Details for Patent: 9,790,208

Which drugs does patent 9,790,208 protect, and when does it expire?

Patent 9,790,208 protects QUVIVIQ and is included in one NDA.

This patent has thirty-seven patent family members in thirty-two countries.

Summary for Patent: 9,790,208

Title:	Crystalline salt form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist
Abstract:	The invention relates to a crystalline form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride, processes for the preparation thereof, pharmaceutical compositions containing said crystalline form, and its use as medicament, especially as orexin receptor antagonist.
Inventor(s):	Christoph Boss, Christine Brotschi, Markus Gude, Bibia Heidmann, Thierry Sifferlen, Markus von Raumer, Jodi T. Williams
Assignee:	Idorsia Pharmaceuticals Ltd
Application Number:	US15/101,832
Patent Claim Types: see list of patent claims	Composition; Compound;

US Patent 9,790,208: Daridorexant Hydrochloride Crystal Form, Claim Scope, Exclusivity and Generic-Entry Risk

US Patent 9,790,208 protects a specific crystalline hydrochloride form of daridorexant, the active ingredient in Quviviq. The patent does not broadly claim daridorexant, every salt, every polymorph, or every pharmaceutical use. Its enforceable scope is concentrated on the claimed solid-state form identified by specified powder X-ray diffraction peaks and pharmaceutical compositions containing that form. The patent issued October 17, 2017, and is listed in FDA patent records for Quviviq. Its ordinary patent expiration is reported as May 29, 2035, subject to any applicable patent-term adjustment or extension reflected in official USPTO records.[1-3]

What drug does US Patent 9,790,208 protect?

The claimed compound is daridorexant hydrochloride, a dual orexin receptor antagonist developed by Idorsia Pharmaceuticals and marketed in the United States as Quviviq.

Item	Details
Active ingredient	Daridorexant
Salt claimed	Hydrochloride
Therapeutic class	Dual orexin receptor antagonist
Primary indication	Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
US brand	Quviviq
US approval	January 7, 2022
Applicant/marketing company	Idorsia Pharmaceuticals Ltd. and associated US entities
Dosage form	Oral tablets
Patent at issue	US 9,790,208
Patent issue date	October 17, 2017
Reported expiration	May 29, 2035

The chemical identity in the claims is more specific than the generic name “daridorexant.” The patent claims the hydrochloride salt in a defined crystalline state, not merely the molecular structure of the free base.

What are the claims of US Patent 9,790,208?

The six claims fall into two categories: crystalline-form claims and composition claims.

Claims 1 through 3: crystalline hydrochloride form

Claim 1 covers a crystalline form of daridorexant hydrochloride having XRPD peaks at 2θ values of 11.0°, 24.1°, and 24.5°, with an allowed positional accuracy of ±0.2°. The measurement condition is material. The claim specifies combined Cu Kα1 and Kα2 radiation without Kα2 stripping.

Claim 2 is narrower. It requires the peaks in claim 1 plus seven additional peaks:

9.2°, 13.8°, 15.1°, 16.3°, 16.8°, 19.8°, and 27.3°.

Claim 3 requires the crystalline form to “essentially show” the XRPD pattern depicted in Figure 2. This is a pattern-based claim and would ordinarily be interpreted with the figure, specification and analytical methodology.

Claim	Subject matter	Relative breadth
1	Daridorexant hydrochloride crystalline form with three specified XRPD peaks	Broadest independent crystal-form claim
2	Same form with ten specified XRPD peaks	Narrower species claim
3	Same form substantially matching Figure 2	Pattern-defined claim
4	Composition containing claim 1 form	Composition claim
5	Composition containing claim 2 form	Narrow composition claim
6	Composition containing claim 3 form	Pattern-defined composition claim

Claims 4 through 6 do not independently protect a new active ingredient or a particular tablet excipient system. They extend the crystal-form protection to pharmaceutical compositions containing the claimed form.

How does the XRPD language limit patent scope?

The XRPD limitations are central to infringement analysis. A product must contain the claimed daridorexant hydrochloride crystalline form and exhibit the specified diffraction characteristics under the stated radiation and processing conditions.

The claim does not require every possible XRPD peak. Claim 1 identifies three required peaks. Claim 2 identifies ten. Claim 3 relies on substantial correspondence to the complete pattern in Figure 2.

