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 Patent Details
Ozempic is a drug owned by Novo Nordisk Inc. It is protected by 25 US drug patents filed from 2018 to 2022. Out of these, 20 drug patents are active and 5 have expired. Ozempic's patents have been open to challenges since 05 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2033. Details of Ozempic's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8129343 | Acylated GLP-1 compounds |
Dec, 2031
(6 years from now) | Active |
| US8536122 | Acylated GLP-1 compounds |
Mar, 2026
(10 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10335462 | Use of long-acting GLP-1 peptides |
Jun, 2033
(8 years from now) | Active |
| US9132239 | Dial-down mechanism for wind-up pen |
Feb, 2032
(6 years from now) | Active |
| US9457154 | Injection device with an end of dose feedback mechanism |
Sep, 2027
(2 years from now) | Active |
| US9687611 | Injection device with torsion spring and rotatable display |
Feb, 2027
(1 year, 9 months from now) | Active |
| USRE46363 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 2 months from now) | Active |
| US9775953 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8920383 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 2 months from now) | Active |
| US10220155 | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(1 year, 2 months from now) | Active |
| US11097063 | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(1 year, 2 months from now) | Active |
| US9108002 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US10357616 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(8 months from now) | Active |
| US10376652 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US9861757 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(8 months from now) | Active |
| US9616180 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US11311679 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US8684969 | Injection device with torsion spring and rotatable display |
Oct, 2025
(5 months from now) | Active |
| US11446443 | Injection device with torsion spring and rotatable display |
Oct, 2025
(5 months from now) | Active |
| US8114833 | Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices |
Aug, 2025
(3 months from now) | Active |
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(11 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(1 year, 10 months ago) |
Expired
|
| US9486588 | Automatic injection device with reset feature |
Jan, 2022
(3 years ago) |
Expired
|
| US8672898 | Automatic injection device with reset feature |
Jan, 2022
(3 years ago) |
Expired
|
| US6899699 | Automatic injection device with reset feature |
Jan, 2022
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ozempic's patents.
Latest Legal Activities on Ozempic's Patents
Given below is the list of recent legal activities going on the following patents of Ozempic.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US9486588 |
| Request for Trial Granted Critical | 28 May, 2024 | US10335462 |
| Request for Trial Granted Critical | 25 Apr, 2024 | US10335462 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Mar, 2024 | US9457154 |
| Petition Requesting Trial | 12 Mar, 2024 | US10335462 |
| Petition Requesting Trial | 29 Nov, 2023 | US10335462 |
| Petition Requesting Trial | 26 Oct, 2023 | US10335462 |
| Request for Trial Granted Critical | 04 Oct, 2023 | US10335462 |
| Request for Trial Denied Critical | 02 Oct, 2023 | US8129343 (Litigated) |
| Request for Trial Denied Critical | 02 Oct, 2023 | US8536122 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Ozempic and ongoing litigations to help you estimate the early arrival of Ozempic generic.
Ozempic's Litigations
Ozempic been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 22, 2020, against patent number US8114833. The petitioner Pfizer Inc., challenged the validity of this patent, with Novo Nordisk A/S as the respondent. Click below to track the latest information on how companies are challenging Ozempic's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10335462 | March, 2024 | Pending | Novo Nordisk A/S | Apotex Inc. et al. |
| US10335462 | November, 2023 |
Trial Instituted
(28 May, 2024) | Novo Nordisk A/S | Sun Pharmaceutical Industries Ltd. et al. |
| US10335462 | October, 2023 |
Trial Instituted
(25 Apr, 2024) | Novo Nordisk A/S | DR. REDDY'S LABORATORIES, INC. et al. |
| US10335462 | March, 2023 |
Trial Instituted
(04 Oct, 2023) | Novo Nordisk A/S | Mylan Pharmaceuticals Inc. et al. |
| US8129343 | March, 2023 |
Institution Denied
(02 Oct, 2023) | Novo Nordisk A/S | Mylan Pharmaceuticals Inc. et al. |
| US8536122 | March, 2023 |
Institution Denied
(02 Oct, 2023) | Novo Nordisk A/S | Mylan Pharmaceuticals Inc. et al. |
| US8114833 | March, 2022 |
Terminated-Settled
(08 Sep, 2022) | Novo Nordisk A/S | Fresenius Kabi USA, LLC |
| US8114833 | December, 2019 |
Terminated-Settled
(21 Jun, 2021) | Novo Nordisk A/S et al. | Pfizer Inc. et al. |
| US8114833 | July, 2020 |
Terminated-Settled
(21 Jun, 2021) | Novo Nordisk A/S | Pfizer Inc. |
FDA has granted some exclusivities to Ozempic. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ozempic, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ozempic.
