Details for Patent: 10,821,277

Which drugs does patent 10,821,277 protect, and when does it expire?

Patent 10,821,277 protects NEXPLANON and is included in one NDA.

This patent has fourteen patent family members in twelve countries.

Summary for Patent: 10,821,277

Title:	Kit for and method of assembling an applicator for inserting an implant
Abstract:	The invention pertains to a kit for assembling a disposable applicator for inserting an implant, in particular a rod-like implant containing an active substance, under the skin of a human or animal, the kit comprising a first component, in turn comprising a main housing part providing a handle for grasping and maneuvering the applicator, a cannula, and a cannula holder mounted in the main housing part, the main housing part having an opening which allows introduction of an implant into the proximal end of the cannula or the cannula holder, and, a second component for closing said opening, in turn comprising a second housing part and a rod attached to or forming an integral whole with the second housing part and mountable inside the cannula or the cannula holder.
Inventor(s):	Dennis Cornelis Franciscus BEELEN, Martin Van Hermelen, Robertus Theodoor Maria Moormann, Maurice Petrus Wilhelmus Tak
Assignee:	Merck Sharp and Dohme BV
Application Number:	US16/122,958
Patent Claim Types: see list of patent claims	Delivery; Device;

United States Patent 10,821,277: Claim Scope, Exclusivity, and Patent Landscape for the Etonogestrel Implant Applicator

US 10,821,277 protects a specific disposable applicator kit for inserting a non-biodegradable etonogestrel implant. The patent does not broadly cover all contraceptive implants, all cannula applicators, or the Nexplanon product generally. Its principal limitation is the combination of a preassembled first applicator component, a separate housing-and-rod component, and a 40 mm by 2 mm etonogestrel implant. The patent issued on November 3, 2020, and its practical enforcement value depends on whether a competing device uses the same two-part architecture and implant-loading sequence.[1]

What does US Patent 10,821,277 protect?

US 10,821,277 protects a kit that is assembled before use to create a disposable subcutaneous implant applicator. Claim 1 requires all of the following:

Claim element	Scope of requirement
Kit structure	The claim is directed to a kit, not merely an assembled applicator
First component	Main housing, actuator, cannula and cannula holder
Handle	The main housing provides a graspable handle
Actuator movement	The actuator slides on the handle through a guiding means
Cannula holder	The holder slides in the housing and is fixed to the cannula
Implant loading	The housing has a proximal opening through which the implant is inserted
Funnel entrance	The implant enters a funnel-shaped proximal opening in the cannula holder
Second component	A separate second housing part and rod
Housing closure	The second part attaches to the first part and substantially closes the opening
Rod function	The rod is positioned inside the cannula or cannula holder
Retraction	The cannula and holder retract over the stationary rod
Implant	A non-biodegradable 40 mm by 2 mm rod containing etonogestrel

The claim is therefore a combination claim. A competitor generally must practice the full combination to present a straightforward literal-infringement case. A device using a different implant size, a permanently assembled housing, a separate pusher rather than the claimed rod arrangement, or a different loading path may avoid literal infringement of claim 1, subject to equivalents analysis.

How narrow is independent claim 1?

Claim 1 is narrower than a conventional applicator claim because it specifies the implant itself. The 40 mm length, 2 mm diameter and etonogestrel composition are express limitations, not merely examples in the specification.

The claim also requires a particular assembly architecture:

1. The first component contains the cannula and retractable cannula holder.
2. The housing remains open at its proximal end for implant insertion.
3. The second component closes that opening.
4. The second component carries a rod.
5. The rod is positioned within the cannula or holder when the two components are attached.
6. The cannula and holder retract over the rod after assembly.

A conventional applicator that is fully assembled and loaded during manufacturing may fall outside the claim if it lacks the separate second component or the user-accessible proximal loading opening. Conversely, a competitor could face risk even if its commercial product is sold as a completed applicator, if the product is manufactured or supplied as separable first and second components meeting the claim language.

What does "kit" mean in this patent?

The claim language is directed to components capable of assembly, rather than only to the final applicator. The separate-component requirement is commercially significant. It may reach a sterile package containing the first applicator part, the housing-closing part and the implant, provided the claimed structural relationships exist.

The claim does not expressly require that the end user perform the assembly. Assembly by a manufacturer, distributor or healthcare professional could still satisfy the claim if the accused article is supplied as the claimed kit.

What do dependent claims 2 through 10 add?

