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KERYDIN Drug Profile
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See Plans and PricingWhen do Kerydin patents expire, and what generic alternatives are available?
Kerydin is a drug marketed by Anacor Pharms Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-one patent family members in twenty-one countries.
The generic ingredient in KERYDIN is tavaborole. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tavaborole profile page.
US ANDA Litigation and Generic Entry Outlook for Kerydin
Kerydin was eligible for patent challenges on July 7, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 16, 2026. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (tavaborole), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for KERYDIN
| International Patents: | 81 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 1 |
| Patent Applications: | 65 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for KERYDIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KERYDIN |
| DailyMed Link: | KERYDIN at DailyMed |
Generic Entry Opportunity Date for KERYDIN
Generic Entry Date for KERYDIN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for KERYDIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
Recent Litigation for KERYDIN
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 |
Pharmacology for KERYDIN
| Drug Class | Oxaborole Antifungal |
| Mechanism of Action | Protein Synthesis Inhibitors |
Synonyms for KERYDIN
| 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 (TN) |
| KS-00000SPV |
| LFQDNHWZDQTITF-UHFFFAOYSA-N |
| MB08883 |
| MFCD10699483 (95%) |
| MolPort-027-845-281 |
| NCGC00264110-01 |
| SCH-900340 |
| SCHEMBL500016 |
| ST24044751 |
| SY038332 |
| Tavaborole |
| Tavaborole (USAN) |
| Tavaborole [USAN:INN] |
| UNII-K124A4EUQ3 |
| W-5454 |
| X3699 |
| Z1739256284 |
| ZINC169990691 |
Paragraph IV (Patent) Challenges for KERYDIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KERYDIN | SOLUTION;TOPICAL | tavaborole | 204427 | 2018-07-09 |
US Patents and Regulatory Information for KERYDIN
| 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 | Y | Start Trial | |||
| 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 | |||
| 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 | |||
| >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 KERYDIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2008131324 | Start Trial |
| Hong Kong | 1109735 | Start Trial |
| Israel | 192402 | Start Trial |
| Japan | 6109140 | Start Trial |
| South Korea | 20130095330 | Start Trial |
| China | 101505603 | Start Trial |
| Slovenia | 2343304 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
