Details for Patent: 10,420,763

Which drugs does patent 10,420,763 protect, and when does it expire?

Patent 10,420,763 protects KYNMOBI and is included in one NDA.

This patent has forty-eight patent family members in twenty countries.

Summary for Patent: 10,420,763

Title:	Sublingual apomorphine
Abstract:	Disclosed are sublingual formulations of apomorphine, and methods of treating Parkinson's disease therewith. The sublingual formulations are films or strips having a first portion comprising apomorphine particles comprising an acid addition salt of apomorphine and a second portion comprising a pH neutralizing agent.
Inventor(s):	Anthony John Giovinazzo, David Bruce Hedden, Marc L. de Somer, Nathan John Bryson
Assignee:	Sumitomo Pharma America Inc
Application Number:	US16/005,105
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 10,420,763: Scope, Claims, Exclusivity and Apomorphine Patent Landscape

U.S. Patent No. 10,420,763 protects a sublingual apomorphine film or strip in which apomorphine particles containing an acid-addition salt are placed in a first portion and a pH-neutralizing agent is placed in a second portion. The patent also covers selected polymers, particle size, excipients, apomorphine hydrochloride, dosage strength and treatment of Parkinson's disease.

The patent is directed to the formulation architecture used by sublingual apomorphine products such as KYNMOBI, rather than to apomorphine as an active ingredient generally. Its strongest commercial relevance is the combination of: (1) a film or strip dosage form, (2) apomorphine salt particles, and (3) spatial separation of the active and pH-neutralizing components.

What does U.S. Patent 10,420,763 protect?

U.S. Patent 10,420,763 protects a pharmaceutical composition in unit dosage form for sublingual administration. The independent composition claim requires all of the following:

Required element	Claim 1 requirement
Dosage form	Unit dosage form
Route	Sublingual administration
Physical form	Film or strip
Active ingredient	Apomorphine particles
Salt form	Acid-addition salt of apomorphine
Structural arrangement	First portion containing apomorphine particles and second portion containing a pH-neutralizing agent

The claim does not cover every apomorphine formulation. An accused product must satisfy the full combination of limitations, either literally or under the doctrine of equivalents.

The claim is narrower than a claim covering apomorphine alone, apomorphine hydrochloride alone, or a sublingual dosage form alone. The two-portion arrangement is central. A formulation that combines the active ingredient and neutralizing agent in a single homogeneous matrix may avoid literal infringement of the “first portion” and “second portion” limitations, depending on the product’s physical structure and claim construction.

How broad is claim 1 of U.S. Patent 10,420,763?

Claim 1 has substantial formulation breadth but meaningful structural limitations.

It does not require:

• A specific apomorphine dose
• Apomorphine hydrochloride specifically
• A particular particle-size range
• A particular pH-neutralizing agent
• A particular polymer
• An antioxidant
• A permeation enhancer
• A particular thickness, dissolution time or release profile
• A particular clinical dosing schedule

The claim covers any acid-addition salt of apomorphine, provided the salt is present as apomorphine particles in the first portion of a sublingual film or strip and a pH-neutralizing agent is present in a second portion.

“Acid-addition salt” is broader than apomorphine hydrochloride. Claim 11 narrows the formulation to apomorphine hydrochloride, but claim 1 may encompass other pharmaceutically acceptable acid salts if they fall within the patent’s specification and claim construction.

The principal design-around issues are:

1. Eliminating the film or strip format.
2. Eliminating sublingual administration.
3. Using a non-salt form of apomorphine, if technically and legally viable.
4. Integrating the neutralizing agent into the same portion as the apomorphine.
5. Using a formulation in which apomorphine is not present as particles.
6. Delivering apomorphine through another route, such as subcutaneous, buccal, nasal or inhaled administration.

What do claims 2 through 12 add?

Claims 2 through 12 create narrower species within claim 1.

Claim	Additional limitation	Commercial significance
2	Polysaccharide	Covers film matrices using polysaccharide materials
3	Mucoadhesive polymer	Targets adhesion and residence time at the sublingual mucosa
4	Lists specific polymers, including carboxymethylcellulose, cellulose derivatives, polyvinylpyrrolidone and poloxamer-type materials	Provides multiple formulation fallbacks
5	Narrows claim 4 to selected cellulose-based polymers	More specific polymer protection
6	Antioxidant	Addresses apomorphine oxidation and chemical stability
7	Permeation enhancer	Targets improved mucosal absorption
8	Glycerol monostearate	Protects a specific excipient combination
9	Organic base as the pH-neutralizing agent	Narrows the neutralizer class
10	Effective particle size of 1 to 10 micrometers	Targets particle engineering and dissolution or absorption performance
11	Apomorphine hydrochloride	Covers the principal commercial salt form
12	2 to 40 mg of acid-addition salt	Covers a broad unit-dose range
13	Treatment of Parkinson's disease using the composition of claim 1	Method-of-use protection tied to the composition

Claims 2 through 12 are composition claims. Claim 13 is a method claim and depends on the composition of claim 1. A product that infringes claim 1 may not necessarily infringe every dependent claim. Conversely, a formulation that avoids a narrower dependent claim can still infringe claim 1.

