US Patent 8,426,392: Ulipristal Acetate Food-Effect Claims, Exclusivity, and Patent Landscape

US Patent No. 8,426,392 protects a specific method of using ulipristal acetate for emergency contraception when the drug is administered orally with food. Its broadest claim requires a 20-to-30 mg dose administered after unprotected intercourse in an oral dosage form with food. The patent also contains narrower claims directed to a 30 mg tablet, administration within 72 hours, high-fat food, specific excipient ranges, and defined pharmacokinetic changes.

The patent is materially different from a conventional compound patent. It does not broadly claim ulipristal acetate itself. Its commercial significance depends on whether a generic applicant’s proposed label, instructions, formulation, or promotional conduct would encourage administration of ulipristal acetate with food.

What does US Patent 8,426,392 cover?

US 8,426,392 covers food-associated administration of ulipristal acetate for emergency contraception. The claim set has four principal elements:

The therapeutic indication is emergency contraception.
The patient is a female subject who has had unprotected intercourse.
The dose is approximately 20 mg to 30 mg, generally corresponding to the marketed 30 mg product.
Administration occurs in an oral dosage form with food.

The patent does not cover every use of ulipristal acetate. Administration without food falls outside the literal scope of claim 1 unless another claim or doctrine applies. The patent also does not appear, from the supplied claims, to cover non-contraceptive uses of ulipristal acetate, such as treatment of uterine fibroids.

Claim-by-claim scope

Claim	Subject matter	Relative breadth
1	Emergency contraception using 20-30 mg oral ulipristal acetate after intercourse, administered with food	Broadest independent method claim
2	Administration before or after food ingestion	Clarifies timing around food
3	Administration with high-fat food	Narrower food condition
4	Oral dosage form is a tablet	Product-form limitation
5	Dose is 30 mg	Commercially important limitation
6	Administration within 72 hours after intercourse	Aligns with the principal labeled use
7	Administration simultaneously with food ingestion	Narrow timing limitation
8	Tablet with specified ranges of active ingredient, diluent, binder, croscarmellose sodium and magnesium stearate	Formulation-dependent method claim
9	Administration produces specified Cmax, AUC and Tmax changes versus fasting administration	Pharmacokinetic result limitation

Claim 1 is the principal infringement risk for a product label that expressly directs users to take a 30 mg ulipristal acetate tablet with food. Claims 5 and 6 closely track the commercial emergency contraceptive product and its ordinary use. Claim 8 is narrower because the accused tablet must satisfy every listed compositional range.

How strong is the patent estate for ulipristal acetate emergency contraception?

The estate is strongest when evaluated as a layered portfolio rather than through US 8,426,392 alone.

Protection category	Representative relevance to ulipristal acetate	Strategic role
Active compound protection	Earlier patents covering ulipristal acetate or related selective progesterone receptor modulators	Core chemical exclusivity
Product and formulation protection	Tablet composition and pharmaceutical formulation claims	Limits alternative dosage forms
Food-effect method claims	US 8,426,392	Targets administration instructions involving food
Method-of-use protection	Emergency contraception and other therapeutic uses	Supports Orange Book and Paragraph IV enforcement
Regulatory exclusivity	FDA new chemical entity exclusivity for the original NDA	Operated independently from patent term
Trade dress and regulatory labeling	Product identity, label and distribution controls	Commercial, rather than patent, barriers

US 8,426,392 is narrower than a compound patent but commercially relevant because its claims correspond to the 30 mg oral emergency contraceptive product. Its strength depends on three issues: whether the generic label encourages use with food, whether the marketed tablet falls within claim 8, and whether the pharmacokinetic limitations in claim 9 can be proven for the accused product.

What are the patent expiration dates for ulipristal acetate and US 8,426,392?

The patent term for US 8,426,392 is generally calculated from the earliest effective nonprovisional or international filing date under the modern 20-year patent-term framework. Based on the patent’s priority structure, its nominal expiration falls in December 2030, subject to any applicable patent-term adjustment, terminal disclaimer, or other USPTO term calculation.

The key distinction is between the patent’s nominal term and regulatory exclusivity:

Exclusivity right	Approximate end point	Effect
FDA five-year new chemical entity exclusivity for ella	August 2015	Restricted ANDA submission during the initial exclusivity period, subject to statutory exceptions
Earlier core ulipristal acetate patent rights	Approximately 2025, depending on the specific patent and term adjustments	Potentially relevant to early generic entry
US 8,426,392	Approximately December 2030	Later method and formulation protection
FDA exclusivity	Does not extend patent duration	Separate statutory right

The precise expiration date should be taken from the USPTO patent-term record rather than inferred solely from the grant date. Patent term adjustment and terminal-disclaimer data can change the operative date.

What is the Orange Book status of US Patent 8,426,392?

