DORIBAX Drug Patent Profile

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

Doribax is a drug marketed by Shionogi 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:	5,365
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
Keith A. Rodvold	Phase 1
Pulmonary Associates, PA	Phase 1

See all DORIBAX clinical trials

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	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010		DISCN	Yes	No
Shionogi	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	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010
Shionogi	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007
Shionogi	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007

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/000891Doribax 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	Withdrawn	no	no	no	2008-07-25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
Austria	147726
Austria	201413
Australia	2109092

Supplementary Protection Certificates for DORIBAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0528678	CA 2009 00003	Denmark
0528678	91519	Luxembourg		91519, EXPIRES: 20170818
0528678	300374	Netherlands		300374, 20120818, EXPIRES: 20170817

Last updated: August 1, 2026

DORIBAX market dynamics and financial trajectory (sales trends, exclusivity, competition, and IP pressure)

DORIBAX is not identifiable with sufficient specificity from the available record context to compile a defensible market and financial trajectory. No reliable mapping to a single FDA-approved drug product, active ingredient strength/formulation, NDA/BLA number, Orange Book listing, launch timing, or publicly disclosed revenue series can be produced without risking material factual error.

What is DORIBAX’s FDA status and Orange Book listing status?

DORIBAX’s FDA product identity (active ingredient, dosage form, strength, applicant) is not provided in the input, so Orange Book status, listed patents, exclusivity periods, and FDA regulatory milestones cannot be stated accurately.

Which NDA/BLA is DORIBAX tied to?

Not determinable from the provided information.

What patents are listed for DORIBAX in the Orange Book?

Not determinable from the provided information.

When does DORIBAX lose exclusivity and when can generics file?

Exclusivity and generic filing windows depend on the specific NDA/BLA, listed exclusivity code(s), and first commercial marketing date. The necessary product identifiers are not present.

Does DORIBAX have Hatch-Waxman exclusivity or pediatric exclusivity extensions?

Not determinable from the provided information.

What is the earliest Paragraph IV filing date for DORIBAX?

Not determinable from the provided information.

What competitive landscape drives DORIBAX pricing pressure?

A complete competitive picture requires the therapeutic class, mechanism-of-action, labeled indication scope, dosing regimen, and rival products on the same formulary tier. These are not specified.

Which branded competitors target the same indication and patient segment?

Not determinable from the provided information.

Which authorized generics or re-packagers already compete with DORIBAX?

Not determinable from the provided information.

What is the likely biosimilar or biologics adjacency risk?

Not determinable from the provided information.

How do DORIBAX sales trends typically evolve after launch?

A sales trajectory cannot be constructed without at least one of: audited prescription data, IMS-like market sales series, company earnings segment reporting, or third-party estimates tied to the correct product.

What do prescriptions, TRx, and net sales look like by quarter?

Not determinable from the provided information.

What share gains or losses drive DORIBAX net revenue?

Not determinable from the provided information.

What financial trajectory does DORIBAX show in company filings?

Company-level disclosures require linkable corporate reporting (parent company, segment, product revenue line item) and the correct drug identity. Those identifiers are absent.

Is DORIBAX reported as a separate revenue line item or embedded in a broader segment?

Not determinable from the provided information.

How does DORIBAX revenue correlate with contract manufacturing, rebates, and charge-backs?

Not determinable from the provided information.

What patent litigation or settlement dynamics could reshape DORIBAX revenue?

Patent-driven revenue shifts require the specific patent estate tied to the exact Orange Book listing, litigation dockets, and any settlement terms (30-month stay, trigger date, authorized generic carve-outs). No product-specific patent record is supplied.

What Paragraph IV challenges exist for DORIBAX?

Not determinable from the provided information.

What court cases or ITC actions affect DORIBAX market exclusivity?

Not determinable from the provided information.

Do any settlements include “at-risk” launch timelines for generic entrants?

Not determinable from the provided information.

How do formulation, method-of-use, and manufacturing patents affect generic entry for DORIBAX?

Generic entry barriers depend on whether patents cover formulations, polymorphs, manufacturing process controls, or method-of-use/dosing regimens. No listing or patent numbers are available.

What dosage forms and strengths are protected?

Not determinable from the provided information.

What manufacturing process claims create IP barriers?

Not determinable from the provided information.

What generic launch scenarios create revenue downside for DORIBAX?

Revenue downside requires scenario modeling tied to actual ANDA filings, expected design-arounds, and likely price erosion and share transfer. No filings or product specifics are provided.

What launch date triggers most likely lead to a market share reset?

Not determinable from the provided information.

How much price erosion is expected post-approval for DORIBAX?

Not determinable from the provided information.

Key Takeaways

• DORIBAX’s market dynamics and financial trajectory cannot be produced from the provided record without risking incorrect drug identity and, by extension, incorrect FDA, exclusivity, IP, and revenue facts.
• No Orange Book status, exclusivity timeline, competitive set, litigation posture, or quantified sales trend can be stated.

FAQs

1. What is DORIBAX’s active ingredient and approved indication?
2. What NDA/BLA application is DORIBAX under and who is the listed applicant?
3. What Orange Book patents and exclusivity codes apply to DORIBAX?
4. Are there any Paragraph IV ANDA challenges or court cases related to DORIBAX?
5. What is DORIBAX’s estimated net sales and prescription trend over the last 8 quarters?

References

No sources were cited because DORIBAX’s drug identity and record context were not provided in the input.