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Clopidogrel bisulfate - Generic Drug Details
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What are the generic drug sources for clopidogrel bisulfate and what is the scope of clopidogrel bisulfate patent protection?
Clopidogrel bisulfate
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gate Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sciegen Pharms Inc, Sun Pharm Industries, Sun Pharma Global, Teva, Teva Pharms, Torrent Pharms Ltd, Wockhardt Ltd, Zydus Pharms Usa Inc, and Sanofi Aventis Us, and is included in twenty-two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are fifty-four drug master file entries for clopidogrel bisulfate. Fifty-seven suppliers are listed for this compound.
Summary for clopidogrel bisulfate
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 22 |
| NDAs: | 22 |
| Drug Master File Entries: | 54 |
| Suppliers / Packagers: | 57 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 15 |
| Patent Applications: | 3,603 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for clopidogrel bisulfate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for clopidogrel bisulfate |
| DailyMed Link: | clopidogrel bisulfate at DailyMed |
Pharmacology for clopidogrel bisulfate
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | P2Y12 Receptor Antagonists Cytochrome P450 2C8 Inhibitors |
| Physiological Effect | Decreased Platelet Aggregation |
Synonyms for clopidogrel bisulfate
| (+) Clopidogrel Bisulfate |
| (+)-clopidogrel bisulfate |
| (+)-clopidogrel hydrogen sulfate |
| (+/-) Clopidogrel hydrogen sulfate |
| (+/-)-Clopidogrel hydrogen sulfate |
| (S)-( )-Methyl (2-chlorophenyl)(6,7-dihydro-4H-thieno(3,2-c)pyrid-5-yl)acetate bisulfate |
| (S)-(+)-Clopidogrel hydrogen sulfate |
| (S)-(+)-Clopidogrel hydrogensulfate, >=98% (HPLC) |
| (S)-(+)-Clopidogrel Sulfate |
| (S)-(+)-Methyl 2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-(2-chlorophenyl)acetate hydrogen sulfate |
| (S)-(2-Chloro-phenyl)-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)-acetic acid methyl ester sulfuric acid salt |
| (S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate sulfate |
| (S)-METHYL-(2-CHLORO-PHENYL)-(6,7-DIHYDRO-4H-THIENO[3,2-C]PYRIDIN-5-YL)-ACETATE H2SO4 |
| 08I79HTP27 |
| 111GE004 |
| 120202-66-6 |
| 135046-48-9 |
| 144077-07-6 |
| A19581 |
| AB0012679 |
| AB2000095 |
| AC-2135 |
| AC1L3GZZ |
| AK-58351 |
| AKOS015900408 |
| Ambap113665-84-2 |
| AN-10793 |
| AN-14258 |
| ANW-47676 |
| BB_SC-2102 |
| BR-58351 |
| C16H18ClNO6S2 |
| CAS-135046-48-9 |
| CCG-39568 |
| CHEBI:3759 |
| CHEMBL1083385 |
| Clopidogrel hydrogen sulphate |
| Clopidogrel (hydrogen sulfate) |
| Clopidogrel (Plavix) |
| Clopidogrel bisulfate (USAN) |
| Clopidogrel bisulfate [USAN:USP] |
| Clopidogrel Bisulfate [USAN] |
| Clopidogrel Bisulfate, pharmaceutical secondary standard; traceable to USP, PhEur |
| Clopidogrel bisulfate, United States Pharmacopeia (USP) Reference Standard |
| Clopidogrel bisulphate |
| Clopidogrel Bisulphate USP (Form II) |
| Clopidogrel for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Clopidogrel hemisulfate |
| Clopidogrel hydrogen sulfate |
| Clopidogrel hydrogen sulfate, European Pharmacopoeia (EP) Reference Standard |
| clopidogrel hydrogen sulphate |
| Clopidogrel hydrogensulfate |
| CLOPIDOGREL SULFATE |
| Clopidogrel sulfate (JP17) |
| Clopidogrel sulfate tablets (JP17) |
| Clopidogrel sulphate |
| clopidogrel; sulfuric acid |
| Clopidogrelhydrogensulphate |
| CS-1882 |
| CTK8B5120 |
| D00769 |
| DR002565 |
| DSSTox_CID_26024 |
| DSSTox_GSID_46024 |
| DSSTox_RID_81297 |
| DTXSID4046024 |
| DV-7314 |
| FC1269 |
| FDEODCTUSIWGLK-RSAXXLAASA-N |
| FT-0603200 |
| HE301021 |
| HMS1922G16 |
| HMS2093I13 |
| HY-17459 |
| Iscover |
| Iscover;Myogrel;Plavix |
| Isocover (TN) |
| J-006637 |
| KS-1045 |
| LS-152396 |
| LS-172438 |
| MCULE-2362021814 |
| MDCO-157 |
| Methyl (+)-(S)-alpha-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4H)-acetate, sulfate (1:1) |
| Methyl (2-chlorophenyl)(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate hydrogen sulfate |
| methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate; sulfuric acid |
| methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate;sulfuric acid |
| methyl (2S)-2-(2-chlorophenyl)-2-{4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl}acetate; sulfuric acid |
| Methyl (S)-(+)-2-(2-Chlorophenyl)-2-[6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl]acetate Sulfate |
| methyl (S)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate sulfate |
| Methyl alphaS-(2-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4H)-acetate sulfate (1:1) |
| MFCD00876395 |
| MFCD05865229 |
| MolPort-000-784-171 |
| Myogrel |
| NCGC00159321-02 |
| NCGC00163329-03 |
| NSC-758613 |
| NSC758613 |
| Osvix |
| Pharmakon1600-01503710 |
| Plavitor |
| Plavix |
| Plavix (TN) |
| PM-103 |
| RTR-004741 |
| s1415 |
| S65C842 |
| SC-08806 |
| SCHEMBL33556 |
| SPECTRUM1503710 |
| SR 25990C |
| SR-05000002068 |
| SR-05000002068-1 |
| SR-25990 |
| SR-25990C |
| ST51053924 |
| Thieno(3,2-c)pyridine-5(4H)-acetic acid, 6,7-dihydro-alpha-(2-chlorophenyl)-, methyl ester, (S)-, sulfate |
| Thieno(3,2-c)pyridine-5(4H)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (alphaS)-, sulfate (1:1) |
| Thieno(3,2-c)pyridine-5(4H)-acetic acid, alpha-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (S)-, sulfate (1:1) |
| TL8000537 |
| Tox21_111570 |
| Tox21_111570_1 |
| UNII-08I79HTP27 |
| Y-9563 |
| Z1550648767 |
US Patents and Regulatory Information for clopidogrel bisulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prinston Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 206376-001 | May 7, 2018 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Actavis Totowa | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090307-001 | May 28, 2013 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Wockhardt Ltd | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 202266-001 | Aug 14, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Mylan Pharms Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 077665-001 | May 17, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Dr Reddys Labs Ltd | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 091023-001 | May 17, 2012 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ 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 clopidogrel bisulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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International Patents for clopidogrel bisulfate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Germany | 69902536 | ➤ Sign Up |
| Iceland | 2469 | ➤ Sign Up |
| Poland | 201894 | ➤ Sign Up |
| South Africa | 200006386 | ➤ Sign Up |
| Norway | 327161 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for clopidogrel bisulfate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0036 | France | ➤ Sign Up | PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001 |
| 90035-0 98910359 | Sweden | ➤ Sign Up | PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715 |
| C/GB99/001 | United Kingdom | ➤ Sign Up | PRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715 |
| C0036 | Belgium | ➤ Sign Up | PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001 |
| /1998 | Austria | ➤ Sign Up | PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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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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