Lipid Disorders Therapeutics

1. Crestor patent expiration

Treatment: Use of rosuvastatin calcium to reduce elevated total-c, ldl-c, apob, nonhdl-c or tg levels; To increase hdl-c in adult patients with primary hyperlipidemia or mixed dyslipidemia; And to slow the progr...

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6858618 ASTRAZENECA Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Dec, 2021

(4 years ago)

US6316460

(Pediatric)

ASTRAZENECA Pharmaceutical compositions
Feb, 2021

(4 years ago)

US7030152 ASTRAZENECA Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Apr, 2018

(7 years ago)

US7964614 ASTRAZENECA Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Apr, 2018

(7 years ago)

USRE37314

(Pediatric)

ASTRAZENECA Pyrimidine derivatives
Jul, 2016

(9 years ago)

US6316460 ASTRAZENECA Pharmaceutical compositions
Aug, 2020

(5 years ago)

US7030152

(Pediatric)

ASTRAZENECA Systematic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Oct, 2018

(7 years ago)

US7964614

(Pediatric)

ASTRAZENECA Systemic inflammatory markers as diagnostic tools in the prevention of atherosclerotic diseases and as tools to aid in the selection of agents to be used for the prevention and treatment of atherosclerotic disease
Oct, 2018

(7 years ago)

US6858618

(Pediatric)

ASTRAZENECA Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia
Jun, 2022

(3 years ago)

USRE37314 ASTRAZENECA Pyrimidine derivatives
Jan, 2016

(10 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-573) Nov 06, 2011
New Indication(I-611) Oct 16, 2012
New Indication(I-621) Feb 08, 2013
Pediatric Exclusivity(PED) Apr 16, 2013
New Patient Population(NPP) Nov 20, 2018
New Indication(I-732) May 27, 2019
Orphan Drug Exclusivity(ODE) May 27, 2023
Orphan Drug Exclusivity(ODE-118) May 27, 2023

Drugs and Companies using ROSUVASTATIN CALCIUM ingredient

Market Authorisation Date: 12 August, 2003

Dosage: TABLET

How can I launch a generic of CRESTOR before it's drug patent expiration?
More Information on Dosage

CRESTOR family patents

Family Patents

2. Juxtapid patent expiration

Treatment: Treatment of hypercholesterolemia, hyperlipidemia and hyperlipoproteinemia in patients with homozygous familial hypercholesterolemia; Treatment of hypercholesterolemia by decreasing the amount or acti...

JUXTAPID's oppositions filed in EPO
JUXTAPID IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5712279 CHIESI Inhibitors of microsomal triglyceride transfer protein and method
Feb, 2020

(5 years ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5739135 CHIESI Inhibitors of microsomal triglyceride transfer protein and method
Apr, 2015

(10 years ago)

US6492365 CHIESI Microsomal triglyceride transfer protein
Dec, 2019

(6 years ago)

US5712279 CHIESI Inhibitors of microsomal triglyceride transfer protein and method
Feb, 2015

(10 years ago)

US7932268 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Aug, 2027

(1 year, 7 months from now)

US8618135 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Mar, 2025

(10 months ago)

US10016404 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Mar, 2025

(10 months ago)

US9433617 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(10 months ago)

US9265758 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(10 months ago)

US9364470 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(10 months ago)

US9861622 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(10 months ago)

US10555938 CHIESI Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Mar, 2025

(10 months ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 21, 2017
Orphan Drug Exclusivity(ODE) Dec 21, 2019
Orphan Drug Exclusivity(ODE-36) Dec 21, 2019

Drugs and Companies using LOMITAPIDE MESYLATE ingredient

NCE-1 date: 21 December, 2016

Market Authorisation Date: 21 December, 2012

Dosage: CAPSULE

More Information on Dosage

JUXTAPID family patents

Family Patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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3. Kynamro patent expiration

Treatment: Adjunctive therapy to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol, apolipoprotein b, total cholesterol, and non-high density lipoprotein cholesterol in pts with h...

