TRIKAFTA (COPACKAGED) Drug Patent Profile

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Which patents cover Trikafta (copackaged), and what generic alternatives are available?

Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-five patents protecting this drug.

The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.

DrugPatentWatch^® Generic Entry Outlook for Trikafta (copackaged)

Trikafta (copackaged) was eligible for patent challenges on October 21, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2037. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRIKAFTA (COPACKAGED)

US Patents:	35
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRIKAFTA (COPACKAGED)
DailyMed Link:	TRIKAFTA (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRIKAFTA (COPACKAGED)

Constraining patent/regulatory exclusivity:

11,453,655

NDA:

212273

Dosage:

TABLET, TABLET;ORAL

Constraining patent/regulatory exclusivity:

11,453,655

NDA:

217660

Dosage:

GRANULES;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for TRIKAFTA (COPACKAGED)

TRIKAFTA (COPACKAGED) is protected by one hundred and twenty-nine US patents and ten FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,453,655.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-001	Apr 26, 2023		RX	Yes	No	8,883,206		Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	12,458,635		Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	8,324,242
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019		RX	Yes	Yes	11,564,916
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021		RX	Yes	No	10,081,621		Y
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023		RX	Yes	Yes	11,578,062		Y

Expired US Patents for TRIKAFTA (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019	8,354,427
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-001	Apr 26, 2023	8,354,427
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-002	Jun 8, 2021	8,354,427
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023	8,354,427
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	TABLET;ORAL	212273-001	Oct 21, 2019	8,629,162
Vertex Pharms Inc	TRIKAFTA (COPACKAGED)	elexacaftor, ivacaftor, tezacaftor; ivacaftor	GRANULE;ORAL	217660-002	Apr 26, 2023	8,629,162

International Patents for TRIKAFTA (COPACKAGED)

When does loss-of-exclusivity occur for TRIKAFTA (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRIKAFTA (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2007235260
Brazil	PI0710965
Canada	2648719
Canada	2869945
China	101460489
China	103254177

Supplementary Protection Certificates for TRIKAFTA (COPACKAGED)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1773816	C300748	Netherlands		PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816	CA 2015 00038	Denmark		PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
1773816	PA2015028	Lithuania		PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816	C20150028 00162	Estonia		PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
1773816	1590036-8	Sweden		PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/12/782/001, 2012-07-25; DEN 2025-05-21 MEDDELADE PRV BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD: 1590036-8,1690018-5, 1490016-1
1773816	15C0045	France		PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725

Trikafta Copackaged Market Dynamics, Revenue Trajectory, and Patent Outlook

Last updated: October 14, 2026

Trikafta, marketed outside the United States as Kaftrio, is Vertex Pharmaceuticals' leading cystic fibrosis product and the main driver of its financial growth. The product combines elexacaftor, tezacaftor, and ivacaftor in a copackaged regimen. U.S. approval began in 2019 for patients aged 12 and older with at least one F508del mutation or another responsive CFTR mutation. FDA approvals later expanded use to younger patients.

Trikafta/Kaftrio revenue has grown from an initial launch product into a roughly $9 billion to $10 billion annual franchise. Growth is now driven less by new U.S. patients and more by international reimbursement, pediatric expansion, treatment of additional genotypes, and conversion from Vertex's older cystic fibrosis therapies. The principal long-term commercial risk is generic entry after patent expiry, not biosimilar competition.

How large is the Trikafta market?

Trikafta/Kaftrio is the dominant product in the cystic fibrosis market. Vertex has effectively consolidated the market for CFTR modulators through its portfolio of Kalydeco, Orkambi, Symdeko/Symkevi, and Trikafta/Kaftrio.

Metric	Position
U.S. active ingredients	Elexacaftor, tezacaftor, ivacaftor
U.S. product	Trikafta
International product	Kaftrio, generally used with Kalydeco
U.S. approval	October 21, 2019
Original U.S. population	Patients aged 12 years and older
Current commercial population	Includes children as young as age 2 for eligible mutations
Administration	Morning elexacaftor/tezacaftor/ivacaftor tablet plus evening ivacaftor tablet
Regulatory pathway	New drug application, not a biologic license application
Principal competitors	Vertex's own earlier CFTR modulators; no approved direct non-Vertex equivalent
Main future entry threat	Abbreviated new drug application, or ANDA, generic entry

Trikafta is a copackaged regimen rather than a single fixed-dose tablet containing all three active ingredients in one dosage unit. The package contains a morning combination tablet and an evening ivacaftor tablet. This structure creates separate formulation and composition-of-matter patent positions around the individual active ingredients and the combined treatment.

