Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Colorcon
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Express Scripts
Mallinckrodt
McKinsey
Harvard Business School

Last Updated: December 7, 2019

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PENCICLOVIR - Generic Drug Details

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What are the generic drug sources for penciclovir and what is the scope of freedom to operate?

Penciclovir is the generic ingredient in one branded drug marketed by Mylan and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Penciclovir has one hundred and five patent family members in thirty-four countries.

There are three drug master file entries for penciclovir. Two suppliers are listed for this compound.

Drug Prices for PENCICLOVIR

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Recent Clinical Trials for PENCICLOVIR

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SponsorPhase
Squarex, LLCPhase 2
EMSPhase 3
NovartisPhase 4

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Recent Litigation for PENCICLOVIR

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District Court Litigation
Case NameDate
Pfizer Inc. v. Ranbaxy Laboratories Limited2007-03-09
NOVARTIS PHARMACEUITCALS CORPORATION v. ROXANE LABORATORIES, INC.
NOVARTIS PHARMACEUTICALS CORPORATION v. ROXANE LABORATORIES, INC.

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Pharmacology for PENCICLOVIR

US Patents and Regulatory Information for PENCICLOVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PENCICLOVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PENCICLOVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0141927 SPC/GB96/014 United Kingdom   Start Trial SPC/GB96/014: 20040810, EXPIRES: 20090809
0182024 SPC/GB94/002 United Kingdom   Start Trial SPC/GB94/002: 20050910, EXPIRES: 20081209
0141927 97C0033 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
Baxter
AstraZeneca
Express Scripts
Medtronic

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