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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 1340593-59-0, Vt-1161, Oteseconazole [usan], Vhh774w97n, Chembl3311228, (2r)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(tetrazol-1-yl)-1-[5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl]propan-2-ol
Molecular Formula
C23H16F7N5O2
Molecular Weight
527.4  g/mol
InChI Key
IDUYJRXRDSPPRC-NRFANRHFSA-N
FDA UNII
VHH774W97N

Oteseconazole
Oteseconazole has been used in trials studying the treatment of Tinea Pedis, Onychomycosis, Candidiasis, Vulvovaginal, and Recurrent Vulvovaginal Candidiasis.
1 2D Structure

Oteseconazole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(tetrazol-1-yl)-1-[5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl]propan-2-ol
2.1.2 InChI
InChI=1S/C23H16F7N5O2/c24-16-4-7-18(19(25)9-16)21(36,11-35-13-32-33-34-35)23(29,30)20-8-3-15(10-31-20)14-1-5-17(6-2-14)37-12-22(26,27)28/h1-10,13,36H,11-12H2/t21-/m0/s1
2.1.3 InChI Key
IDUYJRXRDSPPRC-NRFANRHFSA-N
2.1.4 Canonical SMILES
C1=CC(=CC=C1C2=CN=C(C=C2)C(C(CN3C=NN=N3)(C4=C(C=C(C=C4)F)F)O)(F)F)OCC(F)(F)F
2.1.5 Isomeric SMILES
C1=CC(=CC=C1C2=CN=C(C=C2)C([C@](CN3C=NN=N3)(C4=C(C=C(C=C4)F)F)O)(F)F)OCC(F)(F)F
2.2 Other Identifiers
2.2.1 UNII
VHH774W97N
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Vt-1161

2.3.2 Depositor-Supplied Synonyms

1. 1340593-59-0

2. Vt-1161

3. Oteseconazole [usan]

4. Vhh774w97n

5. Chembl3311228

6. (2r)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(tetrazol-1-yl)-1-[5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl]propan-2-ol

7. (r)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(1h-tetrazol-1-yl)-1-(5-(4-(2,2,2-trifluoroethoxy)phenyl)pyridin-2-yl)propan-2-ol

8. 2-pyridineethanol, Alpha-(2,4-difluorophenyl)-beta,beta-difluoro-alpha-(1h-tetrazol-1-ylmethyl)-5-(4-(2,2,2-trifluoroethoxy)phenyl)-, (alphar)-

9. 2-pyridineethanol, Alpha-(2,4-difluorophenyl)-beta,beta-difluoro-alpha-(1h-tetrazol-1-ylmethyl)-5-[4-(2,2,2-trifluoroethoxy)phenyl]-, (alphar)-

10. Vivjoa

11. Oteseconazole [inn]

12. Oteseconazole (usan/inn)

13. Unii-vhh774w97n

14. Oteseconazole, (+)-

15. Oteseconazole [who-dd]

16. Schembl17113021

17. Chebi:188153

18. Bdbm50046187

19. Who 10138

20. Db13055

21. Sb17420

22. Vt-1161vt-1161

23. Hy-17643

24. Cs-0016914

25. D11785

26. D87154

27. Q27291837

28. (2r)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(1h-tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl}propan-2-ol

29. (alphar)-alpha-(2,4-difluorophenyl)-beta,beta-difluoro-alpha-(1h-tetrazol-1-ylmethyl)-5-[4-(2,2,2-trifluoroethoxy)phenyl]-2-pyridineethanol

2.4 Create Date
2014-09-01
3 Chemical and Physical Properties
Molecular Weight 527.4 g/mol
Molecular Formula C23H16F7N5O2
XLogP34.2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count13
Rotatable Bond Count8
Exact Mass527.11922190 g/mol
Monoisotopic Mass527.11922190 g/mol
Topological Polar Surface Area86 Ų
Heavy Atom Count37
Formal Charge0
Complexity743
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of vulvovaginal candidiasis


5 Pharmacology and Biochemistry
5.1 ATC Code

J - Antiinfectives for systemic use

J02 - Antimycotics for systemic use

J02A - Antimycotics for systemic use

J02AC - Triazole and tetrazole derivatives

J02AC06 - Oteseconazole


API SUPPLIERS

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01

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Medlab Asia & Asia Health
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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Metrochem

02

Changzhou Pharmaceutical Factory

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health
Not Confirmed
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03

Beijing Sjar Technology Developmen...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health
Not Confirmed
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04

Sun-shine Chem

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health
Not Confirmed
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Sun-shine Chem

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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NDC API

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Micro-Macinazione SA

Switzerland
Medlab Asia & Asia Health
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Micro-Macinazione SA

Switzerland
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OTESECONAZOLE

NDC Package Code : 10745-1323

Start Marketing Date : 2019-08-13

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

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  • fda
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Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Digital Content Digital Content

Oteseconazole

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

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Medlab Asia & Asia Health
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Oteseconazole

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Medlab Asia & Asia Health
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Oteseconazole

About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...

Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was founded in 1949 by (Tan Ruiting) with a registered capital of 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of the Shanghai Pharma Group. The company mainly involves leading pharmaceutical manufacturers a wide range of key Intermediates, Active pharmaceutical ingredients, and Finished Formulations that meet with global standards.
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Oteseconazole

About the Company : Wuhan Sun-shine chemical Corporation Limited (Shanghai Sun-shine Chemical Technology Corporation Limited) is a high-tech enterprise engaged inR&D and sales of related compounds of ...