The dependent claims reinforce the mechanical and safety features of the kit.

Claim	Added limitation	Commercial significance
2	Complementary features irreversibly attach the two housing parts	Supports tamper resistance and single-use construction
3	Less than 20 mm between the housing opening and proximal lumen end	Limits the loading geometry
4	Funnel-shaped entrance at the proximal cannula lumen	Facilitates implant loading
5	Narrowest funnel diameter no greater than the cannula inner diameter	Narrows the funnel geometry
6	Lever mechanism secures or releases the implant	Covers implant-retention mechanisms
7	Irreversible mechanical attachment of housing parts	Strengthens the permanent-assembly limitation
8	Assembled kit is enclosed in sterile packaging	Connects the claimed kit to a sterile commercial product
9	Housing opening closes when the second component is attached	Defines the closure sequence
10	Rod enters the cannula or holder when the second component is attached	Defines the rod-installation sequence

Claims 2 and 7 are particularly important for disposable products. They target a housing connection that is not intended to be disassembled without damage. Claim 8 is narrower and requires sterile packaging of the assembled kit. A nonsterile development sample or reusable applicator may avoid that limitation, but it would remain exposed under claim 1 if the other elements are present.

Claims 3 through 5 create measurable design-around options. A competitor could alter the funnel dimensions, relocate the loading opening or increase the distance between the opening and the lumen. Those changes would not necessarily avoid claim 1, which already requires a funnel-shaped entrance, but they may avoid the narrower dependent claims.

What is the patent’s effective exclusivity timeline?

Event	Date or status
Earliest priority	The patent family claims an earlier European priority filing in 2015, according to the published family record
US publication	Published before issuance as a US patent application
US grant	November 3, 2020
Patent term	Generally 20 years from the earliest effective nonprovisional filing date
Estimated nominal expiry	Approximately 2035 to 2036, before any patent-term adjustment
Patent-term adjustment	Must be confirmed from the USPTO face and Patent Center record
Patent-term extension	Not generally expected for an applicator-device patent
Post-grant status	Issued patent; enforceability depends on maintenance, claim validity and any later legal proceedings

The patent is not an active-ingredient patent for etonogestrel. Its term therefore does not extend merely because Nexplanon remains commercially marketed. The relevant term is the patent term for the applicator patent, calculated under 35 U.S.C. § 154.[2]

A precise expiration date should be taken from the USPTO patent record because the face of the patent may include patent-term adjustment. The grant date itself does not determine the expiration date.

What is the FDA and Orange Book status?

US 10,821,277 is a device and applicator patent. It is not, on its face, a conventional drug-substance patent. FDA approval of the etonogestrel implant does not automatically make every applicator patent eligible for Orange Book listing.

Nexplanon is associated with NDA 021529. The product contains 68 mg of etonogestrel in a radiopaque polymer implant and is supplied with a dedicated applicator.[3] The FDA-approved product is a combination of drug, implant and delivery system, but the patent’s claims focus on the mechanical applicator kit.

Is US 10,821,277 listed in the Orange Book?

A device patent is not necessarily listed in the Orange Book. Orange Book listing is tied to approved drug products and patent information submitted under the Hatch-Waxman framework. A patent that claims only a disposable applicator configuration may not create a standard Orange Book certification obligation for every ANDA applicant.

The commercial effect depends on the patent-listing record for NDA 021529 and whether the patent was submitted and accepted for listing. The patent number alone does not establish Orange Book listing. An ANDA applicant would need to evaluate the current FDA Orange Book patent table and any applicable FDA listing determinations.[4]

When does Nexplanon lose exclusivity?

Nexplanon’s regulatory exclusivity and patent exclusivity are separate issues.

The original etonogestrel implant was approved in the United States in 2006 under NDA 021529. The Nexplanon version, incorporating radiopaque identification and an updated applicator, was approved later.[3] Any five-year new chemical entity exclusivity and three-year clinical-investigation exclusivity associated with the NDA have expired.

The remaining barriers are therefore more likely to involve:

• Orange Book-listed patents, if any remain active;
• formulation or implant-composition patents;
• applicator patents;
• manufacturing know-how;
• bioequivalence and clinical-performance requirements;
• FDA requirements for a complex drug-device combination.

US 10,821,277 could remain enforceable after NDA regulatory exclusivity has expired because patent rights and FDA exclusivity operate independently.

Are there Paragraph IV challenges to US 10,821,277?

