Pharsight

1. Orenitram patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP04776104A	2017-10-25	Teva Pharmaceutical Industries Ltd	Patent maintained as amended
EP07755989A	2012-08-08	Sandoz AG	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9593066	March, 2020	Terminated-Denied	United Therapeutics Corp.	Liquidia Technologies, Inc.
US9604901	March, 2020	FWD Entered	United Therapeutics Corp.	Liquidia Technolgies, Inc.
US8497393	October, 2015	FWD Entered	United Therapeutics Corporation	SteadyMed Ltd.

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.
US9050311	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	May, 2024 (7 months from now)
US7417070	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	Jul, 2026 (2 years from now)
US9604901	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 years from now)
US9593066	UNITED THERAP	Process to prepare treprostinil, the active ingredient in remodulin®	Dec, 2028 (5 years from now)
US8497393	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 years from now)
US11723887	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 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).
US8252839	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	May, 2024 (7 months from now)
US9422223	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	May, 2024 (7 months from now)
US9278901	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	May, 2024 (7 months from now)
US7544713	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	Jul, 2024 (9 months from now)
US9393203	UNITED THERAP	Osmotic drug delivery system	Apr, 2026 (2 years from now)
US8410169	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	Feb, 2030 (6 years from now)
US8349892	UNITED THERAP	Solid formulations of prostacyclin analogs	Jan, 2031 (7 years from now)
US8747897	UNITED THERAP	Osmotic drug delivery system	Aug, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Oct 18, 2026

Drugs and Companies using TREPROSTINIL DIOLAMINE ingredient

Market Authorisation Date: 20 December, 2013

Treatment: Use of orenitram for the treatment of pulmonary arterial hypertension (pah) (who group 1).; Method of treating pulmonary hypertension by orally administering a formulation of a pharmaceutically accept...

Dosage: TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
2.5 mg	24 Dec, 2015	1	22 Jan, 2031
0.25 mg and 1 mg	19 May, 2016	1	22 Jan, 2031
0.125 mg and 5 mg	28 Dec, 2020	1	11 Aug, 2031

Strength	Dosage	Availability
EQ 0.125MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 0.25MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 1MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 2.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription
EQ 5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription

ORENITRAM family patents

2. Remodulin patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP13188882A	2019-12-05	Generics [UK] Ltd	Revoked
EP13188882A	2019-11-22	Teva Pharmaceutical Industries Ltd	Revoked
EP04776104A	2017-10-25	Teva Pharmaceutical Industries Ltd	Patent maintained as amended
EP08829225A	2016-10-06	Generics (U.K.) Limited	Revoked
EP08829225A	2016-09-30	Teva Pharmaceutical Industries Ltd	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9593066	March, 2020	Terminated-Denied	United Therapeutics Corp.	Liquidia Technologies, Inc.
US9604901	March, 2020	FWD Entered	United Therapeutics Corp.	Liquidia Technolgies, 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.
US9604901	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 years from now)
US9593066	UNITED THERAP	Process to prepare treprostinil, the active ingredient in remodulin®	Dec, 2028 (5 years from now)
US11723887	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 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).
US9199908	UNITED THERAP	Compounds and methods for delivery of prostacyclin analogs	May, 2024 (7 months from now)
US10076505	UNITED THERAP	Inhalation formulations of Treprostinil	Dec, 2024 (1 year, 2 months from now)
US9713599	UNITED THERAP	Parenteral formulations of treprostinil	Dec, 2024 (1 year, 2 months from now)
US10695308	UNITED THERAP	Inhalation formulations of treprostinil	Dec, 2024 (1 year, 2 months from now)
US8653137	UNITED THERAP	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same	Sep, 2028 (4 years from now)
US8658694	UNITED THERAP	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same	Sep, 2028 (4 years from now)
US7999007	UNITED THERAP	Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same	Mar, 2029 (5 years from now)

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 21 May, 2002

Treatment: Administration of remodulin diluted for intravenous infusion with sterile water for injection or 0.9% sodium chloride injection prior to administration; A method of treating pulmonary hypertension co...

Dosage: INJECTABLE;IV (INFUSION), SUBCUTANEOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg/mL, 20 mL vial	02 Dec, 2011	1	30 Nov, 2017	29 Mar, 2029	Eligible
1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial	07 Dec, 2012	1	30 Nov, 2017	29 Mar, 2029	Eligible

Strength	Dosage	Availability
1MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription
2.5MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription
5MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription
10MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription
20MG/ML	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	Prescription

REMODULIN family patents

3. Tyvaso patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10716793	January, 2021	Final Written Decision - Appealed	United Therapeutics Corporation	Liquidia Technologies, Inc.
US9593066	March, 2020	Terminated-Denied	United Therapeutics Corp.	Liquidia Technologies, Inc.
US9604901	March, 2020	FWD Entered	United Therapeutics Corp.	Liquidia Technolgies, Inc.
US9339507	June, 2017	Terminated-Settled	United Therapeutics Corp.	Watson Laboratories, Inc.
US9358240	June, 2017	Terminated-Settled	United Therapeutics Corp.	Watson Laboratories, 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.
US9604901	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 years from now)
US9593066	UNITED THERAP	Process to prepare treprostinil, the active ingredient in remodulin®	Dec, 2028 (5 years from now)
US11723887	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 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).
US10376525	UNITED THERAP	Treprostinil administration by inhalation	May, 2027 (3 years from now)
US10716793	UNITED THERAP	Treprostinil administration by inhalation	May, 2027 (3 years from now)
US9339507	UNITED THERAP	Treprostinil administration by inhalation	Mar, 2028 (4 years from now)
US9358240	UNITED THERAP	Treprostinil administration by inhalation	May, 2028 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication (I)	Mar 31, 2024

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 30 July, 2009

Treatment: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device

Dosage: SOLUTION;INHALATION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.6 mg/mL, 2.9 mL ampules	13 Apr, 2015	1		15 Dec, 2028	Extinguished

Strength	Dosage	Availability
0.6MG/ML	SOLUTION;INHALATION	Prescription

TYVASO family patents

4. Tyvaso Dpi patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US10716793	January, 2021	Final Written Decision - Appealed	United Therapeutics Corporation	Liquidia Technologies, Inc.
US9593066	March, 2020	Terminated-Denied	United Therapeutics Corp.	Liquidia Technologies, Inc.
US9604901	March, 2020	FWD Entered	United Therapeutics Corp.	Liquidia Technolgies, 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.
US9593066	UNITED THERAP	Process to prepare treprostinil, the active ingredient in remodulin®	Dec, 2028 (5 years from now)
US9604901	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 years from now)
US11723887	UNITED THERAP	Process to prepare treprostinil, the active ingredient in Remodulin®	Dec, 2028 (5 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).
US10130685	UNITED THERAP	Diketopiperazine salts for drug delivery and related methods	Aug, 2025 (1 year, 10 months from now)
US10716793	UNITED THERAP	Treprostinil administration by inhalation	May, 2027 (3 years from now)
US10772883	UNITED THERAP	Diketopiperazine microparticles with defined specific surface areas	Jun, 2030 (6 years from now)
US10421729	UNITED THERAP	Microcrystalline diketopiperazine compositions and methods	Apr, 2035 (11 years from now)

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 23 May, 2022

Treatment: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device

Dosage: POWDER;INHALATION

Strength	Dosage	Availability
0.016MG/INH	POWDER;INHALATION	Prescription
0.032MG/INH	POWDER;INHALATION	Prescription
0.048MG/INH	POWDER;INHALATION	Prescription
0.064MG/INH	POWDER;INHALATION	Prescription