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Details for Patent: 10,010,533
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Which drugs does patent 10,010,533 protect, and when does it expire?
Patent 10,010,533 protects BELRAPZO and BENDEKA and is included in two NDAs.
This patent has nineteen patent family members in fifteen countries.
Summary for Patent: 10,010,533
| Title: | Formulations of bendamustine |
| Abstract: | Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response ("PAR") basis as determined by high performance liquid chromatography ("HPLC") at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5.degree. C. to about 25.degree. C. |
| Inventor(s): | Palepu; Nagesh R. (Southampton, PA), Buxton; Philip Christopher (Great Dunmow, GB) |
| Assignee: | EAGLE PHARMACEUTICALS, INC. (Woodcliff Lake, NJ) |
| Application Number: | 15/432,335 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 10,010,533 |
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Patent Claim Types: see list of patent claims | Composition; |
Drugs Protected by US Patent 10,010,533
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 205580-001 | May 15, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | 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. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 10,010,533
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Canada | 2787568 | Start Trial | |||
| Cyprus | 1118769 | Start Trial | |||
| Denmark | 2528602 | Start Trial | |||
| European Patent Office | 2528602 | Start Trial | |||
| European Patent Office | 3158991 | Start Trial | |||
| Spain | 2609106 | Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