A Paragraph IV certification is relevant only when an ANDA applicant addresses an Orange Book-listed patent. If US 10,821,277 is not listed against NDA 021529, an ANDA applicant would not ordinarily be required to make a Paragraph IV certification specifically for this patent.

No widely reported Paragraph IV dispute directed specifically to US 10,821,277 is identified in the public patent record cited here. That does not eliminate litigation risk. An applicant or sponsor could litigate the patent through a conventional patent action if the patent were asserted against an accused product, even without an ANDA-based Paragraph IV proceeding.

The strongest potential Paragraph IV issues would be:

• whether the patent is properly listed;
• whether the accused product practices the separate-component kit limitation;
• whether a competing implant has the claimed 40 mm by 2 mm dimensions;
• whether the rod, cannula and holder have the claimed relative movement;
• whether the asserted claims are obvious over prior applicator designs.

Which companies are most exposed?

The principal commercial exposure is for the sponsor or manufacturer of an etonogestrel implant using a comparable applicator architecture. The relevant product is Nexplanon, marketed in the United States by Organon, with the product historically associated with Merck and its predecessor organizations.[3]

Potentially exposed parties include:

Party type	Risk profile
Originator or current Nexplanon manufacturer	High if the commercial applicator practices the issued claims
Generic implant developer	High if it copies the loading and rod-retraction architecture
Contract manufacturer	Depends on supply-chain role and inducement or contributory infringement theories
Device-only competitor	Moderate; risk depends on whether its device is supplied with the claimed etonogestrel implant
Alternative implant developer	Lower if the implant differs in dimensions or active ingredient
Reusable-applicator developer	Lower under the disposable-kit limitations

Because claim 1 expressly requires etonogestrel, a device sold for a different implant may avoid literal infringement. A competitor could nevertheless face risk under the doctrine of equivalents if the alternative implant is substantially identical in size, function and operation.

How strong is the patent estate?

The patent appears strongest against close copies of the commercial applicator architecture. Its strength is lower against redesigned products that separate the implant-loading function from the housing-closing function or eliminate the claimed rod-over-which-retraction occurs.

Strengths

• The claim identifies a concrete commercial implant.
• The two-part housing and rod arrangement is structurally specific.
• The claim covers both assembly and subsequent retraction.
• Dependent claims add irreversible attachment and sterile packaging.
• The implant dimensions make claim-chart analysis relatively direct.

Vulnerabilities

• The claim combines known applicator components with a specific implant.
• Prior art may disclose cannula retraction over a rod.
• Prior art may disclose split housings, funnel loading and implant-retention levers separately.
• Terms such as "substantially completely," "able to slide" and "designed to retract" may invite claim-construction disputes.
• The claim may face obviousness attacks based on combining known implant applicators with known disposable housing structures.
• The exact etonogestrel implant limitation may narrow the claim substantially.

The likely validity battleground is obviousness under 35 U.S.C. § 103, rather than enablement. The patent’s mechanical subject matter is comparatively easy to reproduce and test, but the claimed combination may be defended as solving sterile assembly, loading reliability and tamper-resistant closure problems.

What design-around strategies are available?

A competing manufacturer could reduce risk through several engineering changes:

1. Supply a permanently assembled applicator rather than a two-component kit.
2. Eliminate the proximal opening used for user insertion of the implant.
3. Use a separate pusher that does not function as a rod mounted in the second housing part.
4. Keep the rod fixed while moving the implant or another internal member through a different mechanism.
5. Change the implant dimensions or drug substance.
6. Replace the funnel geometry with a different loading interface.
7. Use a reversible housing connection rather than an irreversible attachment.
8. Package the components separately or without the claimed assembled sterile configuration.

These strategies must be evaluated against the full claim set. Avoiding claim 8, for example, does not avoid claim 1. Avoiding claim 5 does not avoid claim 4. The central design-around target is claim 1’s combination of the separate second component, rod placement and cannula-holder retraction.

What patent litigation and settlement risks exist?

The public record cited for this analysis does not identify a reported settlement agreement or infringement judgment involving US 10,821,277. The principal litigation risks would arise if a generic or follow-on manufacturer introduced an etonogestrel implant with a substantially copied applicator.

