United States Patent 7,704,984: Claim Scope, Lo Loestrin Fe Coverage, Expiration, and Generic Competition
U.S. Patent No. 7,704,984 covers a specific 28-day low-dose oral contraceptive regimen: 24 days of norethindrone acetate or norethindrone combined with ethinyl estradiol, followed by 2 days of ethinyl estradiol alone and 2 placebo days. The claims closely correspond to the Lo Loestrin Fe regimen marketed by Warner Chilcott, now associated with the AbbVie/Allergan women’s-health portfolio. The patent is a method-of-use patent, not a composition-of-matter patent.
The core commercial embodiment is:
- 24 tablets containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol;
- 2 tablets containing 10 mcg ethinyl estradiol without progestin; and
- 2 placebo tablets containing approximately 75 mg ferrous fumarate.
The ordinary 20-year patent term from the relevant nonprovisional filing date places the patent’s base expiration in December 2024, subject to any patent-term adjustment, terminal disclaimer, or other statutory modification appearing in the official patent record.
What does U.S. Patent 7,704,984 cover?
Patent 7,704,984 covers a sequential contraceptive dosing method administered daily over a 28-day cycle. The independent claims require both the active ingredients and the order of administration.
| Claim element |
Required limitation |
| Patient |
Female of child-bearing age |
| First phase |
24 daily administrations |
| First phase progestin |
Norethindrone acetate or norethindrone |
| Progestin amount |
About 0.3 to about 1.5 mg norethindrone-acetate equivalent |
| First phase estrogen |
5 to 15 mcg ethinyl estradiol |
| Second phase |
2 daily administrations |
| Second phase estrogen |
5 to 15 mcg ethinyl estradiol |
| Second phase progestin |
Substantially absent |
| Third phase |
Placebo administration |
| Cycle |
28 consecutive daily administrations |
Claims 1 and 7 are the principal independent claims. Claim 1 defines the third composition as a placebo but does not expressly require two placebo days in the claim language supplied. Claim 7 expressly requires the placebo phase to last two days.
The patent does not broadly cover every combined oral contraceptive containing norethindrone acetate and ethinyl estradiol. It requires a particular low-dose regimen and sequence.
How do claims 1 and 7 differ?
Claims 1 and 7 overlap substantially, but claim 7 is more explicit about the duration of the placebo phase.
| Issue |
Claim 1 |
Claim 7 |
| First composition |
24 days |
24 days |
| Norethindrone acetate equivalent |
0.3 to 1.5 mg |
About 0.3 to 1.5 mg |
| Ethinyl estradiol in first phase |
5 to 15 mcg |
5 to 15 mcg |
| Second composition |
2 days |
2 days |
| Second phase |
Ethinyl estradiol, substantially free of progestin |
Ethinyl estradiol, substantially free of progestin |
| Placebo phase |
Placebo, duration less explicit in supplied text |
2 days |
| Total cycle |
28 days |
28 days |
Claim 1 is broader in one respect because the supplied text does not expressly state that the placebo is administered for two days. Claim 7 is narrower because it expressly requires a two-day placebo period. Both claims require the distinctive 24/2/2 sequence.
Claims 2 through 6 narrow claim 1. Claims 8 and 9 narrow claim 7.
What formulations are protected by U.S. Patent 7,704,984?
The strongest product match is the Lo Loestrin Fe formulation approved by the FDA:
| Phase |
Active ingredients |
Duration |
| Phase 1 |
Norethindrone acetate 1 mg plus ethinyl estradiol 10 mcg |
24 days |
| Phase 2 |
Ethinyl estradiol 10 mcg |
2 days |
| Phase 3 |
Ferrous fumarate approximately 75 mg |
2 days |
Claims 3, 4, 6, 8, and 9 are particularly relevant to that product:
- Claim 3 requires norethindrone acetate rather than norethindrone.
- Claim 4 requires approximately 1 mg norethindrone acetate.
- Claim 5 requires approximately 75 mg ferrous fumarate in the placebo.
- Claims 6 and 9 require the same ethinyl estradiol amount in the first and second compositions.
- Claims 8 and 9 apply those limitations to claim 7.
The ferrous fumarate limitation is not the central contraceptive mechanism. It is a claim limitation directed to the placebo tablets. A competing product could avoid dependent claim 5 by using placebo tablets without ferrous fumarate, while still potentially falling within claims 1, 2, 3, 4, 6, 7, 8, or 9.
Does the patent cover norethindrone-only or conventional 21/7 regimens?
No, not on the supplied claim language.
A norethindrone acetate product without ethinyl estradiol would not satisfy the first-composition requirement. A conventional 21 active/7 placebo regimen would not satisfy the required 24-day first phase, 2-day estrogen-only phase, and placebo phase.
A product containing ethinyl estradiol during the final two days but also containing a progestin would face a limitation issue because the second composition must be “substantially free of a progestin.” Whether a formulation is substantially free of progestin would depend on the formulation, concentration, analytical evidence, and claim construction.
A regimen using 24 days of active combination tablets followed by 4 placebo days would generally lack the required two-day estrogen-only phase and would not directly meet the independent claims.
What is the scope of the method-of-use claims?
The claims require performance of the regimen in a female of child-bearing age. They do not claim the tablets as physical products in the abstract. They claim the therapeutic use and sequence.
Potential infringement theories would therefore focus on:
- A generic label directing patients to use the claimed 24/2/2 regimen.
- Product packaging that supplies the same sequence.
- Physician or patient use of the regimen.
- Induced infringement based on instructions, labeling, promotional materials, or distribution practices.
A generic applicant seeking approval for the same FDA-approved regimen would face the method-of-use claims if the patent were listed and enforceable during the relevant period. A label carve-out could avoid a patented method only if the proposed labeling and resulting approved use did not encourage or require the claimed regimen. The practical value of a carve-out would depend on the approved indications, FDA labeling, and whether the patented use is separable from the product’s principal commercial use.
What is the relationship between the patent and Lo Loestrin Fe?
The claimed regimen corresponds closely to the FDA-approved Lo Loestrin Fe product. The product’s labeled dosing schedule uses 24 blue tablets containing norethindrone acetate and ethinyl estradiol, followed by 2 white tablets containing ethinyl estradiol, followed by 2 brown tablets containing ferrous fumarate or placebo-related excipients, depending on the labeling version. FDA labeling identifies the product as an oral contraceptive containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol in the principal active tablets. [2]
The patent’s commercial significance therefore arose from regimen protection rather than protection of a new hormone molecule. Norethindrone acetate and ethinyl estradiol were known active ingredients. The patent position depended on the low-dose 24/2/2 sequence and associated formulation details.
When did U.S. Patent 7,704,984 lose exclusivity?
The patent issued on April 27, 2010. Its relevant U.S. application claims priority to a December 2003 filing and was filed in December 2004. Under the general patent-term rule, the base term runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment and other statutory provisions. [1]
| Event |
Date |
| Earliest priority filing identified in the patent record |
December 22, 2003 |
| U.S. nonprovisional filing |
December 22, 2004 |
| Patent issued |
April 27, 2010 |
| Base 20-year term from nonprovisional filing |
December 22, 2024 |
| FDA approval of Lo Loestrin Fe |
July 2010 |
| FDA pediatric exclusivity |
Must be confirmed from the applicable Orange Book listing and regulatory record |
The base term is therefore December 22, 2024, before accounting for any patent-term adjustment. Patent term adjustment can extend the expiration date for qualifying USPTO delay. The controlling expiration date is the term shown in the USPTO patent record and the applicable FDA Orange Book listing.
What is the Orange Book status of the patent?
The patent was listed in connection with Lo Loestrin Fe and its corresponding norethindrone acetate/ethinyl estradiol product. Its listing function was to notify ANDA applicants that the product was subject to a patent covering the labeled contraceptive regimen.
The listing does not establish that every claim is valid or infringed. An ANDA applicant can challenge the patent through a Paragraph IV certification, seek approval after expiration, or pursue a section viii statement if the patented method can be carved out of the proposed label. The FDA Orange Book identifies listed patents and exclusivity data, but it does not adjudicate infringement or patent validity. [3]
Which companies challenged the Lo Loestrin Fe patent?
The relevant competitive field includes generic manufacturers seeking approval for norethindrone acetate and ethinyl estradiol tablets in the 1 mg/10 mcg strength and the associated 24/2/2 regimen. The legally relevant challenger is the ANDA applicant that filed a Paragraph IV certification against the listed patent.
Paragraph IV activity can generate patent litigation under the Hatch-Waxman Act. A timely notice letter may create a 45-day period for the patent owner to bring suit. A timely infringement action can trigger an FDA approval stay of up to 30 months, subject to statutory exceptions and court rulings. [4]
The patent record and Orange Book should be reviewed together because the identity of an ANDA challenger, the asserted claims, settlement terms, and approval timing can differ by applicant. A patent challenge may also involve other listed patents covering formulation, packaging, or related dosing features.
What patent litigation and settlements affect generic launch timing?
For this patent, launch timing depends on four variables:
- Whether the ANDA applicant filed a Paragraph IV certification.
- Whether the patent owner sued within the statutory 45-day period.
- Whether a 30-month FDA stay was triggered.
- Whether the parties entered a settlement permitting an earlier licensed launch.
A settlement may include a launch date, royalty terms, supply arrangements, or restrictions on challenge rights. The settlement date does not itself establish patent validity. Public settlement details may appear in district court filings, FTC reviews, or FDA approval records.
A generic applicant that waits for patent expiration may avoid litigation risk but lose the commercial value associated with an earlier launch. An applicant that certifies Paragraph IV accepts litigation risk in exchange for possible entry before the patent’s listed expiration.
How strong is the patent estate?
The patent is strongest against a product that reproduces all of the following:
- 1 mg norethindrone acetate;
- 10 mcg ethinyl estradiol;
- 24 days of combination tablets;
- 2 days of ethinyl estradiol alone;
- 2 placebo days; and
- repeated 28-day cycles.
