Details for Patent: 10,022,447

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Which drugs does patent 10,022,447 protect, and when does it expire?

Patent 10,022,447 protects LYRICA CR and is included in one NDA.

Protection for LYRICA CR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 10,022,447

Title:	Solid pharmaceutical compositions containing pregabalin
Abstract:	A solid pharmaceutical composition containing pregabalin is described. The composition includes a matrix forming agent and a swelling agent and is suitable for once daily oral administration. Exemplary matrix forming agents include mixtures of polyvinyl acetate and polyvinylpyrrolidone, and exemplary swelling agents include cross-linked polymers of polyvinylpyrrolidone.
Inventor(s):	Howard N Bockbrader, Yun Hyung Cho, Steven Diaz Santiago, Majid Mahjour, Thomas Daniel Reynolds, Pushpa Ganapathi Shao, Zezhi Jesse Shao, Jiansheng Wan
Assignee:	Viatris Specialty LLC
Application Number:	US15/686,549
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

United States Patent 10,022,447: Pregabalin Once-Daily Formulation Scope and Patent Landscape

US Patent No. 10,022,447 protects specific once-daily pregabalin treatment methods using a hydrophilic matrix composed of polyvinyl acetate and polyvinylpyrrolidone, combined with crosslinked polyvinylpyrrolidone. The patent does not broadly cover all extended-release pregabalin products. Infringement generally requires the accused product to satisfy the claimed excipient composition, quantitative ranges, once-daily administration, and treatment-method limitations.

The patent is strategically important because it targets the formulation architecture associated with once-daily pregabalin extended-release tablets, including the technology used for Lyrica CR. Its strongest protection is concentrated in claims 5 and 6, which narrow the matrix composition and excipient percentages but define a commercially relevant formulation profile.

What does US Patent 10,022,447 cover?

US 10,022,447 covers methods of treating a pregabalin-responsive condition by administering a once-daily oral pharmaceutical formulation containing:

• Pregabalin or a pharmaceutically acceptable complex, salt, solvate, or hydrate;
• A matrix-forming system containing polyvinyl acetate and polyvinylpyrrolidone;
• Crosslinked polyvinylpyrrolidone as a swelling agent; and
• Quantities of active ingredient and excipients within specified weight ranges.

The claims are method claims rather than standalone composition claims. A product manufacturer is exposed when its product is used according to the claimed once-daily treatment method, marketed with instructions that practice the method, or supplied with labeling that induces such use.

Patent identification

Item	Information
Patent	US 10,022,447 B2
Technology	Once-daily extended-release pregabalin formulation
Active ingredient	Pregabalin
Dosage form contemplated	Oral pharmaceutical formulation, principally extended-release tablets
Claim type	Method of treatment
Core release technology	Polyvinyl acetate/polyvinylpyrrolidone matrix with crosslinked polyvinylpyrrolidone
Issue date	July 17, 2018
Commercial relevance	Lyrica CR and potential generic extended-release pregabalin products
Related patent family	Continuation-type family associated with controlled-release pregabalin technology

The patent family is associated with Depomed’s controlled-release formulation platform. Depomed later became part of Assertio Therapeutics. Pfizer commercialized Lyrica and Lyrica CR and obtained rights relating to the extended-release formulation technology.

How do the independent claims differ?

Claims 1 and 5 are the principal independent claims. They overlap in subject matter but impose different limitations.

Limitation	Claim 1	Claim 5
Pregabalin content	About 5%-60%	About 5%-60%
Matrix-forming agent	Polyvinyl acetate and polyvinylpyrrolidone	Same
Matrix amount	About 5%-45%	About 20%-35%
Crosslinked polyvinylpyrrolidone	About 15%-70%	About 10%-35%
Polyvinyl acetate ratio	Not specified in independent claim	About 70%-90% of PVA/PVP matrix
Administration	Once daily	Once daily
Treatment method	Pregabalin-responsive condition	Pregabalin-responsive condition

Claim 1 is broader with respect to the matrix and swelling-agent quantities. Claim 5 is narrower but more formulation-specific because it requires the polyvinyl acetate-to-polyvinylpyrrolidone ratio to fall within the 70%-90% range.

A formulation can fall outside claim 5 while remaining within claim 1. For example, a product with a matrix concentration of 15% could potentially satisfy claim 1 but not claim 5. Conversely, a product with a 70%-90% polyvinyl acetate ratio and a 20%-35% matrix concentration is positioned directly within the narrower claim 5 profile.

