Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 18, 2019

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ORBACTIV Drug Profile

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When do Orbactiv patents expire, and when can generic versions of Orbactiv launch?

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 five patent family members in thirty-three 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.

Summary for ORBACTIV
International Patents:105
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 12
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

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Generic Entry Opportunity Date for ORBACTIV
Generic Entry Date for ORBACTIV*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
NDA:
Dosage:
POWDER;IV (INFUSION)

*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

Synonyms for ORBACTIV
(4''R)-22-O-(3-amino-2,3,6-trideoxy-3-C-methyl-alpha-L-arabino-hexopyranosyl)-N(3'')-((4'-chloro(1,1'-biphenyl)-4-yl)methyl)vancomycin phosphate(1:2)
(4''R)-22-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-alpha-L-arabino-hexopyranosyl)-N(sup 3'')-((4'-chloro(1,1'-biphenyl)-4-yl)methyl)vancomycin phosphate(1:2) (salt)
(4'R)-22-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-alpha-L-arabino-hexopyranosyl)-N(sup 3)'-((4'-chloro(1,1'-biphenyl)-4-yl)methyl)vancomycin phosphate (1:2) (salt)
(4'R)-22-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-alpha-L-arabino-hexopyranosyl)-N(sup 3)'-(p-(p-chlorophenyl)benzyl)vancomycin phosphate (1:2) (salt)
192564-14-0
AKOS030526689
CHEBI:83305
CHEMBL3989766
CS-5054
D05271
HY-B1831A
LY 333328 diphosphate
LY 333328 pound>>Oritavancin (phosphate)
LY333328 diphosphate
Orbactiv (TN)
Oritavancin (diphosphate)
oritavancin bisphosphate
Oritavancin diphosphate
Oritavancin diphosphate (USAN)
Oritavancin diphosphate [USAN]
oritavancin phosphate
PWTROOMOPLCZHB-BHYQHFGMSA-N
UNII-VL1P93MKZN
VL1P93MKZN

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 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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ORBACTIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 41/2016 Austria   Start Trial PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
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
2337575 122016000075 Germany   Start Trial PRODUCT NAME: ORITAVANCIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/989 20150319
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Medtronic
Harvard Business School
Boehringer Ingelheim
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.