VIBERZI Drug Patent Profile

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

Viberzi is a drug marketed by Abbvie and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in VIBERZI is eluxadoline. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.

DrugPatentWatch^® Generic Entry Outlook for Viberzi

Viberzi was eligible for patent challenges on May 27, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2033. This may change due to patent challenges or generic licensing.

There have been twenty-two 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.

There are two tentative approvals for the generic drug (eluxadoline), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VIBERZI

US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	2
Patent Applications:	244
Drug Prices:	Drug price information for VIBERZI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIBERZI
What excipients (inactive ingredients) are in VIBERZI?	VIBERZI excipients list
DailyMed Link:	VIBERZI at DailyMed

See drug prices for VIBERZI

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

Constraining patent/regulatory exclusivity:

9,675,587

NDA:

206940

Dosage:

TABLET;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 VIBERZI

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

Sponsor	Phase
Temple University	Phase 2/Phase 3
University of North Carolina, Chapel Hill	Phase 2
Allergan	Phase 2

See all VIBERZI clinical trials

Pharmacology for VIBERZI

Drug Class	mu-Opioid Receptor Agonist
Mechanism of Action	Opioid mu-Receptor Agonists

Paragraph IV (Patent) Challenges for VIBERZI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIBERZI	Tablets	eluxadoline	75 mg and 100 mg	206940	6	2019-05-28

US Patents and Regulatory Information for VIBERZI

VIBERZI is protected by fifteen US patents.

This potential generic entry date is based on patent 9,675,587.

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
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	11,160,792		Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	9,115,091		Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	8,691,860			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	7,741,356		Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	11,007,179		Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	11,160,792		Y

Expired US Patents for VIBERZI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	9,700,542
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	8,772,325
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	8,609,709
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	10,213,415
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	9,205,076
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	8,609,709

EU/EMA Drug Approvals for VIBERZI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Allergan Pharmaceuticals International Limited	Truberzi	eluxadoline	EMEA/H/C/004098Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).	Withdrawn	no	no	no	2016-09-19

International Patents for VIBERZI

When does loss-of-exclusivity occur for VIBERZI?

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

Australia

Brazil

Canada

China

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

Turkey

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 VIBERZI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014241076
Brazil	112015022753
Canada	2906472
Canada	3254178
China	105228629
China	110917159

Supplementary Protection Certificates for VIBERZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	CA 2017 00008	Denmark		PRODUCT NAME: ELUXADOLIN ELLER EN FARMACEUTISK ACCEPTABEL ENANTIOMER, DIASTEREOMER, RACEMAT ELLER SALT DERAF; REG. NO/DATE: EU/1/16/1126 20160921
1725537	300865	Netherlands		PRODUCT NAME: ELUXADOLINE OF EEN FARMACEUTISCH AANVAARDBAAR ENANTIOMEER,DIASTEREOMEER, RACEMAAT OF ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1126 20160921
1725537	PA2017005	Lithuania		PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537	122017000009	Germany		PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919
2176234	122017000010	Germany		PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537	1790007-7	Sweden		PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REG. NO/DATE: EU/1/16/1126 20160921

Viberzi Market Dynamics, Financial Trajectory, Patent Protection and Generic Risk

Last updated: October 27, 2026

Viberzi, the brand name for eluxadoline, is an oral, schedule IV drug approved by the U.S. Food and Drug Administration for irritable bowel syndrome with diarrhea, or IBS-D, in adults. Its commercial trajectory has been limited by a narrow label, safety restrictions involving the gallbladder and pancreas, competition from Xifaxan and low-cost symptomatic therapies, and the absence of a large international market.

AbbVie inherited Viberzi through its 2019 acquisition of Allergan. The product generated roughly $100 million to $120 million in annual sales before the acquisition but was not a major contributor to AbbVie's post-2020 financial results. Viberzi remains exposed to generic entry through the ANDA pathway, although its commercial decline reduces the financial value of late-stage patent litigation.

What is Viberzi and how does eluxadoline work?

Viberzi contains eluxadoline, a mixed opioid receptor modulator that acts primarily at peripheral mu-opioid receptors, with activity at delta-opioid receptors. It is designed to reduce bowel contractions and fluid secretion while improving diarrhea and abdominal symptoms associated with IBS-D.

The FDA approved Viberzi on May 27, 2015. The labeled dose is 100 mg twice daily for eligible adults, with a lower 75 mg twice-daily dose for selected patients, including some patients without a gallbladder and those unable to tolerate the higher dose.[1]

Viberzi is distinct from Xifaxan, which is rifaximin, and from common antidiarrheal products such as loperamide.

