Novo Nordisk’s marketed portfolio represents one of the most capital-intensive and strategically layered IP positions in the global pharmaceutical landscape. Its leading products in diabetes, obesity, and rare diseases collectively generate over USD 30 billion in annual revenue, supported by dense Orange Book patent listings, late-stage formulation and device claims, and overlapping FDA-granted exclusivities that extend effective market protection well beyond initial patent expirations.
For generic and follow-on companies, this portfolio illustrates how commercial value is defended through cumulative barriers rather than single patents. Early headline patent expiries often coexist with later-expiring secondary patents and regulatory exclusivities, creating entry timelines that are materially different from what molecule-level patent analysis alone would suggest.
This article presents a drug-wise, NDA-centric assessment of Novo Nordisk’s key marketed products, integrating:
- U.S. revenue concentration
- Orange Book–listed patent volume and expiry clustering
- Regulatory exclusivity coverage
- Product-specific defensive strategies
Drug-wise Patent & NDA Overview
This table presents the key patents, NDA numbers, FDA approval dates, patent expiry windows, and exclusivity status for Novo Nordisk’s blockbuster drugs. It provides essential data for understanding patent protection and planning strategic market entry.
| Drug | NDA Number | FDA Approval |
| Ozempic® (Semaglutide) | 209637 | Dec 5, 2017 |
| Wegovy® (Semaglutide) | 215256 | Jun 4, 2021 |
| Rybelsus® (Semaglutide) | 213051 | Dec 9, 2024 |
| Saxenda® (Liraglutide) | 206321 | Dec 23, 2014 |
| Rivfloza® (Nedosiran ) | 215842 | Sep 29, 2023 |
Drug Revenue Overview
Novo Nordisk’s blockbuster drugs not only dominate in therapeutic impact but also contribute significantly to the company’s revenue. Understanding these revenue figures helps gauge market potential, competitive dynamics, and the financial importance of each product.
| Drug Name | Global Revenue (USD Billion) | US-Revenue (USD Billion) | Year |
| Ozempic® (Semaglutide) | $16.9 | $7.16 | 2024 |
| Wegovy® (Semaglutide) | $9.4 | $5.64 | 2024 |
| Rybelsus® (Semaglutide) | $3.28 | $1.31 | 2024 |
| Saxenda® (Liraglutide) | $1.55 | $0.62 | 2024 |
| Rivfloza® (Nedosiran) | Not publicly disclosed | – | 2024 |
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Appendix: Complete List of Orange Book–Listed U.S. Patents
The following section provides a complete, drug-wise list of all Orange Book-listed U.S. patents associated with Novo Nordisk’s key marketed products, along with their reported expiration timelines. This appendix is intended as a reference tool for IP teams, generic portfolio planners, and litigation strategists.
Ozempic® (Semaglutide) – NDA 209637
Orange Book-Listed U.S. Patents & Expiration Date
| Listed U.S. Patents | Expiration Date |
| US8114833B2 | Aug 13, 2025 |
| US8684969B2 | Oct 20, 2025 |
| US9108002B2 | Jan 20, 2026 |
| US9616180B2 | Jan 20, 2026 |
| US9861757B2 | Jan 20, 2026 |
| US10357616B2 | Jan 20, 2026 |
| US10376652B2 | Jan 20, 2026 |
| US8536122B2 | Mar 20, 2026 |
| US8920383B2 | Jul 17, 2026 |
| US9775953B2 | Jul 17, 2026 |
| US10220155B2 | Jul 17, 2026 |
| US11097063B2 | Jul 17, 2026 |
| US9687611B2 | Aug 03, 2026 |
| US9457154B2 | Feb 27, 2027 |
| US8129343B2 | Sep 29, 2027 |
| US9132239B2 | Dec 05, 2031 |
| US10335462B2 | Feb 01, 2032 |
| USRE46363E | Jun 21, 2033 |
Total listed patents: 18
Strategic note: Early expiries are offset by formulation and delivery patents extending protection into the 2030s.