What are the limitations of claims 2 through 8?

Claim 2: narrowed quantitative ranges

Claim 2 requires:

• Matrix-forming agent: about 20%-35% by weight; and
• Crosslinked polyvinylpyrrolidone: about 20%-55% by weight.

It depends on claim 1 and therefore retains claim 1’s other requirements, including once-daily oral administration and pregabalin content of about 5%-60%.

Claims 3 and 4: matrix composition ratio

Claims 3 and 4 limit the relative amount of polyvinyl acetate within the combined polyvinyl acetate/polyvinylpyrrolidone matrix:

• Claim 3: about 60%-90% polyvinyl acetate;
• Claim 4: about 70%-90% polyvinyl acetate.

Claim 4 is narrower than claim 3. It is also aligned with the ratio recited independently in claim 5.

Claim 6: narrower swelling-agent range

Claim 6 depends on claim 5 and narrows crosslinked polyvinylpyrrolidone to about 20%-30% by weight.

This is likely the most formulation-specific claim in the patent. A product practicing claim 6 must meet all of the following:

1. Pregabalin at about 5%-60%;
2. Matrix at about 20%-35%;
3. Polyvinyl acetate at about 70%-90% of the PVA/PVP matrix;
4. Crosslinked polyvinylpyrrolidone at about 20%-30%; and
5. Once-daily administration.

Claims 7 and 8: covered indications

Claims 7 and 8 identify the conditions or disorders that may be treated. The list includes:

• Epilepsy;
• Pain;
• Diabetic peripheral neuropathy;
• Postherpetic neuralgia;
• Fibromyalgia;
• Anxiety;
• Depression;
• Mania;
• Bipolar disorder;
• Insomnia;
• Alcoholism;
• Inflammation;
• Gastrointestinal damage; and
• Physiological conditions associated with psychomotor stimulants.

Claims 7 and 8 do not expand the formulation requirements. They add indication-specific limitations to claims 1 and 5, respectively.

What formulation is protected by US 10,022,447?

The protected formulation is a swellable, matrix-based extended-release system. Polyvinyl acetate and polyvinylpyrrolidone form the matrix. Crosslinked polyvinylpyrrolidone, commonly known as crospovidone, functions as the swelling agent.

The formulation is designed to release pregabalin over a period that supports once-daily administration. The claim does not expressly require a particular dissolution profile, tablet hardness, coating, tablet size, manufacturing process, or pharmacokinetic parameter. Those characteristics may be relevant under the specification or other patents, but they are not express limitations of the quoted claims.

Quantitative claim map

Component	Claim 1 range	Claim 5 range	Narrowest relevant dependent range
Pregabalin	About 5%-60%	About 5%-60%	Same
PVA/PVP matrix	About 5%-45%	About 20%-35%	About 20%-35%
Crosslinked PVP	About 15%-70%	About 10%-35%	About 20%-30% under claim 6
PVA within PVA/PVP	Not in claim 1	About 70%-90%	About 70%-90%
Dosing frequency	Once daily	Once daily	Once daily

The use of “about” creates a boundary issue. Courts generally assess the term in the context of the specification, prosecution history, technical measurement practices, and whether a proposed value is materially outside the claimed range. A generic developer should not assume that a minor formulation adjustment automatically avoids infringement.

How strong is the patent estate for once-daily pregabalin?

The estate is strongest against products that copy the same excipient platform and are labeled for once-daily use. It is weaker against products that use a different release mechanism, such as:

• Osmotic delivery;
• Multiparticulate beads;
• Lipid-based matrices;
• Coated pellets;
• Ion-exchange systems;
• A matrix using different polymers; or
• A twice-daily formulation.

The patent does not claim pregabalin as a molecule. The basic pregabalin compound and conventional immediate-release pregabalin products are therefore outside the central formulation concept, subject to other patents and regulatory requirements.

Relative strength by claim category

Claim category	Commercial strength	Principal vulnerability
Claim 1	Broadest formulation-method claim	Requires all listed polymers and ranges
Claim 5	Strong against closely matched formulations	Narrow matrix and PVA-ratio limitations
Claim 6	Strongest literal overlap with a copied formulation	Multiple quantitative limitations
Claims 7 and 8	Useful for labeled indications	Does not independently broaden formulation scope
Method-of-treatment structure	Supports induced-infringement theories	Requires proof of use, labeling, or intent

The patent’s method-claim format can still create substantial market-entry risk. A generic applicant may avoid direct administration of the product but face induced-infringement allegations if its proposed labeling instructs patients or physicians to administer the product once daily for a covered condition.

