Pharsight

1. Bevespi Aerosphere patents expiration

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).
US10716753	ASTRAZENECA	Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems	May, 2030 (6 years from now)
US8324266	ASTRAZENECA	Compositions, methods and systems for respiratory delivery of two or more active agents	May, 2030 (6 years from now)
US9463161	ASTRAZENECA	Compositions for pulmonary delivery of long-acting muscarinic antagonists and associated methods and systems	May, 2030 (6 years from now)
US8808713	ASTRAZENECA	Compositions for pulmonary delivery of long-acting β2 adrenergic receptor agonists and associated methods and systems	May, 2030 (6 years from now)
US8703806	ASTRAZENECA	Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents	May, 2030 (6 years from now)
US9415009	ASTRAZENECA	Compositions, methods and systems for respiratory delivery of two or more active agents	May, 2030 (6 years from now)
US8815258	ASTRAZENECA	Compositions, methods and systems for respiratory delivery of two or more active agents	Mar, 2031 (7 years from now)

Drugs and Companies using FORMOTEROL FUMARATE; GLYCOPYRROLATE ingredient

Market Authorisation Date: 25 April, 2016

Treatment: Use for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd)

Dosage: AEROSOL, METERED;INHALATION

Strength	Dosage	Availability
0.0048MG/INH;0.0090MG/INH	AEROSOL, METERED;INHALATION	Prescription

BEVESPI AEROSPHERE family patents

2. Brilinta patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP07794121A	2017-12-22	Generics [UK] Limited (trading as Mylan)	Revoked
EP07794121A	2017-12-21	Hexal Biotech GmbH	Revoked
EP07794121A	2017-12-18	Wittkopp, Alexander	Revoked

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.
USRE46276	ASTRAZENECA	Triazolo(4,5-D)pyrimidine compounds	Oct, 2024 (1 year, 30 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).
USRE46276 (Pediatric)	ASTRAZENECA	Triazolo(4,5-D)pyrimidine compounds	Apr, 2025 (1 year, 6 months from now)
US8425934	ASTRAZENECA	Pharmaceutical compositions	Apr, 2030 (6 years from now)
US8425934 (Pediatric)	ASTRAZENECA	Pharmaceutical compositions	Oct, 2030 (7 years from now)
US10300065	ASTRAZENECA	Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction	Jan, 2036 (12 years from now)
US10300065 (Pediatric)	ASTRAZENECA	Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction	Jul, 2036 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication (I)	Nov 5, 2023
M (M)	May 9, 2025
Pediatric Exclusivity (PED)	Nov 9, 2025

Drugs and Companies using TICAGRELOR ingredient

Market Authorisation Date: 20 July, 2011

Treatment: Reducing the rate of cardiovascular death, myocardial infarction (mi), and stroke in a patient receiving 75-100 mg aspirin daily with a history of mi by administering 60 mg ticagrelor twice daily; Red...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
90 mg	20 Jul, 2015	16	04 Sep, 2018	17 Apr, 2030	Eligible
60 mg	30 Sep, 2015	3	04 Sep, 2018	17 Apr, 2030	Eligible

Strength	Dosage	Availability
60MG	TABLET;ORAL	Prescription
90MG	TABLET;ORAL	Prescription

BRILINTA family patents

3. Calquence patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP16735945A	2021-01-21	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10272083	February, 2023	Institution Denied	Acerta Pharma B.V. et al.	Sandoz 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.
US7459554	ASTRAZENECA	Imidazopyrazine tyrosine kinase inhibitors	Nov, 2026 (3 years from now)
US9290504	ASTRAZENECA	4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors	Jul, 2032 (8 years from now)
US11059829	ASTRAZENECA	Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide maleate	Jul, 2036 (12 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).
US9758524	ASTRAZENECA	4-imidazopyridazin-1-yl-benzamides as Btk inhibitors	Jul, 2032 (8 years from now)
US10239883	ASTRAZENECA	4-imidazopyridazin-1-yl-benzamides as BTK inhibitors	Jul, 2032 (8 years from now)
US10272083	ASTRAZENECA	Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor	Jan, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 31, 2022

Drugs and Companies using ACALABRUTINIB MALEATE ingredient

NCE-1 date: 2021-10-31

Market Authorisation Date: 03 August, 2022

Treatment: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy; Treatment of adult patients with chronic lymphocytic leukemia; Treatment of adult patients with prev...

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 100MG BASE	TABLET;ORAL	Prescription

CALQUENCE family patents

4. Calquence patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP16735945A	2021-01-21	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10272083	February, 2023	Institution Denied	Acerta Pharma B.V. et al.	Sandoz 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.
US7459554	ASTRAZENECA	Imidazopyrazine tyrosine kinase inhibitors	Nov, 2026 (3 years from now)
US9290504	ASTRAZENECA	4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors	Jul, 2032 (8 years from now)
US9796721	ASTRAZENECA	Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide	Jul, 2036 (12 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).
US9758524	ASTRAZENECA	4-imidazopyridazin-1-yl-benzamides as Btk inhibitors	Jul, 2032 (8 years from now)
US10239883	ASTRAZENECA	4-imidazopyridazin-1-yl-benzamides as BTK inhibitors	Jul, 2032 (8 years from now)
US10272083	ASTRAZENECA	Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor	Jan, 2035 (11 years from now)
US10167291	ASTRAZENECA	Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide	Jul, 2036 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Nov 21, 2026

Drugs and Companies using ACALABRUTINIB ingredient

Market Authorisation Date: 31 October, 2017

Treatment: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy; Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination wi...

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg	01 Nov, 2021	5		01 Jul, 2036

Strength	Dosage	Availability
100MG	CAPSULE;ORAL	Prescription

CALQUENCE family patents

5. Daliresp patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10173234A	2014-02-17	Generics [UK] Limited	Revoked
EP10173234A	2014-02-17	Hexal AG	Revoked
EP03704652A	2012-12-20	Hexal AG	Revoked

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).
US8431154	ASTRAZENECA	Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient	Feb, 2023 (7 months ago)
US9468598	ASTRAZENECA	Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient	Feb, 2023 (7 months ago)
US8536206	ASTRAZENECA	Process for the preparation of roflumilast	Mar, 2024 (5 months from now)
US8618142	ASTRAZENECA	Process for the preparation of roflumilast	Mar, 2024 (5 months from now)
US8604064	ASTRAZENECA	Process for the preparation of roflumilast	Mar, 2024 (5 months from now)

Drugs and Companies using ROFLUMILAST ingredient

Market Authorisation Date: 28 February, 2011

Treatment: Treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
500 mcg	02 Mar, 2015	7	13 Jul, 2018	08 Mar, 2024	Eligible
250 mcg	25 Jan, 2019	1	07 Sep, 2022	08 Mar, 2024	Eligible

Strength	Dosage	Availability
250MCG	TABLET;ORAL	Prescription
500MCG	TABLET;ORAL	Prescription

DALIRESP family patents

6. Duaklir Pressair patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP09719213A	2016-05-12	Generics (U.K.) Limited	Granted and Under Opposition
EP09719213A	2016-05-06	Hexal AG	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.
USRE46417	ASTRAZENECA	Quinuclidine derivatives and their use as muscarinic M3 receptor ligands	Feb, 2025 (1 year, 4 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6681768	ASTRAZENECA	Powder formulation disintegrating system and method for dry powder inhalers	Aug, 2022 (1 year, 1 month ago)
US8051851	ASTRAZENECA	Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler	Apr, 2027 (3 years from now)
US10085974	ASTRAZENECA	Dosage and formulation	Mar, 2029 (5 years from now)
US11000517	ASTRAZENECA	Dosage and formulation	Mar, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Combination (NC)	Mar 29, 2022

Drugs and Companies using ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE ingredient

Market Authorisation Date: 29 March, 2019

Treatment: Maintenance treatment of chronic obstructive pulmonary disease (copd)

Dosage: POWDER, METERED;INHALATION

Strength	Dosage	Availability
0.4MG/INH;0.012MG/INH	POWDER, METERED;INHALATION	Prescription

DUAKLIR PRESSAIR family patents

7. Epanova patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP05702139A	2010-11-17	Catalent Pharma Solutions, Inc.	Patent maintained as amended
EP05702139A	2010-11-17	S P A SOCIETA' PRODOTTI ANTIBIOTICI S.p.a.	Patent maintained as amended
EP05702139A	2010-11-17	Pronova Biopharma Norge AS	Patent maintained as amended

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.
US9050309	ASTRAZENECA	DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form	Jan, 2033 (9 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).
US9132112	ASTRAZENECA	Type A gelatin capsule containing PUFA in free acid form	Feb, 2025 (1 year, 4 months from now)
US9012501	ASTRAZENECA	Type A gelatin capsule containing PUFA in free acid form	Feb, 2025 (1 year, 4 months from now)
US8383678	ASTRAZENECA	Type a gelatin capsule containing PUFA in free acid form	Feb, 2025 (1 year, 4 months from now)
US7960370	ASTRAZENECA	Type A gelatin capsule containing PUFA in free acid form	Dec, 2026 (3 years from now)
US9050308	ASTRAZENECA	DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form	Jan, 2033 (9 years from now)
US10117844	ASTRAZENECA	DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form	Jan, 2033 (9 years from now)

Drugs and Companies using OMEGA-3-CARBOXYLIC ACIDS ingredient

Market Authorisation Date: 05 May, 2014

Treatment: Treatment of hypertriglyceridemia; Treatment of severe hypertriglyceridemia (500 mg/dl) in adult patients as an adjunct to diet

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS	CAPSULE;ORAL	Discontinued

EPANOVA family patents

8. Koselugo patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP15177189A	2018-04-19	Generics [UK] Limited (trading as Mylan)	Revoked

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.
US8178693	ASTRAZENECA	N3 alkylated benzimidazole derivatives as MEK inhibitors	Mar, 2023 (6 months ago)
US7425637	ASTRAZENECA	N3 alkylated benzimidazole derivatives as MEK inhibitors	Mar, 2024 (5 months from now)
US9156795	ASTRAZENECA	Hydrogen sulfate salt	Dec, 2026 (3 years from now)
US9562017	ASTRAZENECA	Hydrogen sulfate salt	Dec, 2026 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 10, 2025
Orphan Drug Exclusivity (ODE)	Apr 10, 2027

Drugs and Companies using SELUMETINIB SULFATE ingredient

NCE-1 date: 2024-04-10

Market Authorisation Date: 10 April, 2020

Treatment: Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (nf1) who have symptomatic, inoperable plexiform neurofibromas (pn)

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
EQ 10MG BASE	CAPSULE;ORAL	Prescription
EQ 25MG BASE	CAPSULE;ORAL	Prescription

KOSELUGO family patents

9. Lokelma patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP12744254A	2019-08-06	Galenicum Health S.L.U.	Granted and Under Opposition
EP12744254A	2019-08-06	Sandoz AG	Granted and Under Opposition
EP12744254A	2019-08-05	Teva Pharmaceutical Industries Ltd	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.
US10413569	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (8 years from now)
US11406662	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (8 years from now)
US8802152	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Apr, 2032 (8 years from now)
US8877255	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Oct, 2033 (10 years from now)
US10695365	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Oct, 2033 (10 years from now)
US9913860	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Oct, 2033 (10 years from now)
US10300087	ASTRAZENECA	Extended use zirconium silicate compositions and methods of use thereof	Oct, 2035 (12 years from now)
US9592253	ASTRAZENECA	Extended use zirconium silicate compositions and methods of use thereof	Oct, 2035 (12 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).
US9844567	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (8 years from now)
US9861658	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (8 years from now)
US10398730	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (8 years from now)
US8808750	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (8 years from now)
US10335432	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 18, 2023
M (M)	Apr 24, 2023

Drugs and Companies using SODIUM ZIRCONIUM CYCLOSILICATE ingredient

NCE-1 date: 2022-05-18

Market Authorisation Date: 18 May, 2018

Treatment: Treatment of hyperkalemia in adults

Dosage: FOR SUSPENSION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 g/packet and 10 g/packet	18 May, 2022	5		14 Oct, 2035

Strength	Dosage	Availability
5GM/PACKET	FOR SUSPENSION;ORAL	Prescription
10GM/PACKET	FOR SUSPENSION;ORAL	Prescription

LOKELMA family patents

10. Lynparza patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP09740728A	2017-04-20	Teva Pharmaceutical Industries Ltd	Patent maintained as amended
EP04798705A	2012-05-24	STRAWMAN LIMITED	Opposition procedure closed
EP04798705A	2012-05-24	Adams, Harvey Vaughan John	Opposition procedure closed
EP04743564A	2012-04-13	STRAWMAN LIMITED	Patent maintained as amended
EP04743564A	2012-04-13	Adams, Harvey Vaughan John	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8859562	October, 2011	Decision	Thomas Helleday

