BUPIVACAINE Drug Patent Profile
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When do Bupivacaine patents expire, and what generic alternatives are available?
Bupivacaine is a drug marketed by Anthea Pharma, Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Onesource Specialty, Somerset, B Braun Medical, Baxter Hlthcare Corp, Huons, Intl Medicated, and Hengrui Pharma. and is included in thirty-six NDAs.
The generic ingredient in BUPIVACAINE 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.
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Summary for BUPIVACAINE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 36 |
| Drug Prices: | Drug price information for BUPIVACAINE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BUPIVACAINE |
| DailyMed Link: | BUPIVACAINE at DailyMed |
Recent Clinical Trials for BUPIVACAINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| rebro University, Sweden | PHASE4 |
| Region rebro County | PHASE4 |
| Region Skane | PHASE4 |
Medical Subject Heading (MeSH) Categories for BUPIVACAINE
Anatomical Therapeutic Chemical (ATC) Classes for BUPIVACAINE
Paragraph IV (Patent) Challenges for BUPIVACAINE
| 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 BUPIVACAINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospira | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | bupivacaine hydrochloride; epinephrine | INJECTABLE;INJECTION | 071170-001 | Jun 16, 1988 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| B Braun Medical | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;SPINAL | 209087-001 | Apr 2, 2019 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Eugia Pharma | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 203895-003 | Nov 5, 2013 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hengrui Pharma | BUPIVACAINE LIPOSOME | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 214348-002 | Jul 1, 2024 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hospira | BUPIVACAINE HYDROCHLORIDE KIT | bupivacaine hydrochloride | INJECTABLE;INJECTION | 019978-002 | Sep 3, 1992 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for BUPIVACAINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pacira Ireland Limited | Exparel liposomal | bupivacaine | EMEA/H/C/004586Exparel 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 |