KYNAMRO IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7511131 KASTLE THERAPS LLC Antisense modulation of apolipoprotein B expression
Jan, 2027

(1 year, 19 days from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5914396 KASTLE THERAPS LLC 2'-O-modified nucleosides and phosphoramidites
Jun, 2016

(9 years ago)

US6222025 KASTLE THERAPS LLC Process for the synthesis of 2′-O-substituted pyrimidines and oligomeric compounds therefrom
Mar, 2015

(10 years ago)

US6166197 KASTLE THERAPS LLC Oligomeric compounds having pyrimidine nucleotide (S) with 2'and 5 substitutions
Dec, 2017

(8 years ago)

US7101993 KASTLE THERAPS LLC Oligonucleotides containing 2′-O-modified purines
Sep, 2023

(2 years ago)

US7407943 KASTLE THERAPS LLC Antisense modulation of apolipoprotein B expression
Aug, 2021

(4 years ago)

US7015315 KASTLE THERAPS LLC Gapped oligonucleotides
Mar, 2023

(2 years ago)

US6451991 KASTLE THERAPS LLC Sugar-modified gapped oligonucleotides
Feb, 2017

(8 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 29, 2018
Orphan Drug Exclusivity(ODE) Jan 29, 2020
Orphan Drug Exclusivity(ODE-41) Jan 29, 2020

Drugs and Companies using MIPOMERSEN SODIUM ingredient

NCE-1 date: 29 January, 2017

Market Authorisation Date: 29 January, 2013

Dosage: SOLUTION

More Information on Dosage

KYNAMRO family patents

Family Patents

4. Leqvio patent expiration

Treatment: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (hefh) or clinical atherosclerotic cardiovascular disease (ascv...

LEQVIO's oppositions filed in EPO
LEQVIO IPR and PTAB Proceedings
Can you believe LEQVIO received compensation for the extended wait time during the regulatory approval process?
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11078485 NOVARTIS Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
Nov, 2023

(2 years ago)

US9708610 NOVARTIS Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
Jan, 2024

(2 years ago)

US9074213 NOVARTIS Compositions and methods for inhibiting expression of a target gene
Mar, 2022

(3 years ago)

US8232383 NOVARTIS RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA)
Feb, 2023

(2 years ago)

US8546143 NOVARTIS Compositions and methods for inhibiting expression of a target gene
Apr, 2022

(3 years ago)

US10125369 NOVARTIS PCSK9 iRNA compositions and methods of use thereof
Aug, 2034

(8 years from now)

US9370582 NOVARTIS Carbohydrate conjugates as delivery agents for oligonucleotides
Dec, 2028

(2 years from now)

US8106022 NOVARTIS Carbohydrate conjugates as delivery agents for oligonucleotides
Dec, 2029

(3 years from now)

US11530408 NOVARTIS Therapeutic compositions
May, 2024

(1 year, 7 months ago)

US9708615 NOVARTIS Therapeutic compositions
Mar, 2024

(1 year, 10 months ago)

US10273477 NOVARTIS Therapeutic compositions
Mar, 2024

(1 year, 10 months ago)

US8828956 NOVARTIS Carbohydrate conjugates as delivery agents for oligonucleotides
Dec, 2028

(2 years from now)

US8809292 NOVARTIS Compositions and methods for inhibiting expression of the PCSK9 gene
May, 2027

(1 year, 3 months from now)

US10131907 NOVARTIS Glycoconjugates of RNA interference agents
Aug, 2028

(2 years from now)

US10806791 NOVARTIS Carbohydrate conjugates as delivery agents for oligonucleotides
Dec, 2028

(2 years from now)

US10669544 NOVARTIS Therapeutic compositions
Mar, 2024

(1 year, 10 months ago)

US12460206 NOVARTIS NA
Aug, 2034

(8 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).
US10590418 NOVARTIS Methods and compositions for RNAi mediated inhibition of gene expression in mammals
Jul, 2022

(3 years ago)

US10266825 NOVARTIS Compositions comprising alternating 2′-modified nucleosides for use in gene modulation
Nov, 2023

(2 years ago)

US10851377 NOVARTIS Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder
Aug, 2036

(10 years from now)

US8222222 NOVARTIS Compositions and methods for inhibiting expression of the PCSK9 gene
Dec, 2027

(1 year, 11 months from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 22, 2026

Drugs and Companies using INCLISIRAN SODIUM ingredient

NCE-1 date: 22 December, 2025

Market Authorisation Date: 22 December, 2021

Dosage: SOLUTION

More Information on Dosage

LEQVIO family patents

Family Patents

5. Livalo patent expiration

Treatment: Adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein b, triglycerides and to increase hdl-c in adult patients with primary hyperlipidemi...

