Patent and Exclusivity Expirations Report
Report generated for the week of 2025-05-19 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 15 drugs in the patent and exclusivity list. They are:
AirDuo RespiClick by Teva Pharmaceutical Industries Ltd, containing active ingredients Fluticasone Propionate and Salmeterol Xinafoate
ProAir RespiClick by Teva Branded Pharmaceutical Products R&D Inc, containing active ingredient Albuterol Sulfate
Trelegy Ellipta by GlaxoSmithKline, containing active ingredients Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate
Breo Ellipta by GlaxoSmithKline, containing active ingredients Fluticasone Furoate and Vilanterol Trifenatate
Anoro Ellipta by GlaxoSmithKline, containing active ingredients Umeclidinium Bromide and Vilanterol Trifenatate
Edarbyclor by Azurity Pharmaceuticals, containing active ingredients Azilsartan Kamedoxomil and Chlorthalidone
Edarbi by Azurity Pharmaceuticals, containing active ingredient Azilsartan Kamedoxomil
Fycompa by Catalyst Pharmaceuticals, containing active ingredient Perampanel
Mirvaso by Galderma Laboratories, containing active ingredient Brimonidine Tartrate
Vidaza by Bristol-Myers Squibb, containing active ingredient Azacitidine
Cerianna by GE Healthcare, containing active ingredient Fluoroestradiol F-18
Tyvaso DPI by United Therapeutics, containing active ingredient Treprostinil
Astagraf XL by Astellas Pharma, containing active ingredient Tacrolimus
Prograf by Astellas Pharma, containing active ingredient Tacrolimus
Tibsovo by Servier Pharmaceuticals, containing active ingredient Ivosidenib
Patents Expiring This Week
ALBUTEROL SULFATE - POWDER, METERED;INHALATION - PROAIR RESPICLICK
From TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC; a beta-2 adrenergic receptor agonist used to treat asthma, bronchitis, COPD, as well as prevent exercise induced bronchospasms.
EQ 0.09MG BASE/INH
Approved in Mar 31, 2015, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2028-03-26, and the latest expires on 2032-01-13.
| Patent No | Patent Expiration Date | Patent Title |
| 9463288 | 2025-05-19 | Dry powder inhalation apparatus |
| 10765820 | 2025-05-19 | Dry powder inhalation apparatus |
AZILSARTAN KAMEDOXOMIL - TABLET;ORAL - EDARBI
From AZURITY PHARMACEUTICALS INC; an angiotensin II receptor blocker used to treat hypertension alone or in combination with other antihypertensive agents, such as chlorthalidone.
EQ 80MG MEDOXOMIL
Approved in Feb 25, 2011, used as Reference Listed Drug and Reference Standard
EQ 40MG MEDOXOMIL
Approved in Feb 25, 2011, used as Reference Listed Drug
There are 1 future patent(s) for this application. The earliest expires on 2028-03-26, and the latest expires on 2028-03-26.
| Patent No | Patent Expiration Date | Patent Title |
| 7157584 | 2025-05-22 | Benzimidazole derivative and use thereof |
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - TABLET;ORAL - EDARBYCLOR
From AZURITY PHARMACEUTICALS INC; used to treat hypertension.
EQ 40MG MEDOXOMIL;25MG
Approved in Dec 20, 2011, used as Reference Listed Drug and Reference Standard
EQ 40MG MEDOXOMIL;12.5MG
Approved in Dec 20, 2011, used as Reference Listed Drug
There are 3 future patent(s) for this application. The earliest expires on 2028-03-26, and the latest expires on 2031-07-01.
| Patent No | Patent Expiration Date | Patent Title |
| 7157584 | 2025-05-22 | Benzimidazole derivative and use thereof |
BRIMONIDINE TARTRATE - GEL;TOPICAL - MIRVASO
From GALDERMA LABORATORIES LP; an alpha-2 adrenergic agonist used to treat glaucoma and ocular hypertension, as well as facial erythema in rosacea.
EQ 0.33% BASE
Approved in Aug 23, 2013, used as Reference Listed Drug and Reference Standard
There are 8 future patent(s) for this application. The earliest expires on 2025-08-25, and the latest expires on 2031-06-13.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8426410 | U-1428 | TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA | 2025-05-24 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders |
| 8231885 |
|
| 2025-05-24 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders |
| 8410102 | U-1428 | TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA | 2025-05-24 | Methods and compositions for treating or preventing erythema |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - POWDER;INHALATION - TRELEGY ELLIPTA
From GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND; to treat COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema, and is also used for asthma in adults as a maintenance treatment.
