Patent: 10,493,152
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Summary for Patent: 10,493,152
| Title: | Adalimumab formulations |
| Abstract: | The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an histidine buffering agent such as histidine (or histidine buffer system such as histidine/imidiazolium-histidine), and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug. |
| Inventor(s): | Rinaldi; Gianluca (Monterotondo, RO), Fratarcangeli; Silvia (Ceprano, IT), Del Rio; Alessandra (Rome, IT) |
| Assignee: | Fresenius Kabi Deutschland GmbH (Bad Homburg, DE) |
| Application Number: | 15/313,480 |
| Patent Claims: | see list of patent claims |
Details for Patent 10,493,152
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
|---|---|---|---|---|---|---|---|
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | December 31, 2002 | ⤷ Start Trial | 2035-05-15 |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | February 21, 2008 | ⤷ Start Trial | 2035-05-15 |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | April 24, 2013 | ⤷ Start Trial | 2035-05-15 |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | September 23, 2014 | ⤷ Start Trial | 2035-05-15 |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | November 23, 2015 | ⤷ Start Trial | 2035-05-15 |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |
International Patent Family for US Patent 10,493,152
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2015263246 | ⤷ Start Trial |
| Australia | 2018222887 | ⤷ Start Trial |
| Australia | 2020201090 | ⤷ Start Trial |
| Australia | 2022203863 | ⤷ Start Trial |
| Canada | 2947487 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
