United States Patent 8,906,950: Scope, Claims, Expiration, Orange Book Status, and Ketorolac Patent Landscape

United States Patent No. 8,906,950 protects methods of treating ocular pain and burning with a lower-strength 0.4% ketorolac tromethamine ophthalmic composition administered no more than four times daily. Its narrower claims cover a specified preservative and excipient system, while dependent claims cover treatment after refractive surgery, cataract surgery, or allergic conjunctivitis. The patent does not broadly claim ketorolac ophthalmic compositions as chemical products; it claims therapeutic use of those compositions.

The patent issued December 9, 2014, to Allergan, Inc. Its nominal patent-term expiration is September 30, 2029, based on the reported priority date of September 30, 2009. The effective date should be confirmed against the USPTO patent record for any patent-term adjustment.

What does U.S. Patent 8,906,950 protect?

The patent protects a dosing method using aqueous ophthalmic ketorolac tromethamine at 0.4% w/v. The central commercial concept is that 0.4% ketorolac can provide substantially comparable efficacy to 0.5% ketorolac while reducing ocular tolerability problems.

The independent claim architecture is:

Claim	Protected subject matter	Breadth
1	Treatment of ocular pain and burning with aqueous 0.4% ketorolac tromethamine, administered no more than four times daily	Broadest method claim
2	Claim 1 plus edetate disodium, benzalkonium chloride, Octoxynol-40, and pH 7.2-7.6	Formulation-specific
3	A specific formulation containing 0.4% ketorolac, 0.015% edetate disodium, 0.006% benzalkonium chloride, 0.003% Octoxynol-40, 0.79% sodium chloride, and pH 7.2-7.6	Narrowest composition-defined method
4	Claim 1 plus substantially equivalent efficacy to 0.5% ketorolac at the same dosing frequency	Comparative-performance claim
5	Claim 4 plus reduced ocular side effects	Comparative safety claim

Claims 6 through 16 add treatment indications, formulation limitations, efficacy comparisons, and specified adverse effects.

How should the independent claims be construed?

Claim 1: broad 0.4% ketorolac method claim

Claim 1 requires each of the following:

Treatment of ocular pain and burning.
Topical administration.
An aqueous composition.
0.4% w/v ketorolac tromethamine.
Administration no more than four times daily.

The phrase “no more than four times daily” covers dosing frequencies from once daily through four times daily. A product labeled for four-times-daily administration would fall within the dosing limitation if the other elements are met.

Claim 1 does not expressly require:

A particular preservative.
A particular pH.
Sodium chloride.
A particular bottle or delivery device.
A specific postoperative indication.
A demonstrated reduction in adverse events.
A comparison with 0.5% ketorolac.

The claim is therefore the principal blocking claim for a conventional 0.4% ketorolac ophthalmic product used for ocular pain or burning.

Claims 2 and 3: formulation-specific method protection

Claim 2 requires the following excipient ranges:

Ingredient	Claimed concentration
Ketorolac tromethamine	0.4% w/v
Edetate disodium	About 0.001% to about 0.05% w/v
Benzalkonium chloride	About 0.004% to about 0.007% w/v
Octoxynol-40	About 0.001% to about 0.005% w/v
pH	About 7.2 to about 7.6

Claim 3 narrows the formulation to approximately:

0.4% w/v ketorolac tromethamine;
0.015% w/v edetate disodium;
0.006% w/v benzalkonium chloride;
0.003% w/v Octoxynol-40;
0.79% w/v sodium chloride; and
pH from about 7.2 to about 7.6.

Claim 3 is materially narrower than Claim 2 because it recites specific concentrations rather than ranges. A competing product outside one or more of the stated ingredient or pH limitations may avoid literal infringement of Claim 3, although the broader Claim 2 or Claim 1 may remain relevant.

The use of “about” creates ordinary pharmaceutical claim-construction issues. Courts generally assess the term in light of the specification, analytical measurement variability, formulation practice, and prosecution history. Small numerical deviations do not automatically avoid infringement.

