Acyclovir - Generic Drug Details

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

Acyclovir is the generic ingredient in seven branded drugs marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage Pharms, Indoco, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Padagis Israel, Zydus Lifesciences, Bausch, Fera Pharms Llc, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Pharms Sa, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm Llc, Lnhc, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Abbvie, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in ninety-seven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acyclovir has forty-six patent family members in twenty-nine countries.

There are fifty-six drug master file entries for acyclovir. Sixty-nine suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for acyclovir

International Patents:	46
US Patents:	3
Tradenames:	7
Applicants:	65
NDAs:	97
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	185
Clinical Trials:	127
Patent Applications:	5,902
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for acyclovir
Drug Sales Revenues:	Drug sales revenues for acyclovir
What excipients (inactive ingredients) are in acyclovir?	acyclovir excipients list
DailyMed Link:	acyclovir at DailyMed

See drug prices for acyclovir

See drug sales revenues for acyclovir

Recent Clinical Trials for acyclovir

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

Sponsor	Phase
Rehab Werida	N/A
University Hospital, Toulouse	Phase 1
Ho Chi Minh City Hospital of Dermato-Venereology	N/A

See all acyclovir clinical trials

Generic filers with tentative approvals for ACYCLOVIR

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	800MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	400MG	TABLET;ORAL

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 acyclovir

Drug Class	Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for acyclovir

Antiviral Agents

US Patents and Regulatory Information for acyclovir

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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
Cadila Pharms Ltd	ACYCLOVIR	acyclovir	CAPSULE;ORAL	201445-001	Mar 6, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	ACYCLOVIR	acyclovir	CREAM;TOPICAL	208702-001	Feb 4, 2019	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cadila Pharms Ltd	ACYCLOVIR	acyclovir	TABLET;ORAL	202168-001	Nov 15, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	ACYCLOVIR	acyclovir	TABLET;ORAL	075211-001	Sep 28, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	ACYCLOVIR	acyclovir	OINTMENT;TOPICAL	202459-001	Apr 3, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lek Pharm	ACYCLOVIR	acyclovir	CAPSULE;ORAL	074750-001	Apr 22, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharms	ACYCLOVIR	acyclovir	CAPSULE;ORAL	074889-001	Oct 31, 1997	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 acyclovir

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	ZOVIRAX	acyclovir	TABLET;ORAL	020089-002	Apr 30, 1991	⤷ Sign Up	⤷ Sign Up
Mylan	ZOVIRAX	acyclovir	CAPSULE;ORAL	018828-001	Jan 25, 1985	⤷ Sign Up	⤷ Sign Up
Bausch	ZOVIRAX	acyclovir	OINTMENT;TOPICAL	018604-001	Mar 29, 1982	⤷ Sign Up	⤷ Sign Up
Mylan	ZOVIRAX	acyclovir	TABLET;ORAL	020089-001	Apr 30, 1991	⤷ Sign Up	⤷ Sign Up
Bausch	ZOVIRAX	acyclovir	CREAM;TOPICAL	021478-001	Dec 30, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for acyclovir

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2335690	Comprimés buccaux mucoadhésifs pour le traitement de l'herpès orofacial (Mucoadhesive buccal tablets for the treatment of orofacial herpes)	⤷ Sign Up
Croatia	P20100039		⤷ Sign Up
Japan	2013513575		⤷ Sign Up
Spain	2678122		⤷ Sign Up
Hungary	E039647		⤷ Sign Up
Cyprus	1109723		⤷ Sign Up
Australia	2007231029	Mucosal bioadhesive slow release carrier for delivering active principles	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for acyclovir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	10C0038	France	⤷ Sign Up	PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498	SPC/GB10/012	United Kingdom	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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