The product is prescribed to patients with cystic fibrosis who have at least one mutation responsive to the regimen. That mutation-based market has allowed Vertex to expand the addressable population without depending solely on growth in the global cystic fibrosis population.

What is the financial trajectory of Trikafta and Kaftrio?

Trikafta/Kaftrio revenue has followed a rapid launch curve and now represents the majority of Vertex's sales.

Fiscal year	Approximate Trikafta/Kaftrio revenue	Commercial development
2019	Launch-year revenue	U.S. launch in the fourth quarter
2020	Approximately $3.9 billion	First full year of U.S. commercialization
2021	Approximately $5.7 billion	International launches and patient conversion
2022	Approximately $7.5 billion to $8.0 billion	Wider reimbursement and geographic expansion
2023	Approximately $8.9 billion	Mature U.S. franchise with continued international growth
2024	Approximately $10 billion	Pediatric expansion, market penetration, and global uptake

The revenue figures above reflect Vertex's reported Trikafta/Kaftrio product sales, with minor differences possible depending on reporting presentation and foreign-exchange treatment. Vertex reported total company revenue of approximately $9.9 billion in 2023 and approximately $11 billion in 2024, with cystic fibrosis products accounting for nearly all product revenue during that period. [1, 2]

Why has revenue continued to grow after the U.S. launch?

The main growth factors are:

1. International reimbursement and launch sequencing. Many European and other national markets adopted Kaftrio after U.S. approval, producing a lagged revenue contribution.

2. Pediatric label expansion. FDA expanded the product to patients aged 6 to 11 in 2021 and to patients aged 2 to 5 in 2023 for eligible mutations. [3]

3. Conversion from older Vertex products. Patients previously treated with Kalydeco, Orkambi, or Symdeko can transition to Trikafta where clinically appropriate.

4. Mutation coverage. Clinical and regulatory work has increased the number of responsive mutations and patient segments eligible for therapy.

5. High chronic-treatment persistence. Cystic fibrosis is a lifelong condition. Patients generally remain on CFTR modulator treatment unless safety, tolerability, reimbursement, or transplant-related factors intervene.

Growth is likely to moderate as the largest reimbursed markets approach broad treatment penetration. The commercial profile has shifted from launch expansion to franchise defense and lifecycle management.

How dependent is Vertex on Trikafta revenue?

Vertex has substantial concentration risk. Trikafta/Kaftrio is the company's largest product and the principal source of cash flow supporting investment in non-cystic-fibrosis programs, including sickle cell disease, beta thalassemia, acute pain, and type 1 diabetes.

The older CF products remain commercially relevant but are declining or being displaced by Trikafta. That means total CF revenue can continue increasing even while earlier products lose share.

Product	Strategic role
Trikafta/Kaftrio	Core growth and cash-flow product
Kalydeco	Earlier-generation ivacaftor product; supports selected mutation groups
Orkambi	Earlier combination product; largely exposed to substitution by Trikafta
Symdeko/Symkevi	Intermediate-generation product; also exposed to conversion
Casgevy and non-CF pipeline	Diversification efforts, but not yet equivalent revenue contributors during the 2024 period

Trikafta's concentration increases the financial importance of patent litigation, pricing negotiations, manufacturing continuity, and regulatory changes. A successful generic challenge would affect Vertex's revenue base more materially than a challenge to a smaller product.

What patents protect Trikafta?

Trikafta's protection comes from several patent categories rather than one patent:

• Composition-of-matter patents for elexacaftor, tezacaftor, and ivacaftor;
• Combination-treatment patents covering use of the three active ingredients;
• Formulation and dosage-regimen patents;
• Method-of-use patents covering cystic fibrosis treatment in defined mutation populations;
• Manufacturing and crystalline-form patents;
• Patents protecting related intermediates and production processes.

The U.S. product is associated with FDA Orange Book-listed patents for NDA 212273. The applicable patent estate includes patents assigned primarily to Vertex Pharmaceuticals and affiliated entities. The exact Orange Book listing can change as patents issue, expire, are delisted, or are administratively updated. [4]

Public patent records identify protection extending into the 2030s, with certain composition, combination, and method claims reported to expire around 2037 or later, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and claim-specific differences. The relevant expiration date for generic entry is not necessarily the latest date in the estate. A generic applicant can challenge selected patents and may prevail against some claims while leaving others intact.

When does Trikafta lose exclusivity?

Trikafta has several overlapping exclusivity layers.

Exclusivity or protection	Timing
FDA approval	October 2019
New chemical entity exclusivity	Generally expired in 2024
Pediatric exclusivity	Six-month extension associated with qualifying pediatric studies
Orphan-drug exclusivity	Generally runs seven years from approval for the designated indication
Orange Book patent protection	Extends beyond regulatory exclusivity into the 2030s
Generic-entry practical window	Depends on Paragraph IV litigation, settlements, and surviving claims

Regulatory exclusivity is therefore no longer the main barrier. Patent protection is the central barrier to early generic launch.

FDA's orphan-drug exclusivity framework prevents approval of the same drug for the same orphan indication during the seven-year period, subject to statutory exceptions. [5] The existence of orphan exclusivity does not prevent all possible generic activity, particularly where an applicant pursues a different indication or challenges the scope of the protected indication.

Patent-term extension could affect the expiration of a qualifying patent, but the precise effect must be determined from the individual patent and FDA listing. Patent expiry should not be modeled using the 2019 approval date alone.

Are generic companies filing Paragraph IV challenges?

The relevant challenge pathway is an ANDA with a Paragraph IV certification, not a biosimilar application. A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or would not be infringed by the proposed generic.

Vertex has disclosed patent litigation involving generic applicants seeking to challenge patents covering Trikafta and related CF products. Public filings and company disclosures indicate that multiple ANDA filers have challenged parts of Vertex's patent estate. The litigation strategy typically involves:

• Filing patent infringement actions within 45 days of receiving Paragraph IV notices;
• Seeking a 30-month stay of final FDA approval for the challenged ANDA;
• Defending composition, formulation, treatment, and manufacturing claims;
• Pursuing settlements that establish a future launch date or impose other commercial terms.

The existence of litigation does not establish that a generic will launch before patent expiry. The practical outcome depends on the patents challenged, claim construction, validity findings, infringement evidence, and settlement terms.

What is the Orange Book status of Trikafta?

Trikafta is an FDA-approved small-molecule drug and is eligible for Orange Book patent listing. The relevant NDA is 212273. Its listed patents can affect ANDA approval and the timing of a generic launch.

The Orange Book does not provide a single consolidated "Trikafta patent expiry" date. It lists individual patents tied to the approved drug and, in some cases, specific methods of use. A commercial forecast must distinguish:

• The earliest expiry of any listed patent;
• The expiry of blocking composition or combination patents;
• Method-of-use patents that may be carved out;
• Patents subject to Paragraph IV litigation;
• Patents with pediatric exclusivity or patent-term adjustment;
• Non-Orange Book manufacturing and process patents.

A generic applicant may use a section viii statement to carve out a patented method of use, but a carve-out does not solve a composition or formulation patent problem. [4]

What formulation patents protect the copackaged regimen?

The copackaged format creates several potential barriers:

1. The morning tablet containing elexacaftor, tezacaftor, and ivacaftor.
2. The evening ivacaftor tablet.
3. Tablet composition, excipients, dissolution, stability, and dosage strength.
4. The administration schedule separating the morning and evening doses.
5. The combined use of the three active ingredients for CFTR-responsive cystic fibrosis.

A generic manufacturer could attempt a non-infringing formulation, but it would still need to satisfy FDA requirements for pharmaceutical equivalence, bioequivalence, labeling, and quality. Formulation patents can therefore raise development cost and litigation risk even where the underlying active ingredients are chemically accessible.

Manufacturing patents may also affect supply economics. Vertex's process patents and know-how can restrict access to efficient production routes, although a process patent generally does not prevent a generic from developing an alternative non-infringing process.

Is Trikafta exposed to biosimilar competition?

No. Trikafta is a small-molecule drug, not a biologic. The relevant threat is generic substitution through the ANDA pathway. Biosimilar rules under the Public Health Service Act do not govern a generic version of Trikafta.

This distinction matters commercially. An approved ANDA product can often substitute at the pharmacy level under state substitution laws if it meets the applicable requirements. A biosimilar typically involves more complex interchangeability and formulary dynamics.

What licensing deals support Trikafta?

Vertex developed the Trikafta combination within its CFTR-modulator franchise. The underlying ivacaftor program has historical links to Aurora Biosciences and the Cystic Fibrosis Foundation, while Vertex has held the principal commercial rights and has led global development and commercialization.

No publicly disclosed third-party licensing transaction currently appears to divide Trikafta's commercial economics in the way that a co-commercialization agreement would. Royalty and milestone obligations associated with historical research collaborations may exist, but Vertex retains the central revenue and profit exposure.

How strong is the Trikafta patent estate?

The estate is strong commercially but not immune to challenge.

Strengths

• Multiple active ingredients and patent families;
• Large and clinically defined patient population;
• High switching costs for patients and prescribers;
• Chronic use and strong treatment persistence;
• Formulation, combination, method, and manufacturing claims;
• Significant financial resources for litigation;
• No approved direct non-Vertex CFTR-modulator competitor with comparable breadth.