The ±0.2° tolerance is important. A generic manufacturer could not necessarily avoid infringement by producing a material whose corresponding peaks appear at 10.9°, 24.0° and 24.6°. Those values fall within the express tolerance for the relevant peaks. A different polymorph with materially different peak positions could avoid literal infringement, but the result would depend on the complete diffraction pattern and other evidence.

A laboratory comparison would typically evaluate:

1. The salt identity and stoichiometry.
2. The crystalline state of the material.
3. XRPD peak positions and relative intensities.
4. Radiation source and instrument conditions.
5. Whether the sample is a mixture of polymorphs or solvates.
6. Whether drying, milling, humidity or formulation processing changes the measured pattern.

The claims do not expressly require a particular particle size, morphology, water content, residual solvent level, melting point or manufacturing process. Those attributes may be relevant evidentiary facts, but they are not standalone limitations in the supplied claims.

What does claim 1 cover compared with claims 2 and 3?

Claim 1 is the principal enforcement claim because it requires only three identified peaks. It may capture a wider range of samples that belong to the claimed crystal form but do not reproduce every peak listed in claim 2.

Claim 2 provides a more analytically detailed fallback. If a court construes claim 1 narrowly or finds one of its peak limitations indefinite or unsupported, claim 2 may remain useful if the accused material shows the full ten-peak profile.

Claim 3 is potentially useful where the patent holder relies on the overall pattern rather than isolated peaks. The phrase “essentially shows” introduces a degree of pattern comparison that may require expert evidence concerning which deviations are material.

The claims should not be read as covering any daridorexant hydrochloride material that produces three arbitrary peaks. The peaks must correspond to the claimed crystalline form, and the claim language ties the measurement to the specified radiation and accuracy conditions.

What pharmaceutical products are covered by claims 4 through 6?

Claims 4 through 6 cover pharmaceutical compositions containing the claimed crystalline form and a pharmaceutically acceptable carrier. Quviviq tablets are the commercial product most directly associated with this patent.

The composition claims can potentially reach:

• Finished tablets containing the patented crystal form.
• Powder blends before compression.
• Capsules or other oral solid dosage forms containing the same form.
• Formulations using different pharmaceutically acceptable excipients.
• Products with different strengths, provided the claimed crystal form is present.

The claims do not require a particular dose, release profile, tablet shape, coating, excipient, packaging format or indication. A product containing a different polymorph, amorphous daridorexant, a nonhydrochloride salt or the free base would require separate analysis.

What patents protect Quviviq and daridorexant?

US 9,790,208 is a solid-state patent. It should be distinguished from other potential patent categories in the daridorexant estate.

Patent category	Covered by US 9,790,208?	Strategic relevance
Daridorexant molecular structure	No, based on the supplied claims	May be covered by earlier composition-of-matter patents
Hydrochloride salt generally	No, unless limited to the claimed crystalline form	Salt and solid-form patents may overlap
Specific crystalline polymorph	Yes	Main protection provided by this patent
Pharmaceutical compositions	Yes	Limited to compositions containing the claimed form
Method of treating insomnia	No	May be covered by separate method-of-use patents
Tablet formulation or excipient system	Not specifically	Separate formulation patents may apply
Manufacturing process	No express process claim supplied	Process patents may create independent barriers
Dosing regimen	No	Separate clinical-use claims may apply
Biosimilar pathway	No	Daridorexant is a small molecule, so generic rather than biosimilar entry is relevant

The supplied claims do not establish the complete patent estate. A full freedom-to-operate review would need to assess composition-of-matter, salt, polymorph, formulation, method-of-use, manufacturing and regulatory-exclusivity records separately.

When does US Patent 9,790,208 lose exclusivity?

The reported expiration date is May 29, 2035.[2,3] The effective date should be confirmed against the USPTO patent-term calculation because patent-term adjustment can alter the ordinary twenty-year calculation.

The patent issued in 2017, but issuance does not determine expiration for a utility patent. The controlling calculation generally runs from the earliest effective nonprovisional filing date, subject to patent-term adjustment and any applicable patent-term extension.

Milestone	Date
Patent issued	October 17, 2017
FDA Quviviq approval	January 7, 2022
Reported patent expiration	May 29, 2035
Approximate post-approval patent period	More than 13 years

A Hatch-Waxman patent-term extension could affect the endpoint if granted. No such extension should be assumed without a current USPTO or FDA record. Regulatory exclusivity is separate from patent exclusivity.