What do Claims 4 through 16 add?

Claims 4 through 16 protect the clinical positioning of 0.4% ketorolac against 0.5% ketorolac.

Claim 4 requires that the 0.4% method be “substantially as effective” as topical administration of 0.5% ketorolac at the same dosing frequency. Claim 5 further requires reduced ocular side effects.

The specified side effects include:

Ocular discomfort.
Ocular irritation.
Ocular stinging.
Ocular burning.
Foreign-body sensation.

These claims are narrower than Claim 1 but create evidentiary issues. An infringement analysis would likely examine the accused product’s label, clinical study data, regulatory submissions, promotional materials, and dosing instructions. The comparative limitations may also create vulnerability to challenges based on indefiniteness, written description, enablement, or lack of objective boundaries, depending on the patent specification and prosecution history.

Claims 6 through 9 extend the method claims to pain and burning caused by:

Corneal refractive surgery.
Cataract surgery.
Allergic conjunctivitis.

Claims 10, 15, and 16 define reduced ocular side effects through the listed symptoms. These claims do not create a separate product claim. They remain method claims requiring the underlying 0.4% ketorolac treatment and the relevant comparative result.

When does U.S. Patent 8,906,950 lose exclusivity?

The nominal expiration date is September 30, 2029. The patent issued on December 9, 2014, and identifies a priority date in 2009. Under the Hatch-Waxman framework, the relevant commercial barrier may end earlier or later depending on:

Patent-term adjustment.
Any terminal disclaimer.
Orange Book listing status.
ANDA certifications.
Litigation.
A settlement or license.
Separate patents covering the approved product.

Patent expiration does not itself determine when a generic can launch. A generic applicant may launch before expiration after prevailing in litigation, obtaining a favorable settlement date, or accepting a licensed entry date.

Event	Date or status
Earliest reported priority date	September 30, 2009
Patent issued	December 9, 2014
Nominal patent expiration	September 30, 2029
Core protected product concept	0.4% ketorolac ophthalmic treatment
Patent type	Method-of-treatment patent
PTE relevance	No established PTE identified
PTA relevance	Must be checked in the USPTO record

Sources for the controlling term are the patent’s front page, USPTO Patent Center, and any FDA Orange Book listing for the relevant NDA.[1,2]

What is the Orange Book status of U.S. Patent 8,906,950?

The patent’s commercial significance depends heavily on whether it is listed in the FDA Orange Book against the approved 0.4% ketorolac product and which use code is associated with it.

An Orange Book-listed method patent can require an ANDA applicant to submit one of four certifications:

Certification	Meaning
Paragraph I	No patent information has been submitted
Paragraph II	The patent has expired
Paragraph III	The applicant will market after patent expiration
Paragraph IV	The patent is invalid, unenforceable, or will not be infringed

A Paragraph IV notice to the patent owner and NDA holder can trigger a 45-day period for filing an infringement action. A timely action can create a 30-month stay of ANDA approval, subject to statutory exceptions and court decisions.[3]

The relevant FDA product is ketorolac tromethamine ophthalmic solution 0.4%, commercially associated with Acular LS. FDA records should be reviewed by NDA number and product strength because a patent listed against the 0.4% product may not necessarily block an ANDA for 0.5% ketorolac or a different indication.[4]

Which products and competitors are most exposed?

The highest-risk products are generic or follow-on ophthalmic solutions that match all of the following:

0.4% w/v ketorolac tromethamine;
aqueous formulation;
topical ophthalmic administration;
labeling for ocular pain or burning;
administration four times daily or less; and
use after cataract or refractive surgery.

A generic product can face different risk depending on its labeling strategy. If the proposed label includes only an indication outside the asserted claim scope, the manufacturer may pursue a section viii statement or carve out protected use, if FDA permits the proposed labeling. That strategy may not eliminate risk where the approved label, prescribing information, promotional activity, or actual use supports the claimed indication.