Weaknesses

• The product's core mechanism and active ingredients are publicly known;
• Several early regulatory exclusivity periods have expired;
• Generic applicants can select weaker patents for Paragraph IV challenges;
• Method-of-use claims may be vulnerable to carve-outs;
• Patent-term differences create potential gaps between products or indications;
• Revenue concentration increases the incentive for generics to litigate aggressively.

The estate is best characterized as high-value and layered, with meaningful litigation resilience but a non-zero risk of an at-risk generic launch or negotiated early entry.

What generic launch scenarios exist for Trikafta?

Scenario	Commercial effect
No early settlement; patents survive	Generic entry delayed until the relevant blocking patents expire
Settlement with a fixed launch date	Vertex preserves near-term revenue while giving up a defined future date
Generic wins major composition or combination case	Potential accelerated entry and rapid price erosion
Partial invalidity or non-infringement ruling	Selected generic products or indications may enter earlier
Authorized generic launch	Vertex or a partner could control part of the post-exclusivity price decline
Method carve-out only	Limited impact if the generic cannot copy the protected combination or formulation

A first generic entrant could face a more favorable price environment than later entrants, but the magnitude of erosion would depend on the number of approved ANDAs, pharmacy substitution, payer contracting, and Vertex's response. Because Trikafta is a chronic specialty product, erosion could be slower than in a high-volume primary-care market, but its annual treatment cost creates strong payer incentives to use lower-priced alternatives.

What is the competitive outlook for Vertex and Trikafta?

Vertex has the strongest current position in CFTR modulation. The main competitive threat is not another approved CFTR modulator but the eventual loss of exclusivity and the emergence of next-generation treatments.

Potential competitive categories include:

• Gene-editing or gene-delivery approaches intended to correct the underlying CFTR defect;
• Inhaled or oral CF therapies for patients who cannot use current modulators;
• Improved CFTR modulators for rare or unresponsive mutations;
• Generic versions of Trikafta after patent barriers fall.

Vertex's strategic objective is to extend cash flows from CF while transitioning growth to non-CF programs. That strategy reduces long-term dependence on Trikafta only if new products achieve material commercial scale.

Key Takeaways

• Trikafta/Kaftrio is Vertex's largest product and generated approximately $9 billion to $10 billion in annual revenue by 2023-2024.
• Revenue growth has been driven by international uptake, pediatric expansion, mutation coverage, and conversion from older Vertex CF products.
• FDA regulatory exclusivity has largely expired or is nearing expiration; patents remain the principal barrier to generic entry.
• Trikafta is a small-molecule product, so generic ANDA litigation matters more than biosimilar competition.
• The Orange Book estate includes composition, combination, formulation, method-of-use, and related patent protections.
• Paragraph IV challenges and patent litigation create a path to earlier entry, but public litigation alone does not establish an imminent generic launch.
• Vertex's financial exposure is high because CF products account for most of its product revenue.
• The commercial base is resilient because cystic fibrosis treatment is chronic and Trikafta has broad mutation coverage, but long-term growth should moderate as eligible-market penetration rises.

FAQs

What is the generic name of Trikafta?

Trikafta contains elexacaftor, tezacaftor, and ivacaftor. It is marketed as Kaftrio in many markets outside the United States.

Is Trikafta a combination product or a single drug?

It is a copackaged combination regimen. The package includes a morning elexacaftor/tezacaftor/ivacaftor tablet and an evening ivacaftor tablet.

Can a generic manufacturer copy only the morning Trikafta tablet?

A manufacturer would need to satisfy the applicable FDA requirements for the proposed product and address patents covering the morning tablet, the combination regimen, and the labeled use. Copying only one component may not provide a therapeutically equivalent substitute for the full regimen.

Does Trikafta have orphan-drug exclusivity?

Yes. The product received orphan-drug protection for cystic fibrosis, subject to the statutory scope and duration of orphan exclusivity. Patent protection extends beyond the orphan-exclusivity period.

What is the biggest financial risk to Vertex from Trikafta?

The largest direct risk is an earlier-than-expected generic launch following a successful Paragraph IV challenge, settlement, or invalidation of a blocking patent. Loss of reimbursement, safety restrictions, or a competing disease-modifying therapy would create additional risks.

References

1. Vertex Pharmaceuticals Incorporated. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2023.

2. Vertex Pharmaceuticals Incorporated. (2025). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2024.

3. U.S. Food and Drug Administration. (2019-2023). FDA prescribing information and approval history for Trikafta (NDA 212273).

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book, NDA 212273.

5. U.S. Food and Drug Administration. (2024). Orphan drug designation and exclusivity provisions under the Federal Food, Drug, and Cosmetic Act.