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Paclitaxel - Generic Drug Details
What are the generic sources for paclitaxel and what is the scope of paclitaxel 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 four patent family members in thirty-one countries.
There are sixty-nine drug master file entries for paclitaxel. Eleven suppliers are listed for this compound.
Summary for paclitaxel
| International Patents: | 304 |
| US Patents: | 12 |
| Tradenames: | 4 |
| Applicants: | 14 |
| NDAs: | 16 |
| Drug Master File Entries: | 69 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 79 |
| Clinical Trials: | 2,634 |
| Patent Applications: | 7,519 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 075297-001 | Jan 25, 2002 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pliva Lachema | PACLITAXEL | paclitaxel | INJECTABLE;INJECTION | 077413-001 | Mar 12, 2008 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Gland Pharma Ltd | PACITAXEL | paclitaxel | INJECTABLE;INJECTION | 207326-001 | Aug 23, 2016 | AP | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 | ➤ Sign Up | ➤ Sign Up |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | ➤ Sign Up | ➤ Sign Up |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | ➤ Sign Up | ➤ Sign Up |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | ➤ Sign Up | ➤ Sign Up |
| Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for paclitaxel
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2013203699 | ➤ Sign Up |
| European Patent Office | 3248600 | ➤ Sign Up |
| China | 1267214 | ➤ Sign Up |
| European Patent Office | 2481405 | ➤ Sign Up |
| South Korea | 20010014254 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for paclitaxel
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0961612 | 441 | Finland | ➤ Sign Up | |
| 0961612 | C00961612/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014 |
| 1853250 | C300673 | Netherlands | ➤ Sign Up | PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220 |
| 1853250 | 238 50005-2014 | Slovakia | ➤ Sign Up | PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230 |
| 1853250 | CA 2014 00034 | Denmark | ➤ Sign Up | PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: C(2013)9835 20131220 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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