Details for Patent: 10,702,508

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Which drugs does patent 10,702,508 protect, and when does it expire?

Patent 10,702,508 protects ERLEADA and is included in one NDA.

This patent has twenty-nine patent family members in eighteen countries.

Summary for Patent: 10,702,508

Title:	Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer
Abstract:	Described herein are methods of treating non-metastatic castrate-resistant prostate cancer using an approved drug product comprising apalutamide, enzalutamide or darolutamide. Also described here are drug products containing apalutamide enzalutamide or darolutamide, and methods of selling or offering for sale an anti-androgen drug product.
Inventor(s):	Arturo Molina
Assignee:	Janssen Research and Development LLC , Aragon Pharmaceuticals Inc
Application Number:	US15/967,452
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,702,508
Patent Claim Types: see list of patent claims	Use;

United States Patent 10,702,508: Apalutamide Patent Scope, Claims, Exclusivity and Competitive Landscape

United States Patent No. 10,702,508 protects the use of an approved apalutamide product, administered with androgen deprivation therapy, to improve metastasis-free survival in men with nonmetastatic castration-resistant prostate cancer. The patent is directed to the SPARTAN treatment regimen underlying the FDA-approved Erleada indication. Its strongest commercial value is the combination of a narrow patient population, a labeled indication, and the reported median metastasis-free survival of approximately 40.5 months.

The claims do not broadly cover apalutamide as a molecule, all prostate-cancer uses, or every apalutamide formulation. Earlier apalutamide compound and formulation patents address those areas. Patent 10,702,508 is primarily a method-of-use and label-linked patent.

What does United States Patent 10,702,508 protect?

The patent protects methods involving:

• A male human patient.
• Nonmetastatic castration-resistant prostate cancer, commonly abbreviated nmCRPC.
• Administration or provision of an approved drug product containing apalutamide.
• Concurrent androgen deprivation therapy.
• Improvement of metastasis-free survival.
• In dependent claims, a median metastasis-free survival of about 40.5 months.
• In certain claims, labeling that identifies the nmCRPC indication or includes metastasis-free survival data.
• In claim 4, selling the approved drug product under specified label conditions.

The claim set is closely tied to the FDA-approved clinical use of Erleada. FDA approved apalutamide in February 2018 for men with nonmetastatic castration-resistant prostate cancer based principally on the SPARTAN trial [1].

Claim-by-claim scope

Claim	Principal limitation	Practical scope
1	Administering an approved apalutamide product with ADT to a male patient with nmCRPC to improve MFS	Core treatment claim
2	Claim 1 plus median MFS of about 40.5 months	SPARTAN-result limitation
3	Providing approved apalutamide with ADT; ADT limited to orchiectomy or GnRH agonist or antagonist	More specific ADT claim
4	Claim 1 plus selling the product where the RLD label instructs treatment of nmCRPC	Sale and label-linked limitation
5	Claim 1 plus RLD label containing MFS data	Label-content claim
6	Claim 4 plus MFS data on the label	Combined sale and label-data limitation
7	Claim 5 plus apalutamide-arm median MFS of about 40.5 months	Specific clinical-data claim
8	Claim 6 plus apalutamide-arm median MFS of about 40.5 months	Narrowest sale and label-data formulation
9	Claim 1 or 3 plus label instructions for nmCRPC treatment	Label-linked dependent claim
10	Claim 3 plus median MFS of about 40.5 months	Narrow clinical-result claim

Claim 1 is the commercial center of gravity. Claims 2, 7, 8 and 10 narrow the scope through the 40.5-month result. Claims 4 through 9 introduce label and sale conditions that may be important against an applicant seeking approval for the same indication.

What is the technical and clinical basis for the 40.5-month limitation?

The 40.5-month figure comes from the SPARTAN study, a Phase 3 trial evaluating apalutamide plus ongoing androgen deprivation therapy in men with nmCRPC at high risk of developing metastases. The reported median metastasis-free survival was approximately:

Treatment arm	Median metastasis-free survival
Apalutamide plus ADT	40.5 months
Placebo plus ADT	16.2 months
Difference	24.3 months

The trial used metastasis-free survival as the time to radiographic metastasis or death. FDA approved Erleada for this patient population after the trial showed a substantial improvement in the endpoint [1, 2].

