PLAN B Drug Patent Profile

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When do Plan B patents expire, and what generic alternatives are available?

Plan B is a drug marketed by Fdn Consumer and is included in two NDAs.

The generic ingredient in PLAN B is levonorgestrel. There is one drug master file entry for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Plan B

A generic version of PLAN B was approved as levonorgestrel by NOVEL LABS INC on February 22^nd, 2013.

Summary for PLAN B

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	112
Patent Applications:	3,934
What excipients (inactive ingredients) are in PLAN B?	PLAN B excipients list
DailyMed Link:	PLAN B at DailyMed

See drug sales revenues for PLAN B

US Patents and Regulatory Information for PLAN B

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fdn Consumer	PLAN B	levonorgestrel	TABLET;ORAL	021045-001	Jul 28, 1999		DISCN	Yes	No
Fdn Consumer	PLAN B	levonorgestrel	TABLET;ORAL	021045-002	Aug 24, 2006		DISCN	Yes	No
Fdn Consumer	PLAN B ONE-STEP	levonorgestrel	TABLET;ORAL	021998-001	Jul 10, 2009		OTC	Yes	Yes

# Plan B Market Dynamics, Financial Trajectory, FDA Status, and Patent Exclusivity

Last updated: October 6, 2026

Plan B is the leading U.S. consumer brand for levonorgestrel emergency contraception. Its commercial position is strong, but its patent and regulatory exclusivity have largely expired. The brand competes in a low-barrier market against generic levonorgestrel products, prescription ulipristal acetate, and copper intrauterine devices.

Plan B’s financial trajectory has been driven more by brand recognition, broad retail distribution, pricing, and demand shocks than by proprietary technology. Brand-specific revenue is not publicly reported because Plan B is owned by private consumer-health company Foundation Consumer Healthcare. The brand has no publicly identified biosimilar risk, and current generic-entry risk is already reflected in the mature market structure.

What is Plan B and who owns the brand?

Plan B One-Step is an oral emergency contraceptive containing 1.5 milligrams of levonorgestrel. It is intended to reduce the risk of pregnancy after unprotected sex or contraceptive failure. The product does not terminate an established pregnancy and is less effective as time passes after intercourse.

Foundation Consumer Healthcare owns the Plan B brand. Teva Pharmaceuticals sold Plan B and related consumer-health assets to Foundation Consumer Healthcare in 2017. The financial terms were not publicly disclosed.

Item	Detail
Brand	Plan B One-Step
Active ingredient	Levonorgestrel
Dose	1.5 mg orally
Therapeutic category	Emergency contraception
U.S. regulatory status	Nonprescription, over the counter
Current owner	Foundation Consumer Healthcare
Original commercial owner	Women’s Capital Corporation, later acquired by Barr Pharmaceuticals
Former large pharmaceutical owner	Teva Pharmaceuticals
Primary U.S. competitors	Generic levonorgestrel 1.5 mg products, Take Action, My Choice, Aftera, Option 2, ella
Prescription alternative	Ulipristal acetate, marketed as ella
Device alternative	Copper intrauterine device

When did Plan B become available over the counter?

Plan B’s regulatory history moved from prescription distribution to broad nonprescription access.

Date	FDA or commercial milestone
1999	FDA approved Plan B as a prescription emergency contraceptive containing two 0.75 mg levonorgestrel tablets.
2006	FDA approved nonprescription Plan B access for women aged 18 and older.
2009	FDA approved Plan B One-Step, a single-dose 1.5 mg levonorgestrel product.
2011	FDA rejected an application for unrestricted nonprescription access for all ages, citing concerns about the proposed application and supporting data.
2013	FDA approved nonprescription access without age or point-of-sale restrictions.
2017	Teva sold Plan B and related assets to Foundation Consumer Healthcare.
2022 onward	Demand increased as access to abortion and reproductive-health services became more politically and legally contested in the United States.

The 2013 action eliminated the age restriction and allowed Plan B One-Step to be sold without a prescription from retail stores, pharmacies, online sellers, and other consumer channels. FDA continues to identify levonorgestrel emergency contraception as an approved nonprescription product category. [1,2]

What patents protect Plan B and when did exclusivity end?

Plan B’s commercial protection is no longer based on an active blocking patent estate. The relevant protection was tied to the levonorgestrel formulation, emergency-contraception use, and product-specific regulatory rights. Those protections have expired or lost practical significance in the U.S. market.

