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Views: 43 Author: Unibest Industrial Publish Time: 2025-01-27 Origin: Site
Report generated for the week of 2025-01-27 by Unibest Digital Center. Current analysis scope only include the US FDA.
This week, there are 10 drugs in the patent and exclusivity list. They are:
Myfembree by Sumitomo Pharma Switzerland, containing active ingredient Estradiol, Norethindrone Acetate, and Relugolix
Orgovyx by Sumitomo Pharma Switzerland, containing active ingredient Relugolix
Nulibry by Sentynl Therapeutics, containing active ingredient Fosdenopterin Hydrobromide
Delstrigo by Merck Sharp and Dohme, containing active ingredient Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate
Pifeltro by Merck Sharp and Dohme, containing active ingredient Doravirine
Geodon by Viatris Specialty, containing active ingredient Ziprasidone Hydrochloride
Reyvow by Eli Lilly, containing active ingredient Lasmiditan Succinate
Cabenuva Kit by ViiV Healthcare, containing active ingredient Cabotegravir and Rilpivirine
Vocabria by ViiV Healthcare, containing active ingredient Cabotegravir Sodium
Imbruvica by Pharmacyclics, containing active ingredient Ibrutinib
From SUMITOMO PHARMA SWITZERLAND GMBH; used in premenopausal women to control heavy menstrual bleeding due to uterine fibroids.
Approved in May 26, 2021, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2033-09-27, and the latest expires on 2038-05-03.
| Patent No | Patent Expiration Date | Patent Title |
|---|---|---|
| 8058280 | 2025-01-28 | Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof |
| 7300935 | 2025-01-28 | Thienopyrimidine compounds and use thereof |
From SENTYNL THERAPEUTICS INC; used to reduce the risk of death in children with molybdenum cofactor deficiency Type A.
Approved in Feb 26, 2021, 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 |
|---|---|---|---|---|
| 7504095 | U-3092 | METHOD OF TREATING MOLYBDENUM COFACTOR DEFICIENCY TYPE A | 2025-01-31 | Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency |
From SUMITOMO PHARMA SWITZERLAND GMBH; used to treat prostate cancer.
Approved in Dec 18, 2020, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2033-09-27, and the latest expires on 2037-09-29.
| Patent No | Patent Expiration Date | Patent Title |
|---|---|---|
| 7300935 | 2025-01-28 | Thienopyrimidine compounds and use thereof |
| 8058280 | 2025-01-28 | Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof |
From VIIV HEALTHCARE CO; an HIV-integrase inhibitor used for treatment and pre-exposure prophylaxis of HIV-1 infection.
Approved in Jan 21, 2021, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-03-29, and the latest expires on 2026-01-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2025-01-31 | REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 207966 ATLAS-2M |
From VIIV HEALTHCARE CO; a long-acting HIV treatment to keep HIV levels undetectable in patients 12 years and older.
Approved in Jan 21, 2021, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-03-29, and the latest expires on 2026-01-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2025-01-31 | NEW DOSING SCHEDULE FOR CABOTEGRAVIR/RILPIVRINE INJECTION EVERY 2 MONTHS |
From MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC; a non-nucleoside reverse transcriptase inhibitor used in combination with other antiretrovirals to treat HIV-1 infections.
Approved in Aug 30, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2025-01-27 | NEW PATIENT POPULATION |
From MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC; for keeping HIV-1 from multiplying.
Approved in Aug 30, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2025-01-27 | NEW PATIENT POPULATION |
From PHARMACYCLICS LLC; for treating chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom's Macroglobulinemia.
Approved in Nov 13, 2013, used as Reference Listed Drug and Reference Standard
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-08-24, and the latest expires on 2030-02-24.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2025-02-02 | PEDIATRIC EXCLUSIVITY |
From ELI LILLY AND CO; for treating migraine headache with or without aura.
Approved in Jan 31, 2020, used as Reference Listed Drug and Reference Standard
Approved in Jan 31, 2020, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2025-01-31 | NEW CHEMICAL ENTITY |
From VIATRIS SPECIALTY LLC; for treating schizophrenia and other psychiatric disorders.
Approved in Feb 5, 2001, used as Reference Listed Drug and Reference Standard
Approved in Feb 5, 2001, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2025-01-28 | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES |
![Cas No. 1155846-86-8, Benzonitrile, 3-chloro-5-[[1,2-dihydro-2-oxo-4-(trifluoromethyl)-3-pyridinyl]oxy]-](http://imrorwxhnlprli5q.ldycdn.com/cloud/jjBpqKkrllSRikiijlrlin/1155846-640-640.gif)
