HYCAMTIN Drug Patent Profile
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Which patents cover Hycamtin, and when can generic versions of Hycamtin launch?
Hycamtin is a drug marketed by Sandoz and is included in two NDAs. There is one patent protecting this drug.
This drug has eighteen patent family members in sixteen countries.
The generic ingredient in HYCAMTIN is topotecan hydrochloride. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hycamtin
A generic version of HYCAMTIN was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29th, 2010.
Summary for HYCAMTIN
International Patents: | 18 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 108 |
Clinical Trials: | 117 |
Patent Applications: | 7,136 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for HYCAMTIN |
What excipients (inactive ingredients) are in HYCAMTIN? | HYCAMTIN excipients list |
DailyMed Link: | HYCAMTIN at DailyMed |
Recent Clinical Trials for HYCAMTIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
G1 Therapeutics, Inc. | Phase 4 |
Bristol-Myers Squibb | Phase 2 |
Innovative Therapies For Children with Cancer Consortium | Phase 1/Phase 2 |
Pharmacology for HYCAMTIN
Drug Class | Topoisomerase Inhibitor |
Mechanism of Action | Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for HYCAMTIN
US Patents and Regulatory Information for HYCAMTIN
HYCAMTIN is protected by one US patents.
Patents protecting HYCAMTIN
Compound, corresponding compositions, preparation and/or treatment methods
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | HYCAMTIN | topotecan hydrochloride | CAPSULE;ORAL | 020981-001 | Oct 11, 2007 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Sandoz | HYCAMTIN | topotecan hydrochloride | CAPSULE;ORAL | 020981-002 | Oct 11, 2007 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Sandoz | HYCAMTIN | topotecan hydrochloride | INJECTABLE;INJECTION | 020671-001 | May 28, 1996 | AP | RX | Yes | Yes | ⤷ 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 HYCAMTIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
Sandoz | HYCAMTIN | topotecan hydrochloride | INJECTABLE;INJECTION | 020671-001 | May 28, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HYCAMTIN
See the table below for patents covering HYCAMTIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 170487 | ⤷ Try a Trial | |
Ireland | 74873 | Water soluble camptothecin analogs | ⤷ Try a Trial |
New Zealand | 227124 | CAMPTOTHECIN ANALOGUES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Try a Trial |
China | 1087637 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HYCAMTIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |