FAMCICLOVIR - Generic Drug Details

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

Famciclovir is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd V, Hikma, Macleods Pharms Ltd, Natco Pharma, Teva Pharms, and Novartis, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for famciclovir. Ten suppliers are listed for this compound.

Summary for FAMCICLOVIR

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	19
Patent Applications:	6,817
Drug Prices:	Drug price trends for FAMCICLOVIR
What excipients (inactive ingredients) are in FAMCICLOVIR?	FAMCICLOVIR excipients list
DailyMed Link:	FAMCICLOVIR at DailyMed

See drug prices for FAMCICLOVIR

Recent Clinical Trials for FAMCICLOVIR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Queen Mary University of London	Phase 2
EMS	Phase 3
House Research Institute	Phase 3

See all FAMCICLOVIR clinical trials

Pharmacology for FAMCICLOVIR

Drug Class	Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FAMCICLOVIR

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for FAMCICLOVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FAMVIR	Tablets	famciclovir	125 mg, 250 mg and 500 mg	020363	1	2004-12-28

US Patents and Regulatory Information for FAMCICLOVIR

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd V	FAMCICLOVIR	famciclovir	TABLET;ORAL	202438-001	Sep 10, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	FAMCICLOVIR	famciclovir	TABLET;ORAL	078278-003	Mar 21, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	FAMCICLOVIR	famciclovir	TABLET;ORAL	091114-003	Mar 21, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	FAMCICLOVIR	famciclovir	TABLET;ORAL	078278-002	Mar 21, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	FAMCICLOVIR	famciclovir	TABLET;ORAL	091480-002	Jul 22, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 FAMCICLOVIR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994	⤷ Sign Up	⤷ Sign Up
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-002	Jun 29, 1994	⤷ Sign Up	⤷ Sign Up
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	FAMVIR	famciclovir	TABLET;ORAL	020363-003	Dec 11, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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