Posimir Patent Expiration

Posimir is a drug owned by Innocoll Pharmaceuticals Ltd. It is protected by 6 US drug patents filed from 2021 to 2023. Out of these, 2 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 12, 2041. Details of Posimir's patents and their expiration are given in the table below.

Patent strength
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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11771624 Sustained release drug delivery systems with reduced impurities and related methods
Jan, 2041

(14 years from now)

Active
US11400019 Sustained release drug delivery systems with reduced impurities and related methods
Jan, 2041

(14 years from now)

Active
US8753665 Controlled delivery system
Sep, 2025

(1 year, 1 month ago)

Expired
US8846072 Controlled delivery system
Sep, 2025

(1 year, 1 month ago)

Expired
US8153661 Controlled delivery system
Sep, 2025

(1 year, 1 month ago)

Expired
US8153149 Controlled delivery system
Sep, 2025

(1 year, 1 month ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Posimir's patents.

Given below is the list of recent legal activities going on the following patents of Posimir.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 21 Jan, 2026 US11400019
Payment of Maintenance Fee, 12th Year, Large Entity 19 Nov, 2025 US8753665
Patent eCofC Notification 20 May, 2025 US8153661
Recordation of Patent eCertificate of Correction 20 May, 2025 US8153661
Mail Patent eCofC Notification 20 May, 2025 US8153661
Post Issue Communication - Certificate of Correction 29 Apr, 2025 US8153661
Mail Certificate of Correction Memo 14 Mar, 2025 US8153661
Certificate of Correction Memo 12 Mar, 2025 US8153661
Post Issue Communication - Certificate of Correction 13 Oct, 2023 US11400019
Payment of Maintenance Fee, 12th Year, Large Entity 10 Oct, 2023 US8153149


FDA has granted several exclusivities to Posimir. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Posimir, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Posimir.

Exclusivity Information

Posimir holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Posimir's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Feb 01, 2024

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US patents provide insights into the exclusivity only within the United States, but Posimir is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Posimir's family patents as well as insights into ongoing legal events on those patents.

Posimir's Family Patents

Posimir has patent protection in a total of 29 countries. It's US patent count contributes only to 25.7% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Posimir.

