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Paclitaxel - Generic Drug Details
What are the generic sources for paclitaxel and what is the scope of freedom to operate?
Paclitaxel
is the generic ingredient in four branded drugs marketed by Abraxis Bioscience, Gland Pharma Ltd, Accord Hlthcare, Actavis Totowa, Fresenius Kabi Usa, Hospira, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, West-ward Pharms Int, and Hq Spclt Pharma, and is included in sixteen NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Paclitaxel has three hundred and twenty-five patent family members in thirty-one countries.
There are sixty-nine drug master file entries for paclitaxel. Ten suppliers are listed for this compound.
Summary for paclitaxel
| International Patents: | 325 |
| US Patents: | 12 |
| Tradenames: | 4 |
| Applicants: | 14 |
| NDAs: | 16 |
| Drug Master File Entries: | 69 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 2,740 |
| Patent Applications: | 7,545 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for paclitaxel |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for paclitaxel |
| DailyMed Link: | paclitaxel at DailyMed |
Recent Clinical Trials for paclitaxel
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lexicon Pharmaceuticals | Phase 2 |
| Ipsen | Phase 3 |
| Shanghai Zhongshan Hospital | Phase 1 |
Recent Litigation for paclitaxel
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ABRAXIS BIOSCIENCE, LLC v. HBT LABS, INC. | 2018-12-17 |
| ABRAXIS BIOSCIENCE, LLC v. CIPLA LTD. | 2016-12-07 |
| Teva Pharmaceuticals USA Inc. v. Sandoz Inc. | 2014-09-10 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Apotex Inc. | 2017-11-09 |
| Cipla Ltd. | 2017-11-09 |
| Actavis LLC | 2017-04-04 |
Pharmacology for paclitaxel
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for paclitaxel
Synonyms for paclitaxel
| (2alpha,5beta,7beta,10beta,13alpha)-4,10-bis(acetyloxy)-1,7-dihydroxy-13-({(2R,3S)-2-hydroxy-3-phenyl-3-[(phenylcarbonyl)amino]propanoyl}oxy)-9-oxo-5,20-epoxytax-11-en-2-yl benzoate |
| (2aR-(2aalpha,4beta,4abeta,6beta,9alpha(alpha R*,betaS*),11alpha,12alpha,12balpha))-beta-(Benzoylamino)-alpha-hydroxybenzenepropanoic acid 6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12 |
| (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro 4,6,9,11,12,12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano 5Hcyclodeca(3,4)benz(1,2-b)oxet-5-one 6,12b-diacetate, |
| (2beta,5beta,7alpha,8alpha,10alpha,13alpha)-4,10-bis(acetyloxy)-1,7-dihydroxy-13-({(2R,3S)-2-hydroxy-3-phenyl-3-[(phenylcarbonyl)amino]propanoyl}oxy)-9-oxo-5,20-epoxytax-11-en-2-yl benzoate |
| (NAB)-Paclitaxel |
| [diacetoxy-[(2R,3S)-3-benzamido-2-hydroxy-3-phenyl-propanoyl]oxy-dihydroxy-tetramethyl-oxo-[?]yl] benzoate |
| 069P624 |
| 10337-EP2269989A1 |
| 10337-EP2270018A1 |
| 10337-EP2272827A1 |
| 10337-EP2272832A1 |
| 10337-EP2277507A1 |
| 10337-EP2277865A1 |
| 10337-EP2277876A1 |
| 10337-EP2280012A2 |
| 10337-EP2280014A2 |
| 10337-EP2281815A1 |
| 10337-EP2281820A2 |
| 10337-EP2286795A1 |
| 10337-EP2287168A2 |
| 10337-EP2289876A1 |
| 10337-EP2289892A1 |
| 10337-EP2292233A2 |
| 10337-EP2292234A1 |
| 10337-EP2292614A1 |
| 10337-EP2292615A1 |
| 10337-EP2295412A1 |
| 10337-EP2295413A1 |
| 10337-EP2295416A2 |
| 10337-EP2298748A2 |
| 10337-EP2298754A1 |
| 10337-EP2298772A1 |
| 10337-EP2298780A1 |
| 10337-EP2301533A1 |
| 10337-EP2301536A1 |
| 10337-EP2301538A1 |