Product	Active ingredient	Primary IBS-D role	Key commercial distinction
Viberzi	Eluxadoline	Reduces diarrhea and bowel urgency	Controlled opioid-modulating drug
Xifaxan	Rifaximin	Treats IBS-D symptoms and recurrence	Antibiotic with separate approved indications
Imodium	Loperamide	Symptomatic diarrhea control	Low-cost, largely over-the-counter alternative
Lotronex	Alosetron	Severe diarrhea-predominant IBS in selected women	Restricted use because of serious gastrointestinal risks

How large is the Viberzi market?

Viberzi operates in a fragmented IBS-D market rather than a single-drug market. Prescribers select among prescription therapies, over-the-counter antidiarrheals, dietary interventions, and off-label drugs.

The main commercial constraints are:

• IBS-D is a chronic but heterogeneous condition.
• Many patients use inexpensive symptomatic therapies before moving to prescription drugs.
• Xifaxan has stronger recognition in the U.S. IBS-D market.
• Viberzi is unsuitable for patients without a gallbladder, patients with certain alcohol-use patterns, and patients with several pancreatic, hepatic, or biliary conditions.
• Safety warnings increased prescribing friction and patient screening requirements.

Viberzi's initial market opportunity was based on an unmet need for a non-antibiotic prescription treatment that could address diarrhea, urgency, and abdominal pain. The addressable population narrowed after safety restrictions were added to the prescribing information.

What were Viberzi’s sales and financial trajectory?

Allergan reported Viberzi sales in the approximate range of $100 million to $120 million annually during its principal commercial period. Public company reporting did not establish Viberzi as a material revenue driver compared with Allergan's larger products, including Botox, Restasis, Linzess, and several central nervous system and eye-care brands.

Year	Approximate reported Viberzi revenue	Commercial interpretation
2016	$59 million	Early post-launch expansion
2017	$110 million	Increased prescription adoption before later safety pressure
2018	$116 million	Peak or near-peak commercial period
2019	$110 million to $115 million	Mature product with limited growth
2020 onward	Not consistently reported as a standalone brand	Low materiality within AbbVie reporting

The exact figures vary by reporting presentation and fiscal-period treatment in Allergan filings. After AbbVie acquired Allergan, Viberzi was not presented as a separately material revenue line in the way that AbbVie's core immunology and aesthetics products were reported.[2]

What caused Viberzi revenue growth to stall?

Viberzi's growth was constrained by safety-related restrictions and competitive positioning.

In 2017, the FDA warned that Viberzi should not be used in patients without a gallbladder after reports of serious pancreatitis, including deaths. The agency also emphasized risks associated with alcohol use, biliary obstruction, sphincter of Oddi dysfunction, and pancreatitis.[3]

The 2017 warning materially reduced the eligible patient population. Patients without a gallbladder represent a significant portion of the IBS-D population, making the restriction commercially important.

In 2019, the FDA reported additional deaths and serious adverse events associated with Viberzi use in patients without a gallbladder. The agency instructed healthcare professionals to stop prescribing Viberzi to those patients and stated that the product should not be used in that population.[4]

The result was a product with a smaller target population, greater prescriber screening burden, and increased competition from Xifaxan and nonprescription options.

What is the FDA regulatory status of Viberzi?

Viberzi remains an FDA-approved treatment for IBS-D in adults, but its prescribing restrictions are substantial.

Regulatory issue	Status
FDA approval	Approved May 27, 2015
Indication	IBS-D in adults
Dosage form	Oral tablets
Controlled substance	Schedule IV in the United States
Gallbladder status	Contraindicated in patients without a gallbladder
Alcohol-related restrictions	Avoid excessive alcohol use; label includes specific contraindications and warnings
Major safety concerns	Pancreatitis, sphincter of Oddi spasm, constipation, biliary complications
Regulatory pathway	New drug application, not biologic licensing

Viberzi's controlled-substance status creates additional prescribing, dispensing, and compliance requirements. It also differentiates the product from rifaximin and most over-the-counter IBS-D products.[5]

What patents protect Viberzi?

Viberzi's core intellectual property is based on composition-of-matter and related pharmaceutical patents covering eluxadoline and its use in gastrointestinal disorders. The relevant patent estate can include:

• Eluxadoline chemical composition claims.
• Pharmaceutical composition claims.
• Treatment claims for IBS and diarrhea.
• Dosing and administration claims.
• Salt, polymorph, or formulation claims where applicable.
• Manufacturing and intermediate claims.

The most commercially important protection is the core active-ingredient patent. Method-of-use patents generally provide narrower protection because generic applicants can attempt to omit or carve out patented indications through a section viii statement.

Viberzi is a small-molecule drug. It therefore does not receive the biosimilar framework protections that apply to biologics such as monoclonal antibodies. Generic manufacturers can pursue approval through an abbreviated new drug application, subject to patent certifications and applicable exclusivity.

