from low double-digit to mid-teen percentages on net product sales in the U.S., along with potential milestone payments up to $122 million[3].

Financial Performance

Revenue and Net Loss

In the third quarter of 2024, DURECT reported total revenues of $1.9 million and a net loss of $4.3 million. This compares to total revenues of $1.7 million and a net loss of $3.0 million in the third quarter of 2023. For the nine months ended September 30, 2024, total revenues were $5.9 million, with a net loss of $15.6 million[5].

Cash and Debt Position

As of September 30, 2024, DURECT's cash, cash equivalents, and investments stood at $10.5 million, down from $29.8 million at December 31, 2023. The company's debt also decreased to $10.5 million from $16.7 million at the end of 2023[5].

Operating Expenses

DURECT's operating expenses include significant research and development costs, which were $2.164 million in the third quarter of 2024, and $8.53 million for the nine months ended September 30, 2024. Selling, general, and administrative expenses were $3.217 million for the third quarter of 2024 and $9.325 million for the nine months ended September 30, 2024[5].

Regulatory and Development Milestones

Despite the FDA's initial rejection of POSIMIR's New Drug Application in 2014 due to safety concerns, DURECT has made progress. The company completed the Phase 3 PERSIST trial, although the FDA recommended a revised protocol comparing POSIMIR to the active control bupivacaine HCl instead of a placebo[4].

Market Potential

The post-surgical pain market is substantial, with a study indicating that about 86% of patients report pain after surgery, and 74% experience pain through hospital discharge. This expansive market presents a potentially lucrative opportunity for POSIMIR, especially given its non-opioid status and sustained-release mechanism[4].

Risks and Uncertainties

DURECT faces several risks, including the uncertainty of future clinical trial outcomes, the sufficiency of cash resources, and the ability to meet the minimum bid price for continued listing on Nasdaq. Additionally, there are risks related to the commercial success of POSIMIR, which could impact the company's financial trajectory[1].

Conclusion

POSIMIR is positioned to capitalize on the growing demand for non-opioid pain relief solutions, driven by its innovative technology and the critical need to address post-surgical pain. While DURECT faces financial and regulatory challenges, the commercial launch and ongoing agreements suggest a promising market dynamics and financial trajectory for POSIMIR.

Key Takeaways

• FDA Approval: POSIMIR received FDA approval for treating post-surgical pain in adults.
• Commercial Launch: Launched in the U.S. in collaboration with Innocoll Pharmaceuticals.
• Financial Agreements: Includes significant milestone payments and royalties.
• Financial Performance: Reported revenues and net losses, with declining cash and debt positions.
• Market Potential: Substantial market demand driven by the opioid epidemic and post-surgical pain needs.
• Risks and Uncertainties: Includes clinical trial outcomes, cash resources, and commercial success risks.

FAQs

Q1: What is POSIMIR used for? POSIMIR is used for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery.

Q2: Who are the key partners involved in the commercialization of POSIMIR? The key partners involved are DURECT Corporation and Innocoll Pharmaceuticals Limited.

Q3: What technology does POSIMIR use? POSIMIR utilizes DURECT's innovative SABER® platform technology for sustained-release delivery of bupivacaine.

Q4: What are the financial milestones associated with POSIMIR? DURECT is entitled to a $2 million payment upon the first commercial sale, an $8 million milestone payment for patent extension, and tiered royalties along with potential milestone payments up to $122 million.

Q5: What are the primary risks facing DURECT regarding POSIMIR? The primary risks include uncertainty in future clinical trial outcomes, sufficiency of cash resources, and the ability to meet the minimum bid price for continued listing on Nasdaq.

Sources

1. DURECT Corporation Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update - DURECT Corporation.
2. DURECT Corporation Reports Third Quarter 2024 Financial Results and Provides Business Update - DURECT Corporation.
3. Innocoll Pharmaceuticals Limited and DURECT Corporation Announce U.S. Launch of POSIMIR - Marketscreener.
4. Novartis pushes further into pain with Durect deal - BioPharma Dive.
5. DURECT Corporation Reports Third Quarter 2024 Financial Results and Provides Business Update - PR Newswire.