Wuhan Sun-shine chemical Corporation Limited (Shanghai Sun-shine Chemical Technology Corporation Limited) is a high-tech enterprise engaged inR&D and sales of related compounds of new drugs, specialty pharmaceutical API, advanced intermediates, organic synthetic masonry, and high-end reagents, etc. The special services we provide include: the technical development of chiral drugs, the development of an active molecular library. Sun-shine chemical has over 1,500m² of operation premises. The R&D laboratory is more than 1,000m² and is equipped with a variety of R&D laboratory equipment.
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Drugs in Development

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  • Development Update

Details:

Vivjoa (oteseconazole) is a selective and orally bioavailable CYP51 inhibitor antifungal, which is approved in China for the treatment of severe vulvovaginal candidiasis.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Mycovia Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 07, 2024

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Jiangsu Hengrui Pharmaceuticals

Country
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Medlab Asia & Asia Health
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Jiangsu Hengrui Pharmaceuticals

Country
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Medlab Asia & Asia Health
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Details : Vivjoa (oteseconazole) is a selective and orally bioavailable CYP51 inhibitor antifungal, which is approved in China for the treatment of severe vulvovaginal candidiasis.

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 07, 2024

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Details:

VIVJOA® (oteseconazole) is an azole antifungal and designed to selectively inhibit fungal CYP51, which is indicated for the treatment of severe vulvovaginal candidiasis (VVC).


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Jiangsu Hengrui Medicine

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 21, 2023

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02

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : VIVJOA® (oteseconazole) is an azole antifungal and designed to selectively inhibit fungal CYP51, which is indicated for the treatment of severe vulvovaginal candidiasis (VVC).

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 21, 2023

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Details:

VIVJOA (oteseconazole) was statistically superior to placebo in preventing recurrence of infection in women with RVVC and noninferior to fluconazole in treating acute VVC in women with RVVC.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 25, 2022

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03

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : VIVJOA (oteseconazole) was statistically superior to placebo in preventing recurrence of infection in women with RVVC and noninferior to fluconazole in treating acute VVC in women with RVVC.

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 25, 2022

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Details:

Of the 71 VIVJOA (oteseconazole) treated participants in the observational extension study, 85% completed 96 weeks without a recurrent VVC episode, where they had experienced at least three episodes in the year prior to study entry.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 02, 2022

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04

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Of the 71 VIVJOA (oteseconazole) treated participants in the observational extension study, 85% completed 96 weeks without a recurrent VVC episode, where they had experienced at least three episodes in the year prior to study entry.

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 02, 2022

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Details:

Two global VIOLET Phase 3 studies met primary and key secondary endpoints, with authors concluding VIVJOA (oteseconazole) is highly efficacious in preventing recurrence of VVC through 48 weeks in participants with a history of RVVC.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 26, 2022

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05

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Two global VIOLET Phase 3 studies met primary and key secondary endpoints, with authors concluding VIVJOA (oteseconazole) is highly efficacious in preventing recurrence of VVC through 48 weeks in participants with a history of RVVC.

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 26, 2022

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Details:

VIVJOAâ„¢ (oteseconazole) capsules are an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 18, 2022

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06

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : VIVJOAâ„¢ (oteseconazole) capsules are an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 18, 2022

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Details:

85% of patients who took a 12-week course of Vivjoa (oteseconazole) completed 96 weeks without a recurrent VVC episode, with an average time of 92 weeks without recurrence.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2022

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07

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : 85% of patients who took a 12-week course of Vivjoa (oteseconazole) completed 96 weeks without a recurrent VVC episode, with an average time of 92 weeks without recurrence.

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 22, 2022

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Details:

Approval of VIVJOAâ„¢ marks a significant therapeutic advancement for reducing the incidence of RVVC, a condition with substantial unmet need, in permanently infertile and postmenopausal women.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Vivjoa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2022

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08

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Approval of VIVJOAâ„¢ marks a significant therapeutic advancement for reducing the incidence of RVVC, a condition with substantial unmet need, in permanently infertile and postmenopausal women.

Brand Name : Vivjoa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 28, 2022

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Details:

Oteseconazole (VT-1161) is a novel, oral therapy for RVVC that is designed with the goal of having greater selectivity, fewer side effects and improved efficacy for treatment of recurrent vulvovaginal candidiasis (RVVC).


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: VT-1161

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 29, 2021

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09

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Oteseconazole (VT-1161) is a novel, oral therapy for RVVC that is designed with the goal of having greater selectivity, fewer side effects and improved efficacy for treatment of recurrent vulvovaginal candidiasis (RVVC).

Brand Name : VT-1161

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 29, 2021

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Details:

Oteseconazole’s clinical development plan was comprised of three trials – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries.


Lead Product(s): Oteseconazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: VT-1161

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2021

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10

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Oteseconazole’s clinical development plan was comprised of three trials – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries.

Brand Name : VT-1161

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 01, 2021

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Patents & EXCLUSIVITIES

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US Patents

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OTESECONAZOLE

US Patent Number : 11247981

Drug Substance Claim :

Drug Product Claim :

Application Number : 215888

Patent Use Code : U-3366

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-05-09

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OTESECONAZOLE

US Patent Number : 8754227

Drug Substance Claim :

Drug Product Claim :

Application Number : 215888

Patent Use Code : U-3366

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-04-22

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OTESECONAZOLE

US Patent Number : 8236962

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 215888

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-04-22

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OTESECONAZOLE

US Patent Number : 9840492

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 215888

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-03-17

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OTESECONAZOLE

US Patent Number : 10414751

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 215888

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-03-17

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