Pharsight

1. Amvuttra patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP17209680A	2023-01-27	AWA Sweden AB	Granted and Under Opposition

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.
US10131907	ALNYLAM PHARMS INC	Glycoconjugates of RNA interference agents	Aug, 2028 (4 years from now)
US9370581	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US8828956	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US10806791	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US8106022	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (6 years from now)
US10570391	ALNYLAM PHARMS INC	RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases	Nov, 2032 (9 years from now)
US9399775	ALNYLAM PHARMS INC	RNAi agents, compositions and methods of use thereof for treating transthyretin (TTR) associated diseases	Nov, 2032 (9 years from now)
US10612024	ALNYLAM PHARMS INC	Modified double-stranded RNA agents	Aug, 2035 (11 years from now)
US11401517	ALNYLAM PHARMS INC	Modified double-stranded RNA agents	Aug, 2035 (11 years from now)
US10683501	ALNYLAM PHARMS INC	Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases	Jul, 2036 (12 years from now)
US10208307	ALNYLAM PHARMS INC	Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases	Jul, 2036 (12 years from now)
US11286486	ALNYLAM PHARMS INC	Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases	Jul, 2036 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jun 13, 2027
Orphan Drug Exclusivity (ODE)	Jun 13, 2029

Drugs and Companies using VUTRISIRAN ingredient

NCE-1 date: 2026-06-13

Market Authorisation Date: 13 June, 2022

Treatment: Amvuttra is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Dosage	Availability
25MG/0.5ML (25MG/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription

AMVUTTRA family patents

2. Givlaari patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06025389A	2017-12-15	Silence Therapeutics GmbH	Revoked
EP10011217A	2017-04-13	Silence Therapeutics GmbH	Opposition rejected
EP02702247A	2010-12-10	Silence Therapeutics AG	Revoked
EP02702247A	2010-12-10	Sirna Therapeutics	Revoked
EP05002454A	2009-09-24	Silence Therapeutics AG	Granted and Under Opposition
EP05002454A	2009-09-24	ROQUES, Sarah Elizabeth	Granted and Under Opposition
EP05002454A	2009-09-23	PFIZER LIMITED	Granted and Under Opposition
EP05002454A	2009-09-23	Sanofi-Aventis Deutschland GmbH	Granted and Under Opposition
EP05002454A	2009-09-21	Sirna Therapeutics	Granted and Under Opposition
EP02710786A	2007-02-28	Sirna Therapeutics	Opposition rejected
EP02003683A	2006-03-08	atugen AG	Patent maintained as amended
EP02003683A	2006-03-08	Abbott Laboratories	Patent maintained as amended
EP02003683A	2006-03-07	Sirna Therapeutics, Inc.	Patent maintained as amended
EP02003683A	2006-03-07	Quark Biotech, Inc.	Patent maintained as amended
EP00910510A	2003-05-28	atugen AG	Revoked
EP00910510A	2003-05-28	Aventis Pharma Deutschland GmbH	Revoked
EP00910510A	2003-05-28	Grund, Martin, Dr.	Revoked
EP00910510A	2003-05-28	JANSSEN PHARMACEUTICA N.V.	Revoked
EP00910510A	2003-05-28	AstraZeneca AB	Revoked
EP00910510A	2003-05-28	Novartis AG	Revoked
EP00910510A	2003-05-28	Isis Pharmaceuticals, Inc.	Revoked
EP00910510A	2003-05-20	Sirna Therapeutics, Inc.	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9150605	November, 2010	Decision	Charles Allerson et al