Exclusivity Information
Ozempic holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Ozempic's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 05, 2022 |
| New Indication(I-822) | Jan 16, 2023 |
| New Dosing Schedule(D-185) | Mar 28, 2025 |
| New Indication(I-961) | Jan 28, 2028 |
Several oppositions have been filed on Ozempic's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Ozempic's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ozempic patents.
Ozempic's Oppositions Filed in EPO
Ozempic has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 23, 2006, by Owen Mumford Limited. This opposition was filed on patent number EP02726984A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP02726984A | NA | Genentech, Inc. | Patent maintained as amended |
| EP13737808A | Jan, 2021 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP13737808A | Jan, 2021 | Teva Pharmaceutical Industries LTD. | Granted and Under Opposition |
| EP13737808A | Jan, 2021 | Generics [UK] Limited | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Hoffmann Eitle | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Dr. Reddy's Laboratories Limited | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP04797453A | Aug, 2018 | Uexküll & Stolberg Partnerschaft von Patent- und Rechtsanwälten mbB | Opposition rejected |
| EP04797453A | Aug, 2018 | Wittkopp, Alexander | Opposition rejected |
| EP04797453A | Aug, 2018 | Generics (U.K.) Limited | Opposition rejected |
| EP04797453A | Aug, 2018 | Teva Pharmaceutical Industries Ltd | Opposition rejected |
| EP04797453A | Aug, 2018 | Fresenius Kabi Deutschland GmbH | Opposition rejected |
| EP04797453A | Aug, 2018 | Sandoz AG | Opposition rejected |
| EP06701034A | Jan, 2018 | Schwöbel, Thilo | Opposition rejected |
| EP06754730A | Dec, 2011 | Ypsomed AG | Patent maintained as amended |
| EP06754730A | Nov, 2011 | WMC Matthes Consulting | Patent maintained as amended |
| EP06725149A | May, 2011 | AMYLIN PHARMACEUTICALS, INC. | Opposition rejected |
| EP06762643A | Jul, 2010 | Sanofi-Aventis Deutschland GmbH | Patent maintained as amended |
| EP05796880A | Jul, 2010 | Ypsomed AG | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Stöckeler, Ferdinand | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | OWEN MUMFORD LIMITED | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ferring International Center S.A. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | COPERNICUS sp. zo.o. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Genentech, Inc. | Granted and Under Opposition |
| EP06121820A | May, 2010 | SANOFI-AVENTIS DEUTSCHLAND GMBH | Opposition rejected |
| EP02726984A | Mar, 2006 | TecPharma Licensing AG | Patent maintained as amended |
| EP02726984A | Feb, 2006 | OWEN MUMFORD LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Ozempic is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ozempic's family patents as well as insights into ongoing legal events on those patents.
Ozempic's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Ozempic:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Ozempic(Semaglutide) has 5 clinical trials that have been verified in 2024. Out of these 5, 1 trial is in PHASE4.
Generic Launch
Generic Release Date:
Ozempic's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ozempic Generics:
There are no approved generic versions for Ozempic as of now.
How can I launch a generic of Ozempic before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ozempic's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ozempic's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ozempic -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg/1.5 mL and 4 mg/3 mL | 06 Dec, 2021 | 7 | 21 Jun, 2033 | ||
| 8 mg/3 mL | 21 Dec, 2022 | 1 | 01 Feb, 2032 |
Alternative Brands for Ozempic
Ozempic which is used for treating Type 2 diabetes as an adjunct to diet and exercise to improve glycemic control in adults., has several other brand drugs using the same active ingredient (Semaglutide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Ozempic
Ozempic is a drug owned by Novo Nordisk Inc. It is used for treating Type 2 diabetes as an adjunct to diet and exercise to improve glycemic control in adults. Ozempic uses Semaglutide as an active ingredient. Ozempic was launched by Novo in 2017.
Approval Date:
Ozempic was approved by FDA for market use on 05 December, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Ozempic is 05 December, 2017, its NCE-1 date is estimated to be 05 December, 2021.
Active Ingredient:
Ozempic uses Semaglutide as the active ingredient. Check out other Drugs and Companies using Semaglutide ingredient
Treatment:
Ozempic is used for treating Type 2 diabetes as an adjunct to diet and exercise to improve glycemic control in adults.
Dosage:
Ozempic is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG/1.5ML (1.34MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 2MG/3ML (0.68MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 4MG/3ML (1.34MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 8MG/3ML (2.68MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |