NURTEC ODT Drug Patent Profile

Which patents cover Nurtec Odt, and what generic alternatives are available?

Nurtec Odt is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in NURTEC ODT is rimegepant sulfate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the rimegepant sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nurtec Odt

Nurtec Odt was eligible for patent challenges on February 27, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2033. This may change due to patent challenges or generic licensing.

There have been seven 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 NURTEC ODT

US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Drug Prices:	Drug price information for NURTEC ODT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NURTEC ODT
What excipients (inactive ingredients) are in NURTEC ODT?	NURTEC ODT excipients list
DailyMed Link:	NURTEC ODT at DailyMed

See drug prices for NURTEC ODT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NURTEC ODT

NDA:

212728

Dosage:

TABLET, ORALLY DISINTEGRATING;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.

Recent Clinical Trials for NURTEC ODT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Antonios Likourezos	PHASE4
Antonios Likourezos	Phase 4
Weill Medical College of Cornell University	Phase 2

See all NURTEC ODT clinical trials

Pharmacology for NURTEC ODT

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Paragraph IV (Patent) Challenges for NURTEC ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NURTEC ODT	Orally Disintegrating Tablets	rimegepant sulfate	75 mg	212728	7	2024-02-27

US Patents and Regulatory Information for NURTEC ODT

NURTEC ODT is protected by five US patents.

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
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes			Y	Y

International Patents for NURTEC ODT

When does loss-of-exclusivity occur for NURTEC ODT?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Norway

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

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 NURTEC ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2019242604
Brazil	112020019396
Canada	3094693
China	112153969
Denmark	4088720
Eurasian Patent Organization	202092278

Supplementary Protection Certificates for NURTEC ODT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2488512	301187	Netherlands		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1645 20220426
2488512	LUC00272	Luxembourg		PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	PA2022516	Lithuania		PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512	122022000048	Germany		PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 20220425
2488512	2022C/540	Belgium		PRODUCT NAME: RIMEGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426
2488512	CA 2022 00036	Denmark		PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426

Nurtec ODT Market Dynamics, Revenue Trajectory, Competition, and Patent Risk

Last updated: August 6, 2026

Nurtec ODT, Pfizer’s rimegepant product, is a blockbuster oral CGRP antagonist used for acute migraine treatment and preventive therapy. Its commercial trajectory has been driven by dual indications, rapid-dissolving oral delivery, broad payer coverage, and strong growth in the preventive migraine segment. The principal risks are competition from other CGRP drugs, payer step edits, copay pressure, and eventual generic entry after the core patent estate expires in the early-to-mid 2030s.

What is Nurtec ODT and how does it work?

Nurtec ODT contains rimegepant, a small-molecule calcitonin gene-related peptide, or CGRP, receptor antagonist. It is administered as a 75 mg orally disintegrating tablet.

The FDA approved Nurtec ODT in February 2020 for the acute treatment of migraine with or without aura in adults. In May 2021, the FDA approved the product for the preventive treatment of episodic migraine in adults. The preventive indication uses one 75 mg tablet every other day, while acute treatment uses one tablet as needed, with a maximum of one dose in 24 hours.[1]

FDA regulatory status

Regulatory milestone	Date
FDA approval for acute migraine treatment	February 27, 2020
FDA approval for preventive treatment of episodic migraine	May 27, 2021
Active ingredient	Rimegepant sulfate
Dosage form	75 mg orally disintegrating tablet
Regulatory pathway	New Drug Application
Product type	Small molecule
Current commercial owner	Pfizer
Original developer	Biohaven Pharmaceutical

Nurtec ODT is not a biologic. Biosimilar competition is therefore not applicable. Future competition will arise through abbreviated new drug applications, or ANDAs, for generic rimegepant products.

How large is the Nurtec ODT migraine market?

The migraine market is divided among triptans, gepants, CGRP monoclonal antibodies, botulinum toxin, and nonprescription therapies. Nurtec competes in both acute and preventive treatment, giving Pfizer access to a broader treatment base than products limited to one indication.

The principal market segments are:

• Acute migraine treatment, where Nurtec competes with triptans, Ubrelvy, Zavzpret, and generic therapies.
• Preventive migraine treatment, where Nurtec competes with Qulipta, Aimovig, Ajovy, Emgality, Vyepti, and Botox.
• Patients who cannot tolerate triptans or have cardiovascular contraindications.
• Patients who prefer an oral product over an injection.

The commercial opportunity is supported by the prevalence of migraine. The American Migraine Foundation estimates that migraine affects approximately 39 million people in the United States and about 1 billion people globally.[2] Only a portion of these patients receive prescription preventive therapy, leaving room for continued category expansion.

What were Nurtec ODT’s sales and revenue trajectory?

Nurtec ODT reached blockbuster scale before Pfizer completed its acquisition of Biohaven’s commercial migraine portfolio. Biohaven reported approximately $462 million of Nurtec net product revenue in 2021.[3] Pfizer subsequently acquired Biohaven’s commercial CGRP portfolio in October 2022 for approximately $11.6 billion, excluding certain retained assets and obligations.[4]

Pfizer reported the following revenue progression for Nurtec ODT and Vydura, the product’s ex-U.S. brand name:

Fiscal year	Reported revenue profile	Commercial interpretation
2021	Approximately $462 million reported by Biohaven	Rapid launch expansion after acute and preventive approvals
2022	Pfizer ownership began in October	Transition year with partial Pfizer reporting
2023	Approximately $1.0 billion	Full blockbuster status
2024	Approximately $1.0 billion	Mature growth with competitive and access pressure

Pfizer’s public filings identify Nurtec ODT/Vydura as one of the company’s key growth products in its internal medicine portfolio.[5] The product’s revenue base is materially larger than Biohaven’s pre-acquisition sales because Pfizer added global infrastructure, payer contracting resources, and a broader commercial organization.

What drove Nurtec’s revenue growth?

Nurtec’s growth has depended on five commercial factors:

1. Dual indication expansion. The 2021 preventive approval substantially increased the addressable patient population.
2. Oral administration. Many patients prefer an orally disintegrating tablet to injectable CGRP antibodies.
3. Triptan differentiation. Nurtec does not cause vasoconstriction, making it relevant for some patients who cannot use triptans.
4. Direct-to-consumer promotion. Biohaven and Pfizer invested heavily in brand awareness and patient acquisition.
5. Insurance access. Coverage expanded as payer familiarity with gepants increased, although prior authorization remains common.

The product’s revenue curve has moved from launch acceleration to a more mature phase. Future growth depends less on basic category creation and more on market share retention, preventive use, adherence, and international expansion.

How does Nurtec ODT compare with Ubrelvy, Qulipta, and CGRP antibodies?

Nurtec’s closest direct competitor is Ubrelvy, marketed by AbbVie after AbbVie acquired Allergan. Qulipta, also marketed by AbbVie, is a preventive oral CGRP antagonist. These products compete directly for neurologist prescriptions and payer formulary placement.

Product	Active ingredient	Company	Primary use	Dosage form	Competitive position
Nurtec ODT	Rimegepant	Pfizer	Acute and preventive migraine	Orally disintegrating tablet	Dual indication and convenient delivery
Ubrelvy	Ubrogepant	AbbVie	Acute migraine	Conventional oral tablet	Direct acute-use competitor
Qulipta	Atogepant	AbbVie	Preventive migraine	Conventional oral tablet	Direct preventive competitor
Zavzpret	Zavegepant	Pfizer	Acute migraine	Nasal spray	Pfizer’s nonoral acute option
Aimovig	Erenumab	Amgen/Novartis commercialization history	Preventive migraine	Injection	Long-acting CGRP antibody
Ajovy	Fremanezumab	Teva	Preventive migraine	Injection	Multiple injection schedules
Emgality	Galcanezumab	Eli Lilly	Preventive migraine	Injection	Strong antibody competitor
Vyepti	Eptinezumab	Lundbeck	Preventive migraine	Intravenous infusion	Infusion-center model
Botox	OnabotulinumtoxinA	AbbVie	Chronic migraine prevention	Injection procedure	Established chronic migraine option

How does Nurtec compare with Ubrelvy?

Nurtec has two major advantages over Ubrelvy: it is approved for both acute and preventive treatment, and its orally disintegrating formulation does not require water. Ubrelvy has a strong acute-treatment position and may be preferred by physicians who are familiar with its dosing or by payers that place it favorably on formularies.

