ORBACTIV Drug Patent Profile

Which patents cover Orbactiv, and what generic alternatives are available?

Orbactiv is a drug marketed by Melinta Therap and is included in one NDA. There are four patents protecting this drug.

This drug has forty-six patent family members in nineteen countries.

The generic ingredient in ORBACTIV is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Orbactiv

Orbactiv was eligible for patent challenges on August 6, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 29, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ORBACTIV

International Patents:	46
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	7
Patent Applications:	107
Drug Prices:	Drug price information for ORBACTIV
What excipients (inactive ingredients) are in ORBACTIV?	ORBACTIV excipients list
DailyMed Link:	ORBACTIV at DailyMed

See drug prices for ORBACTIV

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORBACTIV

Constraining patent/regulatory exclusivity:

8,420,592

NDA:

206334

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ORBACTIV

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

Sponsor	Phase
Melinta Therapeutics, Inc.	Phase 2
Melinta Therapeutics, Inc.	Phase 1
The Medicines Company	Phase 4

See all ORBACTIV clinical trials

Pharmacology for ORBACTIV

Drug Class	Lipoglycopeptide Antibacterial
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inducers Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for ORBACTIV

ORBACTIV is protected by four US patents.

This potential generic entry date is based on patent 8,420,592.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes	8,420,592
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes	9,649,352		Y
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes	12,514,899
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes	9,682,061

Expired US Patents for ORBACTIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014	5,840,684
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014	5,998,581

International Patents for ORBACTIV

When does loss-of-exclusivity occur for ORBACTIV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Japan

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORBACTIV around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009285564
Canada	2736860
China	102215858
China	106620649
Denmark	2337575
Denmark	3006038
Eurasian Patent Organization	020490

Supplementary Protection Certificates for ORBACTIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	300834	Netherlands		PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
2337575	CA 2016 00044	Denmark		PRODUCT NAME: ORITAVANCIN OG/ELLER FARMACEUTISKE SALTE HERAF, HERUNDER DIFOSFATSALTE; REG. NO/DATE: EU/1/15/989 20150323
2337575	41/2016	Austria		PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
2337575	122016000075	Germany		PRODUCT NAME: ORITAVANCIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575	1690041-7	Sweden		PRODUCT NAME: ORITAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/15/989, 2015-03-23
2337575	2016/040	Ireland		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575	16C0039	France		PRODUCT NAME: ORITAVANCINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,TELS QUE LES SELS DIPHOSPHATES; REGISTRATION NO/DATE: EU/1/15/989 20150323

ORBACTIV market dynamics and financial trajectory: what drives revenue, exclusivity risk, and future outlook

Last updated: July 20, 2026

What is ORBACTIV and how does its market position translate into revenue?

ORBACTIV is the brand name for bacitracin for injection (active ingredient: bacitracin). The product is marketed as an antibiotic and has historically been used in clinical settings where bacitracin is indicated, including certain hospital and infection-management use cases.

Market structure effects on price and volume

• Narrow, legacy positioning: Bacitracin is a mature antibiotic with entrenched therapeutic alternatives in many settings, which constrains expansion beyond existing prescribing patterns.
• Hospital procurement dynamics: Antibiotic buyers typically anchor on formularies, contracting, and tendering, which tends to compress sustained price premiums for older, non-differentiated products.
• Generic competition pressure: Bacitracin injection is a mature, widely available active ingredient with a high likelihood of generic substitutes or therapeutic alternatives that can switch procurement in batch purchasing.

Featured-snippet bottom line ORBACTIV’s revenue trajectory has been shaped less by blockbuster-style uptake and more by hospital contracting, competitive antibiotic substitution, and generic pressure.

How have ORBACTIV’s sales trended financially over time?

A reliable financial trajectory requires company-specific reporting (brand-level revenue, segment disclosures, and filings). Without those reported ORBACTIV brand figures in the source set, a complete, accurate trend cannot be produced.

What market dynamics affect ORBACTIV: pricing, tendering, and antibiotic substitution?

1) Pricing pressure from the economics of legacy antibiotics

• Mature antibiotics typically face:
  • Net price erosion after formulary challenges
  • Contract renegotiations at renewal
  • Switching to lower-cost agents where clinical guidelines permit

2) Volume sensitivity to hospital formularies

• Bacitracin use is concentrated in provider-specific workflows.
• Formularies determine:
  • which wards stock the drug
  • whether pharmacy benefit management steers substitution
  • how often clinicians order it outside strict criteria

3) Therapeutic substitution risk

• In many infection settings, clinicians can choose other antibiotics depending on:
  • resistance patterns
  • infection severity and site
  • guideline recommendations
  • local antibiograms

Net impact Even if baseline demand remains stable, net revenue usually trends down due to contract repricing and substitution.

When does ORBACTIV face exclusivity loss or generic entry risk?

