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Amlodipine besylate - Generic Drug Details
What are the generic drug sources for amlodipine besylate and what is the scope of patent protection?
Amlodipine besylate
is the generic ingredient in eighteen branded drugs marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, China Resources, Cipla, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hebei Changshan, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine Lake, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher Smith Labs, Watson Labs, Wockhardt, Yaopharma Co Ltd, Zydus Pharms Usa, Pfizer, Dr Reddys, Zydus Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Par Pharm, Teva Pharms, Watson Labs Inc, Novartis, Coeptis, Par Pharm Inc, Teva Pharms Usa, Torrent, Daiichi Sankyo, Lupin Ltd, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Sciegen Pharms Inc, Adhera, Boehringer Ingelheim, and Novel Labs Inc, and is included in ninety-nine NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amlodipine besylate has five patent family members in five countries.
There are fifty drug master file entries for amlodipine besylate. Fifty-four suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for amlodipine besylate
| International Patents: | 5 |
| US Patents: | 7 |
| Tradenames: | 18 |
| Applicants: | 63 |
| NDAs: | 99 |
| Drug Master File Entries: | 50 |
| Suppliers / Packagers: | 54 |
| Bulk Api Vendors: | 92 |
| Clinical Trials: | 52 |
| Patent Applications: | 4,210 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for amlodipine besylate |
| Drug Sales Revenues: | Drug sales revenues for amlodipine besylate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for amlodipine besylate |
| DailyMed Link: | amlodipine besylate at DailyMed |
Recent Clinical Trials for amlodipine besylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Jiao Tong University School of Medicine | Phase 4 |
| CSPC Ouyi Pharmaceutical Co., Ltd. | Phase 1 |
| Conjupro Biotherapeutics | Phase 1 |
Recent Litigation for amlodipine besylate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Edwards Lifesciences AG v. CoreValve, Inc. | 2014-04-14 |
| Pfizer Inc. v. Ranbaxy Laboratories Limited | 2008-03-24 |
| Plaintiff(s) v. Defendant(s) | 2008-01-31 |
Generic filers with tentative approvals for AMLODIPINE BESYLATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 2.5MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 10MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 5MG BASE | TABLET;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 amlodipine besylate
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Synonyms for amlodipine besylate
| (R,S,)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulphonate |
| 111470-99-6 |
| 2-(2-Aminoethoxy)methyl-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic Acid 3-Ethyl 5-Methyl Ester Benzenesulfona |
| 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylic acid O3-ethyl ester O5-methyl ester; benzenesulfonic acid |
| 2-[(2-Aminoethoxy)-methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzene sulfonate |
| 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarbo xylic acid 3-ethyl 5-methyl ester benzenesulfonate |
| 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzenesulfonate |
| 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-3-ethoxycarbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine benzenesulfonate |
| 3-Ethyl 5-methyl (+-)-2-((2-aminoethoxy)methyl)-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate |
| 3-ethyl 5-methyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |
| 3-Ethyl 5-Methyl 2-(2-Aminoethoxy)methyl-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate Benzenesulfonate |
| 3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulfonate |
| 3,5-Pyridinedicarboxylic acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, (+-)-, monobenzenesulfonate |
| 3,5-Pyridinedicarboxylic acid, 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl-5-methyl ester, monobenzenesulfonate |