What is the Orange Book status of US 9,790,208?

US 9,790,208 is associated with Quviviq in FDA patent-listing records.[3] An Orange Book listing gives the reference product sponsor a mechanism to receive notice of an abbreviated new drug application containing a Paragraph IV certification. It does not itself prove that every claim is valid or infringed.

For generic applicants, the listed patent creates a certification decision under 21 U.S.C. § 355(j):

• Paragraph I: no patent information is listed.
• Paragraph II: the patent has expired.
• Paragraph III: approval is requested after patent expiration.
• Paragraph IV: the patent is invalid, unenforceable or will not be infringed.

A Paragraph IV notice concerning US 9,790,208 could trigger patent litigation under the Hatch-Waxman framework. A timely infringement action generally can impose a 30-month stay of FDA approval, subject to statutory exceptions and litigation developments.[4]

Which generic-entry risks exist?

The principal generic risk is a product that uses daridorexant hydrochloride but adopts a different solid form. The commercial and regulatory feasibility of that strategy depends on whether the reference product’s active pharmaceutical ingredient, stability profile and bioequivalence can be replicated without using the patented form.

Risk scenarios

Generic strategy	Risk under US 9,790,208	Commercial assessment
Uses the same patented hydrochloride polymorph	High	Direct infringement exposure
Uses a different hydrochloride polymorph	Fact-dependent	Requires solid-state and equivalence data
Uses daridorexant free base	Lower under these claims	May face other patents and development barriers
Uses another salt	Lower under these claims	May require separate formulation and regulatory work
Uses amorphous daridorexant	Lower under these claims	Physical stability may be difficult
Uses a mixture containing the patented form	Potentially high	Depends on whether the claimed form is present and measurable
Uses the patented form only during manufacture	Potentially high	Product-by-process facts and inducement theories may matter

A generic applicant that uses the same crystal form would face the strongest Paragraph IV risk. A design-around using another polymorph could avoid literal infringement, but the applicant would need to establish control of polymorphic conversion during manufacturing, storage and tablet production.

Does the patent create a biosimilar risk?

No biosimilar pathway applies. Daridorexant is a chemically synthesized small molecule, and a competing applicant would generally use the ANDA pathway rather than the biosimilar pathway under the Public Health Service Act.

The relevant competitive threat is an ANDA generic. The patent’s solid-state limitations make polymorph selection, analytical characterization and manufacturing controls central to the generic-entry assessment.

What is the patent strength of US 9,790,208?

The patent has meaningful commercial value because it targets the physical form used in the marketed product. Its strength is narrower than a composition-of-matter patent but potentially more practical if the approved product depends on this specific polymorph for stability, manufacturability or consistent dissolution.

Strengths

• Claims the hydrochloride form used in the commercial product.
• Includes multiple XRPD-based claim formats.
• Has composition claims that extend protection into finished dosage forms.
• Provides narrower fallback claims with ten specified peaks and a full-pattern limitation.
• May complicate a generic’s use of the same API form even if earlier molecular patents have expired.

Vulnerabilities

• The claims depend heavily on analytical characterization.
• XRPD peak-based boundaries can create claim-construction and reproducibility disputes.
• A credible alternative polymorph may reduce literal infringement risk.
• The supplied claims do not cover all forms of daridorexant.
• Validity could be challenged on anticipation, obviousness, enablement, written description or definiteness grounds, depending on the prior-art record and specification support.

The commercial strength therefore depends on whether a generic can develop a stable and bioequivalent alternative form without triggering other patents.

What patent litigation and Paragraph IV activity affect Quviviq?

The supplied claim text does not identify any Paragraph IV notice, ANDA litigation, settlement agreement or final court decision involving US 9,790,208. The patent itself cannot establish litigation status.

For transaction or launch analysis, the relevant records are the FDA Orange Book, Drugs@FDA patent information, district-court dockets and any Abbreviated New Drug Application litigation filings. A litigation filing would be particularly important because the timing of a Paragraph IV action can delay approval and affect the earliest commercial launch date.

