Details for Patent: 11,844,780
Which drugs does patent 11,844,780 protect, and when does it expire?
Patent 11,844,780 protects OGSIVEO and is included in one NDA.
This patent has eighty patent family members in twenty-nine countries.
Summary for Patent: 11,844,780
| Title: | Chlorinated tetralin compounds and pharmaceutical compositions | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | The present disclosures are directed to chlorinated tetralin compounds and pharmaceutical compositions. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Kristin Patterson, Mark Hatcher | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | SpringWorks Therapeutics Inc | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US18/301,742 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; Composition; | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | US Patent 11,844,780: Scope, Claims, Exclusivity, and Desmoid-Tumor Patent LandscapeUS Patent 11,844,780 protects oral treatment of desmoid tumors with a pharmaceutical composition containing an unidentified "compound of Formula IB." Its dependent claims narrow the protected amount to 1-300 micrograms, including nested ranges down to 1-50 micrograms. Claims 7-17 add nirogacestat, including a 50-mg nirogacestat dose. The patent is therefore directed primarily to a method-of-use combination involving a low-microgram Formula IB agent and, in the narrower claims, nirogacestat. The supplied claims do not identify the chemical structure represented by Formula IB. That omission prevents a definitive chemical-scope, infringement, or freedom-to-operate conclusion. The microgram dosage ranges are consistent with a potent hormonal or other highly active small molecule, but dosage alone cannot establish the identity of Formula IB. What does US Patent 11,844,780 protect?The independent claim covers four core elements:
Claim 1 does not expressly require nirogacestat. The broadest claim therefore reaches an oral Formula IB composition used to treat desmoid tumors, whether or not nirogacestat is present.
The claims are method claims rather than composition claims. They require administration to a patient and treatment of a desmoid tumor. A product containing Formula IB, standing alone, would not necessarily infringe unless it is made, sold, or used for the claimed treatment method under applicable induced-infringement standards. How broad is claim 1?Claim 1 is materially broader than claims 7-17 because it does not require nirogacestat, a dose range, a particular patient subgroup, disease progression, prior therapy, or a specific treatment response. The claim does require oral administration. A formulation administered intravenously, by injection, topically, or through another nonoral route would fall outside the literal scope of claim 1 unless another claim or doctrine applied. The claim also requires a pharmaceutical composition. Administration of Formula IB as an unformulated active ingredient could create a claim-construction issue, although most practical oral drug administration would involve a composition containing excipients or a pharmaceutically acceptable salt. The expression "treating a desmoid tumor" is not limited in the text provided to:
Those omissions expand the apparent patient and clinical-use scope. The specification and prosecution history could narrow the interpretation, particularly if Formula IB was defined narrowly or if the applicant relied on specific clinical distinctions during examination. What do claims 2-6 protect?Claims 2-6 create nested dosage ranges:
Each narrower range is contained within claim 2. The practical value of the nested claims is fallback protection. If the 1-300 microgram range is challenged for lack of written description, enablement, anticipation, or obviousness, narrower ranges may survive. The word "about" introduces ordinary patent-law flexibility around the numerical boundaries. The precise tolerance depends on the specification, examples, prosecution history, analytical variability, and the way dose is measured. The claims do not state whether the amount is:
That issue may be resolved by the specification. In a commercial formulation, the most natural reading may be the amount contained in the administered pharmaceutical composition, but the claim language does not independently settle the point. What do claims 7-17 protect with nirogacestat?Claim 7 requires a composition containing both:
Claims 8-17 add Formula IB dose ranges and, in the odd-numbered claims, 50 mg of nirogacestat. The narrower claim architecture is:
The claims do not expressly require that Formula IB and nirogacestat be co-formulated in a single tablet. "The pharmaceutical composition comprises" both agents could support a single dosage unit, a multipart dosage form, or potentially a kit or regimen, depending on the specification and claim construction. The claim language is strongest against a product in which both agents are present in the same administered composition. Nirogacestat is marketed in the United States as Ogsiveo for adults with progressing desmoid tumors who require systemic treatment. The FDA-approved dosage is 150 mg orally twice daily, administered as three 50-mg tablets twice daily. The 50-mg limitation in claims 9, 11, 13, 15, and 17 is therefore consistent with one Ogsiveo tablet, but the claims do not recite the full approved 150-mg twice-daily regimen. [2] What is the identity of Formula IB?The supplied claim text does not disclose the structure or chemical name of Formula IB. That identity is central to the patent analysis. The dosage range of 1-300 micrograms suggests a highly potent compound. It could represent a low-dose hormonal agent, receptor modulator, or another pharmacologically active compound administered at microgram quantities. That inference is not sufficient to identify the molecule or establish infringement. The following issues must be resolved from the patent specification and prosecution record:
Without that information, the claims cannot be mapped reliably to a specific commercial product. When does US Patent 11,844,780 expire?The patent issued on December 19, 2023. US patent term normally runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and applicable priority claims. The issue date is not the expiration date. [1] The claim excerpt does not establish:
