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Tablet formulation comprising semaglutide and a delivery agent

Patent US-9993430-B2 — Tablet formulation comprising semaglutide and a delivery agent

Patent numberUS-9993430-B2 — Granted 2018
AssigneeNOVO NORDISK A/S
InventorsJENSEN, SIMON BJERREGAARD|SAUERBERG, PER|NIELSEN, FLEMMING S.|PEDERSEN, BETTY L.|SKIBSTED, ERIK
Forward citations13
Patent family13 in 6 countries
CPCA61P, A61K
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About this patent

This patent covers a specific oral tablet formulation of semaglutide, the GLP-1 peptide, combined with the absorption-enhancing delivery agent SNAC (the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, "NAC"). Claim 1 is unusually concrete: it claims a tablet containing a granulate that holds no more than 15% (w/w) semaglutide and at least 50% (w/w) NAC salt, where the finished tablet must simultaneously meet five physical specifications — a bulk density of at least 1.0 g/cm³, a median pore diameter of no more than 1.5 μm, a maximum pore diameter of no more than 4 μm, a crushing strength of at least 50 N, and a disintegration time of 12–18 minutes (for a 300–500 mg tablet containing at least 60% NAC salt). The dependent claims tighten the NAC loading to 55% and 60%. Rather than claiming the drug or the delivery agent in the abstract, this patent fences off a manufacturable, physically-characterized solid dosage form — the kind of formulation-engineering claim that protects the actual commercial pill.

The patent is assigned to Novo Nordisk A/S and names five inventors (Jensen, Sauerberg, Nielsen, Pedersen, and Skibsted). It was granted in 2018. The family spans 13 members across 6 countries, indicating focused-but-deliberate international protection rather than the very broad global filings Novo deploys for its anchor compositions. It carries 13 forward citations. For a 2018 grant in a tightly contested therapeutic space, a moderate citation count is expected and does not signal low value — it reflects both recency and the fact that much of the relevant follow-on work is Novo's own continuation activity, which a citation-weighted ranking under-rewards.

Where this patent stands: This is a product-protecting refinement filing rather than a foundational one. The foundational GLP-1-plus-SNAC composition concept is captured by the earlier US-9278123-B2 (2016); this 2018 patent layers on the specific physical-property envelope of the actual tablet. It very plausibly underpins Rybelsus, Novo Nordisk's oral semaglutide product, by claiming the precise granulate composition and tablet specifications needed for reproducible manufacture and absorption. In a field where Novo competes with Eli Lilly on incretin therapeutics, this patent functions as one tier in a layered portfolio — defending the commercial dosage form rather than the core molecule.

Citing patents (13)

Patents that cite this one (forward citations)

US-11117947-B2 · US-2019216739-A1 · US-11833248-B2 · US-10335369-B2 · US-11759501-B2 · US-11034746-B2 · US-11759503-B2 · US-10960052-B2 · US-10933120-B2 · US-11759502-B2 · US-11123296-B2 · US-11033499-B2 · US-11382957-B2

Cited patents (59)

Patents this one cites — its references (backward citations) — showing 58 of 59

WO-2007117706-A2 · US-2009156478-A1 · WO-2011084618-A2 · JP-2008509933-A · JP-2015515459-A · JP-2009542711-A · WO-2008109385-A2 · US-2005009748-A1 · US-5773647-A · US-2013345134-A1 · JP-2004131398-A · US-9278123-B2 · US-2008153779-A1 · US-2005148497-A1 · JP-2007536268-A · WO-2009032749-A2 · US-2007224262-A1 · WO-2008039351-A2 · WO-0050012-A1 · RU-2226402-C2 · WO-2007146234-A2 · US-2006078623-A1 · WO-2006124047-A2 · US-2015072926-A1 · US-8053429-B2 · US-2011218148-A1 · JP-2013543814-A · JP-2012121923-A · US-2015031606-A1 · RU-2158138-C2 · US-2008255250-A1 · US-2016151462-A1 · WO-2006103661-A2 · JP-2011509077-A · WO-2011116139-A2 · WO-2010020978-A1 · US-2009124639-A1 · WO-2011109787-A1 · JP-2014503526-A · CN-101010339-A · WO-2005107773-A2 · US-5866536-A · WO-2008020096-A1 · WO-0141737-A2 · WO-2010092163-A2 · US-2007049557-A1 · WO-2012080471-A1 · US-7417028-B2 · WO-03005944-A1 · US-2010151009-A1 · WO-2005004900-A1 · US-7049283-B2 · WO-0048589-A1 · WO-2011094531-A1 · US-2006078622-A1 · US-2010210526-A1 · US-2011142800-A1 · WO-2009050738-A2

Family members (13)

Related filings for the same invention across jurisdictions.

