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Telmisartan - Generic Drug Details
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What are the generic drug sources for telmisartan and what is the scope of patent protection?
Telmisartan
is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Micro Labs, Mylan, Prinston Inc, Sandoz Inc, Torrent, and Zydus Pharms, and is included in seventeen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Telmisartan has eighty-eight patent family members in thirty-eight countries.
There are thirty-nine drug master file entries for telmisartan. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for telmisartan
| International Patents: | 88 |
| US Patents: | 3 |
| Tradenames: | 2 |
| Applicants: | 17 |
| NDAs: | 17 |
| Drug Master File Entries: | 39 |
| Suppliers / Packagers: | 24 |
| Bulk Api Vendors: | 114 |
| Clinical Trials: | 242 |
| Patent Applications: | 5,684 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for telmisartan |
| Drug Sales Revenues: | Drug sales revenues for telmisartan |
| DailyMed Link: | telmisartan at DailyMed |
Recent Clinical Trials for telmisartan
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of British Columbia | Early Phase 1 |
| Heart and Stroke Foundation of Canada | Early Phase 1 |
| Michael Smith Foundation for Health Research | Early Phase 1 |
Generic filers with tentative approvals for TELMISARTAN
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 80MG; 25MG | TABLET; ORAL |
| Start Trial | Start Trial | 80MG; 12.5MG | TABLET; ORAL |
| Start Trial | Start Trial | 40MG; 12.5MG | 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 telmisartan
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Synonyms for telmisartan
| (1,1'-Biphenyl)-2-carboxylic acid, 4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)- |
| [1,1'-Biphenyl]-2-carboxylic acid, 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]- |
| 144701-48-4 |
| 2-(4-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}phenyl)benzoic acid |
| 2-[4-[[4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl]methyl]phenyl]benzoic acid |
| 2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propyl-benzimidazol-1-yl]methyl]phenyl]benzoic acid |
| 2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl]phenyl]benzoic acid |
| 2-[4-[[4-methyl-6-(1-methylbenzimidazol-2-yl)-2-propylbenzimidazol-1-yl]methyl]phenyl]benzoic acid. |
| 4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-(1,1'-biphenyl)-2-carboxylic acid |
| 4'-((1,7'-Dimethyl-2'-propyl-1H,3'H-[2,5'-bibenzo[d]imidazol]-3'-yl)methyl)-[1,1'-biphenyl]-2-carbox |
| 4'-((1,7'-Dimethyl-2'-propyl-1H,3'H-[2,5'-bibenzo[d]imidazol]-3'-yl)methyl)-[1,1'-biphenyl]-2-carboxylic acid |
| 4'-((1,7'-DIMETHYL-2'-PROPYL-1H,3'H-2,5'-BIBENZO[D]IMIDAZOL-3'-YL)METHYL)BIPHENYL-2-CARBOXYLIC ACID |
| 4'-((4-mehtyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimmidazolyl)methyl)-2-biphenylcarboxylic acid |
| 4'-((4-Methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid |
| 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1h-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid |
| 4'-[(1,4'-dimethyl-2'propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid |
| 4'-[(1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzimidazol-3'-yl)methyl][1,1'-biphenyl]-2-carboxylic acid |
| 4'-[(1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzimidazol-3'-yl)methyl]biphenyl-2-carboxylic acid |
| 4'-[[2-n-Propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)-benzimidazol-1-yl]-methyl]-biphenyl-2-carboxylic acid |
| 4'-[[4-Methyl-6-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl]methyl]biphenyl-2-carboxylic Acid |
