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Clopidogrel bisulfate - Generic Drug Details
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What are the generic sources for clopidogrel bisulfate and what is the scope of freedom to operate?
Clopidogrel bisulfate
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Cspc Ouyi, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, 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.Clopidogrel bisulfate has fifty-five patent family members in forty-three countries.
There are fifty-four drug master file entries for clopidogrel bisulfate. Forty-nine suppliers are listed for this compound.
Summary for clopidogrel bisulfate
| International Patents: | 55 |
| US Patents: | 2 |
| Tradenames: | 2 |
| Applicants: | 21 |
| NDAs: | 22 |
| Drug Master File Entries: | 54 |
| Suppliers / Packagers: | 49 |
| Bulk Api Vendors: | 168 |
| Clinical Trials: | 16 |
| Patent Applications: | 6,814 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for clopidogrel bisulfate |
| Drug Sales Revenues: | Drug sales revenues for clopidogrel bisulfate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for clopidogrel bisulfate |
| DailyMed Link: | clopidogrel bisulfate at DailyMed |
Recent Clinical Trials for clopidogrel bisulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | N/A |
| The First Affiliated Hospital with Nanjing Medical University | Phase 4 |
| CKD Pharmaceutical Limited | Phase 4 |
Recent Litigation for clopidogrel bisulfate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Sanofi-Aventis v. Sun Pharmaceutical Industries Ltd. | 2008-07-11 |
| APOTEX INC. v. LEAVITT | 2008-04-23 |
| United States v. BRISTOL MYERS SQUIBB COMPANY | 2007-05-30 |
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 |
| (S)-(+)-Clopidogrel hydrogensulfate, >=98% (HPLC) |
| (S)-(+)-Clopidogrel hydrogensulfate, 98% |
| (S)-(+)-Clopidogrel Sulfate |
| (S)-(+)-Methyl 2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-(2-chlorophenyl)acetate hydrogen sulfate |
| (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 |
| AKOS015900408 |
| AN-10793 |
| AN-14258 |
| ANW-47676 |
| 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; Certified Reference Material |
| 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 |
| DSSTox_CID_26024 |
| DSSTox_GSID_46024 |
| DSSTox_RID_81297 |
| DTXSID4046024 |
| DV-7314 |
| FC1269 |
| FDEODCTUSIWGLK-RSAXXLAASA-N |
| FT-0603200 |
| 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) |
| 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 |
| SW219457-1 |
| 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 |
Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PLAVIX | TABLET;ORAL | clopidogrel bisulfate | 020839 | 2009-03-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090625-001 | May 17, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sciegen Pharms Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 204165-002 | Sep 15, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Accord Hlthcare | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 202925-002 | Mar 27, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Apotex Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 076274-002 | Mar 4, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Torrent Pharms Ltd | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090844-001 | May 17, 2012 | 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 clopidogrel bisulfate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for clopidogrel bisulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1087976 | Start Trial |
| Bulgaria | 104987 | Start Trial |
| Estonia | 200000745 | Start Trial |
| Norway | 327161 | Start Trial |
| Slovakia | 19092000 | Start Trial |
| Argentina | 014854 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for clopidogrel bisulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0281459 | 35/1998 | Austria | Start Trial | PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715 |
| 0281459 | 9890035-0 98910359 | Sweden | Start Trial | PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715 |
| 0281459 | 9890035 | Sweden | Start Trial | PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715 |
| 0281459 | C990002 | Netherlands | Start Trial | PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715 |
| 0281459 | 98C0036 | France | Start Trial | 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 |
| 0302769 | 98C0036 | Belgium | Start Trial | 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 |
| >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.