The two products are pharmacologically similar but commercially distinct. Nurtec’s preventive indication creates greater prescription persistence and gives Pfizer a broader account strategy with neurologists, primary care physicians, and managed-care plans.

How does Nurtec compare with Qulipta?

Qulipta is a preventive-only oral gepant, while Nurtec has both acute and preventive indications. Qulipta’s daily or twice-daily preventive dosing may fit patients who prefer a regular regimen, while Nurtec’s every-other-day dosing can be attractive for some patients.

The competitive outcome depends on payer policies, physician preference, tolerability, adherence, and whether the patient needs an acute rescue treatment in addition to prevention.

What patents protect Nurtec ODT?

Nurtec’s protection is based on a combination of composition-of-matter, pharmaceutical composition, formulation, and method-of-use patents. The core rimegepant patent estate extends well beyond the original 2020 approval date.

Publicly identified U.S. patents associated with rimegepant and Nurtec-related protection include:

Patent category	Representative protection	Commercial relevance
Active compound	Rimegepant and related CGRP antagonist claims	Protects the underlying molecule
Pharmaceutical composition	Rimegepant formulations and dosage compositions	Can delay generic substitution if listed and enforceable
Orally disintegrating formulation	Tablet composition and delivery characteristics	Protects the Nurtec ODT presentation
Method of use	Acute migraine treatment	Supports the acute indication
Method of use	Preventive migraine treatment	Supports the every-other-day preventive regimen

The FDA Orange Book remains the operative source for current listed patents and regulatory exclusivity. Patent listings and expiration dates can change through corrections, patent-term adjustments, pediatric extensions, and litigation outcomes.[6]

What is the Orange Book status of Nurtec ODT?

Nurtec ODT is an FDA-approved prescription drug listed in the Orange Book. As a small-molecule product, it is eligible for ANDA-based generic competition. A generic applicant must address each listed patent through certification under Hatch-Waxman.

The commercially important patent horizon is generally understood to extend into the 2030s, with the earliest significant core protection reaching roughly 2031 and later formulation or use-related protection potentially extending beyond that date. The effective generic-entry date could be earlier if a Paragraph IV challenge succeeds, or later if Pfizer obtains enforceable protection from later-listed patents.

When does Nurtec ODT lose exclusivity?

Nurtec’s regulatory exclusivity has already expired or is no longer the primary barrier to generic entry. Patent protection, rather than new chemical entity exclusivity, is now the main exclusion mechanism.

A simplified exclusivity timeline is:

Period	Exclusivity or protection event
2020	FDA approval for acute migraine treatment
2020-2025 period	Initial regulatory and market exclusivity protections
2021	Preventive migraine approval
Early 2030s	Earliest meaningful core patent-expiration window
Mid-to-late 2030s	Potential later patent and formulation protection
After patent resolution	Generic rimegepant and possible generic ODT entry

The first generic launch may not occur on the earliest patent expiration date. Generic applicants must address Orange Book patents, resolve any litigation, obtain FDA approval, and assess whether the reference product’s dosage form can be replicated.

Which companies are challenging Nurtec ODT patents?

A Paragraph IV challenge would be the principal route for an ANDA applicant seeking entry before all Orange Book patents expire. Publicly visible litigation activity can change as generic filings become public, settlements are reached, or cases are filed in federal district court.

The likely challenger pool includes large generic manufacturers with experience in complex oral dosage forms, including Teva, Viatris, Sandoz, Dr. Reddy’s, Sun Pharma, Amneal, and Hikma. The presence of a company in this potential pool does not establish that it has filed an ANDA or issued a Paragraph IV certification.

For Nurtec, the commercial litigation question is more complex than a standard tablet because the product is an orally disintegrating formulation. A generic applicant may need to address:

• Rimegepant active-ingredient claims.
• ODT composition claims.
• Dissolution and disintegration characteristics.
• Labeling for acute and preventive indications.
• Method-of-use patents.
• Potential non-infringement or invalidity positions.

What generic entry risks exist for Nurtec ODT?

Generic-entry risk is moderate before the early 2030s and rises materially as core patents approach expiration. The product has several characteristics that can delay or complicate substitution:

1. ODT formulation requirements. Generic manufacturers must develop a product that meets FDA performance and bioequivalence requirements for an orally disintegrating tablet.
2. Multiple patent categories. A challenger may need to clear composition, formulation, and use patents.
3. Dual indications. A generic may use a skinny label that omits a patented indication, although enforcement and prescribing behavior can still create litigation risk.
4. Brand concentration. Pfizer may defend the product aggressively because Nurtec is a billion-dollar asset.
5. Insurance substitution. Even after FDA approval, payer adoption may depend on rebates, formulary contracts, and generic pricing.

The most likely first generic scenario is a limited launch by one or more ANDA applicants after a patent settlement or successful Paragraph IV litigation. A rapid multi-generic price collapse is possible after several manufacturers enter, but the rate of erosion will depend on whether generic competitors can replicate the ODT product and whether Pfizer maintains meaningful brand rebates.

What patent litigation and settlements affect Nurtec ODT?

Patent litigation risk centers on Pfizer’s enforcement of listed patents against ANDA applicants. A standard Hatch-Waxman Paragraph IV filing generally triggers a 30-month stay of FDA approval if the brand company files suit within the statutory period.[7]

A settlement could include:

• A license for generic entry on an agreed future date.
• A royalty-bearing license.
• A commitment not to launch an authorized generic.
• Restrictions on the generic product’s labeling or formulation.
• A business resolution without an admission that the patents are valid or infringed.

The economic value of a settlement depends on the agreed launch date and whether Pfizer authorizes an early generic. For a product with approximately $1 billion in annual sales, each year of delayed generic entry can have substantial value, although net revenue is lower than gross sales because of rebates, discounts, and patient-support spending.

How strong is the Nurtec ODT patent estate?

Nurtec’s patent estate is commercially meaningful because it does not rely on a single claim type. Protection spans the active compound, dosage form, and clinical use. That structure increases the number of potential barriers a generic applicant must address.

The estate’s strengths are:

• A commercially validated active ingredient.
• A differentiated ODT delivery system.
• Two FDA-approved uses.
• A high-value branded market.
• Pfizer’s capacity to fund litigation and manage global patent prosecution.

The main weaknesses are:

• Earlier composition patents are exposed to validity challenges as they age.
• Method-of-use patents can be bypassed through skinny-label strategies.
• Formulation patents may be vulnerable if prior art discloses similar ODT technology.
• Patent expiration is ultimately finite.
• Competing gepants can reduce the economic value of late-stage exclusivity.

The estate should be viewed as stronger for delaying direct substitution than for preventing all competitive treatment options. Patients can switch to Ubrelvy, Qulipta, CGRP antibodies, triptans, or other therapies without infringing Nurtec patents.

What licensing deals support Nurtec ODT?

The central transaction was Pfizer’s acquisition of Biohaven’s commercial CGRP portfolio in 2022. Pfizer paid approximately $11.6 billion in cash for the commercial assets, including Nurtec ODT/Vydura and related rights, while Biohaven retained certain noncommercial assets and other interests.[4]

The transaction transferred to Pfizer:

• Commercial rights to rimegepant in major markets.
• Nurtec ODT and Vydura sales infrastructure.
• The established CGRP commercial platform.
• Rights supporting the acute and preventive migraine franchise.

Pfizer’s ownership also links Nurtec to Zavzpret, Pfizer’s zavegepant nasal spray, creating the potential for portfolio contracting and cross-selling in acute migraine.

What is the competitive outlook for Nurtec ODT?

Nurtec remains one of the leading oral CGRP products, but market growth is becoming more competitive. The main commercial pressures are:

• AbbVie’s combined Ubrelvy and Qulipta portfolio.
• Increased use of CGRP monoclonal antibodies for prevention.
• Payer preference for lower-net-cost alternatives.
• Physician familiarity with established migraine therapies.
• Patient switching caused by prior authorization or copay changes.
• Potential differentiation of nasal and injectable products for patients with nausea or poor oral absorption.

Pfizer’s strongest defense is the product’s dual indication and delivery format. Its key commercial challenge is maintaining net price and market share as competing CGRP products expand.

What is the revenue exposure if Nurtec loses exclusivity?

Nurtec’s annual revenue exposure is approximately $1 billion at current blockbuster scale. The actual loss after generic entry would depend on timing and erosion speed.

