Details for Patent: 9,884,092

Which drugs does patent 9,884,092 protect, and when does it expire?

Patent 9,884,092 protects BYDUREON, BYDUREON PEN, and BYDUREON BCISE, and is included in two NDAs.

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

This patent has forty-two patent family members in twenty-four countries.

Summary for Patent: 9,884,092

Title:	Methods for treating diabetes and reducing body weight
Abstract:	Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.
Inventor(s):	Mark Fineman, Leigh MacConell, Kristin Taylor
Assignee:	Amylin Pharmaceuticals LLC , AstraZeneca Pharmaceuticals LP
Application Number:	US15/168,350
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 9,884,092: Exenatide Sustained-Release Claims, Patent Scope, Expiration, and Generic Risk

US Patent 9,884,092 protects a therapeutic regimen for sustained-release exendin-4, principally exenatide, administered to maintain a mean steady-state plasma concentration of at least 200 pg/mL for at least one month. The strongest commercial overlap is with once-weekly, 2-mg exenatide extended-release products using a poly(lactide-co-glycolide), or PLGA, microsphere formulation. The patent is method-of-use focused. It does not broadly claim every exenatide formulation or every sustained-release delivery device.

What is US Patent 9,884,092?

US 9,884,092 is titled “Methods of treating diabetes using exendin-4.” The patent claims methods of treating diabetes, reducing HbA1C, reducing fasting plasma glucose, or reducing body weight by administering sustained-release exendin-4 or an exendin analog.

The patent’s central limitation is pharmacokinetic rather than purely structural. The administered product must produce:

• A mean steady-state plasma concentration of at least 200 pg/mL;
• Maintenance of that concentration for at least one month; and
• Treatment of diabetes or a specified metabolic outcome.

The claims identify once-weekly subcutaneous administration and a 2-mg dose as narrower embodiments. They also identify a specific formulation containing 5% exendin-4, 2% sucrose, and 93% purified 50:50 poly(D,L-lactide-co-glycolide).

Core patent information

Field	Data
Patent	US 9,884,092 B2
Title	Methods of treating diabetes using exendin-4
Technology	Sustained-release exendin-4 and exendin analog therapy
Primary therapeutic area	Type 2 diabetes
Principal active ingredient	Exendin-4, also known as exenatide
Primary assignee history	Amylin Pharmaceuticals and related successors
Patent type	Utility patent; method-of-treatment claims
Grant date	February 6, 2018
Core concentration threshold	At least 200 pg/mL
Duration requirement	At least one month
Narrow weekly dose	2 mg once weekly
Key polymer	50:50 poly(D,L-lactide-co-glycolide)
Commercial product most closely implicated	Bydureon and Bydureon BCise
Nominal patent-term basis	Earliest claimed nonprovisional priority date, subject to terminal disclaimers and patent-term adjustment

Patent term and terminal-disclaimer information should be determined from the USPTO Patent Center record and the relevant continuation-family records. The patent’s commercial relevance depends on whether it remains listed for a specific approved product and whether any later patent or regulatory exclusivity provides a separate barrier.[1]

What do the claims of US 9,884,092 cover?

Claim 1 is the broadest independent claim in the supplied claim set. It covers a method of treating diabetes by administering sustained-release exendin-4 or an exendin analog in an amount sufficient to achieve a mean steady-state plasma concentration of at least 200 pg/mL for at least one month.

The claim has five material elements:

1. A human patient with diabetes;
2. Administration of a sustained-release pharmaceutical composition;
3. Exendin-4 or an exendin analog as the active agent;
4. A mean steady-state plasma concentration of at least 200 pg/mL; and
5. Maintenance of that concentration for at least one month.

A product could contain exenatide and use a sustained-release system without infringing claim 1 if it did not achieve the claimed pharmacokinetic profile. Conversely, a product with a different sustained-release technology could potentially fall within the claim if it met the concentration and treatment limitations.

