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Last Updated: November 25, 2020

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ORBACTIV Drug Profile

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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 one hundred and eight patent family members in thirty-four countries.

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

US ANDA Litigation and 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 6, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ORBACTIV
International Patents:108
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 14
Clinical Trials: 5
Drug Prices: Drug price information for ORBACTIV
DailyMed Link:ORBACTIV at DailyMed
Drug patent expirations by year for ORBACTIV
Drug Prices for ORBACTIV

See drug prices for ORBACTIV

Generic Entry Opportunity Date for ORBACTIV
Generic Entry Date for ORBACTIV*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
The Medicines CompanyPhase 4
The Medicines CompanyPhase 1

See all ORBACTIV clinical trials

US Patents and Regulatory Information for ORBACTIV

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   Start Trial   Start Trial   Start Trial
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 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   Start Trial   Start Trial
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ORBACTIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2337575 2016/040 Ireland   Start Trial PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575 CA 2016 00044 Denmark   Start Trial PRODUCT NAME: ORITAVANCIN OG/ELLER FARMACEUTISKE SALTE HERAF, HERUNDER DIFOSFATSALTE; REG. NO/DATE: EU/1/15/989 20150323
2337575 41/2016 Austria   Start Trial PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
2337575 2016019 Norway   Start Trial PRODUCT NAME: ORITAVANCIN OG FARMASOEYTISK; REG. NO/DATE: EU/1/15/989 20150415
2337575 300834 Netherlands   Start Trial PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
2337575 122016000075 Germany   Start Trial PRODUCT NAME: ORITAVANCIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575 16C0039 France   Start Trial PRODUCT NAME: ORITAVANCINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,TELS QUE LES SELS DIPHOSPHATES; REGISTRATION NO/DATE: EU/1/15/989 20150323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
AstraZeneca
Express Scripts
Harvard Business School
Moodys

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