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.
US8546143	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of a target gene	Jan, 2022 (1 year, 8 months ago)
US9708610	ALNYLAM PHARMS INC	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Jan, 2024 (3 months from now)
US9708615	ALNYLAM PHARMS INC	Therapeutic compositions	Mar, 2024 (5 months from now)
US10273477	ALNYLAM PHARMS INC	Therapeutic compositions	Mar, 2024 (5 months from now)
US11530408	ALNYLAM PHARMS INC	Therapeutic compositions	May, 2024 (7 months from now)
US9150605	ALNYLAM PHARMS INC	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Aug, 2025 (1 year, 10 months from now)
US10131907	ALNYLAM PHARMS INC	Glycoconjugates of RNA interference agents	Aug, 2028 (4 years from now)
US8828956	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US8106022	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (6 years from now)
US10125364	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Mar, 2033 (9 years from now)
US9133461	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Nov, 2033 (10 years from now)
US11028392	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Oct, 2034 (11 years from now)
US10119143	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Oct, 2034 (11 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).
US9631193	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Mar, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 20, 2024
Orphan Drug Exclusivity (ODE)	Nov 20, 2026

Drugs and Companies using GIVOSIRAN SODIUM ingredient

NCE-1 date: 2023-11-21

Market Authorisation Date: 20 November, 2019

Treatment: Treatment of acute hepatic porphyria

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Dosage	Availability
EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION;SUBCUTANEOUS	Prescription

GIVLAARI family patents

3. Onpattro patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP09731866A	2018-04-05	Merck Sharp & Dohme Corporation	Granted and Under Opposition
EP09731866A	2018-04-05	Moderna Therapeutics, Inc.	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8058069	January, 2019	Final Written Decision	Arbutus Biopharma Corporation	Moderna Therapeutics, Inc.
US9364435	March, 2018	FWD Entered	Arbutus Biopharma Corporation	Moderna Therapeutics, Inc.

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.
US8334373	ALNYLAM PHARMS INC	Nuclease resistant double-stranded ribonucleic acid	May, 2025 (1 year, 7 months from now)
US10240152	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US8168775	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US11079379	ALNYLAM PHARMS INC	Methods of treating transthyretin (TTR) mediated amyloidosis	Aug, 2035 (11 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).
US9943539	ALNYLAM PHARMS INC	2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations	Nov, 2023 (a month from now)
US9943538	ALNYLAM PHARMS INC	2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations	Nov, 2023 (a month from now)
US8642076	ALNYLAM PHARMS INC	Lipid containing formulations	Oct, 2027 (4 years from now)
US8058069	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (5 years from now)
US9364435	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (5 years from now)
US8492359	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (5 years from now)
US8822668	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (5 years from now)
US11141378	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (5 years from now)
US9234196	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US8741866	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US8802644	ALNYLAM PHARMS INC	Lipid formulation	Oct, 2030 (7 years from now)
US8158601	ALNYLAM PHARMS INC	Lipid formulation	Nov, 2030 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Aug 10, 2025
New Chemical Entity Exclusivity (NCE)	Aug 10, 2023

Drugs and Companies using PATISIRAN SODIUM ingredient

NCE-1 date: 2022-08-10

Market Authorisation Date: 10 August, 2018

Treatment: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription

ONPATTRO family patents

4. Oxlumo 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.
US10131907	ALNYLAM PHARMS INC	Glycoconjugates of RNA interference agents	Aug, 2028 (4 years from now)
US8828956	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (5 years from now)
US8106022	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (6 years from now)
US11060093	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (11 years from now)
US10487330	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (11 years from now)
US10465195	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (11 years from now)
US9828606	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (11 years from now)
US11401517	ALNYLAM PHARMS INC	Modified double-stranded RNA agents	Aug, 2035 (11 years from now)
US10612024	ALNYLAM PHARMS INC	Modified double-stranded RNA agents	Aug, 2035 (11 years from now)
US10612027	ALNYLAM PHARMS INC	Modified double-stranded RNA agents	Aug, 2035 (11 years from now)
US10478500	ALNYLAM PHARMS INC	Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression	Oct, 2035 (12 years from now)
US11446380	ALNYLAM PHARMS INC	Compositions and methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression	Oct, 2035 (12 years from now)
US11261447	ALNYLAM PHARMS INC	Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression	Nov, 2038 (15 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).
US10435692	ALNYLAM PHARMS INC	Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA	Dec, 2034 (11 years from now)