Patent and Exclusivity Expirations Report
Report generated for the week of 2024-12-09 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 9 drugs in the patent and exclusivity list. They are:
- SANDOZ INC's HYCAMTIN, containing active ingredient TOPOTECAN HYDROCHLORIDE
- MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC's ZEPATIER, containing active ingredient ELBASVIR; GRAZOPREVIR
- NOVARTIS PHARMACEUTICALS CORP's KISQALI FEMARA CO-PACK (COPACKAGED), containing active ingredient LETROZOLE; RIBOCICLIB SUCCINATE
- NOVARTIS PHARMACEUTICALS CORP's KISQALI, containing active ingredient RIBOCICLIB SUCCINATE
- SAREPTA THERAPEUTICS INC's VYONDYS 53, containing active ingredient GOLODIRSEN
- ABBVIE INC's RINVOQ, containing active ingredient UPADACITINIB
- PFIZER INC's XELJANZ XR, containing active ingredient TOFACITINIB CITRATE
- PF PRISM CV's XELJANZ, containing active ingredient TOFACITINIB CITRATE
- CALLIDITAS THERAPEUTICS AB's TARPEYO, containing active ingredient BUDESONIDE
Patents Expiring This Week
TOPOTECAN HYDROCHLORIDE - CAPSULE;ORAL - HYCAMTIN
From SANDOZ INC; for the treatment of ovarian cancer, SCLC, or cervical cancer.
EQ 0.25MG BASE
Approved in Oct 11, 2007, used as Reference Listed Drug
There are no future patents for this application.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8158645 | NaN | NaN | 2024-12-10 | Compound, corresponding compositions, preparation and/or treatment methods |
EQ 1MG BASE
Approved in Oct 11, 2007, used as Reference Listed Drug and Reference Standard
There are no future patents for this application.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8158645 | NaN | NaN | 2024-12-10 | Compound, corresponding compositions, preparation and/or treatment methods |
Exclusivities Expiring This Week
BUDESONIDE - CAPSULE, DELAYED RELEASE;ORAL - TARPEYO
From CALLIDITAS THERAPEUTICS AB; for reducing the loss of kidney function in IgA nephropathy.
4MG
Approved in Dec 15, 2021, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2028-12-15, and the latest expires on 2030-12-20.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-15 | NEW PRODUCT |
ELBASVIR; GRAZOPREVIR - TABLET;ORAL - ZEPATIER
From MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC; for the treatment of HCV.
50MG;100MG
Approved in Jan 28, 2016, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-09 | NEW PATIENT POPULATION |
GOLODIRSEN - SOLUTION;INTRAVENOUS - VYONDYS 53
From SAREPTA THERAPEUTICS INC; for the treatment of Duchenne muscular dystrophy.
100MG/2ML (50MG/ML)
Approved in Dec 12, 2019, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-12-12, and the latest expires on 2026-12-12.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-12 | NEW CHEMICAL ENTITY |
LETROZOLE; RIBOCICLIB SUCCINATE - TABLET;ORAL - KISQALI FEMARA CO-PACK (COPACKAGED)
From NOVARTIS PHARMACEUTICALS CORP; for the treatment of HR+/HER2- breast cancer.
2.5MG;EQ 200MG BASE
Approved in May 4, 2017, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-09-17, and the latest expires on 2027-09-17.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-10 | NEW PATIENT POPULATION |
RIBOCICLIB SUCCINATE - TABLET;ORAL - KISQALI
From NOVARTIS PHARMACEUTICALS CORP; for the treatment of HR+/HER2- breast cancer.
EQ 200MG BASE
Approved in Mar 13, 2017, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-09-17, and the latest expires on 2027-09-17.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-10 | NEW PATIENT POPULATION |
TOFACITINIB CITRATE - TABLET, EXTENDED RELEASE;ORAL - XELJANZ XR
From PFIZER INC; for the treatment of inflammatory and autoimmune conditions.
EQ 11MG BASE
Approved in Feb 23, 2016, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-14 | TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION |
TOFACITINIB CITRATE - TABLET;ORAL - XELJANZ
From PF PRISM CV; for the treatment of inflammatory and autoimmune conditions.
EQ 10MG BASE
Approved in May 30, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-14 | TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION |
EQ 5MG BASE
Approved in Nov 6, 2012, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-14 | TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION |
UPADACITINIB - TABLET, EXTENDED RELEASE;ORAL - RINVOQ
From ABBVIE INC; for the treatment of several conditions that have inflammation as a characteristic symptom, including rheumatoid arthritis, psoriatic arthritis, eczema, ulcerative colitis, and Crohn's disease.
15MG
Approved in Aug 16, 2019, used as Reference Listed Drug
There are 7 future exclusivity(ies) for this drug product. The earliest expires on 2025-01-14, and the latest expires on 2031-04-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2024-12-14 | TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS |