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approved in Sep 18, 2017, used as Reference Listed Drug and Reference Standard
There are 15 future patent(s) for this application. The earliest expires on 2025-07-27, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7439393 | U-2957 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-2127 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approved in Sep 9, 2020, used as Reference Listed Drug and Reference Standard
There are 15 future patent(s) for this application. The earliest expires on 2025-07-27, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7439393 | U-2957 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - POWDER;INHALATION - BREO ELLIPTA
From GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE; a once-daily combination medicine used to treat asthma or COPD, it helps improve breathing, reduce COPD flare-ups, and help prevent and control asthma symptoms.
0.05MG/INH;EQ 0.025MG BASE/INH
Approved in May 12, 2023, used as Reference Listed Drug
There are 13 future patent(s) for this application. The earliest expires on 2025-11-21, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7439393 | U-3623 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
0.1MG/INH;EQ 0.025MG BASE/INH
Approved in May 10, 2013, used as Reference Listed Drug and Reference Standard
There are 13 future patent(s) for this application. The earliest expires on 2025-11-21, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7439393 | U-1401 | INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-2099 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-1691 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-2100 | INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-3623 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
0.2MG/INH;EQ 0.025MG BASE/INH
Approved in Apr 30, 2015, used as Reference Listed Drug and Reference Standard
There are 13 future patent(s) for this application. The earliest expires on 2025-11-21, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7439393 | U-1691 | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-2100 | INDICATED FOR THE ONCE-DAILY TREATMENT OF ASTHMA IN PATIENTS 18 YEARS AND OLDER | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-3623 | MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 5 YEARS AND OLDER. RECOMMENDED DOSAGES: BREO 100/25 OR 200/25 AGES 18 YEARS AND OLDER; BREO 100/25 AGES 12-17 YEARS, AND BREO 50/25, AGES 5-11 YEARS | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
| 7439393 | U-2099 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING BRONCHITIS AND/OR EMPHYSEMA | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - POWDER;INHALATION - AIRDUO RESPICLICK
From TEVA PHARMACEUTICAL INDUSTRIES LTD; used to prevent asthma attacks, and flare-ups or worsening of COPD associated with chronic bronchitis and/or emphysema.
0.232MG/INH;EQ 0.014MG BASE/INH
Approved in Jan 27, 2017, used as Reference Listed Drug and Reference Standard
0.055MG/INH;EQ 0.014MG BASE/INH
0.113MG/INH;EQ 0.014MG BASE/INH
Approved in Jan 27, 2017, used as Reference Listed Drug
There are 26 future patent(s) for this application. The earliest expires on 2025-11-19, and the latest expires on 2040-02-20.
| Patent No | Patent Expiration Date | Patent Title |
| 9463288 | 2025-05-19 | Dry powder inhalation apparatus |
| 10765820 | 2025-05-19 | Dry powder inhalation apparatus |
PERAMPANEL - SUSPENSION;ORAL - FYCOMPA
From CATALYST PHARMACEUTICALS INC; a non-competitive AMPA glutamate receptor antagonist used to treat partial-onset seizures with or without secondarily generalized seizures, and as adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy.
0.5MG/ML
Approved in Apr 29, 2016, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2026-07-01, and the latest expires on 2026-07-01.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 6949571 | U-2428 | TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY 4 YEARS OF AGE AND OLDER | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-2088 | TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-2089 | TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-106 | TREATMENT OF EPILEPSY | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-2429 | TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
PERAMPANEL - TABLET;ORAL - FYCOMPA
From CATALYST PHARMACEUTICALS INC; a non-competitive AMPA glutamate receptor antagonist used to treat partial-onset seizures with or without secondarily generalized seizures, and as adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy.
8MG
Approved in Oct 22, 2012, used as Reference Listed Drug
2MG; 4MG; 6MG; 10MG; 12MG
Approved in Oct 22, 2012, used as Reference Listed Drug
There are 1 future patent(s) for this application. The earliest expires on 2026-07-01, and the latest expires on 2026-07-01.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 6949571 | U-106 | TREATMENT OF EPILEPSY | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-2089 | TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-2429 | TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-2088 | TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
| 6949571 | U-2428 | TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY 4 YEARS OF AGE AND OLDER | 2025-05-23 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - POWDER;INHALATION - ANORO ELLIPTA
From GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND; used to prevent airflow obstruction and reduce flare-ups in adults with COPD, including bronchitis and emphysema.
