United Drug Patent Portfolio

United owns 4 orange book drugs protected by 35 US patents Given below is the list of United's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11826327 Treatment for interstitial lung disease 03 Feb, 2042
Active
US10421729 Microcrystalline diketopiperazine compositions and methods 01 Apr, 2035
Active
US12679811 Microcrystalline Diketopiperazine Compositions And Methods 14 Mar, 2034
Active
US8747897 Osmotic drug delivery system 11 Aug, 2031
Active
US8349892 Solid formulations of prostacyclin analogs 22 Jan, 2031
Active
US10772883 Diketopiperazine microparticles with defined specific surface areas 11 Jun, 2030
Active
US8410169 Compounds and methods for delivery of prostacyclin analogs 13 Feb, 2030
Active
US7999007 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same 29 Mar, 2029
Active
US11723887 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
Active
US8497393 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
Active
US9593066 Process to prepare treprostinil, the active ingredient in remodulin® 15 Dec, 2028
Active
US9604901 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
Active
US8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same 05 Sep, 2028
Active
US8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same 05 Sep, 2028
Active
US9358240 Treprostinil administration by inhalation 05 May, 2028
Active
US9339507 Treprostinil administration by inhalation 10 Mar, 2028
Active
US10376525 Treprostinil administration by inhalation 14 May, 2027
Active
US10716793 Treprostinil administration by inhalation 14 May, 2027
Active
US11357782 Treprostinil administration by inhalation 14 May, 2027
Active
US7417070 Compounds and methods for delivery of prostacyclin analogs 30 Jul, 2026 Expired
US9393203 Osmotic drug delivery system 27 Apr, 2026 Expired
US10130685 Diketopiperazine salts for drug delivery and related methods 23 Aug, 2025 Expired
US10076505 Inhalation formulations of Treprostinil 16 Dec, 2024 Expired
US10695308 Inhalation formulations of treprostinil 16 Dec, 2024 Expired
US9713599 Parenteral formulations of treprostinil 16 Dec, 2024 Expired
US7544713 Compounds and methods for delivery of prostacyclin analogs 14 Jul, 2024 Expired
US8252839 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024 Expired
US9050311 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024 Expired
US9278901 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024 Expired
US9422223 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024 Expired
US9199908 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024 Expired
US6521212 Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation 13 Nov, 2018 Expired
US6756033 Method for delivering benzindene prostaglandins by inhalation 13 Nov, 2018 Expired
US6765117 Process for stereoselective synthesis of prostacyclin derivatives 24 Oct, 2017 Expired
US5153222 Method of treating pulmonary hypertension with benzidine prostaglandins 16 Oct, 2014 Expired


Given below is the list of recent legal activities going on the following drug patents of United.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 26 Nov, 2025 US8747897 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 26 Nov, 2025 US11357782 (Litigated)
Expire Patent 01 Sep, 2025 US9713599
Payment of Maintenance Fee, 12th Year, Large Entity 13 Aug, 2025 US8658694 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 06 Aug, 2025 US8653137 (Litigated)
Recordation of Patent eCertificate of Correction 08 Jul, 2025 US11826327
Patent eCofC Notification 08 Jul, 2025 US11826327
Mail Patent eCofC Notification 08 Jul, 2025 US11826327
Patent eCofC Notification 08 Jul, 2025 US11826327
Email Notification 08 Jul, 2025 US11826327
Email Notification 08 Jul, 2025 US11826327
Mail Patent eCofC Notification 08 Jul, 2025 US11826327
Recordation of Patent eCertificate of Correction 08 Jul, 2025 US11826327
Expire Patent 05 May, 2025 US8410169 (Litigated)
Maintenance Fee Reminder Mailed 17 Mar, 2025 US9713599


United's Drug Patent Litigations

United's drugs have been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 02, 2015, against patent number US8497393. The petitioner SteadyMed Ltd. et al., challenged the validity of this patent, with United Therapeutics Corporation as the respondent. Click below to track the latest information on how companies are challenging United's patents.

