Patent and Exclusivity Expirations Report
Report generated for the week of 2024-12-16 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 16 drugs in the patent and exclusivity list. They are:
UNITED THERAPEUTICS CORP's REMODULIN, containing active ingredient TREPROSTINIL
VALINOR PHARMA LLC's MOVANTIK, containing active ingredient NALOXEGOL OXALATE
OTSUKA PHARMACEUTICAL CO LTD's ABILIFY, containing active ingredient ARIPIPRAZOLE
INTRA-CELLULAR THERAPIES INC's CAPLYTA, containing active ingredient LUMATEPERONE TOSYLATE
PFIZER INC's TOVIAZ, containing active ingredient FESOTERODINE FUMARATE
CUBIST PHARMACEUTICALS LLC's ZERBAXA, containing active ingredient CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
EISAI INC's LENVIMA, containing active ingredient LENVATINIB MESYLATE
PF PRISM CV's BOSULIF, containing active ingredient BOSUTINIB MONOHYDRATE
AMGEN INC's OTEZLA, containing active ingredient APREMILAST
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV's TISSUEBLUE, containing active ingredient BRILLIANT BLUE G
JANSSEN PHARMACEUTICALS INC's XARELTO, containing active ingredient RIVAROXABAN
BOEHRINGER INGELHEIM PHARMACEUTICALS INC's PRADAXA, containing active ingredient DABIGATRAN ETEXILATE MESYLATE
THERAVIA PHARMA's SIKLOS, containing active ingredient HYDROXYUREA
NOVARTIS PHARMACEUTICALS CORP's TAFINLAR, containing active ingredient DABRAFENIB MESYLATE
HORIZON THERAPEUTICS USA INC's PROCYSBI, containing active ingredient CYSTEAMINE BITARTRATE
NOVARTIS PHARMACEUTICALS CORP's MEKINIST, containing active ingredient TRAMETINIB DIMETHYL SULFOXIDE
Patents Expiring This Week
ARIPIPRAZOLE - TABLET;ORAL - ABILIFY
From OTSUKA PHARMACEUTICAL CO LTD
10MG
Approved in Nov 15, 2002, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2026-07-28, and the latest expires on 2027-03-02.
| Patent No | Patent Expiration Date | Patent Title |
| 8017615*PED | 2024-12-16 | Low hydroscopic aripiprazole drug substance and processes for the preparation thereof |
15MG
Approved in Nov 15, 2002, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2026-07-28, and the latest expires on 2027-03-02.
| Patent No | Patent Expiration Date | Patent Title |
| 8017615*PED | 2024-12-16 | Low hydroscopic aripiprazole drug substance and processes for the preparation thereof |
20MG
Approved in Nov 15, 2002, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2026-07-28, and the latest expires on 2027-03-02.
| Patent No | Patent Expiration Date | Patent Title |
| 8017615*PED | 2024-12-16 | Low hydroscopic aripiprazole drug substance and processes for the preparation thereof |
2MG
Approved in Nov 15, 2002, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2026-07-28, and the latest expires on 2027-03-02.
| Patent No | Patent Expiration Date | Patent Title |
| 8017615*PED | 2024-12-16 | Low hydroscopic aripiprazole drug substance and processes for the preparation thereof |
30MG
Approved in Nov 15, 2002, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2026-07-28, and the latest expires on 2027-03-02.
| Patent No | Patent Expiration Date | Patent Title |
| 8017615*PED | 2024-12-16 | Low hydroscopic aripiprazole drug substance and processes for the preparation thereof |
5MG
Approved in Nov 15, 2002, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2026-07-28, and the latest expires on 2027-03-02.
| Patent No | Patent Expiration Date | Patent Title |
| 8017615*PED | 2024-12-16 | Low hydroscopic aripiprazole drug substance and processes for the preparation thereof |
NALOXEGOL OXALATE - TABLET;ORAL - MOVANTIK
From VALINOR PHARMA LLC
EQ 12.5MG BASE
Approved in Sep 16, 2014, used as Reference Listed Drug
There are 2 future patent(s) for this application. The earliest expires on 2028-09-16, and the latest expires on 2032-04-02.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8067431 | U-1185 | TREATMENT OF OPIOID-INDUCED CONSTIPATION | 2024-12-16 | Chemically modified small molecules |
EQ 25MG BASE
Approved in Sep 16, 2014, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2028-09-16, and the latest expires on 2032-04-02.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8067431 | U-1185 | TREATMENT OF OPIOID-INDUCED CONSTIPATION | 2024-12-16 | Chemically modified small molecules |
TREPROSTINIL - INJECTABLE;IV (INFUSION), SUBCUTANEOUS - REMODULIN
From UNITED THERAPEUTICS CORP
10MG/ML
Approved in May 21, 2002, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2028-09-05, and the latest expires on 2029-03-29.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9713599 | U-2036 | A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER | 2024-12-16 | Parenteral formulations of treprostinil |
| 10695308 | U-2845 | A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION | 2024-12-16 | Inhalation formulations of treprostinil |
| 10076505 | NaN | NaN | 2024-12-16 | Inhalation formulations of treprostinil |
1MG/ML
Approved in May 21, 2002, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2028-09-05, and the latest expires on 2029-03-29.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9713599 | U-2036 | A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER | 2024-12-16 | Parenteral formulations of treprostinil |
| 10695308 | U-2845 | A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION | 2024-12-16 | Inhalation formulations of treprostinil |
| 10076505 | NaN | NaN | 2024-12-16 | Inhalation formulations of treprostinil |
2.5MG/ML
Approved in May 21, 2002, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2028-09-05, and the latest expires on 2029-03-29.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9713599 | U-2036 | A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER | 2024-12-16 | Parenteral formulations of treprostinil |
| 10076505 | NaN | NaN | 2024-12-16 | Inhalation formulations of treprostinil |
| 10695308 | U-2845 | A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION | 2024-12-16 | Inhalation formulations of treprostinil |
20MG/ML
Approved in Jul 30, 2021, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2028-09-05, and the latest expires on 2029-03-29.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9713599 | U-2036 | A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER | 2024-12-16 | Parenteral formulations of treprostinil |
| 10076505 | NaN | NaN | 2024-12-16 | Inhalation formulations of treprostinil |
| 10695308 | U-2845 | A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION | 2024-12-16 | Inhalation formulations of treprostinil |
5MG/ML
Approved in May 21, 2002, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2028-09-05, and the latest expires on 2029-03-29.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 10076505 | NaN | NaN | 2024-12-16 | Inhalation formulations of treprostinil |
| 10695308 | U-2845 | A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION | 2024-12-16 | Inhalation formulations of treprostinil |
| 9713599 | U-2036 | A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER | 2024-12-16 | Parenteral formulations of treprostinil |
Exclusivities Expiring This Week
APREMILAST - TABLET;ORAL - OTEZLA
From AMGEN INC
10MG
Approved in Mar 21, 2014, used as Reference Listed Drug
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2026-07-19, and the latest expires on 2027-10-25.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-20 | REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION |
20MG
Approved in Mar 21, 2014, used as Reference Listed Drug
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2026-07-19, and the latest expires on 2027-10-25.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-20 | REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION |
30MG
Approved in Mar 21, 2014, used as Reference Listed Drug and Reference Standard
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2026-07-19, and the latest expires on 2027-10-25.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-20 | REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION |
BOSUTINIB MONOHYDRATE - TABLET;ORAL - BOSULIF
From PF PRISM CV
EQ 100MG BASE
Approved in Sep 4, 2012, used as Reference Listed Drug and Reference Standard
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-19, and the latest expires on 2031-03-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-19 | TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML) |
EQ 400MG BASE
Approved in Oct 27, 2017, used as Reference Listed Drug
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-19, and the latest expires on 2031-03-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-19 | TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML) |
EQ 500MG BASE
Approved in Sep 4, 2012, used as Reference Listed Drug
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-19, and the latest expires on 2031-03-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-19 | TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML) |
BRILLIANT BLUE G - SOLUTION;OPHTHALMIC - TISSUEBLUE
From DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