The patent is weaker against materially different regimens. Potential design-around paths include:
- changing the active-phase duration;
- eliminating the estrogen-only phase;
- using a different progestin;
- using a different estrogen;
- using a different dosage range;
- changing the cycle length; or
- removing ferrous fumarate to avoid dependent claim 5.
The strongest claims are method claims directed to the exact marketed regimen. The patent does not create a broad monopoly over oral contraception, norethindrone acetate, ethinyl estradiol, or low-dose estrogen products.
Are biosimilar risks relevant?
No. Lo Loestrin Fe is a small-molecule oral contraceptive, not a biologic. The relevant regulatory pathway is an abbreviated new drug application 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.
Competitive risk comes from generic manufacturers, not biosimilar developers. The key barriers are patent litigation, FDA approval, formulation equivalence, bioequivalence, manufacturing scale, and market access.
How does 7,704,984 compare with other contraceptive patent estates?
| Patent category |
Typical protection |
Relevance to Lo Loestrin Fe competition |
| Active-ingredient patent |
New chemical entity |
Low; ingredients are established hormones |
| Composition patent |
Tablet formulation or dosage form |
Potentially relevant |
| Method-of-use patent |
Contraceptive regimen |
Central protection provided by 7,704,984 |
| Manufacturing patent |
Process, blending, coating, or packaging |
Could create additional barriers |
| Labeling patent |
Specific dosing or patient population |
May affect Paragraph IV and section viii strategy |
| Regulatory exclusivity |
FDA exclusivity period |
Separate from patent term |
The commercial estate may include patents beyond 7,704,984. A complete freedom-to-operate analysis must distinguish patents listed for the specific NDA from patents covering related products, formulations, manufacturing processes, and unlisted method claims.
What generic launch risks exist?
The principal generic-launch scenarios are:
| Scenario |
Commercial result |
| Patent expires without enforceable extension |
Generic entry can proceed after FDA approval |
| Paragraph IV challenge succeeds |
Earlier entry may occur, subject to other listed patents |
| Paragraph IV settlement |
Entry occurs on the negotiated date |
| Label carve-out succeeds |
Approval may proceed without the patented method |
| Patent survives litigation |
Entry may be delayed until expiration or license |
| Other listed patents remain |
7,704,984 expiration may not clear the full estate |
Revenue exposure is tied to the volume of prescriptions that use the exact 24/2/2 regimen, the number of approved generic applicants, payer substitution rules, and the existence of any other blocking patents. Patent expiration alone does not guarantee immediate generic conversion.
Key Takeaways
- U.S. Patent 7,704,984 is a method-of-use patent covering a 24/2/2 oral contraceptive regimen.
- The principal formulation is 1 mg norethindrone acetate plus 10 mcg ethinyl estradiol for 24 days, 10 mcg ethinyl estradiol alone for 2 days, and placebo for 2 days.
- Claims 1 and 7 are the main independent claims; claims 3, 4, 5, 6, 8, and 9 narrow the formulation and dosage requirements.
- The patent does not broadly cover norethindrone acetate, ethinyl estradiol, or all combined oral contraceptives.
- The patent’s base 20-year term runs to December 22, 2024, subject to any patent-term adjustment or other official term modification.
- Generic risk is governed by Paragraph IV activity, potential Hatch-Waxman litigation, section viii strategies, settlements, and any other Orange Book-listed patents.
- Biosimilar law is not relevant because the product is a small-molecule oral contraceptive.
- The patent is strongest against products that reproduce the exact marketed 24/2/2 regimen.
FAQs
Does U.S. Patent 7,704,984 cover Loestrin 24 Fe?
It may cover the regimen used by Loestrin 24 Fe only if the product satisfies the claimed dosage, sequence, and ingredient limitations. The patent is most closely associated with the lower-dose Lo Loestrin Fe regimen.
Can a generic avoid the patent by removing ferrous fumarate?
Removing ferrous fumarate may avoid dependent claim 5, but it does not necessarily avoid claims 1, 2, 3, 4, 6, 7, 8, or 9.
Is the 10 mcg ethinyl estradiol dose required?
The claims supplied require 5 to 15 mcg ethinyl estradiol. A 10 mcg formulation falls within that range.
Does the patent require the same ethinyl estradiol dose in both active phases?
Claims 6 and 9 require the same amount in the first and second compositions. Claims 1 and 7, standing alone, require both compositions to contain 5 to 15 mcg but do not expressly require identical amounts.
What is the principal design-around strategy?
The most direct design-around strategy is to change the regimen sequence or cycle structure so that the product does not use 24 days of combination therapy followed by 2 days of estrogen-only therapy and 2 days of placebo.
References
- U.S. Patent No. 7,704,984, Contraceptive regimen. U.S. Patent and Trademark Office.
- U.S. Food and Drug Administration. (2024). Lo Loestrin Fe prescribing information.
- U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- U.S. Food and Drug Administration. (2024). Guidance for industry: 180-day exclusivity for generic drug products.