The key commercial conclusion is that generic manufacturers can market levonorgestrel emergency contraception without obtaining a license from the Plan B brand owner, subject to FDA requirements and applicable manufacturing and labeling rules.

How strong is the Plan B patent estate?

The Plan B patent estate is weak as a current market barrier for four reasons:

1. The active ingredient, levonorgestrel, is a long-established generic molecule.
2. The single-dose oral formulation is technically straightforward.
3. Product-specific regulatory exclusivity has expired.
4. Multiple generic manufacturers already sell equivalent or substitutable products.

The remaining competitive protection is primarily commercial. It includes trademark recognition, retail placement, packaging, consumer advertising, and pharmacy distribution rather than enforceable exclusivity over levonorgestrel emergency contraception.

Does Plan B have Orange Book protection?

Plan B One-Step was approved under FDA New Drug Application No. 021998. Current commercial competition indicates that no active Orange Book patent listing blocks generic levonorgestrel emergency contraception.

Orange Book-listed patents, if any, do not create a current market monopoly comparable to the patent position associated with a recently approved branded drug. Generic products are widely marketed under separate abbreviated new drug applications or other FDA-approved pathways. [3]

Are there Paragraph IV challenges to Plan B?

Paragraph IV risk is no longer the main commercial issue for Plan B. Generic levonorgestrel emergency contraceptive products have been on the market for years, and the principal patent barriers associated with the original brand have expired.

The market therefore reflects post-exclusivity competition rather than an active, high-value Paragraph IV contest. Generic entry has already occurred, and additional products can compete through price, distribution, and retailer relationships.

What is the FDA regulatory status of Plan B?

Plan B One-Step is an FDA-approved nonprescription emergency contraceptive. It is labeled for use after unprotected sex or contraceptive failure. The label states that it works primarily by delaying or preventing ovulation and does not interrupt an implanted pregnancy.

The FDA has not approved Plan B for routine daily contraception, treatment of infertility, or termination of pregnancy. It is distinct from mifepristone, which is used in medication abortion under a separate regulatory framework.

Plan B’s FDA status reduces prescription-channel friction and supports sales through:

• National pharmacy chains
• Grocery and mass-merchandise retailers
• Online pharmacies and e-commerce platforms
• Campus health channels
• Sexual-health clinics
• Public-health and nonprofit distribution programs

The product’s nonprescription status is a major commercial advantage over ella, which remains prescription-only in the United States.

How does Plan B compare with generic levonorgestrel and ella?

Plan B competes on brand trust and availability, while generic products compete primarily on price. Ella competes on clinical positioning, especially when emergency contraception is taken later in the five-day post-intercourse window.

Product category	Active ingredient	U.S. access	Principal advantage	Principal limitation
Plan B One-Step	Levonorgestrel 1.5 mg	OTC	Brand recognition and broad distribution	Higher price than many generics; reduced effectiveness at higher body weight is a consumer concern
Generic levonorgestrel	Levonorgestrel 1.5 mg	OTC	Lower price and broad availability	Limited brand differentiation
Ella	Ulipristal acetate 30 mg	Prescription	Can be used up to five days after intercourse and may retain greater effectiveness later in the window	Prescription access and provider friction
Copper IUD	Copper intrauterine device	Provider-administered	Highly effective emergency contraception and ongoing contraception	Procedure, cost, appointment, and access barriers

The largest direct threat to Plan B is generic levonorgestrel, not a new patented oral product. Generic products can use the same active ingredient and compete with lower retail prices. Ella creates a separate competitive pressure because it offers a different mechanism and a longer labeled use window. [1,4]

What drives Plan B revenue?

Plan B revenue is shaped by volume, price, retail availability, and public events rather than recurring prescriptions. Emergency contraception is an episodic purchase, so brand sales can fluctuate sharply with changes in consumer behavior, public policy, media coverage, and access to reproductive-health services.

Pricing and gross-margin dynamics

Retail prices vary substantially by channel and geography. Brand Plan B commonly sells at a premium to generic levonorgestrel products. The premium reflects:

• National brand recognition
• Consumer trust in the original product
• Shelf placement and retailer distribution
• Advertising and search visibility
• Perceived quality and reliability
• Urgency of the purchase

Generic products compress the price ceiling. A consumer who needs emergency contraception immediately may still select Plan B despite a higher price, but price-sensitive consumers can substitute readily.

