Topotecan hydrochloride - Generic Drug Details
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What are the generic drug sources for topotecan hydrochloride and what is the scope of freedom to operate?
Topotecan hydrochloride
is the generic ingredient in three branded drugs marketed by Sandoz, Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Novast Labs, Rising, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Sandoz Inc, Dash Pharms, and Hospira Inc, and is included in eighteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Topotecan hydrochloride has eighteen patent family members in sixteen countries.
There are eight drug master file entries for topotecan hydrochloride. Six suppliers are listed for this compound.
Summary for topotecan hydrochloride
International Patents: | 18 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 14 |
NDAs: | 18 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 108 |
Clinical Trials: | 434 |
Patent Applications: | 7,232 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in topotecan hydrochloride? | topotecan hydrochloride excipients list |
DailyMed Link: | topotecan hydrochloride at DailyMed |
Recent Clinical Trials for topotecan hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amgen | Phase 3 |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Phase 2 |
Bristol-Myers Squibb | Phase 2 |
Pharmacology for topotecan hydrochloride
Drug Class | Topoisomerase Inhibitor |
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for topotecan hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for topotecan hydrochloride
US Patents and Regulatory Information for topotecan hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 091376-001 | Nov 29, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm Inds Ltd | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 202203-001 | Aug 29, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Actavis Totowa | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 090620-001 | Dec 2, 2010 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz Inc | TOPOTECAN | topotecan hydrochloride | SOLUTION;INTRAVENOUS | 200199-002 | Feb 25, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 topotecan hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | HYCAMTIN | topotecan hydrochloride | INJECTABLE;INJECTION | 020671-001 | May 28, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | HYCAMTIN | topotecan hydrochloride | CAPSULE;ORAL | 020981-001 | Oct 11, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | HYCAMTIN | topotecan hydrochloride | INJECTABLE;INJECTION | 020671-001 | May 28, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | HYCAMTIN | topotecan hydrochloride | CAPSULE;ORAL | 020981-002 | Oct 11, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for topotecan hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1689400 | NOUVEAU COMPOSE, COMPOSITIONS CORRESPONDANTES, METHODES DE FABRICATION ET/OU DE TRAITEMENT (NOVEL COMPOUND, CORRESPONDING COMPOSITIONS, PREPARATION AND/OR TREATMENT METHODS) | ⤷ Try a Trial |
South Korea | 20060122847 | NOVEL COMPOUND, CORRESPONDING COMPOSITIONS, PREPARATION AND/OR TREATMENT METHODS | ⤷ Try a Trial |
Canada | 2545876 | NOUVEAU COMPOSE, COMPOSITIONS CORRESPONDANTES, METHODES DE FABRICATION ET/OU DE TRAITEMENT (NOVEL COMPOUND, CORRESPONDING COMPOSITIONS, PREPARATION AND/OR TREATMENT METHODS) | ⤷ Try a Trial |
Russian Federation | 2006120422 | НОВОЕ СОЕДИНЕНИЕ, СООТВЕТСТВУЮЩИЕ КОМПОЗИЦИИ, СПОСОБЫ ПОЛУЧЕНИЯ И/ИЛИ СПОСОБЫ ЛЕЧЕНИЯ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for topotecan hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0321122 | SPC/GB96/057 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TOPOTECAN; REGISTERED: CH IKS-NR:53857 19961016; UK EU/1/96/027/001 19961112; UK EU/1/96/027/002 19961112 |
0321122 | C970017 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TOPOTECAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, HYDRAAT OF SOLVAAT, IN HET BIJZONDER HET HYDROCHLORI DE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 - EU/1/96/027/002 19961112; FIRST REGISTRATION: CH IKS 53857 19961016 |
0321122 | 2/1997 | Austria | ⤷ Try a Trial | PRODUCT NAME: TOPOTECAN; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 EU/1/96/027/002 19961112; FIRST REGISTRATION: LI 53857 01 19961016 |
0321122 | 97C0009 | Belgium | ⤷ Try a Trial | PRODUCT NAME: TOPOTECAN HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/96/027/001 19961112 ; FIRST REGISTRATION: CH 53857 19961016 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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