No settlement terms should be inferred from the patent’s existence. If a settlement has been reached, the relevant issues would include the agreed generic-entry date, authorized-generic rights, licenses, covenants not to sue and treatment of other daridorexant patents.

How does US 9,790,208 compare with a composition-of-matter patent?

A composition-of-matter patent generally provides broader protection because it can cover the active molecule regardless of salt, polymorph or formulation. US 9,790,208 is narrower but may remain commercially important after a basic compound patent expires.

Issue	Composition-of-matter patent	US 9,790,208
Covers free base	Usually	No express coverage
Covers all salts	Usually only if claimed	No
Covers all polymorphs	Usually not automatically	No, one defined crystal form
Covers commercial product	Often	Likely, if the product uses the claimed form
Design-around potential	Lower	Higher
Analytical dispute risk	Moderate	High
Relevance to generic solid form	Broad	Direct

The patent should be assessed as part of a layered estate rather than as a standalone substitute for a composition-of-matter patent.

What manufacturing and intellectual-property barriers remain?

The principal manufacturing barrier is polymorph control. A manufacturer must ensure that the selected form remains stable through crystallization, drying, milling, blending, compression and storage. Temperature, humidity, solvent exposure and mechanical stress can cause conversion between crystalline and amorphous forms.

A design-around may require:

• A reproducible alternative crystallization process.
• Demonstration that the alternative form does not convert into the patented form.
• Comparative XRPD, DSC, TGA and moisture-uptake testing.
• Stability data under accelerated and long-term conditions.
• Bioequivalence data for the final dosage form.
• Separate review of formulation, use and process patents.

These technical requirements can delay generic development even if a legal design-around is available.

Key Takeaways

• US 9,790,208 is a daridorexant hydrochloride polymorph patent.
• Claims 1 through 3 define the crystalline form through XRPD peaks and an overall diffraction pattern.
• Claims 4 through 6 cover pharmaceutical compositions containing that form.
• The patent does not, based on the supplied claims, cover every daridorexant salt, polymorph, formulation, use or manufacturing process.
• The reported patent expiration is May 29, 2035.
• Quviviq was FDA-approved on January 7, 2022.
• Generic, not biosimilar, entry is the relevant competitive pathway.
• A Paragraph IV challenge could target validity, enforceability or noninfringement.
• The strongest design-around strategy would use a different solid form, but that approach carries technical and regulatory risk.
• The patent’s value depends on whether the approved product consistently contains the claimed polymorph and whether alternative forms are commercially viable.

FAQs

Is US 9,790,208 a patent on daridorexant itself?

No. The supplied claims are directed to a specific crystalline hydrochloride form of daridorexant and pharmaceutical compositions containing that form.

Can a generic use daridorexant with a different salt?

Possibly, as US 9,790,208 expressly claims the hydrochloride crystalline form. Other patents, formulation requirements and FDA equivalence standards would still require separate analysis.

Does a different XRPD peak pattern automatically avoid infringement?

No. The entire claim and analytical method must be evaluated. A different pattern may support noninfringement, but mixtures, polymorph conversion and measurement variation can affect the analysis.

Is Quviviq subject to a biosimilar challenge?

No. Quviviq contains a chemically synthesized small molecule. The relevant pathway is an ANDA for a generic drug.

What is the commercial importance of the patent after 2035?

After expiration, the patent claims should no longer block products solely because they contain the claimed crystalline form, subject to any valid patent-term adjustment, extension or other enforceable rights in the broader daridorexant estate.

References

1. United States Patent and Trademark Office. (2017). US Patent No. 9,790,208, crystalline form of daridorexant hydrochloride.
2. United States Patent and Trademark Office. (n.d.). Patent Center: US Patent No. 9,790,208.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Quviviq (daridorexant).
4. U.S. Food and Drug Administration. (2022). Quviviq prescribing information. Idorsia Pharmaceuticals Ltd.

Drugs Protected by US Patent 9,790,208

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 9,790,208

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	PCT/IB2013/060595	Dec 3, 2013

PCT Information
PCT Filed	December 02, 2014	PCT Application Number:	PCT/IB2014/066509
PCT Publication Date:	June 11, 2015	PCT Publication Number:	WO2015/083071

International Family Members for US Patent 9,790,208

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014358743
Brazil	112016012625
Canada	2929720
Chile	2016001348
China	105793258
Cyprus	1119687