HUMIRA Drug Profile
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Summary for Tradename: HUMIRA
| High Confidence Patents: | 63 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for HUMIRA |
| Recent Clinical Trials: | See clinical trials for HUMIRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HUMIRA |
Recent Clinical Trials for HUMIRA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Teva takeda | Phase 4 |
| Mabscale, LLC | Phase 3 |
| Janssen Research & Development, LLC | Phase 1 |
Recent Litigation for HUMIRA
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| AbbVie Inc. v. Hetero USA, Inc. | 2024-08-08 |
| AbbVie Inc. v. Hetero USA, Inc. | 2023-11-20 |
| Janssen Biotech, Inc. v. Amgen Inc. | 2022-11-29 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Fresenius Kabi USA, LLC et al. | 2019-09-17 |
| 2017-12-20 | |
| Sandoz Inc. | 2017-11-06 |
Note on Biologic Patents
Matching patents to biologic drugs is far more complicated than for small-molecule drugs.
DrugPatentWatch employs three methods to identify biologic patents:
- Brand-side disclosures in response to biosimilar applications
- General brand-side disclosures
- Patents from broad patent text search
These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.
These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
1) High Certainty: US Patents for HUMIRA Derived from Brand-Side Litigation
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | September 23, 2014 | ⤷ Sign Up | 2023-07-18 |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | February 21, 2008 | ⤷ Sign Up | 2034-11-14 |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | April 24, 2013 | ⤷ Sign Up | 2027-09-13 |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | March 09, 2016 | ⤷ Sign Up | 2028-10-06 |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Patent Expiration |
2) High Certainty: US Patents for HUMIRA Derived from Company Disclosures
No patents found based on company disclosures
3) Low Certainty: US Patents for HUMIRA Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | ⤷ Sign Up | 2034-06-16 | Patent claims search |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | ⤷ Sign Up | 2032-12-21 | Patent claims search |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Abbvie Inc. | HUMIRA | adalimumab | Injection | 125057 | ⤷ Sign Up | 2033-03-13 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