0.5% ketorolac products

A 0.5% ketorolac product is not literally within the 0.4% limitation. Claims 4, 5, and 11 through 16 use 0.5% ketorolac as the comparator, not as the accused treatment composition. A 0.5% product therefore presents a different patent profile from a 0.4% product.

0.4% ketorolac products

A competing 0.4% product is the principal target of Claim 1. The presence or absence of the claimed excipients determines exposure under Claims 2 and 3. A formulation that omits Octoxynol-40 may avoid Claims 2 and 3, but it would still require analysis under Claim 1 and any related patent family members.

Preservative-free products

A preservative-free 0.4% ketorolac product may avoid the benzalkonium chloride and Octoxynol-40 limitations in Claims 2 and 3. It does not automatically avoid Claim 1, which does not require those excipients.

What formulation patents protect ketorolac ophthalmic products?

Patent 8,906,950 is primarily a use patent with formulation limitations. It should be analyzed alongside other patent categories:

Patent category	Typical protected subject matter	Relevance to a generic
Active ingredient patents	Ketorolac or salt forms	Usually expired or not central to modern ketorolac products
Formulation patents	pH, preservative system, surfactant, isotonicity, stability	Can block a matching formulation
Method-of-use patents	Postoperative pain, allergic conjunctivitis, dosing frequency	Can require Paragraph IV or section viii analysis
Device patents	Multidose containers, preservative delivery systems	Relevant to specific packaging
Manufacturing patents	Sterile filling, impurity control, process conditions	May create non-Orange Book freedom-to-operate issues
Regulatory exclusivity	New-drug, pediatric, or other FDA exclusivity	Can delay approval independently of patent term

The supplied claims do not cover manufacturing, sterilization, container closure systems, or a standalone composition. Those issues require review of the full patent family and related applications.

How strong is the patent estate?

The patent has meaningful practical strength against a conventional 0.4% ketorolac ophthalmic product because Claim 1 has relatively few technical limitations. Its weakness is that the claim is confined to a specific concentration and therapeutic method. A product with a different ketorolac strength, a different route, or a label that omits the claimed pain-and-burning use may have a stronger noninfringement position.

Strength factors

The claim directly targets the commercial 0.4% strength.
The dosing limitation corresponds to common ophthalmic dosing.
The claim covers multiple causes of ocular pain and burning.
Claims 2 and 3 provide fallback positions for the specified formulation.
Claims 4 through 16 add clinical-comparison limitations that may support the lower-strength product’s commercial rationale.

Weakness factors

The patent does not claim every ketorolac ophthalmic composition.
A different concentration can avoid literal infringement.
A preservative-free or materially different formulation may avoid the narrower claims.
“Substantially as effective” and “reduced ocular side effects” create proof and claim-construction issues.
Method claims require proof of the claimed treatment and, for some claims, the relevant clinical result.

What patent litigation and settlement risks affect generic entry?

A Paragraph IV challenger would likely focus on:

Noninfringement based on concentration, dosing, indication, or formulation.
Invalidity based on anticipation or obviousness over earlier ketorolac ophthalmic products and clinical studies.
Indefiniteness of comparative terms such as “substantially as effective.”
Lack of written description or enablement for the full scope of the claimed formulation ranges.
Improper patent listing or an overbroad use code.

The patent owner would likely rely on the commercial correspondence between the claimed 0.4% product, its four-times-daily regimen, and clinical data comparing 0.4% with 0.5% ketorolac.

No litigation judgment, settlement entry date, or license term should be inferred solely from the patent claims. Such information must be confirmed through FDA Paragraph IV records, district-court dockets, settlement disclosures, and company filings. AbbVie became the parent of Allergan in 2020, making AbbVie the relevant corporate successor for many Allergan pharmaceutical assets.[5]

Is there biosimilar risk for ketorolac ophthalmic products?