The relevant reference product is ella, an oral 30 mg ulipristal acetate emergency contraceptive approved under FDA NDA 022474. FDA product information identifies ulipristal acetate as the active ingredient and describes administration after unprotected intercourse, generally within five days. The supplied claims focus on administration within 72 hours and with food, which may correspond to a listed method of use or a formulation-related Orange Book entry depending on the applicable FDA listing.

Orange Book listing is important because it can require an ANDA applicant to address the patent through one of four certifications:

Paragraph I: no patent information is listed.
Paragraph II: the patent has expired.
Paragraph III: the applicant will wait until patent expiration.
Paragraph IV: the patent is invalid, unenforceable or will not be infringed.

A Paragraph IV certification can trigger notice to the NDA holder and patent owner. If litigation begins within the statutory period, FDA approval may be stayed for up to 30 months, subject to statutory exceptions and court action.

A method-of-use patent presents a narrower Orange Book issue than a compound patent. An ANDA applicant may attempt a section viii “skinny label” that omits the patented use or instruction. That strategy is difficult where the patented use is the principal or only approved use of the reference product, or where the remaining label still encourages the patented administration.

How do the claims affect Paragraph IV generic entry?

The most important claim is claim 1 because it captures the core combination of emergency contraception, oral ulipristal acetate, a 20-to-30 mg dose, and administration with food.

A generic applicant could pursue several positions:

Generic strategy	Potential exposure
Label instructs patients to take the tablet with food	High risk under claim 1
Label says the product may be taken with or without food	Depends on the wording, regulatory context and inducement evidence
Label omits food instructions entirely	Reduces direct label-based risk but may not eliminate induced-infringement arguments
Product is a different dosage form	Avoids claim 4 but not necessarily claim 1
Dose is outside 20-30 mg	May avoid literal claim 1, but could create regulatory and therapeutic problems
Product is not marketed for emergency contraception	Avoids the claimed indication but may not be commercially viable
Tablet composition falls outside claim 8	Avoids claim 8 but does not avoid claims 1, 5 or 6
No clinical evidence of the claim 9 food effect	May avoid claim 9, subject to proof and claim construction

The “with food” limitation is central. Under induced-infringement principles, the generic label, prescribing information, patient instructions, website content, sales materials and regulatory submissions can all be relevant to whether the manufacturer encourages the patented method. The Supreme Court’s decisions in Warner-Lambert v. Teva and GlaxoSmithKline v. Teva demonstrate that label language and the commercial context can materially affect induced-infringement analysis. [4][5]

A section viii strategy is more credible if the approved generic label can omit the food-related method without undermining the FDA-required labeling for emergency contraception. If the FDA label continues to state that the product can be taken with or without food, the legal exposure will depend on whether the “with food” option is treated as an encouraged patented use rather than merely an unavoidable or incidental use.

What formulations are protected by claim 8?

Claim 8 covers a tablet containing all of the following composition ranges:

Component	Claimed range by weight
Ulipristal acetate	3%-18%
Diluent	60%-95%
Binding agent	1%-10%
Croscarmellose sodium	1%-5.5%
Magnesium stearate	1%-4%

The claim is not satisfied merely because a tablet contains ulipristal acetate and these excipients. Every range must be met, subject to ordinary claim-construction principles. A design-around could alter the diluent, binder, disintegrant, lubricant, or relative concentrations. That approach may avoid claim 8 while leaving the broader method claims intact.

The ranges also create a potential analytical dispute. Pharmaceutical compositions frequently contain excipients with overlapping functions, and the parties may contest whether a particular material is a “diluent” or “binding agent.” The patent’s specification and prosecution history would control how those terms are interpreted.

How significant is claim 9’s pharmacokinetic limitation?

Claim 9 requires a defined food effect compared with administration without food:

Mean Cmax decreases by approximately 40%-45%.
Mean AUC0-∞ increases by approximately 20%-25%.
Median Tmax is delayed by at least approximately 1.5 hours.

This is a narrower, evidence-intensive claim. Infringement would likely require pharmacokinetic data for the accused product under fed and fasting conditions. Bioequivalence data submitted to FDA could become relevant, but the regulatory record may not map directly onto every limitation in claim 9.

The claim creates two potential vulnerabilities:

The accused product may not produce all three claimed effects within the stated ranges.
The ranges may raise issues concerning experimental variability, confidence intervals, study design and whether “about” permits a statistically meaningful deviation.

Claim 9 is therefore less likely than claim 1 to provide a simple label-based infringement theory. It may nevertheless increase litigation cost because it creates a fact-intensive technical dispute.

What litigation and settlement risks affect generic launch?

A generic launch risk analysis should separate four events:

Submission of an ANDA with a Paragraph IV certification.
Notice to the patent owner and NDA holder.
Patent litigation within the statutory period.
FDA approval after the 30-month stay or earlier court resolution.

A settlement could provide a launch date before patent expiration, an authorized-generic arrangement, a license, or restrictions on the label. Publicly known settlement terms cannot be inferred from the claims alone. No settlement should be assumed without reviewing district-court dockets, FDA correspondence and the parties’ public disclosures.

