Ph Drug Patent Portfolio

Ph owns 3 orange book drugs protected by 25 US patents Given below is the list of Ph's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10869845 Ephedrine compositions and methods 22 Jan, 2040
Active
US12029710 Ephedrine compositions and methods 22 Jan, 2040
Active
US10653646 Epinephrine compositions and containers 21 Mar, 2039
Active
US11083698 Epinephrine compositions and containers 21 Mar, 2039
Active
US11207280 Epinephrine compositions and containers 21 Mar, 2039
Active
US12133837 Epinephrine compositions and containers 21 Mar, 2039
Active
US10130592 Epinephrine formulations 13 Mar, 2035
Active
US12280024 Epinephrine formulations 13 Mar, 2035
Active
US9119876 Epinephrine formulations 13 Mar, 2035
Active
US9295657 Epinephrine formulations 13 Mar, 2035
Active
US10010575 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US12186362 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9375478 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9687526 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9744209 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9744239 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9750785 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9919026 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9925233 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9925234 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9937223 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9962422 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9968649 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9974827 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active
US9981006 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
Active


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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 05 Jun, 2024 US10869845 (Litigated)
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 30 May, 2024 US10869845 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 10 Nov, 2023 US9375478
Payment of Maintenance Fee, 4th Year, Large Entity 12 Oct, 2023 US10653646
Email Notification 30 Mar, 2023 US10869845 (Litigated)
Change in Power of Attorney (May Include Associate POA) 29 Mar, 2023 US10869845 (Litigated)
Correspondence Address Change 28 Mar, 2023 US10869845 (Litigated)
Email Notification 06 Mar, 2023 US11207280
Change in Power of Attorney (May Include Associate POA) 06 Mar, 2023 US11207280
Correspondence Address Change 01 Mar, 2023 US11207280
Email Notification 27 Feb, 2023 US10653646
Change in Power of Attorney (May Include Associate POA) 27 Feb, 2023 US10653646
Email Notification 24 Feb, 2023 US11083698
Email Notification 24 Feb, 2023 US10869845 (Litigated)
Change in Power of Attorney (May Include Associate POA) 24 Feb, 2023 US11083698


Ph's Family Patents

Ph drugs have patent protection in a total of 7 countries. It has a significant patent presence in the US with 88.9% of its patents being US patents. 3 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



Recent FDA approvals and tentative approvals for Ph

This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.


Generic drugs

Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.

Drug Name Submission class (FDA) Submission Category Submission Date
Levothyroxine Sodium ORIG-2
Orig = Original submission
Suppl = Supplement submission
Number = submission sequence
- 07 Dec, 2015


Clinical Trials

Recent Clinical Trials by Ph:

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Oct, 2024)
PHASE2
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep, 2024)
PHASE4
A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia NephroNet, Inc. AstraZeneca COMPLETED
(Jun, 2024)
PHASE4
Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients Novartis Pharmaceuticals NA COMPLETED
(Jul, 2023)
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients Novartis Pharmaceuticals NA COMPLETED
(Mar, 2023)
PHASE4
Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction Novartis Pharmaceuticals NA COMPLETED
(Mar, 2020)
PHASE4
A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition Shenzhen Kangzhe Pharmaceutical Co., Ltd. NA UNKNOWN
(Aug, 2019)
NA
Investigation of Flare and Remission in Subjects With Atopic Dermatitis LEO Pharma NA WITHDRAWN
(Jul, 2019)
PHASE4
Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia Otsuka Pharmaceutical Europe Ltd H. Lundbeck A/S UNKNOWN
(Apr, 2019)
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction Novartis Pharmaceuticals NA COMPLETED
(Feb, 2019)
PHASE3
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. ZS Pharma, Inc. NA COMPLETED
(Jul, 2018)
PHASE3
Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. Otsuka Pharmaceutical Development & Commercialization, Inc. NA TERMINATED
(Jan, 2016)
PHASE3
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension Novartis Pharmaceuticals NA COMPLETED
(Oct, 2015)
PHASE2
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Bayer COMPLETED
(Aug, 2014)
PHASE3
Aripiprazole for the Augmentation of Antidepressant Therapy Taiwan Otsuka Pharm. Co., Ltd NA COMPLETED
(May, 2014)
PHASE4
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical COMPLETED
(Feb, 2013)
PHASE3
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients APT Pharmaceuticals, Inc. NA NO LONGER AVAILABLE
(Sep, 2012)
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection Novartis Pharmaceuticals NA COMPLETED
(Jul, 2012)
PHASE3
An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. NA COMPLETED
(Apr, 2010)
PHASE2
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) Solvay Pharmaceuticals NA COMPLETED
(Feb, 2010)
PHASE3
Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical COMPLETED
(Aug, 2008)
PHASE4
Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders Otsuka Pharmaceutical Development & Commercialization, Inc. NA COMPLETED
(Sep, 2007)
PHASE2, PHASE3


Ph Drug List

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


1. Adrenalin

Adrenalin is protected by 8 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10653646 Epinephrine compositions and containers 21 Mar, 2039
(13 years from now)
Active
US11083698 Epinephrine compositions and containers 21 Mar, 2039
(13 years from now)
Active
US11207280 Epinephrine compositions and containers 21 Mar, 2039
(13 years from now)
Active
US12133837 Epinephrine compositions and containers 21 Mar, 2039
(13 years from now)
Active
US10130592 Epinephrine formulations 13 Mar, 2035
(9 years from now)
Active
US12280024 Epinephrine formulations 13 Mar, 2035
(9 years from now)
Active
US9119876 Epinephrine formulations 13 Mar, 2035
(9 years from now)
Active
US9295657 Epinephrine formulations 13 Mar, 2035
(9 years from now)
Active

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 Adrenalin's drug page


2. Ephedrine Sulfate

Ephedrine Sulfate is protected by 2 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10869845 Ephedrine compositions and methods 22 Jan, 2040
(14 years from now)
Active
US12029710 Ephedrine compositions and methods 22 Jan, 2040
(14 years from now)
Active

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 Ephedrine Sulfate's drug page


3. Vasostrict

Vasostrict is protected by 15 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10010575 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US12186362 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9375478 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9687526 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9744209 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9744239 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9750785 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9919026 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9925233 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9925234 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9937223 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9962422 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9968649 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9974827 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active
US9981006 Vasopressin formulations for use in treatment of hypotension 30 Jan, 2035
(9 years from now)
Active

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 Vasostrict's drug page


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