DrugPatentWatch Database Preview
Paclitaxel - Generic Drug Details
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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 thirty 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: | 330 |
| US Patents: | 12 |
| Tradenames: | 4 |
| Applicants: | 14 |
| NDAs: | 16 |
| Drug Master File Entries: | 69 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 78 |
| Clinical Trials: | 2,824 |
| Patent Applications: | 7,471 |
| 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 |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 3 |
| Lexicon Pharmaceuticals | Phase 2 |
| University Health Network, Toronto | Phase 2/Phase 3 |
Recent Litigation for paclitaxel
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ABRAXIS BIOSCIENCE, LLC v. SUN PHARMA ADVANCED RESEARCH COMPANY, LTD. | 2019-08-08 |
| ABRAXIS BIOSCIENCE, LLC v. HBT LABS, INC. | 2018-12-17 |
| ABRAXIS BIOSCIENCE, LLC v. CIPLA LTD. | 2016-12-07 |
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 |
Paragraph IV (Patent) Challenges for PACLITAXEL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ABRAXANE | FOR SUSPENSION;IV (INFUSION) | paclitaxel | 021660 | 2015-12-11 |
| TAXOL | INJECTABLE;INJECTION | paclitaxel | 020262 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz Inc | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 078167-001 | Dec 26, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hospira | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 076233-001 | Aug 1, 2002 | DISCN | No | 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 | Y | Start Trial | |||
| Accord Hlthcare | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 205720-001 | Aug 17, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan Labs Ltd | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 091540-001 | Sep 29, 2011 | AP | RX | No | 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 | Y | Start Trial | |||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for paclitaxel
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1853250 | Start Trial |
| Brazil | PI9810945 | Start Trial |
| China | 1638736 | Start Trial |
| Japan | 2015147817 | Start Trial |
| South Korea | 20150065957 | Start Trial |
| South Korea | 20150103745 | Start Trial |
| Slovenia | 2301531 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for paclitaxel
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1853250 | 238 50005-2014 | Slovakia | Start Trial | PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230 |
| 0961612 | 09C0050 | France | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111 |
| 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 |
| 0961612 | 2009C/046 | Belgium | Start Trial | PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111 |
| 0961612 | 91613 | Luxembourg | Start Trial | 91613, EXPIRES: 20220924 |
| 1853250 | C300673 | Netherlands | Start Trial | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 |
| 1853250 | PA2014022 | Lithuania | Start Trial | PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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.
Copyright 2002-2020 thinkBiotech LLC
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2020 - 2021
NCE-1 Patent Challenge Dates 2020 - 2021
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2020 - 2021
NCE-1 Patent Challenge Dates 2020 - 2021
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.