DORIBAX Drug Patent Profile

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

Doribax is a drug marketed by Shionogi Inc and is included in one NDA.

The generic ingredient in DORIBAX is doripenem. There are five drug master file entries for this compound. Additional details are available on the doripenem profile page.

Summary for DORIBAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	3
Patent Applications:	5,324
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DORIBAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DORIBAX
DailyMed Link:	DORIBAX at DailyMed

See drug prices for DORIBAX

Recent Clinical Trials for DORIBAX

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

Sponsor	Phase
Janssen Pharmaceutica
Janssen-Cilag Ltd.,Thailand	Phase 4
Keith A. Rodvold	Phase 1

See all DORIBAX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DORIBAX

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DORIBAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DORIBAX	Injection	doripenem	250 mg/vial and 500 mg/vial	022106	1	2011-10-12

US Patents and Regulatory Information for DORIBAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010		DISCN	Yes	No
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007		DISCN	Yes	No

Expired US Patents for DORIBAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010

EU/EMA Drug Approvals for DORIBAX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Doribax	doripenem	EMEA/H/C/000891 Doribax is indicated for the treatment of the following infections in adults:nosocomial pneumonia (including ventilator-associated pneumonia);complicated intra-abdominal infections;complicated urinary tract infections.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Withdrawn	no	no	no	2008-07-25

International Patents for DORIBAX

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

Country	Patent Number	Title	Estimated Expiration
Portugal	528678
Denmark	0528678
Germany	69231834
China	1078718

Supplementary Protection Certificates for DORIBAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0528678	SPC/GB09/006	United Kingdom		PRODUCT NAME: DORIPENEM; REGISTERED: UK EU/1/08/467/001 20080725
0528678	09C0005	France		PRODUCT NAME: DORIPENEME; REGISTRATION NO/DATE IN FRANCE: EU/1/07/467/001 DU 20080725; REGISTRATION NO/DATE AT EEC: EU/1/08/467/001 DU 20080725
1270575	333	Finland
0528678	C00528678/01	Switzerland		PRODUCT NAME: DORIPENEMUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58667 19.10.2009