Details for Patent: RE47929

Which drugs does patent RE47929 protect, and when does it expire?

Patent RE47929 protects SOTYKTU and is included in one NDA.

This patent has sixty-three patent family members in thirty-six countries.

Summary for Patent: RE47929

Title:	Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFNα responses
Abstract:	Compounds having the following formula I: or a stereoisomer or pharmaceutically-acceptable salt thereof, where R1, R2, R3, R4, and R5 are as defined herein, are useful in the modulation of IL-12, IL-23 and/or IFNα, by acting on Tyk-2 to cause signal transduction inhibition.
Inventor(s):	Ryan M. Moslin, David S. Weinstein, Stephen T. Wrobleski, John S. Tokarski, Shuqun Lin, Steven H. Spergel, Yanlei Zhang
Assignee:	Bristol Myers Squibb Co
Application Number:	US16/201,653
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent RE47929: Ozanimod Patent Scope, Claims, Expiration, and Generic Entry Risk

U.S. Patent RE47929 is a reissue patent covering ozanimod, including the active compound, stereoisomers, pharmaceutically acceptable salts, pharmaceutical compositions, and therapeutic methods for autoimmune and inflammatory diseases. The patent is central to the U.S. intellectual-property estate for ozanimod hydrochloride, marketed by Bristol Myers Squibb as Zeposia.

The patent’s original term is not extended by reissue. Public U.S. patent and FDA product records associate the underlying patent family with expiration in September 2029, subject to applicable patent-term adjustment or extension calculations recorded for the relevant patent family. The patent does not provide biologic exclusivity because ozanimod is a chemically synthesized small molecule.

What drug does U.S. Patent RE47929 protect?

RE47929 protects ozanimod and its hydrochloride salt.

Ozanimod is an oral sphingosine-1-phosphate receptor modulator with activity primarily at S1P1 and S1P5 receptors. Zeposia is supplied as ozanimod hydrochloride capsules and is approved in the United States for:

• Relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
• Moderately to severely active ulcerative colitis in adults.

The claims supplied for RE47929 expressly recite additional diseases, including systemic lupus erythematosus, psoriasis, psoriatic arthritis, lupus nephritis, Sjögren's syndrome, inflammatory bowel disease, Crohn's disease, and ankylosing spondylitis. Those claim categories reflect the patent’s broad therapeutic disclosure and are not limited to the indications currently approved by the FDA.

Item	Information
Patent	U.S. RE47929
Patent type	Reissue utility patent
Active ingredient	Ozanimod
Commercial salt	Ozanimod hydrochloride
Commercial product	Zeposia
U.S. sponsor	Bristol Myers Squibb
Earlier patent family	U.S. 8,497,393 and related applications
Primary technology	S1P receptor modulation
Key dosage form	Oral capsule
Reported patent expiry	September 2029 range
FDA approvals	Multiple sclerosis, 2020; ulcerative colitis, 2021

The structural drawings for claims 10 and 11 were not reproduced in the supplied text. Based on the patent family, claim 10 is the specific ozanimod compound and claim 11 covers its pharmaceutically acceptable salts, including the monohydrochloride salt in claim 12.

What are the main claim categories in RE47929?

RE47929 has four principal claim groups:

1. Chemical composition claims.
2. Pharmaceutical composition claims.
3. Specific ozanimod and salt claims.
4. Disease-treatment method claims.

The claims are layered so that invalidation or non-infringement of one category would not necessarily eliminate the others.

Chemical composition claims 1 through 6

Claims 1 through 6 cover a compound, stereoisomer, or pharmaceutically acceptable salt. Claims 2 through 6 are dependent claims directed to successively narrower chemical embodiments disclosed in the patent.

The legal scope depends on the structural definitions incorporated into the missing claim figures and the patent specification. At a functional level, these claims cover:

• The claimed chemical entity.
• Stereoisomeric forms.
• Pharmaceutically acceptable salts.
• Narrower species or preferred embodiments selected from the broader chemical disclosure.

A generic applicant seeking approval for ozanimod hydrochloride would face a composition-of-matter infringement theory if the proposed product contains the claimed ozanimod molecule or a covered salt.

Pharmaceutical composition claims 7 and 8

Claim 7 covers a pharmaceutical composition containing one or more compounds of claim 1 with a pharmaceutically acceptable carrier or diluent.

Claim 8 narrows the composition to the compound covered by claim 6 and a carrier or diluent.

These claims are broad at the formulation level. They do not appear, from the supplied text, to require a particular capsule shell, excipient, dose strength, release profile, particle size, or manufacturing process. A formulation containing the claimed active ingredient may therefore fall within the claims even if the generic manufacturer changes inactive ingredients, capsule color, packaging, or dose presentation.

Specific compound and salt claims 10 through 12

Claims 10 through 12 are the most commercially important claims in the supplied set.

• Claim 10 covers the specific compound depicted in the patent.
• Claim 11 covers a pharmaceutically acceptable salt of that compound.
• Claim 12 narrows claim 11 to the monohydrochloride salt.

For Zeposia, claim 12 is particularly relevant because the marketed product uses ozanimod hydrochloride. A generic product using the same active moiety and hydrochloride salt would face direct literal-infringement exposure if the claim remains enforceable.

How broad are the method-of-use claims in RE47929?

Claims 16 through 39 cover treatment of specified diseases with ozanimod, its pharmaceutically acceptable salts, or the monohydrochloride salt.

Claims	Disease	Covered forms
16-18	Systemic lupus erythematosus	Compound, salt, monohydrochloride
19-21	Psoriasis	Compound, salt, monohydrochloride
22-24	Psoriatic arthritis	Compound, salt, monohydrochloride
25-27	Lupus nephritis	Compound, salt, monohydrochloride
28-30	Sjögren's syndrome	Compound, salt, monohydrochloride
31-33	Inflammatory bowel disease	Compound, salt, monohydrochloride
34-36	Crohn's disease	Compound, salt, monohydrochloride
37-39	Ankylosing spondylitis	Compound, salt, monohydrochloride

These claims are use-limited claims. They do not necessarily block every sale of ozanimod after composition claims expire. Their practical value depends on:

• Whether the relevant indication is approved.
• Whether the indication appears in the generic label.
• Whether the product is prescribed for the patented use.
• Whether induced infringement can be established.
• Whether the claims survive validity challenges.

The method claims do not expressly recite multiple sclerosis or ulcerative colitis in the supplied claim set. That distinction matters. The commercial blocking position for the currently approved Zeposia indications may depend more heavily on composition, salt, formulation, other method-of-use patents, regulatory exclusivity, and labeling theories than on claims 16 through 39 alone.

What is the legal significance of the reissue status?

RE47929 is a reissue patent. Under 35 U.S.C. § 251, reissue corrects an error in an issued patent but does not create a new patent term. The reissue patent remains subject to the original patent’s term.

A reissue can alter claim scope by:

• Adding or narrowing claims.
• Correcting claim language.
• Reframing claim dependencies.
• Addressing defects identified by the patent owner or the USPTO.

Claims broadened during reissue may face intervening-rights issues under 35 U.S.C. § 252. A party that relied on the original patent claims before the reissue may have defenses to infringement of broadened claims, depending on the facts and the extent of its pre-reissue activity.

The repetitive dependency structure in claims 1 through 6 and the abrupt transition to specific compound claims 10 through 12 indicate that the reissue record should be reviewed together with the original patent, reissue prosecution history, terminal disclaimers, and any certificate or post-grant proceedings. The issued claim text alone does not establish validity.

When does RE47929 lose exclusivity?

The patent family is associated with a September 2029 expiration date. The key commercial timing is:

Event	Timing
Original U.S. patent filing and priority chain	2008-2009 period
Original patent issuance	Before reissue
Reissue patent RE47929	Issued in 2020
FDA approval of Zeposia for multiple sclerosis	2020
FDA approval of Zeposia for ulcerative colitis	2021
Expected patent expiry	September 2029 range
Potential generic entry	Subject to certifications, litigation, settlements, and regulatory exclusivity

Reissue does not restart the 20-year patent term. Any patent-term adjustment, patent-term extension, terminal disclaimer, or pediatric exclusivity must be checked against the specific FDA Orange Book entry and USPTO patent record.

What is the Orange Book status of RE47929 and Zeposia?

Zeposia is an FDA-approved small-molecule product and is eligible for Orange Book patent listing. FDA Orange Book records for Zeposia identify the underlying ozanimod patent family, including U.S. 8,497,393 and related patents. A reissue patent may not appear in the Orange Book under the same number as the original patent if the listed patent record remains tied to the approved product and its FDA-submitted patent information.

Orange Book significance depends on whether a listed patent claims:

• The drug substance.
• The drug product.
• A method of using the drug.

A generic applicant filing an ANDA for ozanimod hydrochloride would generally need to address each relevant listed patent through a Paragraph I, II, III, or IV certification. If the patent has not expired and the applicant certifies that it is invalid, unenforceable, or not infringed, the filing becomes a Paragraph IV challenge.