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approved in Dec 18, 2013, used as Reference Listed Drug and Reference Standard
There are 15 future patent(s) for this application. The earliest expires on 2025-07-27, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7439393 | U-1476 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA. | 2025-05-21 | Phenethanolamine derivatives for treatment of respiratory diseases |
Exclusivities Expiring This Week
AZACITIDINE - POWDER;INTRAVENOUS, SUBCUTANEOUS - VIDAZA
From BRISTOL-MYERS SQUIBB CO; a pyrimidine nucleoside analogue used to treat certain subtypes of myelodysplastic syndrome.
100MG/VIAL
Approved in May 19, 2004, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2029-05-20, and the latest expires on 2029-05-20.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-20 | TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) |
FLUOROESTRADIOL F-18 - SOLUTION;INTRAVENOUS - CERIANNA
From GE HEALTHCARE; a radiolabeled analog of estradiol used as a contrast agent in the PET imaging of estrogen receptor-positive breast cancer lesions.
50ML (4-100mCi/ML)
Approved in May 20, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-20 | NEW CHEMICAL ENTITY |
IVOSIDENIB - TABLET;ORAL - TIBSOVO
From SERVIER PHARMACEUTICALS LLC; an isocitrate dehydrogenase-1 inhibitor used to treat acute myeloid leukemia and cholangiocarcinoma in adults with a susceptible IDH1 mutation.
250MG
Approved in Jul 20, 2018, used as Reference Listed Drug and Reference Standard
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-07-20, and the latest expires on 2030-10-24.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-25 | IN COMBINATION WITH AZACITIDINE OR AS MONOTHERAPY FOR THE TREATMENT OF NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULTS 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
TACROLIMUS - CAPSULE, EXTENDED RELEASE;ORAL - ASTAGRAF XL
From ASTELLAS PHARMA US INC; a calcineurin inhibitor used to prevent organ transplant rejection and to treat moderate to severe atopic dermatitis.
EQ 5MG BASE
Approved in Jul 19, 2013, used as Reference Listed Drug and Reference Standard
EQ 0.5MG BASE; EQ 1MG BASE
Approved in Jul 19, 2013, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-24 | 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) |
TACROLIMUS - CAPSULE;ORAL - PROGRAF
From ASTELLAS PHARMA US INC; a calcineurin inhibitor used to prevent organ transplant rejection and to treat moderate to severe atopic dermatitis.
EQ 5MG BASE
Approved in Apr 8, 1994, used as Reference Listed Drug and Reference Standard
EQ 0.5MG BASE
Approved in Aug 24, 1998, used as Reference Listed Drug
EQ 1MG BASE
Approved in Apr 8, 1994, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2028-07-16, and the latest expires on 2028-07-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-24 | PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS |
TACROLIMUS - FOR SUSPENSION;ORAL - PROGRAF
From ASTELLAS PHARMA US INC; a calcineurin inhibitor used to prevent organ transplant rejection and to treat moderate to severe atopic dermatitis.
EQ 1MG BASE/PACKET
Approved in May 24, 2018, used as Reference Listed Drug and Reference Standard
EQ 0.2MG BASE/PACKET
Approved in May 24, 2018, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2028-07-16, and the latest expires on 2028-07-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-24 | PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY TRANSPLANT, LIVER TRANSPLANTS, AND HEART TRANSPLANT, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS |
TACROLIMUS - INJECTABLE;INJECTION - PROGRAF
From ASTELLAS PHARMA US INC; a calcineurin inhibitor used to prevent organ transplant rejection and to treat moderate to severe atopic dermatitis.
EQ 5MG BASE/ML
Approved in Apr 8, 1994, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2028-07-16, and the latest expires on 2028-07-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-24 | PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS |
TREPROSTINIL - POWDER;INHALATION - TYVASO DPI
From UNITED THERAPEUTICS CORP; a prostacyclin vasodilator for the treatment of pulmonary arterial hypertension to relieve exercise associated symptoms and to prevent clinical deterioration after stopping epoprostenol.
0.016MG/INH; 0.032MG/INH; 0.048MG/INH; 0.064MG/INH
Approved in May 23, 2022, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-23 | NEW PRODUCT |