No. Ketorolac tromethamine is a small-molecule drug, not a biologic. FDA competition proceeds through the ANDA pathway rather than the biosimilar pathway under section 351(k) of the Public Health Service Act. The relevant competitive risks are generic approval, Paragraph IV litigation, section viii carve-outs, formulation differentiation, and launch timing.

What geographic coverage does the patent provide?

U.S. Patent 8,906,950 provides rights only in the United States and its territories. It does not directly block sales in Europe, Canada, Japan, or other markets. Parallel protection depends on foreign family members, national-phase filings, local prosecution, and local patent-term calculations.

A global freedom-to-operate review should distinguish:

U.S. method claims;
Foreign counterpart claims;
Product-label restrictions;
Local regulatory exclusivity;
Manufacturing location and export issues; and
Cross-border supply arrangements.

What generic launch scenarios exist?

Scenario	Commercial consequence
No challenge and Paragraph III certification	Launch generally waits until patent expiry
Paragraph IV challenge without litigation	FDA approval may proceed after statutory conditions are met
Paragraph IV litigation filed	Approval may be stayed for up to 30 months, subject to statutory exceptions
Successful noninfringement or invalidity judgment	Early launch may be possible
Settlement with licensed entry	Launch occurs on the negotiated date and terms
Section viii carve-out	Approval may proceed for nonprotected uses if FDA accepts the labeling
Alternative strength or formulation	May reduce exposure but requires separate regulatory and patent analysis

Key Takeaways

U.S. Patent 8,906,950 is a method-of-treatment patent centered on aqueous 0.4% ketorolac tromethamine.
Claim 1 is the principal broad claim and covers topical administration no more than four times daily for ocular pain and burning.
Claims 2 and 3 narrow protection to a defined preservative, surfactant, pH, sodium chloride, and edetate formulation.
Claims 4 through 16 protect comparative efficacy and reduced ocular side effects against 0.5% ketorolac.
The nominal expiration date is September 30, 2029, subject to USPTO patent-term adjustment.
The patent is most relevant to generic 0.4% ketorolac ophthalmic products, not ordinary 0.5% products.
A preservative-free or materially different 0.4% formulation may avoid the narrower formulation claims but remains exposed to Claim 1.
Ketorolac has generic, not biosimilar, competition.
Orange Book listing, use codes, Paragraph IV certifications, litigation, and settlement terms determine actual launch risk.
The claims do not independently establish protection for manufacturing processes, containers, or device systems.

FAQs

Can a generic avoid U.S. Patent 8,906,950 by using 0.39% ketorolac?

Possibly, but not automatically. The analysis would depend on the claim construction of “0.4%,” the formulation’s measured concentration, prosecution history, and potential equivalents arguments.

Does a preservative-free ketorolac product avoid all claims?

No. It may avoid Claims 2 and 3 if it lacks the specified excipients, but Claim 1 does not require benzalkonium chloride, Octoxynol-40, or edetate disodium.

Does a four-times-daily label fall within the patent?

Yes, assuming the product is an aqueous topical composition containing 0.4% ketorolac tromethamine and the labeled use treats ocular pain and burning.

Can a company sell 0.4% ketorolac for an unclaimed indication?

Potentially, subject to the approved label, Orange Book use code, actual marketing, induced-infringement risk, and any other patent claims covering the product.

Is the patent relevant to ketorolac injection or oral tablets?

No, not on the supplied claims. The claims require topical administration of an aqueous ophthalmic composition, so injectable and oral dosage forms fall outside their literal scope.

References

United States Patent and Trademark Office. (2014). U.S. Patent No. 8,906,950, Methods of treating ocular pain and burning.
United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
AbbVie Inc. (2020). AbbVie completes acquisition of Allergan. https://news.abbvie.com/**

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2468664	⤷ Start Trial
Canada	2967362	⤷ Start Trial
European Patent Office	3217937	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,906,950

Summary for Patent: 8,906,950