What is the patent landscape for Novo Nordisk’s semaglutide products, Ozempic, Wegovy and Rybelsus?

Zachary Silbersher

For the past couple of years, Novo Nordisk was embroiled in patent litigation with numerous prospective generics for Ozempic.  In the fall of 2024, Novo Nordisk wrapped up existing claims and settled with numerous generics, including Mylan, Dr. Reddy’s, Apotex, Sun Pharmaceuticals, among others.  The terms of those settlement agreements, however, are confidential, leaving investors uncertain as to the expected entry date for generic Ozempic.  Novo Nordisk has two other semaglutide drugs, over which it is currently litigating different patents with generics.  What is the patent landscape for Novo Nordisk’s Semaglutide products, Ozempic, Wegovy and Rybelsus?

At the bottom of this blog post is a chart identifying and linking to the patents that Novo Nordisk has listed in the Orange Book for its three semaglutide medications, Ozempic, Wegovy and Rybelsus. The chart suggests that generic Ozempic is likely to enter some time in 2032.  Novo Nordisk listed numerous patents in the Orange Book for Ozempic, but only a couple of those patents likely dictated the negotiated generic entry date. 

Ozempic 

The chart shows that Novo Nordisk has two patents covering the compound for semaglutide, namely, the ‘343 patent and the ‘122 patent.  The ‘343 patent expires much later (in 2031) than the ‘122 patent (in 2026).  In 2023, Mylan filed an inter partes review (IPR) challenge to the ‘343 patent, which failed.  This failure was a major blow to the prospect of generic Ozempic entering the market in the U.S. before 2031.  Any generic formulation for Ozempic will most certainly infringe the ‘343 compound patent, and its invalidity challenge to the patent was not successful.  That likely made it very difficult for the generics to have any leverage to negotiate an entry date before expiration of the ‘343 patent, or December 2031.

After that, the ‘462 patent was also likely important to the negotiated entry date.  The ‘462 patent is a method of use patent for treating type-2 diabetes.  Infringement by the generics is also likely certain given that this type of patent most likely reads closely upon the label for Ozempic.  Mylan, Sun Pharmaceuticals, Dr. Reddy’s and Apotex filed IPRs against the ‘462 patent, which were instituted.  That granted the generics leverage to negotiate an entry date before the expiration of the ‘462 patent, i.e., June 2033.  Novo Nordisk appears to have settled with the generics before the IPRs were completed.  That suggests Novo Nordisk agreed to entry date for the generics before June 2033, i.e., the expiration date of the ‘462 patent.  If Novo Nordisk had not agreed to a date before June 2033, the generics would have otherwise been incentivized to litigate the IPRs to conclusion, which could have earned them a negotiated entry date as early as December 2031, i.e., the expiration of the ‘343 patent.   

Apart from the ‘343 (compound) and ‘462 (method of use) patents, the lion’s share of patents listed for Ozempic cover injection devices or mechanisms for injection devices.  A recent decision from the Federal Circuit has seriously called into question whether it was proper for Novo Nordisk to list these patents in the Orange Book (discussed below in connection with Wegovy and Rybelsus.)  Either way, the injection device patents most likely did not impact the negotiated entry date for the generics since they will all expire before the ‘343 and ‘462 patents.  

Other generics may still emerge from the woodwork.  They may re-file the IPRs challenging the ‘426 patent.  There is quite likely a term in the settlement agreements between Novo Nordisk and the generics that, if the ‘426 patent is otherwise invalidated, and another generic obtains freedom to enter sooner than the negotiated entry date, the generics who already settled are entitled to do the same.

Taking a step back, Novo Nordisk’s defeat of Mylan’s IPR challenge for the ‘343 patent cannot be underestimated.  Without that win, Novo Nordisk would have lacked leverage to negotiate a generic entry date after 2026, i.e., the expiration date for the other compound patent (‘122 patent.) 

It also bears asking why the ‘343 patent expires so much later than the ‘122 patent.  Both are compound patents, and both patents were filed around the same time.  The ‘343 patent was based upon a provisional application filed in March 2005.  Technically, it should have an expiration closer to 2025.  However, Novo Nordisk applied for Patent Term Extension, which is a mechanism that can extend the life of a patent for several years based upon delay due to a pharmaceutical’s approval process at the FDA.  This was an enormous boon to Novo Nordisk because it will allow the company to charge monopoly prices for Ozempic for several more years free from lower-cost generic competition.  (Who is going to pay for that?  Consumers will be forced to pay for that.) 

Wegovy and Rybelsus

The patent landscapes for Wegovy and Rybelsus are quite different.  Novo Nordisk has not listed mechanical injection devices in the Orange Book for these patents.  (Rybelsus is an oral formulation, so Novo Nordisk’s injection device patents do not likely read upon this drug.)  That is likely just as well since, a recent case at the Federal Circuit, Teva v. Amneal, which I wrote about here, held that it is improper to list in the Orange Book mechanical device patents that do not actually recite or require the FDA-approved active ingredient.  Most, if not all, of the injection device patents listed for Ozempic do not appear to require semaglutide.  (This is likely why the FTC previously challenged many of Ozempic’s patents as improperly listed.)  

Both Wegovy and Rybelsus have patents that will not expire until approximately 2040.  In particular, Rybelsus has several patents covering the oral formulation for the drug.  There is one patent, the ‘248 patent, that extends out to 2039.  On the other hand, most of the other patents expire much sooner, within the early 2030’s time-frame.  That puts a lot of pressure on a single patent, namely the ‘248 patent, to keep generic entry to stay off the market for Rybelsus long after 2033.

Wegovy is a bit different.  It has several patents within the late 2030’s time frame.  The likelihood that one of those patents survives both infringement and invalidity challenges from generics is much higher.  That suggests that, standing on its own, Wegovy may not face generic competition until closer to 2040 within the U.S. 

That said, Wegovy is not really going to stand on its own.  Ozempic is not currently FDA-approved for weight loss, whereas Wegovy is approved for weigh loss.  Yet, when generics eventually due enter the market for Ozempic in roughly 2032, doctors will likely be able to prescribe generic Ozempic off-label for weight loss.  Those off-label prescriptions will eat into monopoly market share for Wegovy and Rybelsus, even if those latter two drugs are still technically covered by patent protection for several more years.  (If the law on skinny labelling and induced infringement of off-label sales changes over the next ten years, that may also be a boon for Novo Nordisk.)

Novo Nordisk has already commenced litigating patents against generics for Wegovy and Rybelsus.  Cases against Mylan and Sun Pharmaceuticals, at least, remain pending.  A case against Apotex for Rybelsus also remains pending.  Accordingly, additional negotiated generic entry dates for these drug may be announced in the future.

Below is the chart listing Novo Nordisk‘s semaglutide patents listed in the Orange Book. Hyperlinks to the individual patents can be found here: Link to Patents