BOTOX Drug Profile
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Summary for Tradename: BOTOX
| High Confidence Patents: | 11 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for BOTOX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BOTOX |
Recent Litigation for BOTOX
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Grant Prideco, Inc. v. Schlumberger Technology Corporation | 2023-02-27 |
| Teva Pharmaceuticals International GmbH v. Eli Lilly and Company | 2021-06-07 |
| In re: Aoki | 2013-07-30 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Eli Lilly and Company | 2022-04-11 |
| 2017-02-21 |
Pharmacology for BOTOX
| Mechanism of Action | Acetylcholine Release Inhibitors |
| Physiological Effect | Neuromuscular Blockade |
| Established Pharmacologic Class | Acetylcholine Release Inhibitor Neuromuscular Blocker |
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 BOTOX Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for BOTOX Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Allergan, Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Try a Trial | 2017-07-15 | Company disclosures |
| Allergan, Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Try a Trial | 2013-12-28 | Company disclosures |
| Allergan, Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Try a Trial | 2013-12-28 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for BOTOX Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Allergan, Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Try a Trial | 2033-03-11 | Patent claims search |
| Allergan, Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Try a Trial | 2039-02-26 | Patent claims search |
| Allergan, Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Try a Trial | 2039-02-26 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for BOTOX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2005234633 | ⤷ Try a Trial |
| Germany | 122009000038 | ⤷ Try a Trial |
| Spain | 2334357 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BOTOX
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C02145629/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: THE REGENTS OF THE UNIVERSITY OF COLORADO, A BODY CORPORATE, US |
| 39/2013 | Austria | ⤷ Try a Trial | PRODUCT NAME: BOTULINUMTOXIN TYP A; REGISTRATION NO/DATE: 2-00358; 1-23699; 2-00381 20130117 |
| SPC/GB13/078 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BOTULINUM TOXIN TYPE A; REGISTERED: FI 263103-5/2012 20130116; UK PL 00426/0118 - 0061 20130904; UK PL 00426/0074 - 0139 20130904; UK PL 00426/0119 - 0047 20130904 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