0.025%
Approved in Dec 20, 2019, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-12-20, and the latest expires on 2026-12-20.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-20 | NEW CHEMICAL ENTITY |
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM - POWDER;INTRAVENOUS - ZERBAXA
From CUBIST PHARMACEUTICALS LLC
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
Approved in Dec 19, 2014, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-21, and the latest expires on 2025-04-21.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-19 | GENERATING ANTIBIOTIC INCENTIVES NOW |
CYSTEAMINE BITARTRATE - CAPSULE, DELAYED RELEASE;ORAL - PROCYSBI
From HORIZON THERAPEUTICS USA INC
EQ 25MG BASE
Approved in Apr 30, 2013, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-22, and the latest expires on 2025-06-22.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE |
EQ 75MG BASE
Approved in Apr 30, 2013, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-22, and the latest expires on 2025-06-22.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE |
CYSTEAMINE BITARTRATE - GRANULE, DELAYED RELEASE;ORAL - PROCYSBI
From HORIZON THERAPEUTICS USA INC
EQ 300MG BASE/PACKET
Approved in Feb 14, 2020, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-22, and the latest expires on 2025-06-22.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
Fda has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)
EQ 75MG BASE/PACKET
Approved in Feb 14, 2020, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-22, and the latest expires on 2025-06-22.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
DABIGATRAN ETEXILATE MESYLATE - CAPSULE;ORAL - PRADAXA
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC
EQ 110MG BASE
Approved in Nov 20, 2015, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
EQ 150MG BASE
Approved in Oct 19, 2010, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
EQ 75MG BASE
Approved in Oct 19, 2010, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
DABIGATRAN ETEXILATE MESYLATE - PELLETS;ORAL - PRADAXA
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC
EQ 110MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
EQ 150MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
EQ 20MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
EQ 30MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
EQ 40MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
EQ 50MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | PEDIATRIC EXCLUSIVITY |
DABRAFENIB MESYLATE - CAPSULE;ORAL - TAFINLAR
From NOVARTIS PHARMACEUTICALS CORP
EQ 50MG BASE
Approved in May 29, 2013, used as Reference Listed Drug
There are 10 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-30, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | PEDIATRIC EXCLUSIVITY |
EQ 75MG BASE
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
There are 10 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-30, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | PEDIATRIC EXCLUSIVITY |
FESOTERODINE FUMARATE - TABLET, EXTENDED RELEASE;ORAL - TOVIAZ
From PFIZER INC
4MG
Approved in Oct 31, 2008, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-17 | PEDIATRIC EXCLUSIVITY |
8MG
Approved in Oct 31, 2008, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-17 | PEDIATRIC EXCLUSIVITY |
HYDROXYUREA - TABLET;ORAL - SIKLOS
From THERAVIA PHARMA
100MG
Approved in Dec 21, 2017, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS |
1GM
Approved in Dec 21, 2017, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-21 | TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS |
LENVATINIB MESYLATE - CAPSULE;ORAL - LENVIMA
From EISAI INC
EQ 10MG BASE
Approved in Feb 13, 2015, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-15, and the latest expires on 2027-10-03.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-19 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1 |
EQ 4MG BASE
Approved in Feb 13, 2015, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-15, and the latest expires on 2027-10-03.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-19 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1 |
LUMATEPERONE TOSYLATE - CAPSULE;ORAL - CAPLYTA
From INTRA-CELLULAR THERAPIES INC
EQ 10.5MG BASE
Approved in Apr 22, 2022, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-20 | NEW CHEMICAL ENTITY |
EQ 21MG BASE
Approved in Apr 22, 2022, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-20 | NEW CHEMICAL ENTITY |
EQ 42MG BASE
Approved in Dec 20, 2019, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
Indicated for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-17 | INDICATED FOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I OR II DISORDER (BIPOLAR DEPRESSION) IN ADULTS, AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE |
| 2024-12-20 | NEW CHEMICAL ENTITY |
RIVAROXABAN - FOR SUSPENSION;ORAL - XARELTO
From JANSSEN PHARMACEUTICALS INC
1MG/ML
Approved in Dec 20, 2021, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-20, and the latest expires on 2025-06-20.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-20 | NEW PRODUCT |
TRAMETINIB DIMETHYL SULFOXIDE - TABLET;ORAL - MEKINIST
From NOVARTIS PHARMACEUTICALS CORP
EQ 0.5MG
Approved in May 29, 2013, used as Reference Listed Drug
There are 10 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-30, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | PEDIATRIC EXCLUSIVITY |
EQ 2MG
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
There are 10 future exclusivity(ies) for this drug product. The earliest expires on 2025-04-30, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-22 | PEDIATRIC EXCLUSIVITY |