A definitive expiration date therefore cannot be derived from the claims alone. A patent-term calculation should use the USPTO bibliographic record and continuity data rather than the issue date. Because the claims concern a small-molecule therapy, the patent is not a biosimilar patent. Any product-specific regulatory exclusivity would be analyzed under the Hatch-Waxman framework for new drug applications, not under the biosimilar pathway. What is the Orange Book status of US Patent 11,844,780?A patent is not automatically listed in the Orange Book merely because it covers a drug or treatment method. The NDA holder must submit patent information meeting FDA listing requirements, and the FDA evaluates whether the patent is eligible for publication. FDA regulations distinguish patents claiming the drug substance, drug product, or an approved method of use. [3] The patent’s method-of-use character is important. If the approved Ogsiveo labeling includes a use that falls within the patent claims and the NDA holder submitted the patent in the required manner, it could potentially be listed as a method-of-use patent. The claim text alone does not establish current Orange Book listing status. If listed against an NDA, the patent could affect an ANDA applicant that seeks approval for a use covered by the listed method-of-use patent. An applicant could respond with:
A section viii strategy would be difficult if the patented desmoid-tumor use is central to the generic product’s proposed labeling. What Paragraph IV risks exist?A Paragraph IV challenge could target several claim vulnerabilities. AnticipationA challenger could search earlier references for:
A reference must disclose all claim elements arranged as claimed. A disclosure of nirogacestat for desmoid tumors alone would not anticipate claim 7 unless it also discloses Formula IB. ObviousnessObviousness is likely to be the more important validity issue for the combination claims. A challenger could combine references disclosing:
The patent holder would likely rely on unexpected clinical effects, improved tolerability, reduced ovarian toxicity, improved treatment persistence, or another demonstrated benefit if the specification contains such evidence. Written description and enablementThe breadth of claim 1 depends heavily on the definition of Formula IB. If Formula IB represents a narrow compound, the claims may be relatively focused. If it represents a broad chemical genus, the written-description and enablement record becomes more important. The amount range of 1-300 micrograms also raises support questions if the examples disclose only a small subset of doses. The dependent claims improve survivability if the specification provides data across the nested ranges. IndefinitenessPotential issues include the meaning of:
Those terms are not automatically indefinite. Their interpretation would depend on the specification, technical context, and prosecution history. How does this patent compare with nirogacestat product protection?US Patent 11,844,780 appears to protect a treatment method involving Formula IB, with narrower combination claims that include nirogacestat. It is distinct from patents that may protect:
A generic nirogacestat product would not necessarily infringe claims 7-17 merely because it contains nirogacestat. Those claims also require Formula IB. Conversely, a Formula IB product could face claim 1 risk if it is marketed for oral treatment of desmoid tumors, even without nirogacestat. This creates two separate risk paths:
What manufacturing and geographic barriers apply?The claims are US method claims. Their direct enforceability is generally limited to conduct within the United States, including US manufacture, sale, offer for sale, importation, or use that satisfies applicable infringement rules. The patent does not, based on the supplied claims, recite:
It is therefore not a manufacturing patent on the face of the claims. Manufacturing risk could still arise under separate patents covering Formula IB, nirogacestat, formulation technology, or intermediates. Foreign counterparts may have different claim scope, prosecution outcomes, expiration dates, and enforceability. A US freedom-to-operate conclusion cannot be exported to Europe, Japan, China, Canada, or other markets. How strong is the patent estate?Based only on the supplied claims, Patent 11,844,780 has a layered but chemically dependent estate:
Its commercial strength depends on three facts:
The strongest practical claim set may be claims 9, 11, 13, 15, and 17 if the commercial regimen uses a 50-mg nirogacestat unit together with Formula IB. The broadest claim, claim 1, has the greatest market reach but also the greatest exposure to prior-art and written-description challenges. What patent litigation and settlement issues should be monitored?Relevant litigation triggers include:
No litigation or settlement status can be established from the claim text alone. The FDA Orange Book, USPTO Patent Center, PACER, and relevant district-court dockets are the controlling sources for current status. [1, 3, 4] Key Takeaways
FAQsDoes US Patent 11,844,780 cover Ogsiveo by itself?Not on the supplied claim language. Claims 7-17 require both nirogacestat and a compound of Formula IB. Claim 1 requires Formula IB but does not require nirogacestat. Could a generic avoid the patent by using a different dose of Formula IB?Possibly, but the answer depends on the scope of claim 1 and the definition of Formula IB. Claims 2-6 contain specific dose ranges, but claim 1 has no express dose limitation. Does a 50-mg Ogsiveo tablet fall within claims 9, 11, 13, 15, and 17?It satisfies the nirogacestat amount limitation only if the claimed composition also contains Formula IB within the applicable microgram range. Is Formula IB likely to be ethinyl estradiol?The microgram ranges are consistent with some low-dose hormonal agents, including possible estrogenic compounds, but the supplied claims do not identify Formula IB. A structural conclusion cannot be drawn from dosage alone. Can a generic file a section viii statement against this patent?A section viii strategy may be available if the generic can omit the patented desmoid-tumor use and still obtain approval for a noninfringing indication. That outcome depends on the NDA labeling, Orange Book listing, and FDA's determination that the carve-out is permissible. References
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Drugs Protected by US Patent 11,844,780
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-001 | Nov 27, 2023 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS | ⤷ Start Trial | |||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-002 | Apr 4, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS | ⤷ Start Trial | |||
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677-003 | Apr 4, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 11,844,780
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| European Patent Office | 4010322 | ⤷ Start Trial | CA 2026 00017 | Denmark | ⤷ Start Trial |
| European Patent Office | 4010322 | ⤷ Start Trial | 301374 | Netherlands | ⤷ Start Trial |
| European Patent Office | 4010322 | ⤷ Start Trial | C20260011 | Finland | ⤷ Start Trial |
| European Patent Office | 4010322 | ⤷ Start Trial | LUC50046 | Luxembourg | ⤷ Start Trial |
| European Patent Office | 4010322 | ⤷ Start Trial | PA2026516 | Lithuania | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
