Details for Patent: 11,103,483
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Which drugs does patent 11,103,483 protect, and when does it expire?
Patent 11,103,483 protects BELRAPZO and BENDEKA and is included in two NDAs.
This patent has thirty patent family members in fifteen countries.
Summary for Patent: 11,103,483
| 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 (Uxbridge, GB) |
| Assignee: | Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ) |
| Application Number: | 16/509,920 |
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Patent Claim Types: see list of patent claims | Use; Composition; |
Drugs Protected by US Patent 11,103,483
| 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;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA | ⤷ Sign Up | ||
| Eagle Pharms | BELRAPZO | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 205580-001 | May 15, 2018 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA | ⤷ Sign Up | ||
| Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
