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Lidocaine - Generic Drug Details
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What are the generic drug sources for lidocaine and what is the scope of freedom to operate?
Lidocaine
is the generic ingredient in forty-five branded drugs marketed by Astrazeneca, Noven, Carlisle, Acp Nimble, Aleor Dermaceuticals, Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Fougera Pharms Inc, Glenmark Pharms Ltd, Novast Labs, Septodont Inc, Strides Pharma, Taro, Teligent Pharma Inc, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Mylan Technologies, Teikoku Pharma Usa, Scilex Pharms Inc, Akorn, Abbott, Abraxis Pharm, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Dell Labs, Elkins Sinn, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma Inc, Sagent Pharms Inc, Watson Labs Inc, Oak Pharms, Hi Tech Pharma, Wockhardt Bio Ag, Actavis Mid Atlantic, Lannett Co Inc, Kendall Il, Paco, Powder Pharms, Pfizer, Teva Branded Pharm, Fougera Pharms, Tolmar, Taro Pharms, and Galen Specialty, and is included in one hundred and thirty-six NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Lidocaine has ten patent family members in seven countries.
There are twenty-nine drug master file entries for lidocaine. Forty-five suppliers are listed for this compound.
Summary for lidocaine
| International Patents: | 10 |
| US Patents: | 9 |
| Tradenames: | 45 |
| Applicants: | 63 |
| NDAs: | 136 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 45 |
| Bulk Api Vendors: | 106 |
| Clinical Trials: | 1,223 |
| Patent Applications: | 8,081 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for lidocaine |
| Drug Sales Revenues: | Drug sales revenues for lidocaine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lidocaine |
| DailyMed Link: | lidocaine at DailyMed |
Recent Clinical Trials for lidocaine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Walter Reed National Military Medical Center | Phase 3 |
| Massachusetts Institute of Technology | Phase 1 |
| Beijing Tiantan Hospital | Phase 3 |
Recent Litigation for lidocaine
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories Inc. | 2013-10-08 |
| Endo Pharmaceuticals Inc. v. TWi Pharmaceuticals Inc. | 2012-07-05 |
| Endo Pharmaceuticals Inc. v. Mylan Technologies Inc. | 2011-03-14 |
Pharmacology for lidocaine
| Drug Class | Amide Local Anesthetic Antiarrhythmic |
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for lidocaine
Synonyms for lidocaine
| .alpha.-(Diethylamino)-2,6-acetoxylidide |
| .alpha.-Diethylamino-2,6-acetoxylidide |
| .alpha.-Diethylamino-2,6-dimethylacetanilide |
| .alpha.-Diethylaminoaceto-2,6-xylidide |
| .omega.-Diethylamino-2,6-dimethylacetanilide |
| (2,6-dimethylphenyl)carbamoylmethyl-diethyl-azanium |
| 137-58-6 |
| 2-(Diethylamino)-2',6'-acetoxylidide |
| 2-(Diethylamino)-2'',6''-acetoxylidide |
| 2-(Diethylamino)-N-(2,6-dimethylphenyl)-acetamide |
| 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide |
| 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide # |
| 2-(Diethylamino)-N-(2,6-Dimethylphenyl)ethanamide |
| 2-Diethylamino-N-(2,6-dimethyl-phenyl)-acetamide |
| 2-Diethylamino-N-(2,6-dimethylphenyl)acetamide |
| 2', 2-(diethylamino)- |
| 2',6'-Acetoxylidide, 2-(diethylamino)- |
| 4-12-00-02538 (Beilstein Handbook Reference) |
| 6108-05-0 (mono-hydrochloride, mono-hydrate) |
| 73-78-9 (mono-hydrochloride) |
| 91484-71-8 |
| 98PI200987 |
| A18187 |
| AB00053581 |
| AB00053581_29 |
| AB00053581_30 |
| AB00053581-27 |
| AB00053581-28 |
| AB2000065 |
| AC-10282 |
| AC1L1GGQ |
| AC1Q2Z7J |
| Acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)- |
| After Burn Double Strength Gel |
| After Burn Double Strength Spray |
| After Burn Gel |
| After Burn Spray |
| AJ-08416 |
