EXPAREL Drug Patent Profile
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Which patents cover Exparel, and what generic alternatives are available?
Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. There are eight patents protecting this drug and two Paragraph IV challenges.
This drug has seven patent family members in four countries.
The generic ingredient in EXPAREL is bupivacaine. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.
DrugPatentWatch® Generic Entry Outlook for Exparel
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 22, 2024. This may change due to patent challenges or generic licensing.
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: | 7 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 272 |
| Patent Applications: | 4,283 |
| Formulation / Manufacturing: | see details |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EXPAREL
Generic Entry Date for EXPAREL*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION NDA:
Dosage:
INJECTABLE, LIPOSOMAL;INJECTION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for EXPAREL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NorthShore University HealthSystem | Phase 4 |
| Johnny K. Lee | Phase 4 |
| Tufts Medical Center | Phase 3 |
Pharmacology for EXPAREL
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for EXPAREL
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 eight US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EXPAREL is ⤷ Try a Trial.
This potential generic entry date is based on NEW PATIENT POPULATION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting EXPAREL
Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF PROVIDING POSTSURGICAL PAIN MANAGEMENT, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF PROVIDING LOCAL OR REGIONAL ANALGESIA VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK OR FEMORAL NERVE BLOCK FOR REGIONAL ANALGESIA
Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
Manufacturing of bupivacaine multivesicular liposomes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
Compositions of bupivacaine multivesicular liposomes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING PAIN, FOR EXAMPLE, VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA NERVE BLOCK, FOR EXAMPLE, NTERSCALENE BRACHIAL PLEXUS FOR REGIONAL ANALGESIA
FDA Regulatory Exclusivity protecting EXPAREL
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
| 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 | 022496-001 | Oct 28, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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 | ⤷ Try a Trial |
| Canada | 2309548 | ⤷ Try a Trial | |
| Australia | 1407599 | ⤷ Try a Trial | |
| Japan | 4467789 | ⤷ Try a Trial | |
| Australia | 2015200303 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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