Demand after the Dobbs decision

The 2022 U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization increased public attention to emergency contraception and contributed to demand spikes for related products. Retailers reported periods of elevated demand and temporary purchasing restrictions for emergency contraceptives after the ruling. [5]

The effect on long-term revenue depends on whether higher demand represents:

• Permanent adoption by consumers who previously lacked access
• Stockpiling behavior
• Temporary purchases triggered by political events
• Greater use of emergency contraception following reduced access to abortion services

A sustained increase in household inventory could support volume but also create intermittent retail volatility.

What revenue exposure does Plan B have?

Foundation Consumer Healthcare does not publicly report Plan B revenue as a separate line item. The company is privately held, and available public filings do not provide audited brand-level sales, unit volumes, operating margins, or cash flow.

The commercial exposure can be evaluated through market structure:

Revenue factor	Impact on Plan B
OTC status	Expands consumer access and supports high-volume retail distribution
Brand premium	Supports higher revenue per unit than generic competitors
Generic substitution	Limits pricing power and reduces barriers to switching
Private ownership	Limits public visibility into revenue and profitability
Reproductive-health demand	Can create rapid volume increases after policy or media events
Low manufacturing complexity	Reduces production barriers for competitors
Retail availability	Strong availability supports conversion during time-sensitive purchases
Product concentration	Makes revenue sensitive to a single mature consumer-health brand

Plan B is best viewed as a mature, cash-generative consumer-health asset rather than a growth-stage pharmaceutical franchise. Its value depends on brand durability, channel control, and marketing efficiency.

What licensing deals and ownership transfers affect Plan B?

The principal disclosed ownership transition was Teva’s 2017 sale of Plan B and related consumer-health products to Foundation Consumer Healthcare. The transaction terms were not disclosed.

This transfer separated Plan B from Teva’s broader specialty and generic pharmaceutical portfolio. For Teva, the sale reduced exposure to a noncore consumer-health asset. For Foundation Consumer Healthcare, the acquisition provided a recognized national brand with established OTC distribution.

There is no widely reported current license requiring generic levonorgestrel sellers to pay royalties to the Plan B owner. Generic competitors rely on their own FDA approvals and do not need a Plan B trademark license to sell equivalent active-ingredient products.

What patent litigation and settlement agreements affect Plan B?

There is no active, high-profile patent litigation currently defining the U.S. Plan B market. The major historical legal dispute concerned FDA access and the agency’s handling of the application for broader nonprescription availability.

In 2013, litigation brought by the Center for Reproductive Rights led to an order requiring FDA to make levonorgestrel emergency contraception available without age restrictions. The dispute concerned regulatory access, not a current patent settlement with generic manufacturers. [6]

No major current settlement agreement appears to prevent generic levonorgestrel entry. The market’s competitive conditions indicate that the relevant patent and regulatory barriers have already fallen.

What manufacturing and intellectual-property barriers remain?

Manufacturing barriers are modest. Levonorgestrel is a well-established active pharmaceutical ingredient, and the dosage form is a conventional oral tablet. The main requirements are:

• FDA-compliant active-ingredient sourcing
• Validated tablet manufacturing
• Stability and dissolution testing
• Packaging and labeling compliance
• Good manufacturing practice controls
• Reliable supply-chain management

The most important nonpatent barriers are operational. A supplier must maintain quality, avoid stockouts, secure retailer placement, and comply with federal and state requirements governing OTC drugs.

Trademark protection remains commercially relevant. A generic manufacturer cannot market its product using the Plan B name or packaging that creates a likelihood of confusion. Trademark rights protect the brand identity, not the underlying levonorgestrel technology.

What generic launch risks exist for Plan B?

Generic launch risk is established rather than prospective. Several levonorgestrel emergency contraceptive brands compete with Plan B, and store-brand or private-label products can expand quickly through retailer agreements.

The main risks are:

1. Price erosion from lower-cost alternatives.
2. Private-label substitution by national retailers.
3. Online comparison shopping.
4. Retailer bargaining power.
5. Consumer confusion among multiple levonorgestrel products.
6. Supply disruptions that shift consumers toward competing brands.
7. Reduced willingness to pay a brand premium.

Plan B can defend share through advertising, consumer education, packaging, retailer support, and distribution reliability. It cannot rely on patent exclusion.

What is the geographic coverage of Plan B?

Plan B has its strongest commercial position in the United States, where the brand is broadly recognized and available without a prescription. Emergency contraceptive products containing levonorgestrel are also sold internationally under different brand names, regulatory classifications, and distribution models.

