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 twenty-nine 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||||
| >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 | See Plans and Pricing | |||
| Cyprus | 1118769 | See Plans and Pricing | |||
| Denmark | 2528602 | See Plans and Pricing | |||
| Denmark | 3158991 | See Plans and Pricing | |||
| European Patent Office | 2528602 | See Plans and Pricing | |||
| European Patent Office | 3158991 | See Plans and Pricing | |||
| European Patent Office | 3895694 | See Plans and Pricing | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
