What is Ozempic?
Ozempic (semaglutide) is an injectable medication used to improve blood sugar levels in adults with type 2 diabetes. It belongs to a class of drugs called GLP-1 receptor agonists and works by mimicking the effects of the hormone GLP-1, which helps regulate blood sugar levels. Ozempic slows digestion and decreases appetite, leading to improved glycemic control and potential weight loss benefits.
What is the Ozempic controversy?
The injectable diabetes medication Ozempic (semaglutide) has recently seen its FDA-approved label updated to warn of potential serious intestinal side effects like obstruction or blockage. The newly added FDA warning highlights that Ozempic may cause severe gastrointestinal issues like intestinal obstruction, intense abdominal pain, vomiting, constipation, and abdominal swelling.
OZEMPIC's oppositions filed in EPO
OZEMPIC Litigations
| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US8536122 | NOVO | Acylated GLP-1 compounds |
Mar, 2026
(1 year, 10 months from now) | |
| US8129343 | NOVO | Acylated GLP-1 compounds |
Dec, 2031
(7 years from now) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US8672898 | NOVO | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) | |
| US6899699 | NOVO | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) | |
| US9486588 | NOVO | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) | |
| US8579869 | NOVO | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(9 months ago) | |
| US7762994 | NOVO | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(26 days from now) | |
| US8114833 | NOVO | Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices |
Aug, 2025
(1 year, 3 months from now) | |
| US8684969 | NOVO | Injection device with torsion spring and rotatable display |
Oct, 2025
(1 year, 5 months from now) | |
| US11446443 | NOVO | Injection device with torsion spring and rotatable display |
Oct, 2025
(1 year, 5 months from now) | |
| US11311679 | NOVO | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 8 months from now) | |
| US10376652 | NOVO | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 8 months from now) | |
| US10357616 | NOVO | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 8 months from now) | |
| US9861757 | NOVO | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 8 months from now) | |
| US9108002 | NOVO | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 8 months from now) | |
| US9616180 | NOVO | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 8 months from now) | |
| US9775953 | NOVO | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(2 years from now) | |
| US8920383 | NOVO | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(2 years from now) | |
| US10220155 | NOVO | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(2 years from now) | |
| US11097063 | NOVO | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(2 years from now) | |
| USRE46363 | NOVO | Dial-down mechanism for wind-up pen |
Aug, 2026
(2 years from now) | |
| US9687611 | NOVO | Injection device with torsion spring and rotatable display |
Feb, 2027
(2 years from now) | |
| US9457154 | NOVO | Injection device with an end of dose feedback mechanism |
Sep, 2027
(3 years from now) | |
| US9132239 | NOVO | Dial-down mechanism for wind-up pen |
Feb, 2032
(7 years from now) | |
| US10335462 | NOVO | Use of long-acting GLP-1 peptides |
Jun, 2033
(9 years from now) | |
Ozempic is owned by Novo.
Ozempic contains Semaglutide.
Ozempic has a total of 25 drug patents out of which 4 drug patents have expired.
Expired drug patents of Ozempic are:
- US8672898
- US6899699
- US9486588
- US8579869
Ozempic was authorised for market use on 05 December, 2017.
Ozempic is available in solution;subcutaneous dosage forms.
Ozempic can be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, a method of treating type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof.
Drug patent challenges can be filed against Ozempic from 05 December, 2021.
The generics of Ozempic are possible to be released after 21 June, 2033.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-185) | Mar 28, 2025 |
| New Chemical Entity Exclusivity(NCE) | Dec 05, 2022 |
| New Indication(I-822) | Jan 16, 2023 |
Drugs and Companies using
SEMAGLUTIDE ingredient
NCE-1 date:
Market Authorisation Date:
05 December, 2017Treatment:
A method of treating type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof; Ozempic is indicated as an adjunct to diet and exercise to imp...Dosage:
How can I launch a generic of OZEMPIC before its drug patent expiration?
More Information on Dosage
OZEMPIC family patents