Scope of the independent claims

Claim 15 covers a parallel method directed to reducing HbA1C, fasting plasma glucose, or body weight. It also requires continuous administration and the same minimum concentration and one-month duration.

The distinction between claims 1 and 15 is commercially important:

• Claim 1 is directed to treating diabetes.
• Claim 15 is directed to defined clinical outcomes.
• A product may be vulnerable under claim 15 even if the patentee encounters a dispute over the scope of “treating diabetes.”
• Clinical data showing reductions in HbA1C, fasting glucose, or weight can support infringement allegations under claim 15.

How do the dependent claims narrow the patent?

The dependent claims impose progressively narrower limitations.

Claims	Limitation
2, 15	Continuous-mode administration
3, 16	Once-weekly subcutaneous injection
4	2 mg once weekly
5	Composition contains exendin-4
6, 7	Composition contains specified exendin analogs
8	Sugar is present
9, 10	PLGA, including purified 50:50 PLGA
11, 17	5% exendin-4, 2% sucrose, 93% PLGA
12, 21	Sustained minimum concentration of 200 to 350 pg/mL
13, 22	Co-administration with metformin, sulfonylurea, thiazolidinedione, or combinations
14	Type 2 diabetes
18	HbA1C reduction
19	Fasting plasma glucose reduction
20	Body-weight reduction

Claims 11 and 17 are the most formulation-specific claims. They closely track the composition used in exenatide extended-release microsphere products. They are narrower than the independent claims because they require a particular weight ratio and excipient-polymer system.

What formulation is protected by US 9,884,092?

The most specific protected formulation is:

• 5% by weight exendin-4;
• 2% by weight sucrose; and
• 93% by weight PLGA copolymer.

Claim 10 narrows the polymer to purified 50:50 poly(D,L-lactide-co-glycolide), meaning equal lactide and glycolide content with the D,L polymer configuration.

The claims do not require every formulation to use this composition. Claims 1 and 15 can reach other sustained-release compositions if the pharmacokinetic and therapeutic limitations are met. The formulation claims, however, require the specified exendin-4, sucrose, and PLGA composition.

What is not directly claimed?

The supplied claims do not expressly claim:

• An implant or osmotic pump device;
• A particular microsphere manufacturing process;
• A specific particle-size distribution;
• A specific polymer molecular weight;
• A particular injection device;
• A brand name;
• Exenatide immediate-release injection;
• Lixisenatide, liraglutide, semaglutide, dulaglutide, or tirzepatide;
• A product defined only by chemical composition without the claimed method of use.

Those technologies may be protected by separate patents.

How does the patent relate to Bydureon and Bydureon BCise?

Bydureon is an extended-release exenatide product administered once weekly by subcutaneous injection. The original Bydureon formulation uses exenatide encapsulated in PLGA microspheres. The product was approved by the FDA in 2012, and Bydureon BCise, an autoinjector presentation, was approved later.[2]

The supplied claims align closely with the principal Bydureon clinical and formulation characteristics:

Patent limitation	Bydureon relationship
Exendin-4	Bydureon contains exenatide
Sustained release	Bydureon uses extended-release microspheres
Once-weekly subcutaneous dosing	Matches labeled administration
2-mg dose	Matches the standard Bydureon dose
PLGA polymer	Matches the microsphere delivery platform
HbA1C reduction	Established labeled clinical benefit
Type 2 diabetes	Approved indication

The key infringement issue is not simply whether a product is Bydureon. It is whether the product’s approved method, formulation, and pharmacokinetic profile satisfy every asserted claim limitation. The 200-pg/mL threshold is particularly important because it may require analysis of clinical pharmacokinetic data, population averages, sampling methodology, and the meaning of “mean steady state.”

What is the Orange Book status of US 9,884,092?