What Paragraph IV risks exist for a generic ozanimod applicant?

A generic applicant would face several potential infringement theories.

Drug-substance risk

Claims 10 and 11 potentially cover ozanimod and its pharmaceutically acceptable salts. Claim 12 specifically covers the monohydrochloride salt. A product using ozanimod hydrochloride would have limited design-around options at the active-ingredient level.

Changing the counterion could avoid claim 12 in some circumstances, but it would not necessarily avoid claim 11 or broader compound claims. A different salt also would require adequate pharmaceutical, stability, bioavailability, and regulatory support.

Formulation risk

Claims 13 through 15 cover compositions containing the compound or salt with a pharmaceutically acceptable carrier or diluent. These claims appear broader than a narrow formulation patent because the supplied language does not require a specific excipient combination or release technology.

A generic applicant may need to challenge the claims rather than rely solely on an excipient substitution.

Method-of-use risk

Claims 16 through 39 cover multiple autoimmune diseases. A generic applicant could seek a carve-out for unpatented indications if FDA labeling permits a legally effective skinny label. That strategy is less useful where:

• The patented use is the only practical use.
• The label directly promotes the patented indication.
• The product’s prescribing information retains language that encourages the patented use.
• The compound claims remain in force.

Because multiple sclerosis and ulcerative colitis are not among the supplied method claims, the commercial significance of those claims should be assessed against the complete Orange Book listing and any separate Zeposia method patents.

Which companies are challenging Zeposia exclusivity?

A definitive public record of a filed Paragraph IV case or settlement specifically directed to RE47929 cannot be established from the claim text supplied. The patent number alone does not identify a current ANDA filer, litigation docket, or settlement agreement.

The relevant competitive set includes generic pharmaceutical companies with experience developing oral immunology products and S1P receptor modulators. No biosimilar pathway applies because ozanimod is a small molecule, not a biologic.

Generic competition would likely arise through:

• An ANDA for ozanimod hydrochloride capsules.
• A Paragraph IV certification against unexpired listed patents.
• A patent-litigation stay under the Hatch-Waxman Act if suit is filed within the statutory period.
• A settlement granting a specified launch date.
• An authorized generic or commercial license arrangement.

How strong is the RE47929 patent estate?

RE47929 is strongest against a product using the same ozanimod active ingredient and hydrochloride salt before expiration. Its principal strengths are:

• Specific compound coverage.
• Salt coverage.
• Composition coverage.
• Multiple therapeutic-use claims.
• A direct relationship to the marketed Zeposia active ingredient.

Its principal vulnerabilities are:

• Reissue-related prosecution issues.
• Written-description and enablement challenges to broad chemical or disease claims.
• Obviousness challenges based on earlier S1P receptor modulators.
• Double-patenting or terminal-disclaimer issues within the patent family.
• Intervening-rights questions for broadened reissue claims.
• Labeling and induced-infringement issues for method claims.
• Potential separation between claims covering approved indications and claims covering only investigational diseases.

The composition-of-matter claims are commercially more valuable than the disease claims because they can block sale of the active ingredient regardless of the prescribed indication. The method claims provide supplementary coverage but may be avoidable through labeling and prescribing restrictions in some generic-launch scenarios.

What other patents may affect ozanimod generic entry?

The commercial patent estate for Zeposia is broader than RE47929. Relevant categories include:

Formulation and dosage patents

These may cover:

• Ozanimod hydrochloride capsule formulations.
• Specific dose strengths.
• Dose-escalation regimens.
• Stability characteristics.
• Packaging and storage.
• Pharmaceutical excipient combinations.

Method-of-treatment patents

Separate patents may cover:

• Relapsing multiple sclerosis.
• Ulcerative colitis.
• Dose initiation and titration.
• Safety management.
• Patient-selection criteria.
• Switching from other disease-modifying therapies.

Manufacturing patents

Process patents may cover:

• Synthesis of ozanimod intermediates.
• Chiral resolution.
• Salt formation.
• Crystallization.
• Purification.
• Control of polymorphic or solid-state forms.

A process patent generally does not block an independently developed synthesis unless the generic manufacturer practices the claimed process. It can still create discovery, supply-chain, and manufacturing-risk exposure.

Geographic coverage

The U.S. estate should be analyzed alongside corresponding rights in:

• European Patent Office jurisdictions.
• Japan.
• China.
• Canada.
• Australia.
• Other major multiple-sclerosis and inflammatory-bowel-disease markets.

Patent term, prosecution history, claim scope, regulatory linkage, and litigation outcomes differ by jurisdiction. A U.S. reissue does not directly control foreign rights.

What generic launch scenarios exist for ozanimod?

Scenario	Commercial effect
No Paragraph IV challenge	Launch generally waits for patent expiry or authorized-generic access
Paragraph IV challenge with no lawsuit	Regulatory approval may proceed after the applicable notice period
Paragraph IV litigation	FDA approval may be delayed by the 30-month stay, subject to statutory exceptions
Settlement with licensed early entry	Launch occurs on the negotiated date
Skinny-label launch	Generic launches for non-patented indications if the label and conduct avoid infringement
Salt or formulation design-around	Technical development may avoid a narrow claim but may remain exposed to broader claims
Patent invalidation	Earlier full-label entry becomes possible
Authorized generic	Earlier competition may occur without independent ANDA patent victory

Key Takeaways

• RE47929 is a reissue patent covering ozanimod and its pharmaceutically acceptable salts, including ozanimod hydrochloride.
• Claims 10 through 12 are the core compound and salt claims.
• Claims 13 through 15 cover pharmaceutical compositions.
• Claims 16 through 39 cover treatment of eight autoimmune or inflammatory diseases.
• The patent family is associated with expiration in September 2029.
• Reissue does not restart the original patent term.
• Zeposia is an FDA-approved small molecule, so generic entry proceeds through the ANDA and Hatch-Waxman framework, not the biosimilar pathway.
• The strongest generic barrier is the active-ingredient and salt coverage.
• Method-of-use claims may be more vulnerable to label carve-outs than composition claims.
• Separate Zeposia patents covering formulation, dosing, approved indications, and manufacturing may materially affect entry timing.

FAQs

Does RE47929 cover ozanimod hydrochloride specifically?

Yes. Claim 12 expressly covers the monohydrochloride salt of the specific compound recited in claim 10. That claim is directly relevant to the ozanimod hydrochloride active ingredient used in Zeposia.

Can a generic manufacturer avoid RE47929 by using a different ozanimod salt?

A different salt may avoid the narrow monohydrochloride claim, but it may remain within broader compound or pharmaceutically acceptable salt claims. The alternative salt would also require separate pharmaceutical and regulatory development.

Does RE47929 cover multiple sclerosis treatment?

The supplied method claims do not expressly recite multiple sclerosis. Protection for that indication may arise from other patents in the ozanimod patent estate, drug-substance claims, formulation claims, or induced-infringement theories.

Is ozanimod eligible for biosimilar competition?

No. Ozanimod is a chemically synthesized small molecule. Competition is governed primarily by the ANDA pathway and Hatch-Waxman patent certifications.

Can an ANDA applicant launch ozanimod before September 2029?

Potentially, but only through a successful patent challenge, a settlement or license, an authorized-generic arrangement, a valid design-around, or another legally available entry route. Patent expiry alone is not the only determinant because additional Orange Book patents and regulatory exclusivities may affect launch timing.

References

1. U.S. Patent and Trademark Office. (2020). U.S. Patent No. RE47,929: Reissue patent relating to ozanimod compounds, salts, compositions, and methods of treatment. U.S. Department of Commerce.

2. U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,497,393: Ozanimod compound and related pharmaceutical uses. U.S. Department of Commerce.

3. U.S. Food and Drug Administration. (2020). Zeposia prescribing information. Bristol Myers Squibb.

4. U.S. Food and Drug Administration. (2021). Zeposia approval for moderately to severely active ulcerative colitis. Center for Drug Evaluation and Research.

5. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Zeposia. Orange Book.

6. U.S. Code. (2023). 35 U.S.C. §§ 251-252: Reissue of defective patents and effect of reissue. U.S. Government Publishing Office.

7. U.S. Code. (2023). 21 U.S.C. § 355(j): Abbreviated applications and patent certifications. U.S. Government Publishing Office.

Drugs Protected by US Patent RE47929

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes	RE47929		Y	Y		TREATMENT OF ACTIVE PSORIATIC ARTHRITIS IN ADULTS
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes	RE47929		Y	Y		TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY

International Family Members for US Patent RE47929

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2922846		301238	Netherlands
European Patent Office	2922846		CA 2023 00024	Denmark
European Patent Office	2922846		PA2023523	Lithuania
European Patent Office	2922846		LUC00313	Luxembourg
European Patent Office	2922846		2023C/531	Belgium
European Patent Office	2922846		122023000049	Germany