BUPIVACAINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for bupivacaine hydrochloride and what is the scope of freedom to operate?
Bupivacaine hydrochloride
is the generic ingredient in thirteen branded drugs marketed by Innocoll Pharms, Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Somerset, Steriscience Speclts, Intl Medicated, Fresenius Kabi Usa, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc, and is included in forty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bupivacaine hydrochloride has eighty-three patent family members in twenty-four countries.
There are six drug master file entries for bupivacaine hydrochloride. Twenty-two suppliers are listed for this compound.
Summary for BUPIVACAINE HYDROCHLORIDE
International Patents: | 83 |
US Patents: | 2 |
Tradenames: | 13 |
Applicants: | 16 |
NDAs: | 47 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 1,674 |
Patent Applications: | 1,141 |
What excipients (inactive ingredients) are in BUPIVACAINE HYDROCHLORIDE? | BUPIVACAINE HYDROCHLORIDE excipients list |
DailyMed Link: | BUPIVACAINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for BUPIVACAINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yongtao Sun | Phase 4 |
Montefiore Medical Center | N/A |
University Hospital "Sestre Milosrdnice" | N/A |
Pharmacology for BUPIVACAINE HYDROCHLORIDE
Drug Class | Amide Local Anesthetic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for BUPIVACAINE HYDROCHLORIDE
US Patents and Regulatory Information for BUPIVACAINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma Pharms | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 204842-003 | Feb 11, 2021 | AP | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Hospira | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 018053-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Steriscience Speclts | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091487-003 | Oct 18, 2011 | AP | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for BUPIVACAINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6720279 | ⤷ Try for Free | |
European Patent Office | 3536748 | COLLAGÈNE MODIFIÉ (A MODIFIED COLLAGEN) | ⤷ Try for Free |
Mexico | 368037 | COLÁGENO MODIFICADO. (A MODIFIED COLLAGEN.) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Bupivacaine Hydrochloride
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