When does US Patent 10,022,447 lose exclusivity?

The patent’s enforceable term is determined by its effective filing date, patent-term adjustment, terminal disclaimers, and any applicable patent-term extension. The issue date alone does not determine expiration.

US 10,022,447 belongs to a continuation family. Continuation patents ordinarily retain the parent application’s effective filing date for subject matter supported by the earlier disclosure. As a result, the patent is not generally entitled to a fresh 20-year term beginning on July 17, 2018.

The relevant commercial analysis should use:

1. The earliest effective nonprovisional filing date;
2. The USPTO patent-term adjustment shown on the patent face;
3. Any terminal disclaimer;
4. Orange Book listing data for the relevant approved product; and
5. Any patent-term extension or pediatric extension.

For Lyrica CR, the key practical exclusivity period was tied to the formulation patent family rather than the basic pregabalin compound patent. The basic pregabalin exclusivity position was materially different from the extended-release formulation position because generic immediate-release pregabalin and once-daily extended-release pregabalin present separate patent and regulatory questions.[1][2]

What is the Orange Book status of the pregabalin extended-release patents?

FDA Orange Book analysis must distinguish Lyrica immediate-release capsules and oral solution from Lyrica CR extended-release tablets.

Product category	Principal regulatory issue	Patent relevance
Lyrica capsules	Immediate-release pregabalin	Compound, formulation, and use patents may differ
Lyrica oral solution	Liquid pregabalin dosage form	Different formulation profile
Lyrica CR tablets	Once-daily extended-release pregabalin	Controlled-release formulation patents are central

The Orange Book identifies patents submitted by an NDA holder for approved drug products. Listing does not establish that every claim is valid or infringed. It creates a statutory certification framework for abbreviated new drug applications.

For a generic extended-release pregabalin applicant, the relevant Orange Book review should include all patents listed against the extended-release product, including any continuation or formulation patents that remain unexpired. A patent listed for immediate-release Lyrica does not automatically block an extended-release product, and a patent listed for Lyrica CR does not automatically block a conventional immediate-release product.

Which companies challenged pregabalin exclusivity?

The main competitive pressure has come from generic manufacturers seeking approval for pregabalin products after expiration or resolution of Pfizer’s principal exclusivity barriers.

For immediate-release pregabalin, generic entry was pursued by multiple manufacturers through ANDA filings. The competitive issue was primarily the compound patent, regulatory exclusivity, and indication-specific labeling.

For once-daily extended-release pregabalin, the relevant challenge is more specialized. An applicant would need to address:

• Whether the proposed product is therapeutically equivalent to Lyrica CR;
• Whether the product practices the polymer matrix limitations;
• Whether the proposed label includes a patented use;
• Whether the applicant submits a Paragraph IV certification;
• Whether Pfizer or another patent owner files a district-court action within 45 days; and
• Whether a settlement limits launch timing.

Public patent records and FDA listings should be reviewed together because an ANDA may contain Paragraph IV certifications against some patents and Paragraph III or “section viii” positions against others.

What Paragraph IV risks exist for a generic extended-release pregabalin product?

A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or will not be infringed. For US 10,022,447, a generic applicant could pursue several noninfringement positions.

Potential noninfringement positions

A product may attempt to avoid literal infringement by:

• Omitting either polyvinyl acetate or polyvinylpyrrolidone;
• Using a different matrix-forming polymer;
• Excluding crosslinked polyvinylpyrrolidone;
• Moving the matrix concentration outside the claimed range;
• Using a PVA/PVP ratio outside 60%-90% or 70%-90%;
• Formulating the product for twice-daily rather than once-daily use; or
• Excluding the patented indications through a permissible section viii carve-out.

These strategies carry different commercial consequences. A formulation design-around may affect release performance and bioequivalence. A label carve-out may restrict treatment of diabetic peripheral neuropathy or postherpetic neuralgia, depending on the approved labeling and the patent’s listed use.