| 10337-EP2301928A1 |
| 10337-EP2301933A1 |
| 10337-EP2301940A1 |
| 10337-EP2302382A2 |
| 10337-EP2302383A2 |
| 10337-EP2305243A1 |
| 10337-EP2305250A1 |
| 10337-EP2305640A2 |
| 10337-EP2305642A2 |
| 10337-EP2305671A1 |
| 10337-EP2305679A1 |
| 10337-EP2305689A1 |
| 10337-EP2305808A1 |
| 10337-EP2308833A2 |
| 10337-EP2308839A1 |
| 10337-EP2308861A1 |
| 10337-EP2311455A1 |
| 10337-EP2311808A1 |
| 10337-EP2311827A1 |
| 10337-EP2311829A1 |
| 10337-EP2314295A1 |
| 10337-EP2314574A1 |
| 10337-EP2316452A1 |
| 10337-EP2316832A1 |
| 10337-EP2316833A1 |
| 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine |
| 1203669-79-7 |
| 157069-30-2 |
| 33069-62-4 |
| 4alpha,10beta-bis(acetyloxy)-13alpha-[(2S,3S)-3-benzamido-2-hydroxy-3-phenylpropanoyloxy]-1,7beta-dihydroxy-9-oxo-5beta,20-epoxytax-11-en-2alpha-yl benzoate |
| 5?,20-Epoxy-1,7?-dihydroxy-9-oxotax-11-ene-2?,4,10?,13?-tetrayl 4,10-diacetate 2-benzoate 13-[(2R,3S)-3-(benzoylamino)-2-hydroxy-3-phenylpropanoate] |
| 5beta,20-Epoxy-1,2-alpha,4,7beta,10beta,13alpha-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine |
| 7-epi-Paclitaxel |
| 7,11-Methano-1H-cyclodeca[3,4]benz[1,2-b]oxete, benzenepropanoic acid deriv. |
| 7,11-METHANO-5H-CYCLODECA[3,4]BENZ[1,2-B]OXETE BENZENEPROPANOIC ACID DERIV. |
| 7,4]benz[1,2-b]oxete,benzenepropanoic acid deriv. |
| AB00513812 |
| AB00513812-02 |
| AB00513812-03 |
| AB0069184 |
| ABI 007 |
| ABI-007 |
| ABP000252 |
| Abraxane |
| Abraxane (albumin-bound suspension) |
| Abraxane (TN) |
| Abraxane I.V. Suspension |
| AC1L1VJI |
| ACN-032459 |
| ACon1_002231 |
| ACT02709 |
| AK108391 |
| AKOS007930675 |
| AKOS015969673 |
| AKOS025312303 |
| ANX-513 |
| Anzatax |
| BDBM50001839 |
| Benzenepropanoic acid, beta-(benzoylamino)-alpha-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13 |
| Benzenepropanoic acid, beta-(benzoylamino)-alpha-hydroxy-, 6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,11-dihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H |
| BIDD:PXR0046 |
| BMS 181339-01 |
| BMS-181339 |
| BMS-181339-01 |
| BPBio1_000320 |
| BRD-K62008436-001-03-1 |
| BRD-K62008436-001-05-6 |
| BRD-K62008436-001-22-1 |
| BSPBio_000290 |
| Capxol |
| CAS-33069-62-4 |
| CCG-220155 |
| CCRIS 8143 |
| CHEBI:45863 |
| CHEMBL428647 |
| cMAP_000068 |
| Coroflex Please |
| CS-1145 |
| Cyclopax |
| Cynviloq |
| Cypher select |
| D00491 |
| DB01229 |
| DHP 107 |
| DHP-107 |
| DHP-208 |
| DRG-0190 |
| DSSTox_CID_3413 |
| DSSTox_GSID_23413 |
| DSSTox_RID_77016 |
| DTS-301 |
| DTXSID9023413 |
| Ebetaxel |
| EmPAC |
| EndoTAG 1 |
| EndoTAG-1 |
| Genaxol |
| Genetaxyl |
| Genexol |
| Genexol-PM |
| GS-6554 |
| GTPL2770 |
| HMS2090D07 |
| HMS2095O12 |
| HMS2231A16 |
| HMS3712O12 |
| HSDB 6839 |
| HY-B0015 |
| IG 001 |
| Infinnium |
| Intaxel |
| KBio2_002509 |
| KBio2_005077 |
| KBio2_007645 |
| KBio3_002987 |
| KBioGR_002509 |
| KBioSS_002517 |
| LEP-ETU |
| LipoPac |
| Liposome-entrapped paclitaxel easy-to-use |
| M-8858 |
| M02242 |
| MBT 0206 |
| MEGxp0_001940 |
| MFCD00869953 |
| Mitotax |
| MLS002154218 |
| MLS002695976 |
| MolPort-001-742-627 |
| MPI-5018 |
| N1361 |
| N88686 |
| NA090030 |
| nab-paclitaxel |
| Nanoparticle albumin bound paclitaxel |
| Nanotaxel |
| Nanoxel |
| NCGC00164367-01 |
| NCGC00164367-02 |
| NCGC00164367-03 |
| NCGC00164367-04 |
| NCGC00164367-05 |
| NCGC00164367-10 |
| NCI60_000601 |
| NK 105 |
| Nova-12005 |
| NSC 125973 |
| NSC-125973 |
| NSC-745099 |