The principal litigation theories are likely to include:

Invalidity for lack of novelty or obviousness based on prior food-effect and emergency-contraception disclosures.
Noninfringement based on label language that does not direct administration with food.
Noninfringement of claim 8 based on excipient percentages.
Noninfringement of claim 9 based on failure to meet the pharmacokinetic ranges.
Inequitable conduct or unenforceability defenses, if supported by prosecution-history evidence.

How does ella compare with competing emergency contraceptives?

Product	Active ingredient	Typical dosage	Food-related relevance	Patent risk profile
ella	Ulipristal acetate	30 mg	Food-effect claims directly relevant	Core and method/formulation patents
Plan B and levonorgestrel products	Levonorgestrel	1.5 mg	Food claims for ulipristal acetate do not apply	Separate product and formulation estates
Copper intrauterine device	Copper device	Device-based	Not an oral food-effect product	Device and procedure-related protection

Ulipristal acetate has a distinct patent risk profile because US 8,426,392 ties the commercial 30 mg product to a specific fed-administration method. Levonorgestrel products do not fall within these claims merely because they compete in the same emergency-contraception market.

There is no biosimilar pathway for ella. Ulipristal acetate is a small molecule, so a competing manufacturer would generally use the ANDA pathway rather than the biologics license application and biosimilar pathway.

What are the main geographic and manufacturing barriers?

US 8,426,392 is a US patent. It does not directly block manufacture, sale or use outside the United States. International protection must be assessed through corresponding national patents in the relevant jurisdictions. Patent families may contain different claim scopes, expiration dates, prosecution outcomes and validity positions.

Manufacturing risk is concentrated in two areas:

A tablet manufacturer may reproduce the claimed excipient ranges even if it attempts to design around the method claims.
A generic applicant may avoid claim 8 but still face method-of-use exposure through its label.

The active pharmaceutical ingredient itself may also be subject to separate manufacturing, process, polymorph or composition patents. Those rights are distinct from the food-effect claims and require separate family-level analysis.

Key Takeaways

US 8,426,392 is a method-of-use and formulation-linked patent, not a broad ulipristal acetate compound patent.
Claim 1 is the principal commercial claim because it covers 20-30 mg oral ulipristal acetate for emergency contraception administered with food.
Claims 5 and 6 closely track the commercial 30 mg product and administration within 72 hours.
Claim 8 can be designed around by changing the tablet composition, but that does not necessarily avoid claims 1, 5 or 6.
Claim 9 requires specific pharmacokinetic results and is more technically difficult to enforce.
The patent’s nominal expiration is approximately December 2030, subject to USPTO term adjustments and other term provisions.
FDA NCE exclusivity for ella ended years before the patent’s expected expiration.
A Paragraph IV applicant’s principal defenses would likely involve noninfringement based on label wording, section viii carve-out issues, and invalidity of the food-effect claims.
Ulipristal acetate is a small molecule, so biosimilar litigation is not relevant. Generic entry would proceed through the ANDA framework.
The commercial exposure is concentrated in ella and any generic 30 mg ulipristal acetate product seeking the same emergency-contraception indication.

FAQs

Does US 8,426,392 cover taking ella without food?

No. The supplied claims require administration “with food” or specify food-related conditions. Administration without food, standing alone, does not satisfy that limitation.

Can a generic manufacturer avoid the patent by using a capsule instead of a tablet?

A capsule could avoid claim 4 and may avoid claim 8 if its composition differs. It would not automatically avoid claim 1, which covers an oral dosage form without limiting the dosage form to a tablet.

Does the patent cover ulipristal acetate used for uterine fibroids?

Not based on the supplied claims. Each claim is directed to emergency contraception after unprotected intercourse.

Is a 30 mg ulipristal acetate generic automatically blocked until 2030?

No. The answer depends on all unexpired patent claims, Orange Book listings, Paragraph IV certifications, possible litigation, label design and any settlement or license.

Can FDA approve a generic while US 8,426,392 remains in force?

Yes, FDA approval and patent enforcement are separate systems. A generic may receive approval after satisfying patent-certification and stay requirements, but commercial launch may remain exposed to patent litigation or a court injunction.

References

U.S. Patent No. 8,426,392, “Methods of administering ulipristal acetate,” issued Apr. 23, 2013.
U.S. Food and Drug Administration. (2010). Ella (ulipristal acetate) tablet, 30 mg: Prescribing information. NDA 022474.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
Warner-Lambert Co. v. Teva Pharmaceuticals USA, Inc., 669 F. Supp. 2d 430 (D.N.J. 2009), rev’d in part, 2010 WL 2652472 (Fed. Cir. June 30, 2010).
GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021), rehearing en banc granted in part and opinion modified, 2022 WL 819877 (Fed. Cir. Mar. 17, 2022).
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term information. USPTO.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,426,392	⤷ Start Trial				ELLA IS A PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2011069871	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,426,392

Which drugs does patent 8,426,392 protect, and when does it expire?

Summary for Patent: 8,426,392