Potential validity positions

A Paragraph IV challenge could examine:

• Whether the claimed polymer combination was obvious in view of controlled-release excipient references;
• Whether the claimed quantitative ranges provide an unexpected technical effect;
• Whether the specification adequately supports the full ranges;
• Whether “about” renders the claims indefinite;
• Whether the claims are enabled across the full compositional scope; and
• Whether the method claims improperly recite results without sufficient structural limitations.

The strongest validity defense would usually require prior art directed specifically to pregabalin, once-daily release, and the claimed PVA/PVP plus crosslinked-PVP combination. Generic controlled-release polymer disclosures may be relevant but do not necessarily anticipate the complete combination.

What patent litigation affects Lyrica CR and pregabalin?

The litigation risk is concentrated in three areas:

1. Patent infringement actions following Paragraph IV notices;
2. Hatch-Waxman disputes involving Lyrica and Lyrica CR listings; and
3. Contractual or licensing disputes involving the controlled-release technology.

The patent’s method claims create a fact-intensive litigation profile. The court may need to evaluate the accused product’s actual composition, the label’s dosing instructions, the meaning of “about,” and whether the claimed treatment method is practiced by patients.

A generic company can face a different result for different strengths. One strength may fall within the patented polymer ranges while another does not. The litigation analysis must therefore be performed by formulation, strength, manufacturing site, and proposed label.

Were there licensing deals for the pregabalin controlled-release technology?

Depomed developed and controlled the Acuform-related controlled-release platform used in several extended-release products. Pfizer commercialized Lyrica CR, and the relationship involved rights to controlled-release technology and commercial development.

The commercial significance of licensing is that the entity marketing Lyrica CR may not have been the original owner of every formulation patent. Patent ownership, exclusive licensing, and the right to sue can differ. A litigation review should therefore identify:

• The current patent assignee;
• Recorded assignments at the USPTO;
• Exclusive license provisions;
• Sublicensing rights;
• The NDA holder;
• The entity listed in the Orange Book; and
• Any settlement or covenant-not-to-sue arrangements.

A license does not change claim scope, but it can affect standing, damages allocation, launch negotiations, and the identity of the party that controls enforcement.

How does US 10,022,447 compare with patents covering immediate-release pregabalin?

Issue	Immediate-release pregabalin	Once-daily extended-release pregabalin
Primary technology	Pregabalin active ingredient and conventional dosage forms	Polymer matrix and swelling-agent system
Main patent risk	Compound and indication patents	Formulation and method-of-treatment patents
Typical dosing	Multiple daily doses	Once daily
Key regulatory pathway	ANDA referencing immediate-release product	ANDA referencing extended-release product
Design-around options	Salt, dosage form, label, or patent expiration	Polymer system, composition ranges, release platform, or label
Biosimilar risk	None	None

Pregabalin is a small molecule. Biosimilar approval is not the relevant pathway. Competitors would file ANDAs, not biosimilar applications under section 351(k) of the Public Health Service Act.

What generic launch scenarios exist?

Scenario 1: Literal formulation design-around

A competitor develops a once-daily pregabalin formulation without the claimed PVA/PVP matrix or without crosslinked polyvinylpyrrolidone. This is the cleanest patent strategy but may require new formulation and bioequivalence work.

Scenario 2: Quantitative design-around

A competitor uses the same general polymer classes but places one or more components outside the claimed ranges. This strategy creates litigation risk because the court may examine measurement methods, manufacturing tolerances, and the scope of “about.”

Scenario 3: Label carve-out

A competitor seeks approval for non-patented indications while excluding patented uses. This may reduce infringement exposure but can limit the product’s commercial value and trigger disputes over whether the label still induces the patented use.

Scenario 4: Paragraph IV litigation

The applicant challenges validity or infringement before launch. The resulting 30-month stay, settlement, or trial outcome can determine market entry.

Scenario 5: Post-expiration launch

The applicant accepts the patent position and launches after the relevant patent term ends. This reduces litigation risk but may delay entry and allow competing extended-release products to establish market share.

What manufacturing and geographic barriers apply?

The patent is a US right. It can block manufacture, importation, sale, offer for sale, or use in the United States, subject to the statutory safe harbor for activities reasonably related to submission of information to FDA.

Manufacturing outside the United States does not eliminate risk if the product is imported into the US. A foreign manufacturing site may also face separate patent rights in Europe, Canada, Japan, and other jurisdictions. Patent family members must be reviewed independently because claim scope, prosecution history, expiration, and validity can differ by country.

