Eagle Pharmaceuticals, Inc. announced that an additional patent has been issued related to Bendeka by the United States Patent and Trademark Office (USPTO). Patent number 10,010,533 will expire January 2031. The USPTO has now issued or allowed a total of 15 patents in the Bendeka family of patents expiring from 2026 to 2033.
The newly issued patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing Eagle’s total Orange Book listed patents for Bendeka to 131.
As a result of a court decision issued on June 8, 2018, Bendeka now has Orphan Drug Exclusivity (ODE). The FDA will not be able to approve any drug applications referencing Bendeka until the ODE expires in December 2022. Moreover, the company now does not expect generic Treanda entrants into the market until December 2022, rather than November 2019.
“We believe that with the recent positive ODE decision and the strength of our intellectual property portfolio, Bendeka has longevity well beyond 2022,” stated Scott Tarriff, chief executive officer of Eagle Pharmaceuticals.
The following table lists issued patents for Eagle’s liquid bendamustine hydrochloride formulations:
|
U.S. Patent No. |
Patent Expiration |
|||
| 8,609,707 | 1/28/2031 | |||
| 8,791,270*PED (owned by Teva Pharmaceutical Industries Ltd.) |
7/12/2026 | |||
| 9,000,021 | 3/15/2033 | |||
| 9,034,908 | 3/15/2033 | |||
| 9,144,568 | 3/15/2033 | |||
| 9,265,831 | 1/28/2031 | |||
| 9,572,796 | 1/28/2031 | |||
| 9,572,797 | 1/28/2031 | |||
| 9,572,887 | 3/15/2033 | |||
| 9,572,888 | 3/15/2033 | |||
| 9,579,384 | 3/15/2033 | |||
| 9,579,397 | 3/15/2033 | |||
| 9,579,398 | 3/15/2033 | |||
| 9,579,399 | 3/15/2033 | |||
| 10,010,533 |
1/28/2031 |
|||
Under a February 2015 exclusive license agreement for Bendeka, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution.
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Reference:
1Orange Book patent 270 owned by Cephalon, Inc.
(Source: Eagle Pharmaceuticals, Inc.)