The FDA Orange Book identifies patents submitted by approved drug sponsors for listed drug products. A patent may be listed as a composition-of-matter patent, a formulation patent, a method-of-use patent, or another patent category recognized by FDA procedures.[3]

For a method-of-use patent such as US 9,884,092, the relevant Orange Book issue is whether the patent was submitted for Bydureon or Bydureon BCise and whether the approved labeling contains the patented method. The product label would need to correspond to the claimed use, such as treatment of type 2 diabetes or reduction of HbA1C.

An Orange Book listing does not itself prove validity or infringement. It does affect generic approval timing because an ANDA applicant must address listed patents through:

• Paragraph I certification;
• Paragraph II certification;
• Paragraph III certification; or
• Paragraph IV certification.

A Paragraph IV certification asserts that the listed patent is invalid, unenforceable, or not infringed.[4]

When does US 9,884,092 lose exclusivity?

The patent’s enforceable expiration date depends on the earliest relevant nonprovisional priority date, patent-term adjustment, terminal disclaimers, and any applicable patent-term extension. A continuation patent generally receives the term of the earliest effective nonprovisional application in the chain rather than a new 20-year term.

The patent was granted on February 6, 2018. The nominal expiration is expected to fall in the late 2020s if the family claims priority to a 2006 or 2007 nonprovisional filing. The precise expiration date must be taken from the USPTO patent record, not inferred from the grant date.

FDA exclusivity is separate from patent exclusivity:

• New chemical entity exclusivity generally lasts five years, but exenatide was approved substantially earlier.
• Three-year clinical-investigation exclusivity may apply to a later dosage form or change supported by new clinical studies.
• Orphan-drug exclusivity does not generally apply to type 2 diabetes exenatide products.
• Patent protection can continue after FDA exclusivity ends.

Which companies are challenging the exenatide patent estate?

The main competitive threat is from generic or follow-on exenatide extended-release products rather than biosimilars. Exenatide is a peptide drug, but FDA approval of a follow-on product would generally proceed through an abbreviated application or other applicable pathway, not the biosimilar pathway reserved for biological products licensed under the Public Health Service Act.[5]

Potential challengers would focus on:

• Noninfringement of the 200-pg/mL threshold;
• Failure to maintain the concentration for one month;
• A different dosing interval;
• A different delivery system;
• Lack of literal overlap with the 5%/2%/93% formulation;
• Invalidity based on anticipation or obviousness;
• Written-description or enablement issues involving the broad analog sequence listing;
• Indefiniteness surrounding “mean steady state plasma concentration.”

No company can be treated as a confirmed Paragraph IV challenger solely because it develops an exenatide product. A confirmed challenge requires an ANDA notice, FDA filing disclosure, court docket, or sponsor announcement.

How strong is the patent estate for exenatide extended release?

US 9,884,092 is strongest against a product that reproduces the full Bydureon profile: 2 mg of exenatide, once-weekly subcutaneous dosing, PLGA microspheres, and a plasma concentration within the claimed range.

Its relative weaknesses are:

• It is not a broad composition-of-matter claim to exenatide.
• It relies on pharmacokinetic performance that may vary across patients and studies.
• It is directed to methods, creating distinct inducement and divided-infringement issues.
• Alternative polymers, implants, dosing frequencies, or concentrations may avoid narrower claims.
• The claims do not independently cover every manufacturing step.

The wider exenatide patent estate may include separate patents covering PLGA microspheres, drug-loading processes, release kinetics, delivery devices, formulations, and use of exenatide in combination therapy. Freedom-to-operate analysis therefore requires review of the entire continuation and related-family portfolio, not US 9,884,092 alone.

What generic entry risks exist?

A generic applicant seeking approval for an equivalent weekly exenatide extended-release product would face four principal risks:

1. Orange Book-listed method-of-use patents could trigger a Paragraph IV dispute.
2. The reference product’s formulation may overlap claims 9 to 11 and 17.
3. Pharmacokinetic equivalence could support an infringement theory under claims 1, 3, 4, 12, 15, 16, and 21.
4. Product labeling that encourages treatment of type 2 diabetes or HbA1C reduction could support induced-infringement allegations.