LIVALO IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5753675 KOWA CO Quinoline analogs of mevalonolactone and derivatives thereof
May, 2015

(10 years ago)

US6465477 KOWA CO Stable pharmaceutical composition
Dec, 2016

(9 years ago)

US5856336

(Pediatric)

KOWA CO Quinoline type mevalonolactones
Jun, 2021

(4 years ago)

US5856336 KOWA CO Quinoline type mevalonolactones
Jan, 2021

(5 years ago)

US5854259 KOWA CO Quinoline type mevalonolactones
Dec, 2015

(10 years ago)

US7022713 KOWA CO Hyperlipemia therapeutic agent
Feb, 2024

(1 year, 10 months ago)

US8557993 KOWA CO Crystalline forms of pitavastatin calcium
Feb, 2024

(1 year, 11 months ago)

US7022713

(Pediatric)

KOWA CO Hyperlipemia therapeutic agent
Aug, 2024

(1 year, 4 months ago)

US8557993

(Pediatric)

KOWA CO Crystalline forms of pitavastatin calcium
Aug, 2024

(1 year, 5 months ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 03, 2014
New Patient Population(NPP) May 16, 2022
Pediatric Exclusivity(PED) Nov 16, 2022

Drugs and Companies using PITAVASTATIN CALCIUM ingredient

NCE-1 date: 16 November, 2021

Market Authorisation Date: 03 August, 2009

Dosage: TABLET

How can I launch a generic of LIVALO before it's drug patent expiration?
More Information on Dosage

LIVALO family patents

Family Patents

6. Nexletol patent expiration

Treatment: Use of nexletol as an adjunct to diet and maximally tolerated statin therapy to lower ldl-c in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular dise...

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US12404227 ESPERION THERAPS INC NA
Jun, 2040

(14 years from now)

US7335799 ESPERION THERAPS INC Hydroxyl compounds and compositions for cholesterol management and related uses
Dec, 2030

(4 years from now)

US11613511 ESPERION THERAPS INC Methods of making bempedoic acid and compositions of the same
Jun, 2040

(14 years from now)

US12398087 ESPERION THERAPS INC NA
Jun, 2040

(14 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).
US10118881 ESPERION THERAPS INC Hydroxyl compounds and compositions for cholesterol management and related uses
Dec, 2023

(2 years ago)

US8497301 ESPERION THERAPS INC Hydroxyl compounds and compositions for cholesterol management and related uses
Dec, 2023

(2 years ago)

US10941095 ESPERION THERAPS INC Hydroxyl compounds and compositions for cholesterol management and related uses
Dec, 2023

(2 years ago)

US9000041 ESPERION THERAPS INC Hydroxyl compounds and compositions for cholesterol management and related uses
Dec, 2023

(2 years ago)

US9624152 ESPERION THERAPS INC Hydroxyl compounds and compositions for cholesterol management and related uses
Dec, 2023

(2 years ago)

US11744816 ESPERION THERAPS INC Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Mar, 2036

(10 years from now)

US11926584 ESPERION THERAPS INC Methods of making bempedoic acid and compositions of the same
Jun, 2040

(14 years from now)

US11760714 ESPERION THERAPS INC Methods of making bempedoic acid and compositions of the same
Jun, 2040

(14 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Feb 21, 2025
New Indication(I-943) Mar 22, 2027
New Indication(I-944) Mar 22, 2027

