Details for Patent: 8,754,090
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Which drugs does patent 8,754,090 protect, and when does it expire?
Patent 8,754,090 protects IMBRUVICA and is included in two NDAs.
Protection for IMBRUVICA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.
This patent has fifty-nine patent family members in eighteen countries.
Summary for Patent: 8,754,090
| Title: | Use of inhibitors of bruton's tyrosine kinase (Btk) |
| Abstract: | Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile. |
| Inventor(s): | Buggy; Joseph J. (Mountain View, CA), Fyfe; Gwen (San Francisco, CA), Loury; David J. (San Jose, CA) |
| Assignee: | Pharmacyclics, Inc. (Sunnyvale, CA) |
| Application Number: | 13/340,522 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,754,090 |
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Patent Claim Types: see list of patent claims | Use; |
| Scope and claims summary: | Patent Analysis: US Patent 8754090 Background and Overview United States Patent 8754090, awarded to pharmaceutical company Celgene, pertains to the use of lenalidomide in combination with an alkylating agent for the treatment of multiple myeloma and diffuse large B-cell lymphoma. The patent focuses on a pharmaceutical composition containing lenalidomide, an immunomodulatory drug, paired with an alkylating agent such as melphalan or cyclophosphamide. Claims and Scope The main claim (1) describes a pharmaceutical composition comprising lenalidomide and an alkylating agent, wherein the composition is used for treating multiple myeloma or diffuse large B-cell lymphoma. Further claims (2-5) detail specific aspects, including the presence of a solvent, a stabilizer, or a pH regulator. Claim (6) encompasses using the composition in combination with other therapeutic agents, such as corticosteroids. Patent Strategies and Limitations The patent takes a broad approach by claiming a composition rather than a specific formulation or method of use. This strategy may provide Celgene with protections against competitors attempting to develop similar products using lenalidomide and an alkylating agent combination. However, the composition claims could be considered a combination patent, which may face stricter enforceability and potentially increase the risk of opposition or invalidation. |
Drugs Protected by US Patent 8,754,090
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-002 | Dec 20, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||||
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||||
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-004 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
International Family Members for US Patent 8,754,090
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2011261185 | ⤷ Sign Up | |||
| Australia | 2015275321 | ⤷ Sign Up | |||
| Australia | 2018204179 | ⤷ Sign Up | |||
| Australia | 2020202752 | ⤷ Sign Up | |||
| Australia | 2022201741 | ⤷ Sign Up | |||
| Australia | 2022201742 | ⤷ Sign Up | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
