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 |
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 |
|---|---|---|---|---|---|---|---|
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 2017-07-15 | Company disclosures |
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 2013-12-28 | Company disclosures |
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 2013-12-28 | Company disclosures |
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 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 |
|---|---|---|---|---|---|---|---|
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 2039-02-26 | Patent claims search |
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 2039-02-26 | Patent claims search |
| Abbvie Inc. | BOTOX | onabotulinumtoxina | For Injection | 103000 | ⤷ Sign Up | 2034-03-16 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for BOTOX
Supplementary Protection Certificates for BOTOX
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 132013902177250 | Italy | ⤷ Sign Up | PRODUCT NAME: TOSSINA BOTULINICA DI TIPO A(BOTOX); AUTHORISATION NUMBER(S) AND DATE(S): NL25449, 20110826;034883013/M, 20130123 |
| 92250 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: TOXINE BOTULIQUE DE TYPE A DE CLOSTRIDIUM BOTULINUM |
| SPC/GB12/053 | United Kingdom | ⤷ Sign Up | CORRECTED ENTRY FOLLOWS; REASON FOR LAPSE IN JOURNAL 6768 - 06.02.2019 WAS PUBLISHED IN ERROR, THE REASON FOR LAPSE WAS FEES NOT PAID. ; APPLICANT: ALLERGAN, INC.; 2525 DUPONT DRIVE, IRVINE, CALIFORNIA 92612, UNITED STATES OF AMERICA; PRODUCT: BOTULINUM TOXIN; PRODUCT TYPE: MEDICINAL; AUTHORISED: UK PL 00426/0074-0110 24 SEPTEMBER 2012; UK PL 00426/0118-0030 24 SEPTEMBER 2012; UK PL 00426/0119-0012 24 SEPTEMBER 2012; AUTHORISED EXTENSION:; PATENT NO: EP1658858; TITLE: USE OF BOTULINUM TOXIN FOR THE TREATMENT OF RECALCITRANT VOIDING DYSFUNCTION.; SPC NO: SPC/GB12/053; REASON FOR LAPSE: SURRENDERED; DATE LAPSED: 15 JANUARY 2019 |
| CR 2013 00041 | Denmark | ⤷ Sign Up | PRODUCT NAME: BOTULINUM TOXIN, HERUNDER BOTULINUM TOXIN A; NAT. REG. NO/DATE: 43623, 31350, 46039 (DK) 20130219; FIRST REG. NO/DATE: FI 25162,15424, 28146 20130116 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