What is the strongest limitation in the patent?

The strongest limitation is the spatial organization of the dosage form.

The patent does not merely require apomorphine in a sublingual film. It requires a first portion containing apomorphine particles and a second portion containing the pH-neutralizing agent. This limitation may distinguish the patent from earlier formulations that mix all ingredients uniformly.

The likely technical purpose is to control the local chemical environment. Apomorphine salts can be affected by pH, oxidation and mucosal absorption conditions. A separate neutralizing portion can alter the local pH after administration while preserving the physical and chemical properties of the active-containing portion.

The patent’s strongest dependent limitations are likely:

• Claim 10, because a 1 to 10 micrometer particle size may be measurable through product testing.
• Claim 11, because apomorphine hydrochloride is a commercially important salt.
• Claim 12, because the 2 to 40 mg range captures common clinical strengths.
• Claim 13, because it links the composition to Parkinson’s disease treatment.

Claims 4 and 5 may be easier to test if the generic manufacturer’s formulation disclosure identifies its polymer system. Claim 8 is narrow because glycerol monostearate is a specific excipient.

What patent expiration date applies to U.S. Patent 10,420,763?

The patent issued on September 24, 2019. Public patent records identify a March 4, 2013 U.S. nonprovisional filing date for the relevant family. On a standard 20-year patent-term calculation, the nominal expiration date is March 4, 2033, before any adjustment for patent term adjustment, terminal disclaimer or other recorded term events.[1]

Event	Date
U.S. filing associated with patent family	March 4, 2013
Patent issued	September 24, 2019
Nominal 20-year expiration	March 4, 2033
FDA approval of KYNMOBI	May 2020
Relevant regulatory framework	Hatch-Waxman small-molecule pathway

The legally operative expiration date must be determined from the USPTO patent-term data and the patent’s official term records. A patent term adjustment could move the expiration date beyond the basic 20-year calculation. Any terminal disclaimer could limit the term to another patent’s expiration date.

What is the Orange Book status of U.S. Patent 10,420,763?

U.S. Patent 10,420,763 has been associated with the KYNMOBI apomorphine hydrochloride sublingual film product in the FDA’s Orange Book patent-listing framework.[2]

KYNMOBI is approved as apomorphine hydrochloride sublingual film for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease.[3] The product is a small-molecule drug, so generic competition proceeds through an abbreviated new drug application, or ANDA, rather than a biosimilar application.

An Orange Book listing can affect the timing of an ANDA approval and can trigger patent litigation if an applicant makes a Paragraph IV certification. The listing does not establish that every claim of the patent covers every generic formulation. It identifies a patent that the listed drug sponsor asserts is relevant to the approved product.

How does U.S. Patent 10,420,763 relate to KYNMOBI?

KYNMOBI uses apomorphine hydrochloride in a sublingual film dosage form. The product’s approved strengths include 10 mg, 15 mg, 20 mg, 25 mg and 30 mg of apomorphine hydrochloride, administered sublingually for acute “off” episodes.[3]

The commercial overlap with the patent is strong:

KYNMOBI product characteristic	Relationship to Patent 10,420,763
Apomorphine hydrochloride	Expressly covered by claim 11
Sublingual administration	Required by claim 1
Film dosage form	Required by claim 1
Multiple dose strengths	Consistent with claim 12’s 2 to 40 mg range
Parkinson’s disease indication	Covered by claim 13
Mucoadhesive and film-forming excipients	Potentially relevant to claims 2 through 5
Particle engineering	Potentially relevant to claim 10
Local pH control	Central to claim 1 and claim 9

The patent therefore has direct product relevance. Its commercial value depends on whether the marketed film has the claimed first-portion and second-portion structure, not only whether it contains apomorphine hydrochloride in a film.

Which other patents are relevant to the apomorphine sublingual film landscape?

The relevant landscape includes earlier Cynapsus and Sunovion patents directed to sublingual apomorphine formulations, film composition, particle size, excipient systems, administration and treatment of Parkinson’s disease.

A representative landscape is below.

