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Bupivacaine - Generic Drug Details
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What are the generic sources for bupivacaine and what is the scope of bupivacaine patent protection?
Bupivacaine
is the generic ingredient in thirteen branded drugs marketed by Pacira Pharms Inc, Aurobindo Pharma Ltd, Hospira, Mylan Asi, Intl Medicated, Fresenius Kabi Usa, Baxter Hlthcare Corp, Septodont, and Amphastar Pharms Inc, and is included in thirty-eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for bupivacaine. One supplier is listed for this compound.
Summary for bupivacaine
| US Patents: | 4 |
| Tradenames: | 13 |
| Applicants: | 9 |
| NDAs: | 38 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 77 |
| Clinical Trials: | 826 |
| Patent Applications: | 6,326 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for bupivacaine |
| DailyMed Link: | bupivacaine at DailyMed |
Pharmacology for bupivacaine
| Ingredient-type | Amides |
| Drug Class | Amide Local Anesthetic |
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for bupivacaine
Synonyms for bupivacaine
| ( inverted exclamation markA)-bupivacaine |
| (.+/-.)-1-Butyl-2',6'-pipecoloxylidide |
| (.+/-.)-Bupivacaine |
| (+-)-Bupivacaine |
| (+/-)-Bupivacaine |
| (1)-1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide |
| (inverted exclamation markA)-bupivacaine |
| (RS)-bupivacaine |
| 1-butyl-2 inverted exclamation mark ,6 inverted exclamation mark -pipecoloxylidide |
| 1-butyl-2-(2,6-xylycarbamoyl)piperidine |
| 1-Butyl-2',6'-pipecoloxylidide |
| 1-butyl-n-(2,6-dimethylphenyl)-2-piperidinecarboxamid |
| 1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide |
| 1-butyl-N-(2,6-dimethylphenyl)-piperidine-2-carboxamide |
| 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide |
| 14252-80-3 (HCl) |
| 18010-40-7 (HCl) |
| 180B929 |
| 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)- |
| 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, (.+/-.)- |
| 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, (+-)- |
| 2',6'-Pipecoloxylidide, 1-butyl- |
| 2180-92-9 |
| 38396-39-3 |
| 4CH-013994 |
| 73360-54-0 (HCl.H2O) |
| AB00053674 |
| AB00053674_10 |
| AB00053674_11 |
| AB00053674-08 |
| AB00053674-09 |
| AC-2096 |
| AC1L1DRE |
| AC1Q5LX4 |
| AH 250 |
| AK-90074 |
| AKOS001637202 |
| AKOS016842516 |
| AN-14284 |
| Anekain |
| ANW-45984 |
| API0007792 |
| AX8041457 |
| BDBM50350790 |
| Bio-0886 |
| Bloqueina |
| BPBio1_000298 |
| BRD-A01636364-003-05-2 |
| BRD-A01636364-003-08-6 |
| BS-5224 |
| BSPBio_000270 |
| BSPBio_002607 |
| bucain |
| Bucaine |
| Bucaine (TN) |
| Bupivacaina |
| Bupivacaina [INN-Spanish] |
| Bupivacaine (INN) |
| Bupivacaine (USAN/INN) |
| Bupivacaine [INN:BAN] |
| Bupivacaine [USAN:INN:BAN] |
| bupivacaine base |
| Bupivacaine Carbonate |
| Bupivacaine HCL KIT |
| Bupivacaine hydrochloride anhydrous |
| Bupivacaine liposome injectable suspension |
| Bupivacaine Monohydrochloride, Monohydrate |
| Bupivacaine,hydrochloride |
| Bupivacainum |
| Bupivacainum [INN-Latin] |
| Bupivan |
| C07529 |
| C18H28N2O |
| Carbostesin |
| cBupivacaine |
| CHEBI:3215 |
| CHEBI:77431 |
| CHEMBL1098 |
| CS-W023182 |
| CTK8B4736 |
| D07552 |
| D0A0FL |
| DB00297 |
| DepoBupivacaine |
| DivK1c_000758 |
| dl-1-Butyl-2,6-pipecoloxylidide |
| dl-1-Butyl-2',6'-pipecoloxylidide |
| DL-Bupivacaine |
| DTXSID2022703 |
| DUR-843 |
| EINECS 218-553-3 |
| EINECS 253-911-2 |
| Epitope ID:122662 |
| Exparel |
| Exparel (TN) |
| FT-0623286 |
| FT-0699781 |
| GTPL2397 |
| HE058460 |
| HE301859 |
| HMS2090F12 |
| HMS3428P06 |
| HSDB 7790 |
| IDI1_000758 |
| J10217 |
| KB-218680 |
| KBio1_000758 |
| KBio2_002004 |
| KBio2_004572 |
| KBio2_007140 |
| KBio3_001827 |
| KBioGR_001516 |
| KBioSS_002004 |
| KS-00000ZRC |
| L000695 |
| LAC-43 |
| LAC-43 (Salt/Mix) |
| LEBVLXFERQHONN-UHFFFAOYSA-N |
| LP075507 |
| LS-109841 |
| LS-2222 |
| M-9606 |
| Marcain (TN) |
| Marcaina |
| Marcaine |
| Marcaine (TN) |
| Marcaine HCL |
| Marcaine hydrochloride (Salt/Mix) |
| Marcaine Spinal |
| Marcaine spinal (Salt/Mix) |
| MCULE-2286784276 |
| MFCD00243007 |
| MFCD00941462 |
| MolPort-004-955-820 |
| N-(2,6-dimethylphenyl)(1-butyl(2-piperidyl))carboxamide |
| NCGC00178579-01 |
| NCGC00178579-02 |
| NINDS_000758 |
| Prestwick0_000305 |
| Prestwick1_000305 |
| Prestwick2_000305 |
| Prestwick3_000305 |
| Q-100271 |
| R962 |
| racemic bupivacaine |
| SBI-0051846.P002 |
| SC-26838 |
| SCHEMBL25438 |
| Sensorcaine |
| Sensorcaine (TN) |
| Sensorcaine-MPF |
| Sensorcaine-MPF Spinal |
| Sensorcaine-MPFSpinal |
| SKY 0402 |
| SKY-0402 |
| SKY0402 |
| SPBio_001558 |
| SPBio_002489 |
| Spectrum_001524 |
| Spectrum2_001589 |
| Spectrum3_000974 |
| Spectrum4_001098 |
| Spectrum5_001483 |
| ST065773 |
| ST2415271 |
| STL484283 |
| TC-134729 |
| Transdur-Bupivacaine |
| Vivacaine (TN) |
| Win 11318 |
| Win 11318 HCl |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Asi | BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091487-003 | Oct 18, 2011 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Aurobindo Pharma Ltd | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 207183-002 | May 13, 2016 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Hospira | MARCAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 016964-006 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Hospira | BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070609-001 | Mar 3, 1987 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for bupivacaine
| 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 | ➤ Sign Up | ➤ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-001 | Oct 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Pacira Pharms Inc | EXPAREL | bupivacaine | INJECTABLE, LIPOSOMAL;INJECTION | 022496-002 | Oct 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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International Patents for bupivacaine
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2001522870 | ➤ Sign Up |
| Spain | 2373861 | ➤ Sign Up |
| Canada | 2309548 | ➤ Sign Up |
| Austria | 535232 | ➤ Sign Up |
| Australia | 2006200044 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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