Family Patents

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Clinical Trials

Recent Clinical Trials on Posimir:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Nebulized Bupivacaine Analgesia for Cleft Palate Repair Assiut University NA RECRUITING
(Sep 1, 2026)
PHASE3
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty University of California, San Francisco NA COMPLETED
(Sep 1, 2026)
PHASE3
Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis Foundation for Orthopaedic Research and Education NA COMPLETED
(Sep 1, 2026)
PHASE1
Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion Foundation for Orthopaedic Research and Education NA ENROLLING BY INVITATION
(Sep 1, 2026)
PHASE2, PHASE3
Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain The University of Hong Kong NA RECRUITING
(Sep 1, 2026)
PHASE3
A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer. OncoZenge AB NA RECRUITING
(Sep 1, 2026)
PHASE3
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 2 Yale University NA RECRUITING
(Sep 1, 2026)
PHASE2
Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery Assiut University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures Assiut University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis Siriraj Hospital NA ENROLLING BY INVITATION
(Sep 1, 2026)
PHASE2
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1 Yale University NA COMPLETED
(Aug 1, 2026)
PHASE1
Transnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache University of California, Davis NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Liposomal Bupivacaine vs Standard Bupivacaine for Post-Rhinoplasty Analgesia Washington University School of Medicine NA RECRUITING
(Aug 1, 2026)
PHASE2
Pharmacokinetic and Safety Study of HYR-PB21 vs Bupivacaine Hydrochloric Acid in Healthy Participants Fruithy Holdings Limited NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Effect of Height Based vs Conventional Dose of Spinal Anesthesia in Lower Limb Surgeries Liaquat National Hospital & Medical College NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
THIS STUDY AIMS TO COMPARE TWO DRUGS KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING SPINAL ANESTHESIA STUDY POPULATION IS PT UNDERGOING C SECTION . DOSE OF KETAMINE IS 0.25mg/kg and That of TRAMAL 0.5mg/kg. KRL Hospital, Islamabad NA COMPLETED
(Aug 1, 2026)
PHASE2
Postoperative Pain Management for Hip Surgeries: UltrasoundGuided Suprainguinal Fascia Iliaca Compartment Block Versus Suprainguinal Fascia Iliaca Compartment Block in Combination With Sciatic Nerve Block Ain Shams University NA COMPLETED
(Aug 1, 2026)
PHASE1
This Study Aims to Determine Whether Lower Doses (4 µg) of Intrathecal Dexmedetomidine Can Provide Comparable Analgesic Benefits While Minimizing Adverse Hemodynamic Effects in Patients Encountered in Our Setup( Shifa International Hospital Islamabad). Shifa International Hospital NA ENROLLING BY INVITATION
(Aug 1, 2026)
PHASE1, PHASE2
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study Yale University NA RECRUITING
(Jul 1, 2026)
PHASE2
Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement Beth Israel Deaconess Medical Center NA COMPLETED
(Jul 1, 2026)
PHASE2, PHASE3
A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation Mayo Clinic NA COMPLETED
(Jul 1, 2026)
PHASE2, PHASE3
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2 Yale University NA RECRUITING
(Jul 1, 2026)
PHASE2
A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block McGill University Health Centre/Research Institute of the McGill University Health Centre NA COMPLETED
(Jul 1, 2026)
PHASE2
Adductor Canal Block: Efficacy in Postoperative Pain Management for Cardiac Surgery Montreal Heart Institute NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients. Children's Cancer Hospital Egypt 57357 NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Efficacy of Nerve Blocks for Episodic Migraine Mayo Clinic NA RECRUITING
(Jun 1, 2026)
PHASE2
Influence of Superficial Parasternal Intercostal Plane Block on Internal Thoracic Artery Caliber to Facilitate Surgical Harvesting in CABG Ain Shams University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Continuous ESP Block in Patients Undergoing CABG Surgery. Instituto do Coracao NA RECRUITING
(Jun 1, 2026)
PHASE3
Pediatric Postoperative Analgesia Herniorrhaphy Study Heron Therapeutics NA WITHDRAWN
(May 1, 2026)
PHASE2
Dexmedetomidine in Postoperative Analgesia New Valley University NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2, PHASE3
Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty Asklepieion Voulas General Hospital NA COMPLETED
(May 1, 2026)
PHASE2
Clinical Observation of Bupivacaine Liposome for Lower Extremity Nerve Block Hainan Medical College NA COMPLETED
(May 1, 2026)
PHASE2
Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy Rebel Medicine Inc NA RECRUITING
(May 1, 2026)
PHASE2
"Dexa vs Dexmedetomidine With Bupivacaine in TAP Block for Laparotomy Analgesia Sahiwal medical college sahiwal NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Comparison of Hemodynamic Effects of Bupivacaine in Spinal Anesthesia Liaquat National Hospital & Medical College NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain National Institutes of Health Clinical Center (CC) NA COMPLETED
(Apr 9, 2026)
PHASE1
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA COMPLETED
(Apr 1, 2026)
PHASE3
Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial) M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Video-assisted Thoracoscopic Surgery - Exparel Study Nada Sadek NA COMPLETED
(Apr 1, 2026)
PHASE2
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain Stanford University NA RECRUITING
(Apr 1, 2026)
PHASE2
The Role of Peripheral Afferents in Modulating Post-stroke Central Pain Institut National de la Santé Et de la Recherche Médicale, France NA RECRUITING
(Apr 1, 2026)
PHASE3
IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia University of Iowa NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD Northwestern University NA RECRUITING
(Apr 1, 2026)
PHASE2
Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment New York University NA RECRUITING
(Apr 1, 2026)
PHASE2
COntralateral CorticoSTeroid Injection in Total Knee Arthroplasty Unity Health Toronto NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery George Washington University NA RECRUITING
(Apr 1, 2026)
PHASE3
Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes Ganesh M. Shankar NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Improving Postoperative Analgesia After Functional Endoscopic Surgery South Egypt Cancer Institute NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Ultrasound Guided Erectror Spinae Block Versus Intracavitary During Medical Thoracoscopy Kafrelsheikh University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Liposomal Bupivacaine With Standard Bupivacaine Versus Dexmedetomidine With Standard Bupivacaine The University of Hong Kong NA COMPLETED
(Mar 1, 2026)
PHASE3
MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section Assiut University NA COMPLETED
(Mar 1, 2026)
PHASE2, PHASE3
A Study of Bupivacaine Liposome Injection in the Treatment of Pain After Thoracoscopic Surgery Jiangsu HengRui Medicine Co., Ltd. NA RECRUITING
(Mar 1, 2026)
PHASE2
Peritumoral and Periganglionic Infiltration of Levobupivacaine Prior to Conservative Surgery for Triple-negative Breast Cancer Institut Jean-Godinot NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2
Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries Benha University NA RECRUITING
(Mar 1, 2026)
PHASE3
Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy Liaquat National Hospital & Medical College NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Hernia Abd Wall Recons - BDE vs Exparel Baylor Research Institute NA ENROLLING BY INVITATION
(Mar 1, 2026)
PHASE2




Generic Launch

Generic Release Date:

Posimir's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 12, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Posimir Generic API suppliers:

Bupivacaine is the generic name for the brand Posimir. 1 company has already filed for the generic of Posimir. Check out the entire list of companies who have already received approval for Posimir's generic

Alternative Brands for Posimir

Posimir which is used for providing sustained local anesthesia for at least 24 hours after surgery., has several other brand drugs using the same active ingredient (Bupivacaine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Heron Theraps Inc
Zynrelef Kit
Innocoll Pharms
Xaracoll
Pacira Pharms Inc
Exparel
Purdue Pharma Lp
Chirocaine


Apart from brand drugs containing the same ingredient, some generics have also been filed for Bupivacaine, Posimir's active ingredient. Check the complete list of approved generic manufacturers for Posimir





About Posimir

Posimir is a drug owned by Innocoll Pharmaceuticals Ltd. It is used for providing sustained local anesthesia for at least 24 hours after surgery. Posimir uses Bupivacaine as an active ingredient. Posimir was launched by Innocoll in 2021.

Approval Date:

Posimir was approved by FDA for market use on 01 February, 2021.

Active Ingredient:

Posimir uses Bupivacaine as the active ingredient. Check out other Drugs and Companies using Bupivacaine ingredient

Treatment:

Posimir is used for providing sustained local anesthesia for at least 24 hours after surgery.

Dosage:

Posimir is available in solution form for infiltration use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
660MG/5ML (132MG/ML) SOLUTION Discontinued INFILTRATION