Patent family or subject	Principal subject matter	Relationship to 10,420,763
U.S. Patent No. 9,125,910	Sublingual apomorphine formulations	Earlier foundational protection for sublingual apomorphine dosage forms
U.S. Patent No. 10,420,763	Two-portion film or strip with apomorphine salt particles and pH neutralizer	Focuses on dosage-form architecture and particle-containing active portion
Related continuation families	Film matrices, excipients, dose ranges and administration	May create overlapping but separately enforceable claim sets
KYNMOBI Orange Book patents	Product-specific formulation and use protection	Relevant to ANDA patent certifications and launch timing

The landscape should be analyzed by claim category rather than by patent count:

• Active ingredient claims are weak because apomorphine is an established molecule.
• Route-of-administration claims are stronger where they require sublingual delivery.
• Film claims are commercially important because they distinguish KYNMOBI from injectable apomorphine products.
• Spatially separated component claims can create a distinct infringement issue.
• Particle-size claims are technically measurable but may be vulnerable to non-infringement through different particle specifications.
• Method claims may be relevant to labeling, especially where a generic seeks approval for the same Parkinson’s disease use.

How many patents cover KYNMOBI?

The KYNMOBI estate has included multiple U.S. patents and patent families rather than a single blocking patent. U.S. Patent 10,420,763 is one component of that estate.

The practical patent-count question has three answers:

1. One patent directly analyzed here: U.S. Patent 10,420,763.
2. Multiple related U.S. patents: The broader estate includes earlier and later patents covering sublingual apomorphine formulations and related subject matter.
3. One or more Orange Book-listed patents: The controlling number depends on the specific Orange Book edition and the product listing at the time of review.[2]

Patent families may include continuations with overlapping specifications but different claim scope. A continuation can preserve prosecution leverage after an earlier patent issues, even when the claims are directed to related technology.

What Paragraph IV challenges or generic entry risks exist?

A generic applicant seeking to market an apomorphine sublingual film could make one or more of the following certifications:

Certification	Effect
Paragraph I	No patent information is listed
Paragraph II	Listed patent has expired
Paragraph III	Applicant will wait until patent expiration
Paragraph IV	Listed patent is invalid, unenforceable or not infringed
Section viii statement	Applicant seeks approval without the patented method of use

For Patent 10,420,763, a Paragraph IV strategy could challenge:

• Whether the generic film has separate first and second portions.
• Whether apomorphine is present as particles.
• Whether the active is an acid-addition salt.
• Whether the pH-neutralizing agent is located in the claimed second portion.
• Whether the generic product falls within the 1 to 10 micrometer particle-size range.
• Whether the product contains the claimed dosage range.
• Whether the claims are anticipated or obvious in view of earlier sublingual apomorphine formulations.
• Whether the patent has adequate written description or enablement for the full scope of claim 1.

A generic applicant might also pursue a formulation that avoids the two-portion architecture, uses a different physical dosage form, or omits the patented Parkinson’s method from its label through a section viii carve-out. That strategy does not automatically avoid composition claims.

Does biosimilar risk apply to apomorphine?

No. Apomorphine hydrochloride is a small-molecule active ingredient. The relevant competitive pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act, not a biosimilar application under section 351(k) of the Public Health Service Act.

The principal regulatory barriers are therefore:

• Pharmaceutical equivalence
• Bioequivalence
• Comparative dissolution and performance
• Manufacturing controls
• Patent certifications
• Labeling and method-of-use issues

The formulation is more complex than a conventional immediate-release tablet. A generic applicant may need to demonstrate that its film has comparable drug release and absorption characteristics while managing differences in polymer composition, film structure, particle size and pH modulation.

How strong is the patent estate?

The estate is strongest against a product that closely copies the commercial architecture of KYNMOBI: an apomorphine hydrochloride sublingual film with a separated neutralizing component and a comparable dose.

Risk factor	Assessment
Product overlap	High for a KYNMOBI-like sublingual film
Claim breadth	Moderate; claim 1 has broad ingredient coverage but requires a two-portion structure
Detectability	Moderate to high for salt, dose, polymer and particle size; more difficult for internal spatial arrangement
Design-around potential	Meaningful through alternative dosage forms or integrated excipient systems
Small-molecule generic risk	Real after patent and regulatory barriers are cleared
Biosimilar risk	Not applicable
Litigation leverage	Strongest if Orange Book-listed patents cover the proposed product
Remaining term	Potentially extends into 2033 on the basic filing-date calculation

The patent is not a molecule patent. Its value is concentrated in formulation and product architecture. That generally produces a narrower infringement perimeter than composition-of-matter protection but can still delay a directly substitutable generic.

What litigation and settlement issues should be monitored?

The critical litigation triggers are:

• A Paragraph IV notice concerning Patent 10,420,763.
• A 45-day Hatch-Waxman patent-infringement action.
• A district court ruling on “first portion” and “second portion.”
• Claim construction concerning “apomorphine particles.”
• A settlement providing a permitted generic entry date.
• A covenant not to sue or license covering an alternative film architecture.
• A change in Orange Book listing status.
• FDA approval or commercial launch of an ANDA product.

A settlement may establish an entry date before the nominal patent expiration. The commercial effect would depend on the settlement terms, authorized-generic provisions, manufacturing restrictions and any separate patents remaining in force.

What geographic coverage does U.S. Patent 10,420,763 provide?

The patent provides rights only in the United States. Corresponding international applications may have generated national patents in Europe, Canada, Australia and other jurisdictions, but those rights must be assessed separately.

Geographic differences matter because:

• Patent expiration dates vary by national filing and grant history.
• Claim scope can differ materially.
• Patent-term adjustment and supplementary protection mechanisms are jurisdiction-specific.
• Regulatory exclusivity periods differ.
• Patent litigation and generic-launch rules are not uniform.

A U.S. launch analysis should not assume that a foreign counterpart has identical claims or the same expiration date.

What manufacturing and intellectual-property barriers remain?

The key manufacturing barriers are reproducible production of a multilayer or otherwise segmented film, uniform apomorphine particle distribution, control of oxidation, stable incorporation of the neutralizing component and consistent sublingual performance.

A generic manufacturer may face process and analytical challenges in proving:

• Separation of the first and second portions.
• Particle-size distribution.
• Apomorphine salt identity and content uniformity.
• Film thickness and mechanical properties.
• Dissolution and disintegration.
• pH behavior after wetting.
• Stability under oxygen, light and humidity.
• Mucoadhesion and transmucosal absorption.

These barriers can increase development cost even where a non-infringing formulation is technically possible.

Key Takeaways

• U.S. Patent 10,420,763 is a formulation patent directed to a sublingual apomorphine film or strip.
• Claim 1 requires apomorphine salt particles in a first portion and a pH-neutralizing agent in a second portion.
• Claim 11 specifically covers apomorphine hydrochloride.
• Claim 12 covers 2 to 40 mg of the acid-addition salt.
• Claim 13 covers treatment of Parkinson’s disease using the claimed formulation.
• The nominal expiration date is March 4, 2033, subject to the official USPTO term calculation.
• The patent has direct relevance to KYNMOBI, but infringement depends on the product’s internal film architecture.
• Generic competition would proceed through an ANDA and could involve Paragraph IV litigation.
• Biosimilar regulation does not apply.
• The principal design-around route is an alternative formulation that avoids the claimed separated portions or avoids the film-and-strip structure.

FAQs

Can a generic apomorphine injection infringe U.S. Patent 10,420,763?

Generally, no. Claim 1 requires a sublingual film or strip. An injectable apomorphine product would not meet that dosage-form limitation.

Does a buccal apomorphine film fall within the patent?

It may avoid literal infringement of claim 1 because the claim requires sublingual administration. The result would depend on the product’s actual administration instructions and whether a court applies the doctrine of equivalents.

Does claim 10 require every apomorphine particle to be between 1 and 10 micrometers?

The claim requires apomorphine particles having an effective particle size from 1 to 10 micrometers. Particle-size testing methodology and the meaning of “effective particle size” would be important in an infringement dispute.

Can an ANDA applicant omit the Parkinson’s disease indication?

An applicant may attempt a section viii labeling carve-out for a patented method of use. That strategy does not avoid composition claims covering the film itself.

Does discontinuation of KYNMOBI eliminate the patent?

No. Commercial discontinuation does not by itself terminate an issued patent. Patent enforceability depends on expiration, invalidation, unenforceability, abandonment of relevant rights or other legal events.

References

1. United States Patent and Trademark Office. (2019). U.S. Patent No. 10,420,763: Pharmaceutical compositions comprising apomorphine.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2020). KYNMOBI (apomorphine hydrochloride) sublingual film prescribing information. Sunovion Pharmaceuticals Inc.
4. United States Patent and Trademark Office. (2015). U.S. Patent No. 9,125,910: Sublingual apomorphine formulations.
5. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355.

Drugs Protected by US Patent 10,420,763

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020		DISCN	Yes	No	10,420,763		Y			TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020		DISCN	Yes	No	10,420,763		Y			TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	No	10,420,763		Y			TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No	10,420,763		Y			TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No	10,420,763		Y			TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE

International Family Members for US Patent 10,420,763

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010259971
Australia	2017200329
Australia	2019200308
Australia	2021201259
Brazil	112012000204