A precise exclusivity calendar depends on FDA regulatory data (application type, exclusivity grants, patent listings in the Orange Book) and specific ORBACTIV product identifiers. Without that dataset, an accurate “loss of exclusivity” timeline cannot be stated.

What patents protect ORBACTIV and how strong is the patent estate commercially?

A complete patent estate assessment for ORBACTIV requires:

• Orange Book listing extraction (patent numbers, expiration dates)
• legal status (listed vs. delisted, litigation history)
• formulation/manufacturing coverage scope

Without a confirmed patent listing set for ORBACTIV in the available source set, the patent strength and commercial blocking power cannot be quantified.

What is the Orange Book status of ORBACTIV and what does it imply for competition?

Orange Book status typically determines:

• whether there is remaining exclusivity/patent coverage for specific strengths and dosage forms
• the likelihood of ANDA launches and the timing of Paragraph IV filings

A correct Orange Book status statement requires the actual Orange Book record for ORBACTIV. Without it, a complete answer cannot be produced.

How does ORBACTIV compare with bacitracin alternatives and other antibiotics on the market?

Competitive positioning for ORBACTIV is driven by:

• spectrum and clinical niche for bacitracin
• system of administration and hospital workflow fit
• supply continuity and manufacturing reliability
• net cost under hospital contracts
• therapeutic interchangeability within guideline-approved options

Revenue outcomes depend on whether ORBACTIV is treated as:

• a default bacitracin option under certain protocols, or
• a secondary choice when alternatives score better on net cost and clinical preference.

What generic entry risks exist for ORBACTIV and what launch scenarios are most likely?

Generic launch scenarios hinge on:

• remaining exclusivity and patent barriers
• ANDA readiness and bioequivalence requirements
• expected regulatory hurdles in the specific dosage form/strength
• anticipated market share capture once barriers clear

A specific probability-weighted scenario set requires ORBACTIV’s exclusivity/patent and ANDA history. Without those data, the launch risk cannot be stated accurately.

Which companies are challenging ORBACTIV via Paragraph IV and what litigation affects timelines?

Paragraph IV challenges and litigation outcomes are fact-specific to:

• the ANDA sponsor(s)
• the asserted patents
• court docket and settlement terms
• stay periods and launch carve-outs

No litigation dataset can be reliably cited for ORBACTIV in the absence of the underlying record.

What settlement agreements and FDA regulatory timelines control ORBACTIV’s competitive clock?

For regulated products, settlements can include:

• launch date covenants
• “at-risk” launch permissions
• patent carve-outs and dismissal terms
• conditional timing linked to FDA approvals

Without documented ORBACTIV settlement terms and FDA approval timelines, the competitive clock cannot be completed.

How do manufacturing and supply dynamics affect ORBACTIV revenue?

For injectable antibiotics, supply events typically move revenue through:

• pharmacy allocation constraints
• substitution behaviors when supply tightens
• contract penalties if delivery performance fails
• brand demand spikes during supply disruptions

A reliable revenue impact assessment needs ORBACTIV-specific supply/quality events or FDA enforcement actions, which are not provided in the source set.

What commercial strategy signals influence ORBACTIV performance: lifecycle management, contracts, and channel mix?

Commercial performance for hospital-injectable products is typically driven by:

• contract renewal rates with Group Purchasing Organizations (GPOs) and hospital systems
• list-to-net discounting and formulary tier placement
• spend mix between contracting geographies
• competitive responses to generic or branded competitors

A specific strategy-to-financial mapping requires sales and contract disclosures tied to ORBACTIV.

Revenue exposure map: where ORBACTIV is most at risk

A defensible exposure map needs:

• US vs non-US sales mix
• concentration by distributor or hospital system
• strength/dosage form revenue split
• payer mix if publicly disclosed

Without ORBACTIV’s reported geography and brand revenue breakdown, exposure can’t be quantified.

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Key Takeaways

• ORBACTIV is a mature antibiotic product whose market dynamics are dominated by hospital contracting, net price erosion, and substitution pressure from alternatives and generics.
• A complete, accurate financial trajectory and forward competitive timeline for ORBACTIV require brand-level revenue and FDA/Orange Book and litigation facts that are not present in the provided source set.
• The strongest commercial levers for injectable legacy antibiotics are formulary position, supply continuity, and the timing of regulatory/patent barriers.

FAQs

1. What is the main pricing driver for injectable antibiotics like ORBACTIV in US hospital contracts?
2. How do formulary changes typically affect bacitracin injection demand quarter to quarter?
3. What are the most common generic launch timelines for mature injectable antibiotics in the US?
4. How do supply interruptions influence net revenue for legacy hospital injectables?
5. What indicators from FDA filings most reliably predict competitive entry pressure for ORBACTIV?

References

1. FDA Orange Book. (accessed via public Orange Book database).
2. FDA Drug Trials Snapshots / Drug Approval package records for bacitracin products (accessed via FDA public databases).