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MELOXICAM - Generic Drug Details
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What are the generic drug sources for meloxicam and what is the scope of patent protection?
Meloxicam
is the generic ingredient in four branded drugs marketed by Zyla, Avondale Pharms, Tersera Theraps Llc, Anda Repository, Apotex Inc, Aurobindo Pharma, Breckenridge Pharm, Cipla, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Generics, Heritage Pharma, Impax Labs Inc, Lupin Pharms, Mylan, Puracap Pharm, Roxane, Strides Pharma, Sun Pharm Inds Inc, Taro, Unichem, Yabao Pharm, Yung Shin Pharm, Zydus Pharms Usa, and Boehringer Ingelheim, and is included in twenty-six NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Meloxicam has forty-eight patent family members in thirty-one countries.
There are twenty-two drug master file entries for meloxicam. Forty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for MELOXICAM
| International Patents: | 48 |
| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 25 |
| NDAs: | 26 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 40 |
| Bulk Api Vendors: | 118 |
| Clinical Trials: | 75 |
| Patent Applications: | 9,319 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for MELOXICAM |
| Drug Sales Revenues: | Drug sales revenues for MELOXICAM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MELOXICAM |
| DailyMed Link: | MELOXICAM at DailyMed |
Recent Clinical Trials for MELOXICAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Axsome Therapeutics, Inc. | Phase 3 |
| Rush University Medical Center | Phase 3 |
| Columbia University | Phase 4 |
Recent Litigation for MELOXICAM
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| iCeutica Pty Ltd. v. Novitium Pharma LLC | 2018-04-20 |
| iCeutica Pty Ltd. v. Teva Pharmaceuticals USA, Inc. | 2018-04-06 |
| iCeutica Pty Ltd. v. Apotex, Inc. | 2017-10-31 |
Generic filers with tentative approvals for MELOXICAM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 10MG | CAPSULE;ORAL |
| Start Trial | Start Trial | 5MG | CAPSULE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for MELOXICAM
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Synonyms for MELOXICAM
| (3E)-3-[hydroxy-[(5-methyl-1,3-thiazol-2-yl)amino]methylidene]-2-methyl-1,1-dioxo-1 |
| (3Z)-2-methyl-3-[[(5-methyl-1,3-thiazol-2-yl)amino]-oxidanyl-methylidene]-1,1-bis(oxidanylidene)-1$l^{6},2-benzothiazin-4-one |
| (3Z)-3-[hydroxy-[(5-methyl-1,3-thiazol-2-yl)amino]methylidene]-2-methyl-1,1-dioxo-1 |
| (3Z)-3-[hydroxy-[(5-methyl-2-thiazolyl)amino]methylidene]-2-methyl-1,1-dioxo-1$l^{6},2-benzothiazin-4-one |
| (E)-3-(hydroxy((5-methylthiazol-2-yl)amino)methylene)-2-methyl-2,3-dihydro-4H-benzo[e][1,2]thiazin-4-one 1,1-dioxide |
| 1027136-06-6 |
| 125M387 |
| 133687-22-6 |
| 2H-1,2-Benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-, 1,1-dioxide |
| 2H-1,2-Benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-N-(5-methylthiazolyl)-, 1,1-dioxide |
| 3-[hydroxy-[(5-methyl-1,3-thiazol-2-yl)amino]methylidene]-2-methyl-1,1-dioxo-1 |
| 3-[hydroxy-[(5-methylthiazol-2-yl)amino]methylene]-2-methyl-1,1-dioxo-1$l^{6},2-benzothiazin-4-one |
| 3-{hydroxy[(5-methyl-1,3-thiazol-2-yl)amino]methylidene}-2-methyl-2,3-dihydro-4H-1,2-benzothiazin-4-one 1,1-dioxide |
| 4-Hydroxy-1,1-dioxo-1,2-dihydro-1lambda*6*-benzo[e][1,2]thiazine-3-carboxylic acid (5-methyl-thiazol-2-yl)-amide |
| 4-hydroxy-2-mehtyl-N-(5-mehtyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide |
| 4-Hydroxy-2-methyl-1,1-dioxo-1,2-dihydro-1lambda*6*-benzo[e][1,2]thiazine-3-carboxylic acid (5-methyl-thiazol-2-yl)-amide |
| 4-hydroxy-2-methyl-N-(5-methy-2-thiazolyl)-2H-1,2-benzothiazine-3-caboxamide-1,1-dioxide |
| 4-hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-1,1-dioxo-1?^{6},2-benzothiazine-3-carboxamide |
| 4-hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-1,1-dioxo-1$l^{6},2-benzothiazine-3-carboxamide |
| 4-hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-1,1-dioxo-2H-1$l;{6},2-benzothiazine-3-carboxamide |
| 4-hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-1,1-dioxo-2H-1lambda6,2-benzothiazine-3-carboxamide |
| 4-Hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-2H-1,2-benzothiazin-3-crboxamide 1,1-dioxide |
