HEPSERA Drug Patent Profile

Which patents cover Hepsera, and when can generic versions of Hepsera launch?

Hepsera is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hepsera

A generic version of HEPSERA was approved as adefovir dipivoxil by SIGMAPHARM LABS LLC on August 29^th, 2013.

Summary for HEPSERA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	19
Patent Applications:	5,359
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HEPSERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HEPSERA
What excipients (inactive ingredients) are in HEPSERA?	HEPSERA excipients list
DailyMed Link:	HEPSERA at DailyMed

See drug prices for HEPSERA

Recent Clinical Trials for HEPSERA

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

Sponsor	Phase
Yeungnam University Hospital	Phase 4
Daegu Catholic University Medical Center	Phase 4
Yeungnam University	Phase 4

See all HEPSERA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HEPSERA

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for HEPSERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEPSERA	Tablets	adefovir dipivoxil	10 mg	021449	1	2010-06-08

US Patents and Regulatory Information for HEPSERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	AB	RX	Yes	Yes

Expired US Patents for HEPSERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002

International Patents for HEPSERA

See the table below for patents covering HEPSERA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	580151
Japan	H0692307
Australia	5632886
Canada	1272956	UTILISATION THERAPEUTIQUE DE PHOSPHONYLMETHOXY-ALKYL- ADENINES (THERAPEUTICAL APPLICATION OF PHOSPHONYLMETHOXY-ALKYL ADENINES)
Philippines	23112	THERAPEUTICAL APPLICATION OF PHOSPHONYLMETHOXYALKYL ADENINES

Supplementary Protection Certificates for HEPSERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481214	C300131	Netherlands		PRODUCT NAME: ADEFOVIR DIPIVOXIL, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE ZUURADDITIE ZOUTEN, METAALZOUTEN EN SOLVATEN HIERVAN; NAT. REGISTRATION NO/DATE: EU/1/03/251/001 20030306; FIRST REGISTRATION: EU/1/03/251/001 20030306
0481214	03C0034	France		PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
0481214	91036	Luxembourg		91036, EXPIRES: 20160910
0481214	SPC/GB03/030	United Kingdom		PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306
0481214	300131	Netherlands		300131, 20110910, EXPIRES: 20160909