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10716793 January, 2021 Final Written Decision
(02 Feb, 2023)
United Therapeutics Corporation Liquidia Technologies, Inc.
US9604901 March, 2020 Final Written Decision
(08 Oct, 2021)
United Therapeutics Corp. Liquidia Technolgies, Inc.
US9593066 March, 2020 Institution Denied
(13 Oct, 2020)
United Therapeutics Corp. Liquidia Technologies, Inc.
US9339507 June, 2017 Terminated-Settled
(27 Aug, 2018)
United Therapeutics Corp. Watson Laboratories, Inc.
US9358240 June, 2017 Terminated-Settled
(27 Aug, 2018)
United Therapeutics Corp. Watson Laboratories, Inc.
US8497393 October, 2015 Final Written Decision
(31 Mar, 2017)
United Therapeutics Corporation SteadyMed Ltd. et al.


United Drug Patents' Oppositions Filed in EPO

United drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 08, 2012, by Sandoz Ag. This opposition was filed on patent number EP07755989A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP13188882A Dec, 2019 Generics [UK] Ltd Revoked
EP13188882A Nov, 2019 Teva Pharmaceutical Industries Ltd Revoked
EP04776104A Oct, 2017 Teva Pharmaceutical Industries Ltd Patent maintained as amended
EP08829225A Oct, 2016 Generics (U.K.) Limited Revoked
EP08829225A Sep, 2016 Teva Pharmaceutical Industries Ltd Revoked
EP07755989A Aug, 2012 Sandoz AG Revoked


United's Family Patents

United drugs have patent protection in a total of 22 countries. It's US patent count contributes only to 39.2% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree.

Family Patents





Clinical Trials

Recent Clinical Trials by United:

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease United Therapeutics NA ENROLLING BY INVITATION
(Sep 1, 2026)
PHASE3
Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer Institute of Cancer Research, United Kingdom NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin ± Sulfonylurea/SGLT2 Inhibitor Therapy (UNIGUIDE-2) The United Bio-Technology (Hengqin) Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE3
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study) Institute of Cancer Research, United Kingdom NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma Academic and Community Cancer Research United NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer Institute of Cancer Research, United Kingdom NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma Academic and Community Cancer Research United NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Phase I Drug-Drug Interaction Study of UBT251 Injection in Participants With Overweight or Obesity The United Bio-Technology (Hengqin) Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE1
Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer Academic and Community Cancer Research United NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF) United Therapeutics NA RECRUITING
(Jul 1, 2026)
PHASE3
Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD) Zhuhai United Laboratories Co., Ltd. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1
Modified VR-CAP and Acalabrutinib as First Line Therapy for the Treatment of Transplant-Eligible Patients With Mantle Cell Lymphoma Academic and Community Cancer Research United NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab Institute of Cancer Research, United Kingdom NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) United Therapeutics NA TERMINATED
(May 1, 2026)
PHASE3
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis United Therapeutics NA COMPLETED
(May 1, 2026)
PHASE3
UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study The United Bio-Technology (Hengqin) Co., Ltd. NA COMPLETED
(May 1, 2026)
PHASE2
A Study to Evaluate the Efficacy and Safety of UI022/UI023 Korea United Pharm. Inc. NA COMPLETED
(May 1, 2026)
PHASE3
Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations Academic and Community Cancer Research United NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers: United Medical and Dental College NA RECRUITING
(Apr 1, 2026)
PHASE3
Phase I Trial of Defactinib and VS-6766. Institute of Cancer Research, United Kingdom NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1


United Drug List

Given below is the complete list of United's drugs and the patents protecting them.


1. Orenitram

Orenitram is protected by 16 patents, out of which 9 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US8747897 Osmotic drug delivery system 11 Aug, 2031
(4 years from now)
Active
US8349892 Solid formulations of prostacyclin analogs 22 Jan, 2031
(4 years from now)
Active
US8410169 Compounds and methods for delivery of prostacyclin analogs 13 Feb, 2030
(3 years from now)
Active
US11723887 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US8497393 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US9593066 Process to prepare treprostinil, the active ingredient in remodulin® 15 Dec, 2028
(2 years from now)
Active
US9604901 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US7417070 Compounds and methods for delivery of prostacyclin analogs 30 Jul, 2026
(2 months ago)
Expired
US9393203 Osmotic drug delivery system 27 Apr, 2026
(5 months ago)
Expired
US7544713 Compounds and methods for delivery of prostacyclin analogs 14 Jul, 2024
(2 years ago)
Expired
US8252839 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024
(2 years ago)
Expired
US9050311 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024
(2 years ago)
Expired
US9278901 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024
(2 years ago)
Expired
US9422223 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024
(2 years ago)
Expired
US6765117 Process for stereoselective synthesis of prostacyclin derivatives 24 Oct, 2017
(8 years ago)
Expired
US5153222 Method of treating pulmonary hypertension with benzidine prostaglandins 16 Oct, 2014
(11 years ago)
Expired