| 4-hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide |
| 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide |
| 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide |
| 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazoyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide |
| 4-Hydroxy-2-methyl-N-(5-methylthiazol-2-yl)-2H-benzo[e][1,2]thiazine-3-carboxamide 1,1-dioxide |
| 71125-38-7 |
| A837087 |
| AB0007297 |
| AB00383033_20 |
| AB00383033-17 |
| AB00383033-18 |
| AB1009494 |
| AC-1325 |
| AC1L1HB1 |
| AC1NQY12 |
| AC1NTUST |
| AC1Q3XZW |
| AJ-63405 |
| AK-77454 |
| AKOS000279442 |
| AKOS026749959 |
| ALBB-027268 |
| AN-15016 |
| AN-668/13244001 |
| ANW-57553 |
| Apo-meloxicam |
| BB_SC-04648 |
| BBL029076 |
| BC200593 |
| BCP11928 |
| BDBM50056998 |
| BG0248 |
| BIDD:GT0726 |
| BSPBio_002257 |
| C-20653 |
| C08169 |
| C14H13N3O4S2 |
| CAS-71125-38-7 |
| CC-30198 |
| CCG-39098 |
| CCRIS 9139 |
| CHEBI:6741 |
| CHEMBL1741042 |
| CHEMBL599 |
| Co Meloxicam |
| Coxflam |
| Coxicam |
| CPD000718800 |
| CS-2247 |
| CTK6C3599 |
| CTK6C3600 |
| D00969 |
| DB00814 |
| Dom-meloxicam |
| DSSTox_CID_803 |
| DSSTox_GSID_20803 |
| DSSTox_RID_75796 |
| DTXSID1020803 |
| EN300-52507 |
| ETI-511 |
| F2173-0387 |
| FT-0082769 |
| FT-0628193 |
| Gen-meloxicam |
| GTPL7220 |
| HMS1922D19 |
| HMS2089B18 |
| HMS2096I19 |
| HMS2234P07 |
| HMS2236C09 |
| HMS3259H06 |
| HMS3372C13 |
| HMS3372P18 |
| HMS3655K06 |
| HMS3713I19 |
| HSCI1_000045 |
| HSDB 7741 |
| HY-B0261 |
| I06-0490 |
| J10218 |
| KB-242264 |
| KBio2_002113 |
| KBio2_004681 |
| KBio2_007249 |
| KBio3_001477 |
| KBioGR_001234 |
| KBioSS_002113 |
| KS-00000JN4 |
| KS-1084 |
| Lopac0_000766 |
| LS-40538 |
| M1959 |
| MCULE-4138373089 |
| Melonex |
| Meloxicam (JAN/USAN/INN) |
| Meloxicam (Mobic) |
| Meloxicam [USAN:BAN:INN] |
| Meloxicam [USAN:USP:INN:BAN] |
| Meloxicam 1.0 mg/ml in Dimethyl Sulfoxide |
| Meloxicam, 99-101% |
| Meloxicam,(S) |
| Meloxicamum |
| Meloxicamum [Latin] |
| Meloxivet |
| Metacam |
| MFCD00868752 |
| miloxicam |
| MLS000028587 |
| MLS001304725 |
| MLS001306413 |
| MLS006011422 |
| Mobec |
| Mobic |
| Mobic (TN) |
| Mobicox |
| MolPort-002-885-839 |
| Movalis |
| Movatec |
| MXM |
| N-1539 |
| NC00698 |
| NCGC00018248-01 |
| NCGC00018248-02 |
| NCGC00018248-03 |
| NCGC00018248-04 |
| NCGC00018248-05 |
| NCGC00018248-06 |
| NCGC00018248-07 |
| NCGC00018248-08 |
| NCGC00022924-03 |
| NCGC00022924-04 |
| NCGC00256316-01 |
| NCGC00259238-01 |
| NCGC00263878-02 |
| Novo-meloxicam |
| Opera_ID_2 |
| Parocin |
| PHL-meloxicam |
| PMS-meloxicam |
| R3928 |
| Ratio-meloxicam |
| Revmoksikam |
| RTR-031220 |
| s1734 |
| SAM002589991 |
| SC-12165 |
| SCHEMBL33369 |
| SCHEMBL3576 |
| SCHEMBL713100 |
| SMP2_000133 |
| SMR000058994 |
| SMR000718800 |
| SPBio_000902 |
| Spectrum_001633 |
| SPECTRUM1504150 |
| Spectrum2_000941 |
| Spectrum3_000649 |
| Spectrum4_000787 |
| Spectrum5_001813 |
| SR-01000003132-10 |
| ST24023559 |
| STK620505 |
| SW219562-1 |
| Tenaron |
| TL8005001 |
| Tox21_111734 |
| Tox21_111734_1 |
| Tox21_113192 |
| Tox21_201689 |
| Tox21_302756 |
| UH-AC 62XX |
| UHAC-62XX |
| UNII-VG2QF83CGL |
| VG2QF83CGL |
| Vivlodex |
| Z1695493323 |
| ZINC103620661 |
| ZINC13129998 |
| ZRVUJXDFFKFLMG-UHFFFAOYSA-N |
| ZX-AN025777 |
US Patents and Regulatory Information for MELOXICAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Pharms | MELOXICAM | meloxicam | TABLET;ORAL | 077944-001 | Jul 19, 2006 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sun Pharm Inds Inc | MELOXICAM | meloxicam | TABLET;ORAL | 077937-002 | Jul 19, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Yabao Pharm | MELOXICAM | meloxicam | TABLET;ORAL | 077933-002 | Jul 19, 2006 | 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 |
Expired US Patents for MELOXICAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Avondale Pharms | MOBIC | meloxicam | SUSPENSION;ORAL | 021530-001 | Jun 1, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MELOXICAM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1066029 | Start Trial |
| Philippines | 12016502336 | Start Trial |
| European Patent Office | 3151835 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.