Wegovy® (Semaglutide) – NDA 215256
Orange Book–Listed U.S. Patents & Expiration Date
| Listed U.S. Patents | Expiration Date |
| US8129343B2 | Dec 5, 2031 |
| US8536122B2 | Mar 20, 2026 |
| US9764003B2 | Jun 21, 2033 |
| US10888605B2 | Aug 24, 2038 |
| US11318191B2 | Feb 17, 2041 |
| US11478533B2 | May 13, 2040 |
| US11752198B2 | Aug 24, 2038 |
| US12214017B2 | Aug 24, 2038 |
Total listed patents: 8
Strategic note: Wegovy® is protected by some of the latest-expiring device and formulation patents in the GLP-1 class.
Rybelsus® (Oral Semaglutide) – NDA 213051
Orange Book–Listed U.S. Patents & Expiration Date
| Listed U.S. Patents | Expiration Date |
| US8129343B2 | Dec 5, 2031 |
| US8536122B2 | Mar 20, 2026 |
| US10278923B2 | May 2, 2034 |
| US11382957B2 | Dec 16, 2031 |
| US11833248B2 | Feb 1, 2039 |
| US12239739B2 | May 2, 2034 |
| US12396953B2 | Feb 1, 2039 |
Total listed patents: 7
Strategic note: Oral delivery adds an additional absorption and formulation complexity layer absent in injectables.
Saxenda® (Liraglutide) – NDA 206321
Orange Book–Listed U.S. Patents & Expiration Date
| Listed U.S. Patents | Expiration Date |
| US8114833B2 | Aug 13, 2025 |
| US9968659B2 | Jan 9, 2037 |
Total listed patents: 2
Strategic note: Leaner patent estate and declining revenue profile make Saxenda® the most attractive near-term generic target.
Rivfloza® (Nedosiran) – NDA 215842
Orange Book–Listed U.S. Patents & Expiration Date
| Listed U.S. Patents | Expiration Date |
| US10351854B2 | Oct 9, 2035 |
| US10738311B2 | Oct 9, 2035 |
| US11053502B2 | Oct 29, 2035 |
| US11286488B2 | Oct 12, 2038 |
| US11359203B2 | Oct 9, 2035 |
| US11661604B2 | Oct 12, 2038 |
Total listed patents: 6
Strategic note: Long-dated patents combined with orphan exclusivity significantly delay generic feasibility.
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Exclusivity Date Overview
This table summarizes the FDA-granted regulatory exclusivities applicable to Novo Nordisk’s key products, alongside their NDA numbers, exclusivity codes, and expiration dates.
Unlike patents, these exclusivities arise from regulatory frameworks-such as New Chemical Entity (NCE), New Product (NPP), Orphan Drug, and Pediatric extensions-and can independently block generic or follow-on approvals even if patents are successfully challenged or expire.
For generic companies, tracking these exclusivity periods is essential to accurately assess the earliest feasible market-entry dates and to distinguish between patent barriers and regulatory lock-outs.
| Drug | NDA Number | Exclusivity Code | Code Name / Type | Exclusivity Expiration |
| Ozempic® (Semaglutide) | 209637 | I‑961 | FDA Internal Exclusivity Identifier (likely linked to Orphan Drug or Pediatric Extension depending on NDA context) | Jan 28, 2028 |
| Wegovy® (Semaglutide) | 215256 | NPP | New Product Exclusivity | Dec 23, 2025 |
| Wegovy® (Semaglutide) | 215256 | I‑935 | FDA Internal Exclusivity Identifier (likely Pediatric or Clinical Investigation) | Mar 8, 2027 |
| Wegovy® (Semaglutide) | 215256 | I‑973 | FDA Internal Exclusivity Identifier (likely Orphan Drug or QIDP extension) | Aug 15, 2028 |
| Rybelsus® (Oral Semaglutide) | 213051 | I‑976 | FDA Internal Exclusivity Identifier (likely Orphan Drug or Pediatric Extension) | Oct 17, 2028 |
| Rivfloza® (Nedosiran ) | 215842 | NPP | New Product Exclusivity | Mar 27, 2028 |
| Rivfloza® (Nedosiran ) | 215842 | NCE | New Chemical Entity Exclusivity | Sep 29, 2028 |
| Rivfloza® (Nedosiran ) | 215842 | ODE‑443 | Orphan Drug Exclusivity (Code 443) | Sep 29, 2030 |
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