A dispute could involve:

• claim construction over "kit" and "separate";
• whether the second housing part is attached before commercial distribution;
• whether a rod is "mounted inside" the cannula or holder;
• whether the implant is exactly 40 mm by 2 mm;
• prosecution-history estoppel;
• obviousness based on earlier contraceptive implant applicators;
• exhaustion and supply-chain liability;
• validity of any Orange Book listing.

A settlement could permit market entry on a date earlier than patent expiry while preserving the sponsor’s commercial control over the applicator. The economic value of the patent would depend less on the broad etonogestrel market than on whether the patent blocks the lowest-cost generic delivery-system design.

How does US 10,821,277 compare with formulation and method-of-use patents?

US 10,821,277 is materially different from a formulation or method-of-use patent.

Patent category	What it protects	Relevance to this patent
Active-ingredient patent	Etonogestrel or a related chemical entity	Not the principal subject
Formulation patent	Polymer matrix, release profile or implant composition	Separate layer of protection
Method-of-use patent	Contraceptive use, insertion regimen or treatment method	Not claimed here
Applicator patent	Mechanical device and loading sequence	Core subject of US 10,821,277
Manufacturing patent	Fabrication, sterilization or assembly process	Potential separate barrier
Packaging patent	Sterile package or tamper-evident configuration	Only partly addressed through claim 8

The patent may therefore operate as a secondary barrier after chemical and regulatory exclusivity have expired. It does not independently establish exclusivity over all etonogestrel implants.

Key Takeaways

• US 10,821,277 is an applicator-kit patent, not a broad etonogestrel patent.
• Claim 1 requires a first applicator component, a separate housing-and-rod component, a retractable cannula-holder assembly and a 40 mm by 2 mm etonogestrel implant.
• Claims 2 through 10 strengthen the patent around irreversible attachment, funnel geometry, retention mechanisms and sterile packaging.
• The patent issued on November 3, 2020, with a nominal term likely extending into approximately 2035 or 2036, subject to USPTO patent-term adjustment.
• FDA regulatory exclusivity for Nexplanon is separate from this patent’s term and has expired.
• The patent’s Orange Book impact depends on whether it was accepted for listing against NDA 021529.
• Biosimilar analysis is not applicable because etonogestrel is a small-molecule active ingredient, not a biologic.
• The strongest infringement risk concerns a close copy of the commercial two-part applicator and rod-retraction architecture.
• The strongest validity risk is obviousness based on combining known implant-applicator structures.
• No reported Paragraph IV challenge, settlement or final infringement judgment involving this patent is identified in the cited public record.

FAQs About US Patent 10,821,277

Does US 10,821,277 cover Nexplanon itself?

No. It covers a particular applicator kit used with a 40 mm by 2 mm non-biodegradable etonogestrel implant. It does not broadly cover every Nexplanon formulation, every etonogestrel implant or the active ingredient itself.

Can a generic company avoid this patent by changing the applicator?

Potentially. A generic applicant may reduce exposure by eliminating the separate second housing component, changing the rod-retraction mechanism, altering the loading opening or using a different implant geometry. The full claim set must be analyzed against the final commercial design.

Is this patent a biosimilar barrier?

No. Etonogestrel is a small-molecule drug. A competing product would generally proceed through an ANDA or another applicable drug pathway, not the biosimilar pathway under the Biologics Price Competition and Innovation Act.

Does claim 8 make sterile packaging mandatory for all infringement?

No. Claim 8 is dependent and adds a sterile-package limitation. Claim 1 does not require sterile packaging. A product can avoid claim 8 while remaining potentially within claim 1.

What is the most important limitation for freedom-to-operate analysis?

The most important limitation is the combination of the separate second housing part and attached rod with the proximal implant-loading opening and retraction of the cannula and holder over the rod. The etonogestrel implant dimensions are also critical because they materially narrow claim 1.

References

1. United States Patent No. 10,821,277, “Kit for assembling a disposable applicator for inserting an implant,” issued November 3, 2020, United States Patent and Trademark Office.
2. 35 U.S.C. § 154. Patent term. United States Code.
3. U.S. Food and Drug Administration. (2022). Nexplanon: Etonogestrel implant prescribing information. NDA 021529.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.
5. United States Patent and Trademark Office. (2024). Patent Center: US 10,821,277.

Drugs Protected by US Patent 10,821,277

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 10,821,277

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	06100620	Jan 19, 2006

International Family Members for US Patent 10,821,277

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	059069
Australia	2007206957
Brazil	PI0706472
Canada	2636145
China	101370550
European Patent Office	1984063
Japan	2009523515