A current Orange Book review is required to determine the precise live patent list, expiration dates, pediatric exclusivity adjustments, and any changes caused by terminal disclaimers or patent-term extension. The Orange Book remains the controlling commercial reference for listed U.S. patents and exclusivity.[6]

When does Viberzi lose exclusivity?

Viberzi's practical exclusivity is determined by three separate factors:

1. FDA regulatory exclusivity.
2. Patent expiration.
3. The timing and outcome of ANDA challenges.

Viberzi's five-year new chemical entity exclusivity expired well before the current commercial period. The principal remaining barrier is patent protection, not FDA exclusivity.

The first generic-launch date cannot be determined solely from the original FDA approval date. It depends on:

• The expiration of each listed patent.
• Whether an applicant files a Paragraph IV certification.
• Whether the patent holder brings litigation within 45 days.
• Whether the litigation triggers a 30-month stay.
• Whether the parties settle.
• Whether the generic applicant obtains a judgment of invalidity, unenforceability, or non-infringement.
• Whether the applicant uses a section viii carve-out for method-of-use claims.

Have generic manufacturers filed Paragraph IV challenges to Viberzi?

Publicly visible commercial information does not identify a major, widely reported Viberzi Paragraph IV litigation campaign comparable to the challenges involving blockbuster drugs such as Humira, Revlimid, or Eliquis.

The absence of a prominent litigation record does not eliminate generic risk. Viberzi's limited annual sales may reduce the incentive for a large ANDA manufacturer to fund aggressive litigation, but low development cost for an oral small molecule can still support a later generic filing.

A generic applicant could pursue several strategies:

• Challenge composition patents under Paragraph IV.
• Wait for patent expiration and file under Paragraph III.
• File a section viii statement against method-of-use claims.
• Target a lower-cost launch after the branded market has contracted.
• Enter through a settlement that provides a future launch date.

What formulation patents protect Viberzi?

Viberzi is marketed as an oral tablet rather than an extended-release injectable, transdermal system, or complex delivery device. This limits the commercial value of formulation patents relative to products with sophisticated delivery technology.

Potential formulation claims may cover:

• Tablet composition.
• Excipient selection.
• Stability.
• Manufacturing process.
• Dosage strength.
• Solid-state characteristics.

For generic competition, formulation patents are most relevant if they are listed in the Orange Book and if they prevent a therapeutically substitutable tablet from reaching the market. A generic manufacturer may avoid some formulation claims by using a different excipient system or manufacturing route, provided the product satisfies FDA equivalence requirements.

What method-of-use patents cover Viberzi?

Method-of-use protection may cover treatment of IBS-D, reduction of diarrhea, or specific dosing regimens. These patents are commercially narrower than composition patents.

A generic applicant can sometimes pursue a label that excludes a patented indication. That strategy is more difficult when the remaining unpatented indication is central to the product's commercial use or when the FDA-approved label would still encourage infringement.

Because Viberzi has one principal approved indication, method-of-use carve-outs may be less commercially powerful than they are for drugs with multiple independent indications.

How strong is the Viberzi patent estate?

Viberzi's patent estate is moderate from a technical perspective but less valuable commercially than it was during the product's growth period.

Factors supporting patent strength

• A small-molecule composition patent can block direct substitution until expiration.
• Eluxadoline has a defined chemical entity rather than a broad mixture.
• A branded oral tablet can be protected by composition and manufacturing claims.
• Controlled-substance and safety requirements may raise operational hurdles for some generic entrants.

Factors weakening practical exclusivity

• The core product has a narrow market.
• The principal indication is concentrated in IBS-D.
• Generic manufacturers can use the ANDA pathway.
• Method-of-use patents may be vulnerable to label carve-outs.
• Viberzi lacks the complex biologic manufacturing barriers associated with antibody products.
• Safety restrictions reduce the economic value of prolonging exclusivity.

Patent strength and commercial strength are separate. Viberzi may retain enforceable claims while generating insufficient revenue to justify extensive litigation.

Which companies compete with Viberzi?

The competitive landscape is led by Xifaxan, manufactured by Salix Pharmaceuticals, a division of Bausch Health, and by inexpensive symptomatic treatments.

Competitor	Company	Competitive position
Xifaxan	Bausch Health/Salix	Main branded prescription competitor for IBS-D
Loperamide	Multiple manufacturers	Low-cost symptomatic alternative
Alosetron	Generic and branded sources	Option for selected women with severe IBS-D
Antispasmodics	Multiple manufacturers	Used for abdominal pain and cramping
Dietary and behavioral therapy	Various providers	Common first-line or adjunctive approach

Xifaxan benefits from broader prescriber familiarity and a commercial platform spanning hepatic encephalopathy, travelers' diarrhea, and IBS-D. Viberzi's narrower indication and safety restrictions limit its competitive reach.

