Pharsight

1. Cubicin patent expiration

Treatment: Method of treating bacterial infections; Method for treating bacterial infection; Treatment of the following infections: complicated skin and skin structure infections and staphylococcus aureus bloods...

Application	Filing Date	Opposition Party	Legal Status

EP10832379A	2019-04-11	Pajaro Limited	Granted and Under Opposition
EP10832379A	2019-04-10	HGF Limited	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9138456	November, 2019	Institution Denied	Cubist Pharmaceuticals LLC et al.	Amneal Pharmaceuticals LLC et al.
US9138456	November, 2019	Terminated-Denied	Cubist Pharmaceuticals LLC	Amneal Pharmaceuticals LLC
US8058238	July, 2015	Terminated-Settled	Cubist Pharmaceuticals LLC	Fresenius Kabi USA LLC
US8129342	July, 2015	Terminated-Settled	Cubist Pharmaceuticals LLC	Fresenius Kabi USA LLC
US6468967	November, 2014	Final Written Decision	Cubist Pharmaceuticals LLC et al.	Fresenius-Kabi USA LLC
US6468967	November, 2014	FWD Entered	Cubist Pharmaceuticals LLC	Fresenius-Kabi USA LLC
US6852689	November, 2014	Final Written Decision	Cubist Pharmaceuticals LLC et al.	Fresenius-Kabi USA LLC
US6852689	November, 2014	FWD Entered	Cubist Pharmaceuticals LLC	Fresenius-Kabi USA LLC
US8058238	July, 2015	Institution Denied	Cubist Pharmaceuticals LLC et al.	Fresenius Kabi USA LLC
US8058238	July, 2015	Terminated-Denied	Cubist Pharmaceuticals LLC	Fresenius Kabi USA LLC
US6468967	October, 2014	Institution Denied	Cubist Pharmaceuticals, Inc. et al.	Agila Specialties Inc. et al.
US6468967	October, 2014	Terminated-Denied	Cubist Pharmaceuticals, Inc.	Agila Specialties Inc.
US6852689	October, 2014	Institution Denied	Cubist Pharmaceuticals Incorporated et al.	Agila Specialties Inc. et al.
US6852689	October, 2014	Terminated-Denied	Cubist Pharmaceuticals Incorporated	Agila Specialties Inc.
US8058238	October, 2014	Institution Denied	Cubist Pharmaceuticals, Inc. et al.	Agila Specialities Inc. et al.
US8058238	October, 2014	Terminated-Denied	Cubist Pharmaceuticals, Inc.	Agila Specialities Inc.
US8058238	October, 2014	Institution Denied	Cubist Pharmaceuticals, Inc. et al.	Agila Specialties Inc. et al.
US8058238	October, 2014	Terminated-Denied	Cubist Pharmaceuticals, Inc.	Agila Specialties Inc.
US8129342	October, 2014	Institution Denied	Cubist Pharmaceuticals, Inc. et al.	Agila Specialities Inc. et al.
US8129342	October, 2014	Terminated-Denied	Cubist Pharmaceuticals, Inc.	Agila Specialities Inc.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9138456	CUBIST PHARMS LLC	Lipopeptide compositions and related methods	Nov, 2030 (4 years from now)
US6468967	CUBIST PHARMS LLC	Methods for administration of antibiotics	Sep, 2019 (6 years ago)
US8058238	CUBIST PHARMS LLC	High purity lipopeptides	Nov, 2020 (5 years ago)
US6852689	CUBIST PHARMS LLC	Methods for administration of antibiotics	Sep, 2019 (6 years ago)
US8129342	CUBIST PHARMS LLC	High purity lipopeptides	Nov, 2020 (5 years ago)
USRE39071	CUBIST PHARMS LLC	Anhydro-and isomer-a-21978c cyclic peptides	Jun, 2016 (9 years ago)
US8003673	CUBIST PHARMS LLC	Daptomycin for the treatment of biofilm and catheter salvage	Sep, 2028 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population(NPP)	Mar 29, 2020
M(M-211)	Sep 01, 2020

Drugs and Companies using DAPTOMYCIN ingredient

Market Authorisation Date: 12 September, 2003

Dosage: POWDER

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
500 mg/vial	19 Nov, 2008	1			Extinguished

Strength	Dosage	Availability
500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER	Discontinued
250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER	Discontinued

CUBICIN family patents

2. Zyvox patent expiration

Treatment: Treatment of microbial infections

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6559305	PFIZER	Linezolid—crystal form II	Jan, 2021 (4 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6514529	PFIZER	Oxazolidinone tablet formulation	Mar, 2021 (4 years ago)
US6559305	PFIZER	Linezolid—crystal form II	Jan, 2021 (4 years ago)
US6559305 (Pediatric)	PFIZER	Linezolid—crystal form II	Jul, 2021 (4 years ago)
US5688792	PFIZER	Substituted oxazine and thiazine oxazolidinone antimicrobials	Nov, 2014 (11 years ago)
US5688792 (Pediatric)	PFIZER	Substituted oxazine and thiazine oxazolidinone antimicrobials	May, 2015 (10 years ago)
US6514529 (Pediatric)	PFIZER	Oxazolidinone tablet formulation	Sep, 2021 (4 years ago)

Drugs and Companies using LINEZOLID ingredient

Market Authorisation Date: 18 April, 2000

Dosage: SOLUTION; TABLET; FOR SUSPENSION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2 mg/mL, 100 mL bag	29 Dec, 2009	1	16 Jul, 2015	18 Nov, 2014	Extinguished
2 mg/mL, 300 mL bag	01 Sep, 2009	1	27 Jun, 2012	18 Nov, 2014	Deferred
100 mg/5 mL	03 Aug, 2009	1	03 Jun, 2015	29 Jan, 2021	Deferred
600 mg	21 Dec, 2005	1	18 May, 2015	18 Nov, 2014	Eligible

Pharsight

Pharsight

Gram Positive Bacterial Infections Therapeutics

1. Cubicin patent expiration

CUBICIN family patents

2. Zyvox patent expiration

ZYVOX family patents

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Strength	Dosage	Availability
600MG/300ML (2MG/ML)	SOLUTION	Prescription
600MG	TABLET	Discontinued
200MG/100ML (2MG/ML)	SOLUTION	Prescription
400MG/200ML (2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	Discontinued
400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	Discontinued
100MG/5ML	FOR SUSPENSION	Prescription

Pharsight

Pharsight

Gram Positive Bacterial Infections Therapeutics

1. Cubicin patent expiration

CUBICIN family patents

2. Zyvox patent expiration

ZYVOX family patents

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Have Questions?