| 4'-[[4-METHYL-6-(1-METHYL-2-BENZIMIDAZOLYL)-2-PROPYL-1-BENZIMIDAZOLYL]METHYL]-2-BIPHENYLCARBOXYLIC ACID |
| 4'-[2-n-propyl-4-methyl-6-(1-methyl benzimidazol-2-yl)benzimidazol-1-yl methyl]biphenyl-2-carboxylic acid |
| 4'-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}-[1,1'-biphenyl]-2-carboxylic acid |
| 4''-((1,4''-dimethyl-2''-propyl(2,6''-bi-1H-benzimidazol)-1''-yl)methyl)-(1,1''-biphenyl)-2-carboxylic acid |
| 4''-((4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid |
| 4''-[(1,4''-dimethyl-2''propyl[2,6''-bi-1H-benzimidazol]-1''-yl)methyl]-[1,1''-biphenyl]-2-carboxylic acid |
| 4''-[(1,7''-dimethyl-2''-propyl-1H,3''H-2,5''-bibenzimidazol-3''-yl)methyl][1,1''-biphenyl]-2-carboxylic acid |
| 4''-[(1,7''-dimethyl-2''-propyl-1H,3''H-2,5''-bibenzimidazol-3''-yl)methyl]biphenyl-2-carboxylic acid |
| 4'[(1,4'-DIMETHYL-2'-PROPYL[2,6'-BI-1H-BENZIMIDAZOL]-1'-YL)METHYL][1,1'-BIPHENYL]-2-CARBOXYLIC ACID |
| 4CA-1224 |
| 66930-EP2270011A1 |
| 66930-EP2272841A1 |
| 66930-EP2277866A1 |
| 66930-EP2277879A1 |
| 66930-EP2295406A1 |
| 66930-EP2295422A2 |
| 66930-EP2298772A1 |
| 66930-EP2298779A1 |
| 66930-EP2301923A1 |
| 66930-EP2301931A1 |
| 66930-EP2301936A1 |
| 66930-EP2305219A1 |
| 66930-EP2305650A1 |
| 66930-EP2308839A1 |
| 701T484 |
| A808270 |
| AB0012010 |
| AB00639941_08 |
| AB00639941_09 |
| AB00639941-06 |
| AB00639941-07 |
| AB07687 |
| AB2000262 |
| AC-2013 |
| AC1L24EB |
| AC1Q5U7O |
| AJ-26708 |
| AK-72892 |
| AKOS005557501 |
| ALBB-028954 |
| AM90292 |
| AN-14373 |
| API0004337 |
| AX8018372 |
| Bay 68-9291 |
| BAY-68-9291 |
| BAY68-9291 |
| BBL029085 |
| BCP04513 |
| BCP0726000055 |
| BDBM50043280 |
| BG0644 |
| BIBR 277 |
| BIBR 277 SE |
| BIBR 277SE |
| BIBR-277 |
| BIBR-277-SE |
| BIBR-277SE |
| BIBR277 |
| BIDD:GT0365 |
| BR-72892 |
| BRD-K73999723-001-02-2 |
| BSPBio_002738 |
| C-23026 |
| C07710 |
| C33H30N4O2 |
| CAS-144701-48-4 |
| CC-34667 |
| CCG-39514 |
| CHEBI:9434 |
| CHEMBL1017 |
| CPD000466326 |
| CS-1699 |
| D00627 |
| DB00966 |
| DL-511 |
| DSSTox_CID_3636 |
| DSSTox_GSID_23636 |
| DSSTox_RID_77121 |
| DTXSID8023636 |
| FT-0631170 |
| GP9498 |
| GTPL592 |
| HMS1922P07 |
| HMS2051P16 |
| HMS2090P17 |
| HMS2093M22 |
| HMS2231P07 |
| HMS3393P16 |
| HMS3655C08 |
| HMS3715L17 |
| HSDB 7590 |
| HY-13955 |
| I06-0281 |
| J10282 |
| KB-60708 |
| KBio3_001958 |
| KBioGR_001842 |
| Kinzal |
| Kinzal/Pritor |
| Kinzalmono |
| KS-00000D1K |
| KS-1215 |
| L001035 |
| LS-44263 |
| MCULE-8479555254 |
| MFCD00918125 |
| MFCD00918125 (98%) |
| Micardis |
| Micardis (TN) |
| MLS000759432 |
| MLS001076687 |
| MLS001424174 |
| MLS006011851 |
| MolPort-003-666-621 |
| NC00296 |
| NCGC00095150-01 |
| NCGC00095150-02 |
| NCGC00095150-03 |
| NCGC00095150-04 |
| NCGC00095150-06 |
| NCGC00095150-07 |
| NCGC00095150-08 |
| NSC-759811 |
| NSC759811 |
| Pharmakon1600-01505261 |
| Pritor |
| PubChem14979 |
| Q-101933 |
| RMMXLENWKUUMAY-UHFFFAOYSA-N |
| S-2837 |
| s1738 |
| SAM001246602 |
| SBI-0206733.P001 |
| SC-12741 |
| SCHEMBL4464 |
| SMR000466326 |
| SPBio_002131 |
| SPECTRUM1505261 |
| Spectrum2_001976 |
| Spectrum3_001089 |
| Spectrum4_001261 |
| Spectrum5_001053 |
| SR-01000759355 |
| SR-01000759355-4 |
| SR-01000759355-5 |
| ST2410854 |
| STK624049 |
| SW197676-3 |
| SY052776 |
| T-170 |
| Targit |
| Targit;Temax;BIBR277;Micardis |
| Tazlok |
| Telmisartan (JP17/USAN/INN) |
| Telmisartan (Micardis) |
| Telmisartan [INN] |
| Telmisartan [USAN:INN] |
| Telmisartan [USAN:USP:INN:BAN] |
| Telmisartan for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Telmisartan for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Telmisartan tablets (JP17) |
| Telmisartan, >=98% (HPLC), solid |
| Telmisartan, European Pharmacopoeia (EP) Reference Standard |
| Telmisartan, Pharmaceutical Secondary Standard; Certified Reference Material |