PublicationCountryKindFiledStatus
US-2018235888-A1 (priority)USA12018PENDING
US-9993430-B2 (priority)USB22013GRANTED
US-2015150811-A1 (priority)USA12013PENDING
CN-104487056-A (priority)CNA2013PENDING
JP-2015521610-A (priority)JPA2013PENDING
EP-2863895-A1 (priority)EPA12013PENDING
WO-2013189988-A1 (priority)WOA12013PENDING
EP-2863895-B1 (priority)EPB12013GRANTED
ES-2871328-T3 (priority)EST32013UNKNOWN
US-2021275458-A1 (priority)USA12021PENDING
US-11033499-B2 (priority)USB22018GRANTED
JP-2019073541-A (priority)JPA2019PENDING
JP-6517690-B2 (priority)JPB22013GRANTED

Patent landscape

The space immediately around this patent is densely clustered and overwhelmingly controlled by Novo Nordisk itself. Of the 20 nearest patents, the large majority are Novo filings on GLP-1/SNAC solid compositions, oral dosing, and delivery agents — a self-reinforcing portfolio. Notably, Novo Nordisk does not appear in the TOP_ASSIGNEES citation chart at all; that chart is led by Eli Lilly and Company (4 patents, 514 citations) and Depomed (1 patent, 494 citations), reflecting older, heavily-cited oral-delivery and peptide-formulation work. Novo dominates the nearest-neighbor relevance set despite not leading the citation ranking — its patents are recent and citation-lagged, so the citation-weighted score systematically under-represents its present grip on this niche. Among the cited leaders, Emisphere Technologies (4 patents, 87 citations) is the originator of the SNAC carrier chemistry underlying these formulations, and Merrion Research (130 citations) holds foundational oral-enhancer work.

Closest related filings:

  • US-9278123-B2 — Solid compositions comprising a GLP-1 agonist and a salt of NAC (Novo Nordisk · 24 citations · 49-member family). The broader genus filing that this tablet patent narrows; it claims the composition concept, while US-9993430-B2 adds the specific physical tablet specifications.
  • US-12396953-B2 — Solid compositions comprising a GLP-1 agonist and a salt of NAC (Novo Nordisk · 0 citations · 43-member family). A 2025 continuation in the same family lineage with a large 43-member family — strategic IP the citation-weighted score under-rewards, extending protection well beyond the 2018 grant.
  • US-11622996-B2 — Solid compositions comprising a GLP-1 agonist and a salt of NAC (Novo Nordisk · 0 citations · 29-member family). A 2023 continuation; another lightly-cited but on-point filing reinforcing the same composition family.
  • US-7939494-B2 — Method for administering GLP-1 molecules (Emisphere Technologies · 16 citations · 39-member family). Earlier third-party work on GLP-1 administration using carrier chemistry, representing the prior-art root that Novo's portfolio builds upon.

The TECHNOLOGY_CONCENTRATION data confirms how tightly clustered this space is: Therapeutic Drug Activity (A61P) sits at 20.9× the corpus baseline and Pharmaceutical Preparations (A61K) at 19.5× — both an order of magnitude above the general corpus, evidence that the surrounding patents are sharply focused on a single formulation problem rather than spread across a broad technical area. Because the dominant nearest-neighbor holder (Novo Nordisk) is also the assignee of the subject patent, the practical

Related patents

US-9993430-B2 · 2018
Tablet formulation comprising semaglutide and a delivery agent
NOVO NORDISK A/S
US-9278123-B2 · 2016
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
NOVO NORDISK A/S
US-12396953-B2 · 2025
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
NOVO NORDISK A/S
US-11622996-B2 · 2023
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
NOVO NORDISK A/S
US-10933120-B2 · 2021
Compositions of GLP-1 peptides and preparation thereof
NOVO NORDISK A/S
US-11167014-B2 · 2021
Solid glp-1 derivative compositions for oral administration
NOVO NORDISK A/S
US-2022265777-A1 · 2022
Solid compositions comprising a glp-1 agonist, an sglt2 inhibitor and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid
NOVO NORDISK A/S
US-2022395559-A1 · 2022
Solid compositions comprising a glp-1 agonist, an sglt2 inhibitor and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid
NOVO NORDISK A/S
US-10335369-B2 · 2019
Compositions comprising a delivery agent and preparation thereof
NOVO NORDISK A/S
US-11123296-B2 · 2021
Compositions comprising a delivery agent and preparation thereof
NOVO NORDISK A/S
US-2018263915-A1 · 2018
Pharmaceutical Composition for Oral GLP-1 Administration Comprising a Tablet Core and Immediate Release Coating
NOVO NORDISK A/S
US-10278923-B2 · 2019
Oral dosing of GLP-1 compounds
NOVO NORDISK A/S

View the full ranked list in the interactive report →

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