Pharsight

1. Cubicin patents expiration

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	Terminated-Denied	Cubist Pharmaceuticals LLC	Amneal Pharmaceuticals LLC

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).
US8003673	CUBIST PHARMS LLC	Daptomycin for the treatment of biofilm and catheter salvage	Sep, 2028 (4 years from now)
US9138456	CUBIST PHARMS LLC	Lipopeptide compositions and related methods	Nov, 2030 (7 years from now)

Drugs and Companies using DAPTOMYCIN ingredient

Market Authorisation Date: 12 September, 2003

Treatment: Treatment of the following infections: complicated skin and skin structure infections and staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocardi...

Dosage: POWDER;INTRAVENOUS

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
250MG/VIAL	POWDER;INTRAVENOUS	Discontinued
500MG/VIAL	POWDER;INTRAVENOUS	Prescription

CUBICIN family patents

2. Dificid patents expiration

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.
US8586551	CUBIST PHARMS LLC	18-membered macrocycles and analogs thereof	Jul, 2023 (2 months ago)
US7378508	CUBIST PHARMS LLC	Polymorphic crystalline forms of tiacumicin B	Jul, 2027 (3 years from now)
US7863249	CUBIST PHARMS LLC	Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof	Jul, 2027 (3 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8586551 (Pediatric)	CUBIST PHARMS LLC	18-membered macrocycles and analogs thereof	Jan, 2024 (3 months from now)
US7906489	CUBIST PHARMS LLC	18-membered macrocycles and analogs thereof	Mar, 2027 (3 years from now)
US7863249	CUBIST PHARMS LLC	Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof	Jul, 2027 (3 years from now)
US8859510	CUBIST PHARMS LLC	Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof	Jul, 2027 (3 years from now)
US7906489 (Pediatric)	CUBIST PHARMS LLC	18-membered macrocycles and analogs thereof	Sep, 2027 (3 years from now)
US7378508 (Pediatric)	CUBIST PHARMS LLC	Polymorphic crystalline forms of tiacumicin B	Jan, 2028 (4 years from now)
US7863249 (Pediatric)	CUBIST PHARMS LLC	Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof	Jan, 2028 (4 years from now)
US8859510 (Pediatric)	CUBIST PHARMS LLC	Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof	Jan, 2028 (4 years from now)
US9808530	CUBIST PHARMS LLC	Composition of tiacumicin compounds	May, 2034 (10 years from now)
US9808530 (Pediatric)	CUBIST PHARMS LLC	Composition of tiacumicin compounds	Nov, 2034 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population (NPP)	Jan 24, 2023
Orphan Drug Exclusivity (ODE)	Jan 24, 2027
Pediatric Exclusivity (PED)	Jul 24, 2023

Drugs and Companies using FIDAXOMICIN ingredient

Market Authorisation Date: 27 May, 2011

Treatment: Treatment of clostridioides difficile-associated diarrhea (cdad) in patients from 6 months of age and older

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
200 mg	27 May, 2015	1		31 Jul, 2027

Strength	Dosage	Availability
200MG	TABLET;ORAL	Prescription

DIFICID family patents

3. Sivextro patents expiration

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.
US8420676	CUBIST PHARMS LLC	Oxazolidinone derivatives	Feb, 2028 (4 years from now)
US7816379	CUBIST PHARMS LLC	Oxazolidinone derivatives	Jun, 2028 (4 years from now)
US9624250	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (6 years from now)
US10442829	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (6 years from now)
US8426389	CUBIST PHARMS LLC	Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Dec, 2030 (7 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10065947	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (6 years from now)
US9988406	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jun 20, 2019
New Patient Population (NPP)	Jun 19, 2023
Generating Antibiotic Incentives Now (GAIN)	Jun 20, 2024

Drugs and Companies using TEDIZOLID PHOSPHATE ingredient

NCE-1 date: 2023-06-21

Market Authorisation Date: 20 June, 2014

Treatment: Method of treating bacterial infections; Method of treating acute bacterial skin and skin structure infections (absssi) caused by designated susceptible bacteria

Dosage: TABLET;ORAL

Strength	Dosage	Availability
200MG	TABLET;ORAL	Prescription

SIVEXTRO family patents

4. Zerbaxa patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14842042A	2020-12-21	Lederer & Keller Patentanwälte Partnerschaft mbB	Opposition rejected

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.
US7129232	CUBIST PHARMS LLC	Cephem compounds	May, 2028 (4 years from now)
US8685957	CUBIST PHARMS LLC	Tazobactam arginine compositions	Sep, 2032 (9 years from now)
US8476425	CUBIST PHARMS LLC	Tazobactam arginine compositions	Sep, 2032 (9 years from now)
US8906898	CUBIST PHARMS LLC	Solid forms of ceftolozane	May, 2034 (10 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10028963	CUBIST PHARMS LLC	Methods for treating intrapulmonary infections	Sep, 2032 (8 years from now)
US9724353	CUBIST PHARMS LLC	Methods for treating intrapulmonary infections	Sep, 2032 (8 years from now)
US9320740	CUBIST PHARMS LLC	Ceftolozane-tazobactam pharmaceutical compositions	Mar, 2034 (10 years from now)
US10420841	CUBIST PHARMS LLC	Ceftolozane antibiotic compositions	Mar, 2034 (10 years from now)
US8968753	CUBIST PHARMS LLC	Ceftolozane-tazobactam pharmaceutical compositions	Mar, 2034 (10 years from now)
US9872906	CUBIST PHARMS LLC	Ceftolozane antibiotic compositions	Mar, 2034 (10 years from now)
US11278622	CUBIST PHARMS LLC	Ceftolozane antibiotic compositions	Mar, 2034 (10 years from now)
US10933053	CUBIST PHARMS LLC	Treating infections with ceftolozane/tazobactam in subjects having impaired renal function	Sep, 2034 (10 years from now)
US10376496	CUBIST PHARMS LLC	Treating infections with ceftolozane/tazobactam in subjects having impaired renal function	Sep, 2034 (10 years from now)
US10125149	CUBIST PHARMS LLC	Synthesis of cephalosporin compounds	Aug, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Dec 19, 2019
New Patient Population (NPP)	Apr 21, 2025
Generating Antibiotic Incentives Now (GAIN)	Dec 19, 2024

Drugs and Companies using CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM ingredient

NCE-1 date: 2023-12-20

Market Authorisation Date: 19 December, 2014

Treatment: Treatment of ventilator-associated bacterial pneumonia; Treatment of hospital-acquired bacterial pneumonia; Treatment of complicated urinary tract infection; Treatment of complicated intra-abdominal i...

Dosage: POWDER;INTRAVENOUS