| AKOS001026768 |
| alfa-Dietilamino-2,6-dimetilacetanilide |
| alfa-Dietilamino-2,6-dimetilacetanilide [Italian] |
| alpha-Diethylamino-2,6-dimethylacetanilide |
| Alphacaine |
| Alphacaine;Xylocaine;lignocaine |
| AN-23138 |
| Anestacon |
| Anestacon Jelly |
| ANW-42187 |
| ARONIS23855 |
| AS-13718 |
| BBL005525 |
| BCP09081 |
| BDBM50017662 |
| BIDD:GT0342 |
| Bio1_000379 |
| Bio1_000868 |
| Bio1_001357 |
| Bio2_000079 |
| Bio2_000559 |
| BPBio1_000197 |
| BRD-K52662033-001-02-6 |
| BRD-K52662033-003-05-5 |
| BRD-K52662033-003-14-7 |
| BRN 2215784 |
| BSPBio_000179 |
| BSPBio_001359 |
| BSPBio_003004 |
| C07073 |
| C14H22N2O |
| Cappicaine |
| CAS-137-58-6 |
| CAS-73-78-9 |
| CCG-100824 |
| CDS1_000283 |
| CHEBI:6456 |
| CHEMBL79 |
| Cito optadren |
| CPD000058189 |
| CS-2070 |
| CTK3J2126 |
| Cuivasil |
| D00358 |
| Dalcaine |
| DB00281 |
| Dentipatch |
| Dentipatch (TN) |
| DermaFlex |
| Diethylaminoacet-2,6-xylidide |
| Diethylaminoaceto-2,6-xylidide |
| Dilocaine |
| DivK1c_000174 |
| DivK1c_001323 |
| DSSTox_CID_25166 |
| DSSTox_GSID_45166 |
| DSSTox_RID_80716 |
| DTXSID1045166 |
| Duncaine |
| EINECS 205-302-8 |
| ELA-Max |
| EMBOLEX |
| Epitope ID:116205 |
| Esracaine |
| FT-0082378 |
| FT-0600570 |
| Gravocain |
| GTPL2623 |
| HMS1791D21 |
| HMS1989D21 |
| HMS2051C21 |
| HMS2089E15 |
| HMS2235O14 |
| HMS3371J04 |
| HMS3393C21 |
| HMS3428O07 |
| HMS3651G09 |
| HMS548M19 |
| HSDB 3350 |
| HY-B0185 |
| I01-2704 |
| IDI1_000174 |
| IDI1_033829 |
| Isicaina |
| Isicaine |
| J10173 |
| Jetocaine |
| K-4450 |
| KBio1_000174 |
| KBio2_000079 |
| KBio2_001598 |
| KBio2_002647 |
| KBio2_004166 |
| KBio2_005215 |
| KBio2_006734 |
| KBio3_000157 |
| KBio3_000158 |
| KBio3_002224 |
| KBioGR_000079 |
| KBioGR_000599 |
| KBioSS_000079 |
| KBioSS_001598 |
| KS-000046GY |
| L-Caine |
| L0156 |
| Lanabiotic |
| Leostesin |
| Lida-Mantle |
| Lidaform HC (Salt/Mix) |
| Lidamantle HC (Salt/Mix) |
| Lidocaina |
| Lidocaina [INN-Spanish] |
| LIDOCAINE (73-58-6 (MONOHYDROCHLORIDE); 6108-05-0 (MONOHYDROCHLORIDE MONOHYDRATE)) |
| Lidocaine (Alphacaine) |
| Lidocaine (JP17/USP/INN) |
| Lidocaine (VAN) |
| Lidocaine [USAN:INN:JAN] |
| Lidocaine [USP:INN:BAN:JAN] |
| Lidocaine 1.0 mg/ml in Methanol |
| Lidocaine Base |
| Lidocaine Carbonate |
| Lidocaine Hydrocarbonate |
| Lidocaine Monohydrochloride |
| Lidocaine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Lidocaine, 97.5% |
| Lidocaine, analytical standard |
| Lidocaine, British Pharmacopoeia (BP) Reference Standard |
| Lidocaine, European Pharmacopoeia (EP) Reference Standard |
| Lidocaine, Pharmaceutical Secondary Standard; Certified Reference Material |
| Lidocaine, powder |
| Lidocaine, United States Pharmacopeia (USP) Reference Standard |
| Lidocaine(Alphacaine) |
| Lidocainum |
| Lidocainum [INN-Latin] |
| Lidocaton |
| Lidoderm |
| Lidoject-1 |
| Lidoject-2 |
| LIDOPEN |
| Lidothesin (Salt/Mix) |
| Lignocaine |
| Lignocaine base |
| Lignocainum |
| Lopac-L-5647 |
| Lopac0_000669 |
| LQZ |
| LS-805 |
| M620 |
| Maricaine |
| Maybridge1_002571 |
| MCULE-9294700940 |
| MFCD00026733 |
| MLS000069724 |
| MLS000758263 |
| MLS001074177 |
| MLS001423964 |
| MolPort-001-783-478 |
| N-(2,6-dimethylphenyl)-N(2),N(2)-diethylglycinamide |
| N-(2,6-dimethylphenyl)-N~2~,N~2~-diethylglycinamide |
| N-(2,6-Dimethylphenyl)-N2,N2-diethylglycinamide |
| N~1~-(2,6-dimethylphenyl)-N~2~,N~2~-diethylglycinamide |
| N1-(2,6-dimethylphenyl)-2-(diethylamino)acetamide |
| N1-(2,6-dimethylphenyl)-N2,N2-diethylglycinamide |
| NC00074 |
| NCGC00015611-01 |
| NCGC00015611-02 |
| NCGC00015611-03 |
| NCGC00015611-04 |
| NCGC00015611-05 |
| NCGC00015611-06 |
| NCGC00015611-07 |
| NCGC00015611-08 |
| NCGC00015611-09 |
| NCGC00015611-10 |
| NCGC00015611-11 |
| NCGC00015611-12 |
| NCGC00015611-13 |
| NCGC00015611-14 |