The phrase “about 40.5 months” is likely to be construed as an approximate clinical-result limitation rather than as a requirement that every individual patient achieve 40.5 months. A generic manufacturer could argue that the claim requires the relevant treatment arm or label to report the specified median, not that the patient receiving the drug must individually survive without metastasis for that duration.

How strong is the patent estate for apalutamide?

Patent 10,702,508 is strong against an ANDA that seeks approval for the same nmCRPC indication because the proposed product, patient population, dosing regimen and label would closely track the patented method. It is weaker against:

• A product approved only for a non-infringing indication.
• A label that omits the nmCRPC use.
• A product used outside the claimed approved-product and label conditions.
• A challenge to the meaning of “improving metastasis free survival.”
• An invalidity attack based on obviousness, written description, enablement or indefiniteness.
• A product that does not use apalutamide, such as darolutamide or enzalutamide.

The patent does not independently prevent all generic apalutamide sales after expiry of earlier compound patents. Its value depends on whether a generic applicant seeks the patented indication, retains the indication in its label, or can be enjoined under a method-of-use infringement theory.

Principal strengths

1. Direct alignment with the approved indication.
   The claims track the nmCRPC indication that FDA approved for Erleada.

2. Clinical specificity.
   The 40.5-month MFS limitation links dependent claims to the SPARTAN data.

3. ADT requirement.
   The claims require combination use with ADT, reflecting the clinical regimen and narrowing potential design-around arguments.

4. Label linkage.
   Claims 4 through 9 address products sold with labels that identify the patented use or include the relevant MFS data.

5. Late priority position.
   The patent extends protection beyond the earliest apalutamide compound patents and targets a commercially important indication.

Principal weaknesses

1. Method-of-use character.
   The patent does not provide composition-of-matter protection for apalutamide.

2. Narrow patient population.
   The claims are limited to male patients with nmCRPC, not metastatic disease, hormone-sensitive disease or prostate cancer generally.

3. Potential label carve-out.
   An ANDA applicant may seek approval for non-patented indications while omitting the nmCRPC indication, subject to the precise Orange Book listing and applicable FDA requirements.

4. Clinical-data limitations in dependent claims.
   A challenger may dispute whether a population-level median is a proper limiting claim element and whether “about 40.5 months” is definite.

5. Label-dependent claims.
   A claim requiring specific RLD label content may face arguments concerning infringement, claim construction and whether the accused product’s label satisfies every limitation.

What patents protect Erleada and apalutamide?

The apalutamide estate includes multiple patent categories:

Patent category	Subject matter	Commercial role
Compound patents	Apalutamide and related androgen-receptor inhibitors	Broad molecule-level protection
Composition patents	Pharmaceutical compositions containing apalutamide	Product and formulation protection
Method-of-use patents	Prostate-cancer treatment, including nmCRPC	Indication protection
Clinical-regimen patents	Apalutamide with ADT and specified patient populations	Regimen protection
Label-linked patents	Use tied to approved labeling and clinical data	ANDA and launch protection

Patent 10,702,508 belongs to the method-of-use and clinical-regimen category. It should be analyzed together with the compound and formulation patents listed for Erleada in the FDA Orange Book, rather than treated as the entire apalutamide estate [3].

The patent was issued on July 7, 2020. Its term is based on its priority chain and is expected to extend into 2036, subject to any adjustment, extension, terminal disclaimer or other USPTO-recorded term event. The relevant Orange Book patent expiration date must be confirmed against the FDA’s current listing because the patent’s statutory term and its listed regulatory expiration date can differ.

What is the Orange Book status of United States Patent 10,702,508?

Patent 10,702,508 is associated with the Erleada reference product and is directed to the approved nmCRPC use. Its regulatory significance is greater than that of a patent covering an unapproved research use because FDA labeling identifies apalutamide plus ADT for nmCRPC.

For an ANDA applicant, the relevant certification framework is generally:

• Paragraph I: no patent information has been submitted.
• Paragraph II: the listed patent has expired.
• Paragraph III: the applicant will market after patent expiry.
• Paragraph IV: the listed patent is invalid, unenforceable or will not be infringed.
• Section viii statement: the applicant will omit a patented method of use from its labeling.

A Paragraph IV certification concerning this patent could trigger Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). A timely suit by the patent owner or NDA holder can generate a statutory stay of FDA approval, generally for up to 30 months, subject to statutory exceptions and court decisions [4].

When does apalutamide lose exclusivity?

Apalutamide has several overlapping exclusivity layers:

Exclusivity layer	Relevance
New chemical entity exclusivity	Protected the initial FDA approval period
Orphan-drug exclusivity	Not generally the central protection for the nmCRPC approval
Patent protection	Covers the compound, formulation and approved uses
Pediatric exclusivity	May add six months to qualifying listed exclusivities
Method-of-use patents	Can delay approval or restrict the labeled indication

The first FDA approval of Erleada occurred in 2018. The key commercial question is not only when the earliest apalutamide compound patent expires, but whether later method-of-use and formulation patents remain enforceable and whether a generic can launch with a carved-out label.

Patent 10,702,508 is strategically important because it reaches beyond the initial molecule patent timeline. Its projected term into the mid-2030s makes it a potential barrier to a full-label generic launch, even if earlier compound claims expire sooner.

Which companies are challenging or competing with Erleada?

The direct commercial competitors are androgen-receptor pathway inhibitors used in advanced prostate cancer.

Product	Active ingredient	Company	Relevant disease positioning
Erleada	Apalutamide	Janssen / Johnson & Johnson	nmCRPC and metastatic castration-sensitive prostate cancer
Xtandi	Enzalutamide	Astellas and Pfizer	nmCRPC, metastatic castration-sensitive and metastatic castration-resistant disease
Nubeqa	Darolutamide	Bayer and Orion	nmCRPC and metastatic hormone-sensitive prostate cancer
Zytiga	Abiraterone acetate	Janssen	Metastatic prostate-cancer settings, generally with prednisone
Orgovyx and other ADT products	Relugolix or other agents	Multiple companies	ADT backbone rather than direct apalutamide substitutes

Xtandi and Nubeqa create the greatest branded competition in the nmCRPC and hormone-sensitive settings. Their patents do not directly invalidate Patent 10,702,508 because they cover different active ingredients. They reduce the patent’s commercial value by giving physicians and payers alternatives that do not practice apalutamide claims.

What generic entry risks exist for apalutamide?

A generic entrant has several potential launch strategies.

Full-label ANDA

A full-label ANDA would include the nmCRPC indication and would face the strongest infringement risk under claim 1. The applicant could file a Paragraph IV certification and challenge validity or non-infringement.

Section viii carve-out

A generic applicant could seek approval with the patented nmCRPC indication omitted, if FDA permits the proposed labeling and the remaining indications support approval. This strategy could reduce literal infringement risk but would not eliminate all litigation exposure. Promotional conduct, physician substitution, product distribution and label content could become relevant.

Launch after patent expiry

The applicant could file a Paragraph III certification and launch after the relevant listed patent expires. Earlier compound or formulation patents would also need to be cleared.

Invalidity challenge

The most likely legal theories include:

• Obviousness based on prior clinical and pharmacologic knowledge.
• Lack of written description for the claimed treatment result.
• Enablement of the full scope of the patient population.
• Indefiniteness of “about 40.5 months.”
• Failure of label and sale limitations to establish infringement.
• Non-infringement based on omission of the patented indication.

What patent litigation and settlement issues affect apalutamide?

A Paragraph IV case involving Patent 10,702,508 would likely focus on:

1. Whether the patent is properly listed for the approved use.
2. Whether the ANDA label contains the patented indication.
3. Whether a carved-out label avoids the claim.
4. Whether the approved product limitation covers the proposed generic product.
5. Whether the 40.5-month MFS language limits the independent claim or only dependent claims.
6. Whether the claim’s sale limitation can be infringed by the ANDA applicant before commercial launch.
7. Whether the patent is valid in view of the SPARTAN trial design and pre-filing clinical literature.

No specific public settlement terms are established by the claim text alone. A settlement could permit an agreed generic launch date before the projected expiration of the patent, subject to antitrust review and FDA treatment of the agreement. Settlement analysis must distinguish between an agreement covering the compound patents, formulation patents and Patent 10,702,508 because each may have a different expiration date and litigation posture.

How does Patent 10,702,508 compare with Xtandi and Nubeqa patents?

Patent 10,702,508 has narrower disease and product scope than the broader patent estates surrounding enzalutamide and darolutamide, but it has strong indication-specific relevance.

Factor	Erleada, Patent 10,702,508	Xtandi	Nubeqa
Active ingredient	Apalutamide	Enzalutamide	Darolutamide
Core protection discussed	nmCRPC method and ADT regimen	Compound, formulation and multiple uses	Compound, formulation and multiple uses
Key clinical metric	MFS of about 40.5 months	MFS and overall-survival data across indications	MFS and survival data across indications
Direct infringement by another AR inhibitor	No	No	No
Generic risk	Label and method-of-use dependent	Compound and use patent dependent	Later-launch and use patent dependent
Main competitive threat	Substitution by other AR inhibitors	Substitution by apalutamide or darolutamide	Substitution by apalutamide or enzalutamide

The patent is strongest as an indication barrier and weaker as a product monopoly. A competitor can avoid infringement by selling a different active ingredient, while a generic apalutamide manufacturer must address the patent estate directly.

What is the revenue exposure from Patent 10,702,508?

The patent protects a high-value prostate-cancer indication rather than the entire apalutamide market. Revenue exposure depends on:

• The proportion of Erleada sales attributable to nmCRPC.
• Whether later approvals expand use into metastatic castration-sensitive disease.
• The timing of compound, formulation and method-of-use patent expiry.
• The availability of competing AR inhibitors.
• Payer substitution policies.
• Whether a generic launches with a carved-out label or full labeling.
• The number and timing of Paragraph IV challengers.

A full-label generic could cause rapid price erosion after launch. A carve-out generic may have a slower effect because physicians could continue prescribing the branded product for the patented indication, although substitution and payer controls can still reduce branded volume.

Key Takeaways

• Patent 10,702,508 is an apalutamide method-of-use patent focused on nmCRPC.
• Claim 1 covers apalutamide plus ADT in male patients with nonmetastatic castration-resistant prostate cancer.
• Claims 2, 7, 8 and 10 incorporate the approximately 40.5-month median MFS result.
• Claims 4 through 9 tie infringement to sale and reference-product label content.
• The patent does not broadly cover apalutamide as a molecule or all prostate-cancer uses.
• The patent is strategically relevant to full-label ANDA applications for generic apalutamide.
• A section viii carve-out may reduce risk if the patented indication can be omitted from the generic label.
• The commercial estate must be analyzed with Erleada compound, formulation and other method-of-use patents.
• Xtandi and Nubeqa are principal therapeutic competitors but do not directly practice apalutamide claims.
• The projected term extends into the mid-2030s, subject to the official USPTO and Orange Book term records.

FAQs

Does Patent 10,702,508 cover apalutamide monotherapy?

No. The principal claims require apalutamide in combination with androgen deprivation therapy. Claim 3 specifically identifies orchiectomy and GnRH agonists or antagonists as qualifying ADT.

Does the patent cover metastatic castration-resistant prostate cancer?

No. The claims are directed to nonmetastatic castration-resistant prostate cancer. Use in metastatic disease falls outside the express patient-population limitation.

Can a generic apalutamide product launch before Patent 10,702,508 expires?

Potentially. A generic may challenge the patent, omit the patented indication through a section viii statement, or reach a settlement permitting an agreed launch date. The outcome depends on the complete Orange Book patent set and the final generic label.

Is the 40.5-month MFS result required by claim 1?

No. Claim 1 does not recite the 40.5-month figure. The limitation appears in dependent claims 2, 7, 8 and 10.

Does the patent protect the Erleada formulation?

Not as a general formulation patent. Patent 10,702,508 is principally a method-of-use patent. Separate composition and formulation patents must be reviewed to assess physical-product protection.

References

1. U.S. Food and Drug Administration. (2018). FDA approves apalutamide for non-metastatic castration-resistant prostate cancer.
2. Smith, M. R., Saad, F., Chowdhury, S., et al. (2018). Apalutamide treatment and metastasis-free survival in prostate cancer. New England Journal of Medicine, 378(15), 1408-1418.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Code. (2023). 35 U.S.C. § 271(e)(2), infringement relating to submission of an abbreviated new drug application.
5. United States Patent and Trademark Office. (2020). U.S. Patent No. 10,702,508, Methods of treating prostate cancer.

Drugs Protected by US Patent 10,702,508

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No						TREATMENT IN COMBINATION WITH ANDROGEN DEPRIVATION THERAPY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) THAT IMPROVES METASTASIS FREE SURVIVAL
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes						TREATMENT IN COMBINATION WITH ANDROGEN DEPRIVATION THERAPY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) THAT IMPROVES METASTASIS FREE SURVIVAL

International Family Members for US Patent 10,702,508

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	111851
Australia	2018351714
Australia	2024219755
Brazil	112020007439