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Orenitram's drug page


2. Remodulin

Remodulin is protected by 13 patents, out of which 6 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US7999007 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same 29 Mar, 2029
(2 years from now)
Active
US11723887 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US8497393 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US9593066 Process to prepare treprostinil, the active ingredient in remodulin® 15 Dec, 2028
(2 years from now)
Active
US9604901 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same 05 Sep, 2028
(1 year, 11 months from now)
Active
US8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same 05 Sep, 2028
(1 year, 11 months from now)
Active
US10076505 Inhalation formulations of Treprostinil 16 Dec, 2024
(1 year, 9 months ago)
Expired
US10695308 Inhalation formulations of treprostinil 16 Dec, 2024
(1 year, 9 months ago)
Expired
US9713599 Parenteral formulations of treprostinil 16 Dec, 2024
(1 year, 9 months ago)
Expired
US9199908 Compounds and methods for delivery of prostacyclin analogs 24 May, 2024
(2 years ago)
Expired
US6765117 Process for stereoselective synthesis of prostacyclin derivatives 24 Oct, 2017
(8 years ago)
Expired
US5153222 Method of treating pulmonary hypertension with benzidine prostaglandins 06 Oct, 2014
(12 years ago)
Expired

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Remodulin's drug page


3. Tyvaso

Tyvaso is protected by 13 patents, out of which 4 have expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11826327 Treatment for interstitial lung disease 03 Feb, 2042
(15 years from now)
Active
US11723887 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US8497393 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US9593066 Process to prepare treprostinil, the active ingredient in remodulin® 15 Dec, 2028
(2 years from now)
Active
US9604901 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US9358240 Treprostinil administration by inhalation 05 May, 2028
(1 year, 6 months from now)
Active
US9339507 Treprostinil administration by inhalation 10 Mar, 2028
(1 year, 5 months from now)
Active
US10376525 Treprostinil administration by inhalation 14 May, 2027
(7 months from now)
Active
US10716793 Treprostinil administration by inhalation 14 May, 2027
(7 months from now)
Active
US6521212 Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation 13 Nov, 2018
(7 years ago)
Expired
US6756033 Method for delivering benzindene prostaglandins by inhalation 13 Nov, 2018
(7 years ago)
Expired
US6765117 Process for stereoselective synthesis of prostacyclin derivatives 24 Oct, 2017
(8 years ago)
Expired
US5153222 Method of treating pulmonary hypertension with benzidine prostaglandins 16 Oct, 2014
(11 years ago)
Expired

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Tyvaso's drug page


4. Tyvaso Dpi

Tyvaso Dpi is protected by 10 patents, out of which 1 has expired. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US11826327 Treatment for interstitial lung disease 03 Feb, 2042
(15 years from now)
Active
US10421729 Microcrystalline diketopiperazine compositions and methods 01 Apr, 2035
(8 years from now)
Active
US12679811 Microcrystalline Diketopiperazine Compositions And Methods 14 Mar, 2034
(7 years from now)
Active
US10772883 Diketopiperazine microparticles with defined specific surface areas 11 Jun, 2030
(3 years from now)
Active
US11723887 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US9593066 Process to prepare treprostinil, the active ingredient in remodulin® 15 Dec, 2028
(2 years from now)
Active
US9604901 Process to prepare treprostinil, the active ingredient in Remodulin® 15 Dec, 2028
(2 years from now)
Active
US10716793 Treprostinil administration by inhalation 14 May, 2027
(7 months from now)
Active
US11357782 Treprostinil administration by inhalation 14 May, 2027
(7 months from now)
Active
US10130685 Diketopiperazine salts for drug delivery and related methods 23 Aug, 2025
(1 year, 1 month ago)
Expired

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Tyvaso Dpi's drug page


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