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.
US7151102	ASTRAZENECA	Phthalazinone derivatives	Apr, 2022 (1 year, 5 months ago)
US7449464	ASTRAZENECA	Phthalazinone derivatives	Oct, 2024 (1 year, 11 days from now)
US7981889	ASTRAZENECA	Phthalazinone derivatives	Oct, 2024 (1 year, 11 days from now)
US8247416	ASTRAZENECA	Phthalazinone derivative	Sep, 2028 (4 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).
US8912187	ASTRAZENECA	Phthalazinone derivatives	Mar, 2024 (5 months from now)
US9169235	ASTRAZENECA	Phthalazinone derivatives	Mar, 2024 (5 months from now)
US9566276	ASTRAZENECA	Phthalazinone derivatives	Mar, 2024 (5 months from now)
US8143241	ASTRAZENECA	DNA damage repair inhibitors for treatment of cancer	Aug, 2027 (3 years from now)
US8071579	ASTRAZENECA	DNA damage repair inhibitors for the treatment of cancer	Aug, 2027 (3 years from now)
US11633396	ASTRAZENECA	Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one	Oct, 2029 (6 years from now)
US8475842	ASTRAZENECA	Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one	Dec, 2029 (6 years from now)
US8859562	ASTRAZENECA	Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer	Aug, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	May 8, 2027
New Indication (I)	Mar 11, 2025

Drugs and Companies using OLAPARIB ingredient

Market Authorisation Date: 17 August, 2017

Treatment: Treatment of brca mutated ovarian cancer using parp inhibitor; Treatment of deleterious or suspected deleterious germline or somatic brca-mutated metastatic castration-resistant prostate cancer, which...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg and 150 mg	01 Nov, 2022	1		04 Aug, 2031

Strength	Dosage	Availability
100MG	TABLET;ORAL	Prescription
150MG	TABLET;ORAL	Prescription

LYNPARZA family patents

11. Symbicort patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP03703575A	2009-11-25	NORTON HEALTHCARE LIMITED	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7759328	January, 2017	Terminated-Denied	AstraZeneca AB	Complex Innovations, 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).
US7967011 (Pediatric)	ASTRAZENECA	Inhalation device	Feb, 2022 (1 year, 7 months ago)
US7759328	ASTRAZENECA	Composition for inhalation	Jan, 2023 (8 months ago)
US11311558	ASTRAZENECA	Composition for inhalation	Jan, 2023 (8 months ago)
US10166247	ASTRAZENECA	Composition for inhalation	Jan, 2023 (8 months ago)
US8575137	ASTRAZENECA	Composition for inhalation	Jan, 2023 (8 months ago)
US8143239	ASTRAZENECA	Composition for inhalation	Jan, 2023 (8 months ago)
US11311558 (Pediatric)	ASTRAZENECA	Composition for inhalation	Jul, 2023 (2 months ago)
US10166247 (Pediatric)	ASTRAZENECA	Composition for inhalation	Jul, 2023 (2 months ago)
US8575137 (Pediatric)	ASTRAZENECA	Composition for inhalation	Jul, 2023 (2 months ago)
US8143239 (Pediatric)	ASTRAZENECA	Composition for inhalation	Jul, 2023 (2 months ago)
US7759328 (Pediatric)	ASTRAZENECA	Composition for inhalation	Jul, 2023 (2 months ago)
US8875699	ASTRAZENECA	Inhaler cap strap	Nov, 2024 (1 year, 1 month from now)
US8875699 (Pediatric)	ASTRAZENECA	Inhaler cap strap	May, 2025 (1 year, 7 months from now)
US7587988	ASTRAZENECA	Inhaler device counter	Apr, 2026 (2 years from now)
US7587988 (Pediatric)	ASTRAZENECA	Inhaler device counter	Oct, 2026 (3 years from now)
US8387615	ASTRAZENECA	Inhaler cap strap	Mar, 2027 (3 years from now)
US8387615 (Pediatric)	ASTRAZENECA	Inhaler cap strap	Sep, 2027 (3 years from now)
US8528545	ASTRAZENECA	Inhaler device that reduces the risk for miscounting a dosage	Oct, 2028 (5 years from now)
US8616196	ASTRAZENECA	Inhalation device and a method for assembling said inhalation device	Apr, 2029 (5 years from now)
US8528545 (Pediatric)	ASTRAZENECA	Inhaler device that reduces the risk for miscounting a dosage	Apr, 2029 (5 years from now)
US8616196 (Pediatric)	ASTRAZENECA	Inhalation device and a method for assembling said inhalation device	Oct, 2029 (6 years from now)

Drugs and Companies using BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE ingredient

Market Authorisation Date: 21 July, 2006

Treatment: Use for the treatment of asthma in patients 6 years of age and older; Use for reducing exacerbations of chronic obstructive pulmonary disease; Use for maintenance treatment of chronic obstructive pulm...