A simplified scenario framework is:

Scenario	Generic-entry timing	Revenue impact
Delayed entry	After later patent expiry in the mid-2030s	Longer period of high-margin branded sales
Limited first entry	One authorized or licensed generic	Moderate price and volume pressure
Early successful Paragraph IV	Before core patent expiry	Sharp legal and commercial disruption
Multi-generic entry	Several manufacturers launch together	Rapid price erosion and brand-volume decline

For Pfizer, the financial risk is material but manageable relative to the company’s total revenue base. Nurtec is more important to Pfizer’s internal medicine portfolio than to consolidated company revenue. For Biohaven, by contrast, the product was central to the company’s valuation and became the principal asset monetized through the Pfizer transaction.

How does Nurtec ODT compare with competing patent estates?

Product	Company	Patent and exclusivity profile	Generic or biosimilar risk
Nurtec ODT	Pfizer	Compound, ODT formulation, and use patents	ANDA generic risk in the 2030s
Ubrelvy	AbbVie	Ubrogepant compound and use/formulation protection	ANDA generic risk in the 2030s
Qulipta	AbbVie	Atogepant compound and use protection	ANDA generic risk later in the 2030s
Emgality	Eli Lilly	Biologic patents and regulatory exclusivity	Biosimilar risk, not ANDA risk
Aimovig	Amgen/Novartis	Biologic patent estate	Biosimilar and patent litigation risk
Botox	AbbVie	Biologic and method-of-use protection	Complex biologic competition

Nurtec’s ODT formulation gives it a different patent profile from conventional oral gepants. Its small-molecule status creates eventual generic risk, while antibody competitors face biosimilar development and interchangeability questions.

Key Takeaways

• Nurtec ODT is Pfizer’s rimegepant product for acute and preventive migraine.
• The product reached approximately $1 billion in annual revenue after Pfizer acquired Biohaven’s commercial CGRP business.
• Its strongest commercial advantages are dual indication, ODT delivery, and use in patients who cannot take triptans.
• Ubrelvy and Qulipta are the closest direct competitors.
• Nurtec is a small molecule, so future competition will come through ANDAs rather than biosimilars.
• The core patent protection is expected to remain commercially relevant into the early 2030s, with later formulation or use patents potentially extending protection.
• Paragraph IV litigation, patent settlements, and payer contracting will determine the timing and severity of generic erosion.
• Revenue risk is approximately $1 billion annually at the current product scale, although net exposure depends on rebates and the timing of generic entry.

FAQs

Is Nurtec ODT a biologic or a small-molecule drug?

Nurtec ODT is a small-molecule drug containing rimegepant. It is subject to ANDA-based generic competition rather than the biosimilar pathway.

Can generic manufacturers copy the Nurtec ODT dosage form?

A generic manufacturer may seek approval for a rimegepant orally disintegrating tablet, but it must satisfy FDA bioequivalence, pharmaceutical equivalence, manufacturing, and labeling requirements.

Does Nurtec ODT have a preventive migraine indication?

Yes. The FDA approved Nurtec ODT for preventive treatment of episodic migraine in adults in May 2021. The approved preventive regimen is 75 mg every other day.

Which company originally developed Nurtec ODT?

Biohaven developed Nurtec ODT and commercialized it before Pfizer acquired Biohaven’s commercial CGRP portfolio in 2022.

Could Pfizer launch an authorized generic of Nurtec ODT?

Pfizer could pursue an authorized generic or enter into a generic license agreement, but such a strategy would depend on patent litigation, payer economics, and the expected timing of independent generic entry.

References

1. U.S. Food and Drug Administration. (2021). Nurtec ODT prescribing information. FDA.
2. American Migraine Foundation. (n.d.). Migraine facts and statistics. American Migraine Foundation.
3. Biohaven Pharmaceutical Holding Company Ltd. (2022). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission.
4. Pfizer Inc. (2022, October 3). Pfizer completes acquisition of Biohaven Pharmaceutical Holding Company’s CGRP migraine portfolio. Pfizer.
5. Pfizer Inc. (2024). Annual report 2023. U.S. Securities and Exchange Commission.
6. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
7. U.S. Code, 21 U.S.C. § 355(j). (2024). Abbreviated new drug applications and patent certifications. United States Code.