Geographic performance depends on:

• Whether emergency contraception is OTC or prescription-only
• National reimbursement and pharmacy structures
• Cultural and political attitudes
• Availability of generic products
• Local contraceptive guidelines
• Import and manufacturing requirements
• Retail and e-commerce penetration

The United States remains the key market for the Plan B brand. International sales do not necessarily accrue to the same owner or use the Plan B trademark.

How strong is the Plan B commercial franchise?

Plan B has a strong brand franchise but a weak exclusivity franchise.

Dimension	Assessment
Brand recognition	Strong
FDA access	Strong
Retail distribution	Strong
Patent protection	Minimal to none as a current barrier
Generic resistance	Weak
Pricing power	Moderate, supported by urgency and brand trust
Manufacturing complexity	Low
Litigation protection	Limited current relevance
Consumer switching costs	Low
Long-term growth potential	Moderate, dependent on demand and channel expansion

The brand remains commercially resilient because consumers often purchase emergency contraception under time pressure and may favor a familiar product. Generic competition prevents that advantage from becoming a durable pharmaceutical monopoly.

What is the likely financial trajectory for Plan B?

Plan B’s near-term revenue outlook is supported by brand recognition, OTC access, reproductive-health demand, and broad retail distribution. Its long-term growth rate is likely to be lower than its strongest post-event demand periods because the product is mature and generic alternatives are widely available.

The most likely financial trajectory is:

• Stable base demand from recurring emergency-contraception use
• Periodic volume spikes after policy changes or media events
• Continued generic price pressure
• Moderate brand-premium retention
• Higher online and retail availability
• Margin protection through marketing and supply-chain efficiency
• Limited benefit from new patent exclusivity

The principal investment question is not whether Plan B can prevent generic entry. That question has already been resolved by market structure. The relevant question is whether Foundation Consumer Healthcare can retain consumer preference and retailer support despite equivalent lower-priced products.

Key Takeaways

• Plan B One-Step is an OTC levonorgestrel emergency contraceptive owned by Foundation Consumer Healthcare.
• Teva sold the brand to Foundation Consumer Healthcare in 2017 in a transaction with undisclosed terms.
• FDA removed age restrictions in 2013, giving Plan B unrestricted nonprescription access in the United States.
• The product has no meaningful current patent barrier preventing generic competition.
• Generic levonorgestrel products are the principal competitive threat.
• Ella offers a prescription-based alternative with a longer labeled post-intercourse window.
• Plan B-specific revenue, profit, and unit data are not publicly disclosed.
• Demand can rise sharply after reproductive-health policy changes, but event-driven increases may not persist.
• The brand’s value rests on recognition, retail access, pricing, and distribution rather than exclusivity.
• No active patent litigation or settlement agreement currently appears to control generic entry.

FAQs About Plan B Market and Patent Status

Does Plan B still have patent protection?

Plan B’s commercially relevant patent protection has expired or no longer prevents generic levonorgestrel emergency contraception from reaching the U.S. market.

Can pharmacies substitute generic levonorgestrel for Plan B?

Pharmacies and retailers can sell generic levonorgestrel products, but automatic substitution rules depend on the specific product, state law, and dispensing context because Plan B is an OTC brand rather than a conventional prescription product.

Is Plan B a biosimilar product?

No. Plan B is a small-molecule oral drug. Biosimilar rules apply to biologic medicines, not levonorgestrel tablets.

Could a new emergency-contraception drug displace Plan B?

A new product with improved efficacy later in the dosing window, fewer weight-related concerns, longer shelf life, or stronger access advantages could take share. The main current prescription competitor is ulipristal acetate, marketed as ella.

Does Plan B generate public company revenue?

Plan B’s owner, Foundation Consumer Healthcare, is privately held. Public filings do not provide a separately reported Plan B revenue figure.

References

1. U.S. Food and Drug Administration. (2022). Plan B and other emergency contraceptives. https://www.fda.gov
2. U.S. Food and Drug Administration. (2013, June 20). FDA approves Plan B One-Step emergency contraceptive for use without a prescription. https://www.fda.gov
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov
4. U.S. Food and Drug Administration. (2022). Prescribing information: ella (ulipristal acetate) tablet. https://www.accessdata.fda.gov
5. Kaiser Family Foundation. (2022). The impact of the Dobbs decision on contraception and emergency contraception. https://www.kff.org
6. Center for Reproductive Rights. (2013). Tummino v. Hamburg and access to emergency contraception. https://reproductiverights.org