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Tavaborole - Generic Drug Details
What are the generic sources for tavaborole and what is the scope of patent protection?
Tavaborole
is the generic ingredient in one branded drug marketed by Anacor Pharms Inc and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Tavaborole has eighty-one patent family members in twenty-one countries.
There are six drug master file entries for tavaborole. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for tavaborole
| International Patents: | 81 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 1 |
| Patent Applications: | 86 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tavaborole |
| DailyMed Link: | tavaborole at DailyMed |
Recent Clinical Trials for tavaborole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
Recent Litigation for tavaborole
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Anacor Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. | 2018-10-29 |
| Anacor Pharmaceuticals, Inc. v. Lupin Limited | 2018-10-17 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2018-07-10 |
| Mylan Pharmaceuticals Inc. | 2018-07-06 |
| FlatWing Pharmaceuticals, LLC | 2017-11-21 |
Generic filers with tentative approvals for TAVABOROLE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 5% | SOLUTION;TOPICAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for tavaborole
| Drug Class | Oxaborole Antifungal |
| Mechanism of Action | Protein Synthesis Inhibitors |
Synonyms for tavaborole
| 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole |
| 174671-46-6 |
| 2,1-Benzoxaborole, 5-fluoro-1,3-dihydro-1-hydroxy- |
| 3338AH |
| 5-fluoro-1-hydroxy-3H-2,1-benzoxaborole |
| 5-Fluoro-1-hydroxyl-1,3-dihydrobenzo[c][1,2]oxaborole |
| 5-Fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole |
| 5-fluoro-1,3-dihydro-2,1-benzoxaborol-1-ol |
| 5-fluoro-2,1-benzoxaborol-1(3H)-ol |
| 5-Fluoro-3H-benzo[c][1,2)oxaborol-1-ol |
| 5-fluoro-3H-benzo[c][1,2]oxaborol-1-ol |
| 5-FLUOROBENZO[C][1,2]OXABOROL-1(3H)-OL |
| AK163946 |
| AKOS006303927 |
| AN 2690 |
| AN-2690 |
| AN-2690(Tavaborole) |
| AN2690 |
| BCP08730 |
| BDBM50370987 |
| C7H6BFO2 |
| CHEBI:77942 |
| CHEMBL443052 |
| CS-1058 |
| CTK8H2675 |
| D10169 |
| DB09041 |
| DS-8392 |
| DTXSID00169888 |
| EX-A1086 |
| FT-0697827 |
| HSDB 8342 |
| HY-10980 |
| K124A4EUQ3 |
| KB-74687 |
| Kerydin |
| Kerydin (TN) |
| KS-00000SPV |
| LFQDNHWZDQTITF-UHFFFAOYSA-N |
| MB08883 |
| MFCD10699483 (95%) |
| MolPort-027-845-281 |
| NCGC00264110-01 |
| SCH-900340 |
| SCHEMBL500016 |
| ST24044751 |
| SY038332 |
| Tavaborole (USAN) |
| Tavaborole [USAN:INN] |
| UNII-K124A4EUQ3 |
| W-5454 |
| X3699 |
| Z1739256284 |
| ZINC169990691 |
Paragraph IV (Patent) Challenges for TAVABOROLE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KERYDIN | SOLUTION;TOPICAL | tavaborole | 204427 | 2018-07-09 |
US Patents and Regulatory Information for tavaborole
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Anacor Pharms Inc | KERYDIN | tavaborole | SOLUTION;TOPICAL | 204427-001 | Jul 7, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for tavaborole
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2008131324 | Start Trial |
| Hong Kong | 1109735 | Start Trial |
| Israel | 192402 | Start Trial |
| Japan | 6109140 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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