A design-around product could reduce risk by using a different polymer system, a different dose, a nonweekly schedule, or a pharmacokinetic profile outside the claimed concentration range. Such changes could create regulatory equivalence problems even if they reduce patent exposure.

How does US 9,884,092 compare with competing GLP-1 drugs?

Product	Active ingredient	Delivery	Relationship to US 9,884,092
Bydureon	Exenatide	Weekly PLGA microspheres	Closest potential overlap
Byetta	Exenatide	Twice-daily injection	Generally outside weekly sustained-release limitations
Trulicity	Dulaglutide	Weekly injection	Different peptide and delivery technology
Ozempic	Semaglutide	Weekly injection	Different peptide and formulation
Victoza	Liraglutide	Daily injection	Different peptide and schedule
Mounjaro	Tirzepatide	Weekly injection	Different active ingredient and patent estate

The patent does not create a general monopoly over weekly GLP-1 therapy. Its scope is tied to exendin-4 or specified exendin analogs and the claimed concentration-based treatment method.

Key Takeaways

• US 9,884,092 is primarily a method-of-treatment patent for sustained-release exendin-4.
• The central limitation is a mean steady-state plasma concentration of at least 200 pg/mL for at least one month.
• The narrowest commercial embodiment is 2 mg of exenatide administered once weekly by subcutaneous injection.
• Claims 11 and 17 target a 5% exendin-4, 2% sucrose, 93% purified 50:50 PLGA formulation.
• Bydureon and Bydureon BCise are the products with the closest technical overlap.
• The patent does not broadly cover all GLP-1 drugs, all exenatide products, or all sustained-release devices.
• Generic risk depends on Orange Book listing, the approved label, pharmacokinetic data, formulation identity, and the patent’s verified expiration date.
• The exact enforceable expiration date requires the USPTO record, including patent-term adjustment and any terminal disclaimer.

FAQs

Does US 9,884,092 cover immediate-release exenatide?

No. The supplied claims require a sustained-release composition and, in most claims, a concentration maintained for at least one month. Immediate-release exenatide generally would not satisfy those limitations.

Does the patent cover semaglutide or tirzepatide?

No. The claims are directed to exendin-4 or specified exendin analogs. Semaglutide and tirzepatide are protected by separate patent estates.

Can a weekly exenatide product avoid US 9,884,092?

Potentially, if it does not meet one or more limitations, such as the claimed plasma concentration, formulation composition, dose, or treatment outcome. Avoidance would require claim-by-claim analysis of the product and labeling.

Is US 9,884,092 a formulation patent?

Partly. Claims 9 to 11 and 17 contain formulation limitations, but the independent claims are method claims. The patent does not claim the PLGA formulation in isolation across all uses.

Does FDA approval end when the patent expires?

No. FDA approval and patent rights are separate. A product can remain approved after patent expiration, while a generic applicant may face patent litigation before expiration.

References

1. United States Patent and Trademark Office. (n.d.). Patent Center: US Patent No. 9,884,092. U.S. Department of Commerce.

2. U.S. Food and Drug Administration. (2012). BYDUREON (exenatide extended-release) prescribing information. FDA.

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

4. U.S. Food and Drug Administration. (2003). Guidance for industry: 180-day generic drug exclusivity under the Hatch-Waxman amendments. FDA.

5. U.S. Food and Drug Administration. (2020). Considerations in demonstrating interchangeability with a reference product: Guidance for industry. FDA.

Drugs Protected by US Patent 9,884,092

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	9,884,092*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	9,884,092*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		DISCN	Yes	No	9,884,092*PED				Y

International Family Members for US Patent 9,884,092

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006283517
Australia	2011200663
Australia	2013205769
Brazil	PI0615358