Dosage: AEROSOL, METERED;INHALATION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
80 mcg/4.5 mcg per inhalation and 160 mcg/4.5 mcg per inhalation	26 Jun, 2018	1	15 Mar, 2022	16 Oct, 2028	Deferred

Strength	Dosage	Availability
0.08MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription
0.16MG/INH;0.0045MG/INH	AEROSOL, METERED;INHALATION	Prescription

SYMBICORT family patents

12. Symbicort Aerosphere patents expiration

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).
US10716753	ASTRAZENECA	Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems	May, 2030 (6 years from now)
US9415009	ASTRAZENECA	Compositions, methods and systems for respiratory delivery of two or more active agents	May, 2030 (6 years from now)

Drugs and Companies using BUDESONIDE; FORMOTEROL FUMARATE ingredient

Market Authorisation Date: 28 April, 2023

Treatment: Maintenance treatment of patients with chronic obstructive pulmonary disease (copd)

Dosage: AEROSOL, METERED;INHALATION

SYMBICORT AEROSPHERE family patents

13. Tagrisso 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.
US11524951	ASTRAZENECA	2-(2,4,5-substituted-anilino)pyrimidine compounds	Jul, 2032 (8 years from now)
US9732058	ASTRAZENECA	2-(2,4,5-substituted-anilino)pyrimidine compounds	Jul, 2032 (8 years from now)
US8946235	ASTRAZENECA	2-(2,4,5-substituted-anilino) pyrimidine compounds	Aug, 2032 (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).
US10183020	ASTRAZENECA	Pharmaceutical compositions comprising AZD9291	Jan, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 18, 2027
New Indication (I)	Dec 18, 2023

Drugs and Companies using OSIMERTINIB MESYLATE ingredient

Market Authorisation Date: 13 November, 2015

Treatment: Treatment of patients with metastatic epidermal growth factor receptor (egfr) t790m mutation-positive non-small cell lung cancer (nsclc), who have progressed on or after egfr tki therapy; Treatment of...

Dosage: TABLET;ORAL

TAGRISSO family patents

14. Tudorza Pressair 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.
USRE46417	ASTRAZENECA	Quinuclidine derivatives and their use as muscarinic M3 receptor ligands	Feb, 2025 (1 year, 4 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6681768	ASTRAZENECA	Powder formulation disintegrating system and method for dry powder inhalers	Aug, 2022 (1 year, 1 month ago)
US8051851	ASTRAZENECA	Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler	Apr, 2027 (3 years from now)
US11000517	ASTRAZENECA	Dosage and formulation	Mar, 2029 (5 years from now)
US10085974	ASTRAZENECA	Dosage and formulation	Mar, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M (M)	Mar 29, 2022

Drugs and Companies using ACLIDINIUM BROMIDE ingredient

Market Authorisation Date: 23 July, 2012

Treatment: Maintenance treatment of chronic obstructive pulmonary disease (copd)

Dosage: POWDER, METERED;INHALATION

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Application	Filing Date	Opposition Party	Legal Status

EP15192658A	2018-07-24	Generics (U.K.) Limited	Opposition rejected
EP12759801A	2016-10-06	STADA Arzneimittel AG	Opposition rejected

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Pharsight

Astrazeneca patents expiration

1. Bevespi Aerosphere patents expiration Share with your colleague

BEVESPI AEROSPHERE family patents

2. Brilinta patents expiration Share with your colleague

BRILINTA family patents

3. Calquence patents expiration Share with your colleague

CALQUENCE family patents

4. Calquence patents expiration Share with your colleague

CALQUENCE family patents

5. Daliresp patents expiration Share with your colleague

DALIRESP family patents

6. Duaklir Pressair patents expiration Share with your colleague

DUAKLIR PRESSAIR family patents

7. Epanova patents expiration Share with your colleague

EPANOVA family patents

8. Koselugo patents expiration Share with your colleague

KOSELUGO family patents

9. Lokelma patents expiration Share with your colleague

LOKELMA family patents

10. Lynparza patents expiration Share with your colleague

LYNPARZA family patents

11. Symbicort patents expiration Share with your colleague

SYMBICORT family patents

12. Symbicort Aerosphere patents expiration Share with your colleague

SYMBICORT AEROSPHERE family patents

13. Tagrisso patents expiration Share with your colleague

TAGRISSO family patents

14. Tudorza Pressair patents expiration Share with your colleague

TUDORZA PRESSAIR family patents

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1. Bevespi Aerosphere patents expiration

2. Brilinta patents expiration

3. Calquence patents expiration

4. Calquence patents expiration

5. Daliresp patents expiration

6. Duaklir Pressair patents expiration

7. Epanova patents expiration

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