Drugs and Companies using BEMPEDOIC ACID ingredient

NCE-1 date: 22 February, 2024

Market Authorisation Date: 21 February, 2020

Dosage: TABLET

More Information on Dosage

NEXLETOL family patents

Family Patents

7. Welchol patent expiration

Treatment: Use as a bile acid sequestrant for lowering cholesterol; A method for reducing serum glucose levels in adults with type 2 diabetes mellitus; Use as a bile acid sequestrant

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5693675 COSETTE Alkylated amine polymers
Dec, 2014

(11 years ago)

US6784254 COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(11 years ago)

US6433026 COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(11 years ago)

US5607669 COSETTE Amine polymer sequestrant and method of cholesterol depletion
Jun, 2014

(11 years ago)

US5679717 COSETTE Method for removing bile salts from a patient with alkylated amine polymers
Apr, 2014

(11 years ago)

US7229613 COSETTE Method for lowering serum glucose
Apr, 2022

(3 years ago)

US6066678 COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(11 years ago)

US5919832 COSETTE Amine polymer sequestrant and method of cholesterol depletion
Apr, 2014

(11 years ago)

US5917007 COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(11 years ago)

US7101960 COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(11 years ago)

US5917007

(Pediatric)

COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(11 years ago)

US5693675

(Pediatric)

COSETTE Alkylated amine polymers
Jun, 2015

(10 years ago)

US5679717

(Pediatric)

COSETTE Method for removing bile salts from a patient with alkylated amine polymers
Oct, 2014

(11 years ago)

US6066678

(Pediatric)

COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(11 years ago)

US5607669

(Pediatric)

COSETTE Amine polymer sequestrant and method of cholesterol depletion
Dec, 2014

(11 years ago)

US5919832

(Pediatric)

COSETTE Amine polymer sequestrant and method of cholesterol depletion
Oct, 2014

(11 years ago)

US6433026

(Pediatric)

COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(11 years ago)

US6784254

(Pediatric)

COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(11 years ago)

US7101960

(Pediatric)

COSETTE Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(11 years ago)

US7229613

(Pediatric)

COSETTE Method for lowering serum glucose
Oct, 2022

(3 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-608) Oct 02, 2012
Pediatric Exclusivity(PED) Apr 02, 2013
M(M-232) Oct 20, 2024

Drugs and Companies using COLESEVELAM HYDROCHLORIDE ingredient

Market Authorisation Date: 26 May, 2000

Dosage: CAPSULE; FOR SUSPENSION; TABLET; BAR, CHEWABLE

How can I launch a generic of WELCHOL before it's drug patent expiration?
More Information on Dosage

WELCHOL family patents

Family Patents

8. Zetia patent expiration

Treatment: To reduce elevated total-c, ldl-c, apo b and non-hdl-c in patients with primary hyperlipidemia by administration of ezetimibe alone or in combination with a statin or with fenofibrate; To reduce plasm...

ZETIA's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5846966

(Pediatric)

ORGANON Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors
Mar, 2014

(11 years ago)

USRE42461 ORGANON Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
Oct, 2016

(9 years ago)

USRE37721 ORGANON Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
Oct, 2016

(9 years ago)

USRE42461

(Pediatric)

ORGANON Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
Apr, 2017

(8 years ago)

USRE37721

(Pediatric)

ORGANON Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
Apr, 2017

(8 years ago)

US7030106 ORGANON Sterol absorption inhibitor compositions
Jan, 2022

(3 years ago)

US7030106

(Pediatric)

ORGANON Sterol absorption inhibitor compositions
Jul, 2022

(3 years ago)

US5846966 ORGANON Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors
Sep, 2013

(12 years ago)

US7612058 ORGANON Methods for inhibiting sterol absorption
Oct, 2025

(2 months ago)

US7612058

(Pediatric)

ORGANON Methods for inhibiting sterol absorption
Apr, 2026

(3 months from now)




Drug Exclusivity Drug Exclusivity Expiration
Pediatric Exclusivity(PED) Dec 05, 2011
M(M-109) Jan 24, 2015

Drugs and Companies using EZETIMIBE ingredient

Market Authorisation Date: 25 October, 2002

Dosage: TABLET

How can I launch a generic of ZETIA before it's drug patent expiration?
More Information on Dosage

ZETIA family patents

Family Patents