| NSC125973 |
| NSC745099 |
| OAS-PAC-100 |
| OncoGel |
| Onxal |
| Onxol |
| P-SSMM-VIP |
| P88XT4IS4D |
| Paclical |
| Pacliex |
| Pacligel |
| Paclitaxel (JAN/USP/INN) |
| Paclitaxel (Taxol) |
| Paclitaxel [USAN:USP:INN:BAN] |
| Paclitaxel natural for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Paclitaxel semi-synthetic for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Paclitaxel semi-synthetic for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Paclitaxel-SSMM-VIP |
| Paclitaxel, Antibiotic for Culture Media Use Only |
| Paclitaxel, European Pharmacopoeia (EP) Reference Standard |
| Paclitaxel, from semisynthetic (from Taxus sp.), >=97% |
| Paclitaxel, from Taxus brevifolia, >=95% (HPLC), powder |
| Paclitaxel, From Taxus brevifolia, 95% |
| Paclitaxel, from Taxus yannanensis, powder |
| Paclitaxel, Pharmaceutical Secondary Standard; Certified Reference Material |
| Paclitaxel, Taxus brevifolia |
| Paclitaxel, United States Pharmacopeia (USP) Reference Standard |
| Paclitaxel,(S) |
| Paclitaxel/ |
| Padexol |
| Paxceed |
| Paxene |
| Paxoral |
| Plaxicel |
| Prestwick3_000155 |
| Q-201533 |
| QW 8184 |
| RCINICONZNJXQF-MZXODVADSA-N |
| RL03195 |
| SCHEMBL3976 |
| SDP-013 |
| Sindaxel |
| SMR000857385 |
| SR-01000075350 |
| SR-01000075350-1 |
| SR-01000075350-3 |
| SR-01000075350-6 |
| SR-01000075350-7 |
| SR-01000075350-9 |
| ST2419771 |
| Tax-11-en-9-one, 5beta,20-epoxy-1,2alpha,4,7beta,10beta,13alpha- hexahydroxy-, 4,10-diacetate 2-benzoate, 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine (8CI) |
| Tax-11-en-9-one, 5beta,20-epoxy-1,2alpha,4,7beta,10beta,13alpha-hexahydroxy-, 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine (8CI) |
| Tax-11-en-9-one,20-epoxy-1,2.alpha.,4,7.beta., 10.beta.,13.alpha.- hexahydroxy-, 4,10-diacetate 2- benzoate,13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine |
| TaxAlbin |
| TAXOL |
| TAXOL (TN) |
| Taxol (TN) (Bristol Meyers) |
| Taxol A |
| Taxus Express |
| Taxus Liberte |
| Taxus stent |
| Tox21_112107 |
| UNII-P88XT4IS4D |
| Vascular Wrap |
| Xorane |
| Yewtaxan |
| ZINC96006020 |
| Zisu |
| ZX-AFC000078 |
US Patents and Regulatory Information for paclitaxel
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | AP | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | 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 paclitaxel
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for paclitaxel
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 201907915 | Start Trial |
| Australia | 673057 | Start Trial |
| China | 102343094 | Start Trial |
| Brazil | 0210056 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for paclitaxel
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1853250 | 2014C/037 | Belgium | Start Trial | PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230 |
| 0961612 | 441 | Finland | Start Trial | |
| 1853250 | CA 2014 00034 | Denmark | Start Trial | PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220 |
| 1853250 | 37/2014 | Austria | Start Trial | PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230 |
| >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 verifification 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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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
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Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.