| Telmisartan, United States Pharmacopeia (USP) Reference Standard |
| Telmisattan |
| Temax |
| TL8000991 |
| TLS |
| Tox21_111452 |
| Tox21_111452_1 |
| U5SYW473RQ |
| UNII-U5SYW473RQ |
| YM-086 |
| Z2210710360 |
| ZINC1530886 |
| ZX-AN079767 |
Paragraph IV (Patent) Challenges for TELMISARTAN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MICARDIS | TABLET;ORAL | telmisartan | 020850 | 2006-12-26 |
US Patents and Regulatory Information for telmisartan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | TELMISARTAN | telmisartan | TABLET;ORAL | 203325-001 | Aug 26, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Alembic Pharms Ltd | TELMISARTAN | telmisartan | TABLET;ORAL | 202130-001 | Jul 7, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Glenmark Pharms Ltd | TELMISARTAN | telmisartan | TABLET;ORAL | 090032-003 | Jul 7, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sandoz Inc | TELMISARTAN | telmisartan | TABLET;ORAL | 203867-002 | Nov 3, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Jubilant Generics | TELMISARTAN | telmisartan | TABLET;ORAL | 204164-002 | Aug 22, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Prinston Inc | TELMISARTAN | telmisartan | TABLET;ORAL | 207882-003 | May 3, 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 telmisartan
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | Start Trial | Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | Start Trial | Start Trial |
| Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for telmisartan
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Uruguay | 25980 | Start Trial |
| South Korea | 100572080 | Start Trial |
| Bulgaria | 65027 | Start Trial |
| Uruguay | 25972 | Start Trial |
| European Patent Office | 1144386 | Start Trial |
| Slovenia | 1144386 | Start Trial |
| African Regional IP Organization (ARIPO) | 1300 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for telmisartan
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0502314 | 1190006-5.L | Sweden | Start Trial | PRODUCT NAME: TELMISARTAN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT, OCH AMLODIPIN, VALFRITT I FORM AV FARMACEUTISKT GODTAGBARA SALT SAERSKILT AMOLODIPINBESILAT; REG. NO/DATE: EU/1/10/648/001-028 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-10-07" SEGODKNR="EU/1/10/648/001-028 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-10-07" FLAG="L" SPCNR="1190006-5" 20101007 |
| 0502314 | SPC/GB02/037 | United Kingdom | Start Trial | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| 0502314 | SPC/GB99/014 | United Kingdom | Start Trial | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/98/089/001 19981211; UK EU/1/98/089/002 19981211; UK EU/1/98/089/003 19981211; UK EU/1/98/089/004 19981211; UK EU/1/98/089/005 19981211; UK EU/1/98/089/006 19981211; UK EU/1/98/089/007 19981211; UK EU/1/98/089/008 19981211; UK EU/1/98/089/009 19981211; UK EU/1/98/089/010 19981211 |
| 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 |
| 0502314 | 24/2002 | Austria | Start Trial | PRODUCT NAME: TELMISARTAN, GEGEBENENFALLS IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/02/213/001- EU/1/02/213/010 20020419 |
| 0502314 | 3/2011 | Austria | Start Trial | PRODUCT NAME: TELMISARTAN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE UND AMLODIPIN, GGF. IN FORM SEINER PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE AMLODIPINBESILAT; REGISTRATION NO/DATE: EU/1/10/648/001 - EU/1/10/648/028 20101007 |
| 0502314 | C990007 | Netherlands | Start Trial | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT; REGISTRATION NO/DATE: EU/1/98/089/001-EU/1/98/089/010 19981211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.