| NCGC00015611-15 |
| NCGC00015611-16 |
| NCGC00015611-18 |
| NCGC00022176-05 |
| NCGC00022176-06 |
| NCGC00022176-07 |
| NCGC00022176-08 |
| NCGC00022176-09 |
| Neosporin Plus (Salt/Mix) |
| NINDS_000174 |
| NNJVILVZKWQKPM-UHFFFAOYSA-N |
| Norwood Sunburn Spray |
| NSC 40030 |
| NSC-40030 |
| NSC40030 |
| Octocaine |
| Octocaine-100 |
| Octocaine-50 |
| Opera_ID_385 |
| Prestwick0_000050 |
| Prestwick1_000050 |
| Prestwick2_000050 |
| Prestwick3_000050 |
| Remicaine |
| Rocephin Kit |
| RTR-031283 |
| Rucaina |
| s1357 |
| SAM001247018 |
| SB19118 |
| SBB080556 |
| SBI-0050648.P004 |
| SC-19460 |
| SCHEMBL15689 |
| SCHEMBL17967359 |
| SMR000058189 |
| Solarcaine aloe extra burn relief cream |
| Solcain |
| SPBio_001525 |
| SPBio_002100 |
| Spectrum_001118 |
| Spectrum2_001343 |
| Spectrum3_001392 |
| Spectrum4_000070 |
| Spectrum5_001549 |
| ST023341 |
| STK552033 |
| SW196598-4 |
| Tox21_110183 |
| Tox21_110183_1 |
| TR-031283 |
| UNII-98PI200987 |
| Versatis |
| W-108233 |
| WLN: 2N2 & 1VMR B1 F1 |
| Xilina |
| Xilocaina |
| Xilocaina [Italian] |
| Xllina |
| Xycaine |
| Xylestesin |
| Xylesthesin |
| Xyline |
| Xylocain |
| Xylocaine |
| Xylocaine (TN) |
| Xylocaine 5% Spinal |
| Xylocaine CO2 |
| Xylocaine Dental Ointment |
| Xylocaine Endotracheal |
| Xylocaine Test Dose |
| Xylocaine Viscous |
| Xylocaine-Mpf |
| Xylocaine-Mpf with Glucose |
| Xylocard |
| Xylocitin |
| Xyloneural (free base) |
| Xyloneural (Salt/Mix) |
| Xylotox |
| Z55135799 |
| Zilactin-L |
| ZINC20237 |
| Zingo |
| Zingo (Salt/Mix) |
| Ztilido |
| ZTlido |
US Patents and Regulatory Information for lidocaine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | XYLOCAINE | lidocaine | OINTMENT;TOPICAL | 008048-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| B Braun | LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | lidocaine hydrochloride | INJECTABLE;INJECTION | 018967-003 | Mar 30, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Intl Medication | LIDOCAINE HYDROCHLORIDE VISCOUS | lidocaine hydrochloride | SOLUTION;ORAL | 086389-001 | Feb 2, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca | XYLOCAINE | lidocaine hydrochloride | INJECTABLE;INJECTION | 010418-009 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hi Tech Pharma | LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;ORAL | 040014-001 | Jul 10, 1995 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Aurobindo Pharma Ltd | LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | lidocaine hydrochloride | INJECTABLE;INJECTION | 203082-001 | Mar 14, 2013 | AP | RX | 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 |
Expired US Patents for lidocaine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teikoku Pharma Usa | LIDODERM | lidocaine | PATCH;TOPICAL | 020612-001 | Mar 19, 1999 | Start Trial | Start Trial |
| Teikoku Pharma Usa | LIDODERM | lidocaine | PATCH;TOPICAL | 020612-001 | Mar 19, 1999 | Start Trial | Start Trial |
| Noven | DENTIPATCH | lidocaine | FILM, EXTENDED RELEASE;BUCCAL | 020575-001 | May 21, 1996 | Start Trial | Start Trial |
| Teikoku Pharma Usa | LIDODERM | lidocaine | PATCH;TOPICAL | 020612-001 | Mar 19, 1999 | Start Trial | Start Trial |
| Teikoku Pharma Usa | LIDODERM | lidocaine | PATCH;TOPICAL | 020612-001 | Mar 19, 1999 | Start Trial | Start Trial |
| Teikoku Pharma Usa | LIDODERM | lidocaine | PATCH;TOPICAL | 020612-001 | Mar 19, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for lidocaine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112013028802 | Start Trial |
| Mexico | 349572 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2012153396 | Start Trial |
| Japan | 5856153 | Start Trial |
| Taiwan | I543761 | Start Trial |
| Taiwan | 201249431 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.