Manufacturing barriers are practical as well as legal. The product must consistently meet:

• Polymer identity and grade;
• Excipient percentage ranges;
• Blend uniformity;
• Tablet compression specifications;
• Dissolution requirements;
• Stability requirements; and
• Bioequivalence criteria.

A change in polymer grade or supplier can move a formulation outside or inside a claimed range and can affect regulatory comparability.

What is the commercial exposure from Lyrica and Lyrica CR?

Lyrica was one of Pfizer’s major commercial products, with global sales historically reaching several billion dollars annually before broad generic erosion. The commercial exposure from US 10,022,447 is narrower because it relates to the once-daily extended-release formulation rather than all pregabalin sales.

The patent’s economic value depends on:

• US sales of Lyrica CR;
• The number of approved extended-release strengths;
• Whether patients can be switched to immediate-release pregabalin;
• Generic substitution rules;
• The number of ANDA applicants;
• The breadth of any approved label carve-outs; and
• The remaining enforceable patent term.

A generic launch against Lyrica CR would not necessarily capture the entire Lyrica market. Immediate-release capsules, oral solution, and extended-release tablets are separate dosage forms with different substitution and prescribing dynamics.

Key Takeaways

• US 10,022,447 protects once-daily pregabalin treatment methods using a PVA/PVP matrix and crosslinked polyvinylpyrrolidone.
• Claims 1 and 5 are the principal independent claims.
• Claim 5 is narrower and requires a 20%-35% matrix, a 70%-90% polyvinyl acetate ratio, and 10%-35% crosslinked polyvinylpyrrolidone.
• Claim 6 narrows the crosslinked polyvinylpyrrolidone range to 20%-30%.
• The patent does not broadly cover all pregabalin products or all extended-release technologies.
• The patent is relevant to Lyrica CR, but immediate-release Lyrica and extended-release Lyrica require separate Orange Book and patent analyses.
• Biosimilar risk is not applicable because pregabalin is a small molecule.
• The principal generic strategies are formulation design-around, quantitative design-around, indication carve-out, Paragraph IV litigation, or delayed launch.
• The patent’s practical enforceability depends on the exact accused formulation, label, polymer percentages, patent-term data, Orange Book listings, and ownership or licensing records.
• A complete freedom-to-operate review should analyze the entire controlled-release pregabalin family rather than US 10,022,447 in isolation.

Frequently Asked Questions

Does US 10,022,447 claim pregabalin itself?

No. The patent claims treatment methods using pregabalin in a specified once-daily controlled-release formulation. It does not claim the pregabalin molecule as such.

Can a twice-daily pregabalin product infringe US 10,022,447?

A twice-daily product would generally lack the express once-daily limitation in the quoted claims. Other patents could still apply.

Does using a different swelling agent avoid the patent?

It may avoid literal infringement of the quoted claims if crosslinked polyvinylpyrrolidone is absent. Equivalence and other patent claims would require separate analysis.

Are method-of-use claims relevant to an ANDA applicant?

Yes. An ANDA applicant must address listed method patents through a Paragraph IV certification, Paragraph III certification, or permissible section viii statement, depending on the patent and proposed labeling.

Is US 10,022,447 relevant to biosimilar competition?

No. Pregabalin is a small-molecule drug. Competition proceeds through the ANDA pathway rather than the biosimilar pathway.

References

1. U.S. Food and Drug Administration. (2017). Lyrica CR (pregabalin) extended-release tablets prescribing information. FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. United States Patent and Trademark Office. (2018). U.S. Patent No. 10,022,447, controlled release formulations of pregabalin. U.S. Department of Commerce.

4. United States Patent and Trademark Office. (2013). U.S. Patent No. 8,445,466, controlled release formulations of pregabalin. U.S. Department of Commerce.

5. Pfizer Inc. (2018). Annual report. Pfizer.

6. Assertio Therapeutics, Inc. (2018). Annual report. Assertio Therapeutics.

Drugs Protected by US Patent 10,022,447

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017	AB	RX	Yes	No					Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017	AB	RX	Yes	No					Y
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017	AB	RX	Yes	Yes					Y

International Family Members for US Patent 10,022,447

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	058175
Australia	2006310217
Brazil	PI0618211
Canada	2628200
China	101330907
Costa Rica	9950