| 470A996 |
| A802368 |
| AB0012646 |
| AB2000306 |
| AC-079 |
| AK122586 |
| AKOS001260256 |
| AKOS016340493 |
| Amcard |
| Amdepin |
| Amdipin |
| Amlodin |
| Amlodipine (besylate) |
| Amlodipine benzenesulfonate |
| Amlodipine benzenesulphonate |
| Amlodipine besilate |
| Amlodipine besilate (JP17) |
| Amlodipine besylate (Norvasc) |
| Amlodipine besylate (USAN) |
| Amlodipine besylate [USAN:USP] |
| Amlodipine besylate [USAN] |
| Amlodipine besylate, >=98% (HPLC) |
| Amlodipine besylate, European Pharmacopoeia (EP) Reference Standard |
| Amlodipine besylate, Pharmaceutical Secondary Standard; Certified Reference Material |
| Amlodipine besylate, racemic mixture |
| Amlodipine besylate, United States Pharmacopeia (USP) Reference Standard |
| Amlodipine for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Amlodipine-besylate(Norvasc) |
| Amlogard |
| Amlopin |
| Amlosyn |
| Antacal |
| AOB5215 |
| API0005435 |
| Astudar |
| AX8246764 |
| BCP21993 |
| BCP9000059 |
| benzenesulfonic acid; O3-ethyl O5-methyl 2-(2-azanylethoxymethyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate |
| C20H25ClN2O5.C6H6O3S |
| C26H31ClN2O8S |
| CA0135 |
| Cardiorex |
| CAS-111470-99-6 |
| CCG-39531 |
| CHEBI:2669 |
| CHEMBL1200402 |
| CHEMBL3193637 |
| CHEMBL3207778 |
| Cordarene |
| CS-3988 |
| D00615 |
| DSSTox_CID_23909 |
| DSSTox_GSID_43909 |
| DSSTox_RID_80087 |
| DTXSID2043909 |
| F6170-0024 |
| FT-0082675 |
| FT-0622301 |
| HMS2094E13 |
| HMS2232D22 |
| HMS2235B19 |
| HMS3269B19 |
| HMS3372O18 |
| HMS3373F15 |
| HMS3413H11 |
| HMS3677H11 |
| HSDB 7079 |
| HY-B0317B |
| Istin |
| Istin;Norvasc;Norvasc |
| J10223 |
| J10238 |
| KBio2_001053 |
| KBio2_003621 |
| KBio2_006189 |
| KBioSS_001053 |
| KS-1029 |
| LS-131175 |
| MCULE-3638128556 |
| MFCD00864687 |
| MFCD00887594 |
| MLS001361394 |
| Monopina |
| Myodura |
| NCGC00095835-01 |
| NCGC00165957-04 |
| Norlopin |
| Norvas |
| Norvasc (TN) |
| Norvask |
| NSC-758922 |
| NSC758922 |
| Pelmec |
| Pharmakon1600-01505202 |
| Q-101934 |
| Q-200627 |
| Q27105760 |
| r-amlodipine |
| s1813 |
| SCHEMBL41282 |
| SMR000875356 |
| Spectrum_000573 |
| SPECTRUM1505202 |
| SR-05000001461-2 |
| Stamlo |
| SW198880-2 |
| Tensivask |
| Terloc |
| Tox21_111525 |
| Tox21_113476 |
| UK 48340-26 |
| UK-48,340 |
| UK-48,340-26 |
| UK-48340-26 |
| UK-4834026 |
| VU0244594-3 |
| ZPBWCRDSRKPIDG-UHFFFAOYSA-N |
Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NORVASC | TABLET;ORAL | amlodipine besylate | 019787 |
US Patents and Regulatory Information for amlodipine besylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | amlodipine besylate; benazepril hydrochloride | CAPSULE;ORAL | 077375-002 | May 21, 2010 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva Pharms Usa | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 202491-004 | Nov 3, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Micro Labs | AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 207435-004 | Nov 2, 2017 | AB | 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 amlodipine besylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-002 | Jul 31, 1992 | Start Trial | Start Trial |
| Pfizer | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-001 | Jul 31, 1992 | Start Trial | Start Trial |
| Pfizer | NORVASC | amlodipine besylate | TABLET;ORAL | 019787-003 | Jul 31, 1992 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for amlodipine besylate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20042539 | Start Trial |
| Argentina | 037565 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03043635 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for amlodipine besylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0503785 | C300375 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819 |
| 0502314 | C300478 | Netherlands | Start Trial | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 |
| 1507558 | 12C0033 | France | Start Trial | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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