- All
- Product Name
- Product Keyword
- Product Model
- Product Summary
- Product Description
- Multi Field Search
Views: 50 Author: Unibest Industrial Publish Time: 2024-11-04 Origin: Site
Report generated for the week of 2024-11-04 by Unibest Digital Center. Current analysis scope only include the US FDA.
This week, there are 11 drugs in the patent and exclusivity list. They are:
- BAUSCH AND LOMB INC's XIIDRA, containing active ingredient LIFITEGRAST
- FRESENIUS KABI USA LLC's OMEGAVEN, containing active ingredient FISH OIL TRIGLYCERIDES
- MYLAN SPECIALTY LP's TOBI PODHALER, containing active ingredient TOBRAMYCIN
- ASTRAZENECA LP's SYMBICORT, containing active ingredient BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
- ASTRAZENECA AB's BYETTA, containing active ingredient EXENATIDE SYNTHETIC
- HOFFMANN-LA ROCHE INC's ALECENSA, containing active ingredient ALECTINIB HYDROCHLORIDE
- HOFFMANN LA ROCHE INC's ZELBORAF, containing active ingredient VEMURAFENIB
- GISKIT PHARMA BV's EXEM FOAM KIT, containing active ingredient AIR POLYMER-TYPE A
- MERCK SHARP AND DOHME CORP's PREVYMIS, containing active ingredient LETERMOVIR
- MERCK SHARP AND DOHME LLC's PREVYMIS, containing active ingredient LETERMOVIR
- BRISTOL MYERS SQUIBB CO's SPRYCEL, containing active ingredient DASATINIB
From ASTRAZENECA LP; for controlling and preventing symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease.
Approved in Jul 21, 2006, used as Reference Listed Drug and Reference Standard
There are 9 future patent(s) for this application. The earliest expires on 2025-05-10, and the latest expires on 2029-10-07.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date |
|---|---|---|---|
| 8875699 | NaN | NaN | 2024-11-10 |
Approved in Jul 21, 2006, used as Reference Listed Drug and Reference Standard
There are 9 future patent(s) for this application. The earliest expires on 2025-05-10, and the latest expires on 2029-10-07.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date |
|---|---|---|---|
| 8875699 | NaN | NaN | 2024-11-10 |
From FRESENIUS KABI USA LLC; as an oil-based ib lipid emulsion that is a source of calories and fatty acids in pediatric patients with PNAC.
Approved in Jul 27, 2018, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2025-07-11, and the latest expires on 2025-07-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date |
|---|---|---|---|
| 10350186 | U-2585 | TREATMENT OF PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS IN PATIENTS UNDER THE AGE OF 12 | 2024-11-05 |
Approved in Jul 27, 2018, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2025-07-11, and the latest expires on 2025-07-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date |
|---|---|---|---|
| 10350186 | U-2585 | TREATMENT OF PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS IN PATIENTS UNDER THE AGE OF 12 | 2024-11-05 |
From BAUSCH AND LOMB INC; for reducing both symptoms and signs of dry eye disease.
Approved in Jul 11, 2016, used as Reference Listed Drug and Reference Standard
There are 11 future patent(s) for this application. The earliest expires on 2025-03-10, and the latest expires on 2033-12-18.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date |
|---|---|---|---|
| 7745460 | U-1880 | TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | 2024-11-05 |
| 7790743 | U-1880 | TREATMENT OF SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | 2024-11-05 |
| 10124000 | U-1900 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) | 2024-11-05 |
| 9216174 | NaN | NaN | 2024-11-05 |
| 7928122 | NaN | NaN | 2024-11-05 |
From MYLAN SPECIALTY LP; for treating people with cystic fibrosis who have an on-going lung infection with P.aerugionsa.
Approved in Mar 22, 2013, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2025-06-20, and the latest expires on 2030-11-04.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date |
|---|---|---|---|
| 11484671 | U-909 | TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA | 2024-11-07 |
From GISKIT PHARMA BV; as a foam that can be used with trasnvaginal ultrasound to asess tubal patency in women with infertility.
Approved in Nov 7, 2019, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-07 | NEW CHEMICAL ENTITY |
From HOFFMANN-LA ROCHE INC; for treating certain types of NSCLC with an abnormal ALK gene.
Approved in Dec 11, 2015, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-04-18, and the latest expires on 2031-04-18.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-06 | NaN |
From BRISTOL MYERS SQUIBB CO; for treating Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia.
Approved in May 30, 2008, used as Reference Listed Drug and Reference Standard
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-05-09, and the latest expires on 2026-06-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-09 | NaN |
Approved in Oct 28, 2010, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-05-09, and the latest expires on 2026-06-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-09 | NaN |
Approved in Jun 28, 2006, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-05-09, and the latest expires on 2026-06-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-09 | NaN |
Approved in Jun 28, 2006, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-05-09, and the latest expires on 2026-06-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-09 | NaN |
Approved in Jun 28, 2006, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-05-09, and the latest expires on 2026-06-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-09 | NaN |
Approved in Oct 28, 2010, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-05-09, and the latest expires on 2026-06-21.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-09 | NaN |
From ASTRAZENECA AB; for controlling blood sugar levels.
Approved in Apr 28, 2005, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-04 | NaN |
Approved in Apr 28, 2005, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-04 | NaN |
From MERCK SHARP AND DOHME LLC; for preventing disease caused by cytomegalovirus in people who have received a bone marrow transplant or kidney transplant.
Approved in Aug 30, 2024, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-08-30, and the latest expires on 2030-06-05.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-08 | 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) |
Approved in Aug 30, 2024, used as Reference Listed Drug
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-08-30, and the latest expires on 2030-06-05.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-08 | 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) |
From MERCK SHARP AND DOHME CORP; for preventing disease caused by cytomegalovirus in people who have received a bone marrow transplant or kidney transplant.
Approved in Nov 8, 2017, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-06-05, and the latest expires on 2030-06-05.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-08 | NaN |
Approved in Nov 8, 2017, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-06-05, and the latest expires on 2030-06-05.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-08 | NaN |
From MERCK SHARP AND DOHME CORP; for preventing disease caused by cytomegalovirus in people who have received a bone marrow transplant or kidney transplant.
Approved in Nov 8, 2017, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-06-05, and the latest expires on 2030-06-05.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-08 | NaN |
Approved in Nov 8, 2017, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-06-05, and the latest expires on 2030-06-05.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-08 | NaN |
From HOFFMANN LA ROCHE INC; for treating melanoma and Erdheim-Chester disease.
Approved in Aug 17, 2011, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
|---|---|
| 2024-11-06 | NaN |
