TYSABRI Drug Profile
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Summary for Tradename: TYSABRI
| High Confidence Patents: | 6 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for TYSABRI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TYSABRI |
Recent Clinical Trials for TYSABRI
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 1 |
| BioLineRx, Ltd. | Phase 1 |
| Queen Mary University of London | Phase 2 |
Recent Litigation for TYSABRI
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 |
|---|---|
| Miltenyi Biomedicine GmbH et al. | 2022-04-12 |
| Swiss Pharma International AG | 2016-04-18 |
| Swiss Pharma International AG et al. | 2016-04-18 |
Pharmacology for TYSABRI
| Mechanism of Action | Integrin Receptor Antagonists |
| Established Pharmacologic Class | Integrin Receptor Antagonist |
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 TYSABRI Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for TYSABRI Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2009-12-01 | Company disclosures |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2005-01-30 | Company disclosures |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2015-03-24 | Company disclosures |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2014-01-25 | Company disclosures |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2017-03-07 | Company disclosures |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2020-08-05 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for TYSABRI Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2033-01-08 | Patent claims search |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2032-02-15 | Patent claims search |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2033-05-28 | Patent claims search |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2032-04-02 | Patent claims search |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2026-02-28 | Patent claims search |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2037-02-03 | Patent claims search |
| Biogen Inc. | TYSABRI | natalizumab | Injection | 125104 | ⤷ Sign Up | 2033-01-04 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for TYSABRI
Supplementary Protection Certificates for TYSABRI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C00804237/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: ELAN PHARMACEUTICALS, INC., US |
| CA 2006 00023 | Denmark | ⤷ Sign Up | PRODUCT NAME: NATALIZUMAB |
| 300240 | Netherlands | ⤷ Sign Up | PRODUCT: NATALIZUMAB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; FIRST REGISTRATION, DATE: EU/1/06/346/001, 20060627 |
| 06C0027 | France | ⤷ Sign Up | PRODUCT NAME: NATALIZUMAB; NAT. REGISTRATION NO/DATE: EU/1/06/346/001 20060627; FIRST REGISTRATION: FR - EU/1/06/346/001 20060627 |
| 300238 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NATALIZUMAB; REGISTRATION NO/DATE: EU/1/06/346/001 20060630 |
| 23/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: NATALIZUMAB; REGISTRATION NO/DATE: EU/1/06/346/001 20060627 |
| 132006901471186 | Italy | ⤷ Sign Up | PRODUCT NAME: NATALIZUMAB(TYSABRI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/06/346/001, 20060627 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