Are biosimilars a risk for Viberzi?

No. Viberzi is a chemically synthesized small molecule, not a biologic. Biosimilar competition is therefore irrelevant.

The relevant threat is generic substitution through the ANDA pathway. Generic competition would likely produce sharper price compression than biosimilar competition because FDA-approved therapeutically equivalent tablets can receive pharmacy substitution subject to state law and payer policy.

What licensing deals affect Viberzi?

Viberzi was developed through a chain of transactions involving Furiex Pharmaceuticals, Forest Laboratories, Actavis, and Allergan. Forest Laboratories acquired Furiex in 2014, and Actavis acquired Forest Laboratories the same year. Actavis later adopted the Allergan name. AbbVie acquired Allergan in 2019.[7]

The transaction history matters because rights to Viberzi were consolidated through corporate acquisitions rather than through a major later-stage licensing deal. No publicly reported licensing transaction has made Viberzi a material standalone asset after the AbbVie-Allergan transaction.

What litigation and settlement risks affect Viberzi?

Viberzi's most important legal exposure has been product-liability risk linked to pancreatitis and biliary complications, not a highly visible patent battle.

The FDA safety communications increased the likelihood of:

• Personal-injury claims.
• Failure-to-warn allegations.
• Medical monitoring claims.
• Regulatory scrutiny of promotional materials.
• Insurance and reserve exposure.

A major patent settlement would be economically rational only if expected generic erosion were large enough to justify the legal expense. Given Viberzi's declining revenue profile, a future generic entrant may prefer a lower-cost challenge or delayed entry rather than protracted litigation.

What generic launch scenarios exist for Viberzi?

Scenario 1: Delayed generic entry after patent expiry

This is the simplest pathway. A manufacturer files an ANDA with a Paragraph III certification and launches after the last relevant patent expires.

Scenario 2: Paragraph IV challenge

A challenger alleges that listed patents are invalid, unenforceable, or not infringed. Litigation could delay launch through the 30-month stay, unless resolved earlier.

Scenario 3: Section viii carve-out

A generic applicant omits patented method-of-use language from its labeling. This approach is more viable when the remaining label supports a commercially meaningful non-infringing use.

Scenario 4: Settlement with a negotiated launch date

The patent holder and generic applicant agree to a future entry date. The economic value of this structure depends on the remaining brand revenue and the strength of the asserted patents.

The most likely commercial outcome is gradual erosion rather than a high-value, first-day generic shock. Viberzi's prescription base and revenue scale are smaller than those of major chronic-care blockbusters.

What is Viberzi’s geographic coverage?

Viberzi's commercial significance is concentrated in the United States. The product has not developed the broad global revenue base associated with multinational therapies for diabetes, oncology, immunology, or cardiovascular disease.

Geographic limitations reduce:

• International royalty potential.
• Manufacturing scale.
• Global supply-chain leverage.
• The value of non-U.S. patent estates.
• The ability to offset U.S. generic erosion with overseas growth.

The United States remains the primary market for assessing Viberzi's patents, FDA status, payer position, and generic-entry risk.

What manufacturing and intellectual-property barriers protect Viberzi?

Viberzi's manufacturing barriers are modest compared with biologics and complex drug-device products. The active ingredient is a small molecule delivered in a conventional tablet. Generic manufacturers must still establish:

• Pharmaceutical equivalence.
• Bioequivalence.
• Appropriate controls for a controlled substance.
• Manufacturing compliance.
• Stability and impurity controls.
• Compliance with applicable FDA labeling requirements.

These requirements create regulatory cost but do not represent a durable barrier comparable to proprietary cell lines, antibody production systems, inhaler devices, or long-acting injectable technology.

Key Takeaways

• Viberzi is eluxadoline, an FDA-approved oral treatment for IBS-D.
• Allergan's Viberzi revenue reached roughly $100 million to $120 million annually before the AbbVie acquisition.
• The product's commercial trajectory was weakened by pancreatitis and gallbladder-related safety restrictions.
• Patients without a gallbladder are contraindicated from using Viberzi.
• Viberzi is a schedule IV controlled substance.
• The product has no biosimilar risk because it is a small molecule.
• Generic risk arises through ANDA filings, Paragraph IV challenges, section viii carve-outs, and post-expiry entry.
• The core patent estate is more important legally than commercially because annual revenue has declined and is no longer separately material in AbbVie's public reporting.
• Xifaxan, loperamide, alosetron, antispasmodics, and dietary interventions constrain Viberzi's market share.
• The United States is the principal market for Viberzi revenue, regulatory status, and patent analysis.

FAQs

Is Viberzi still being marketed in the United States?

Viberzi remains an FDA-approved product for adult IBS-D, subject to its boxed warnings, contraindications, and controlled-substance requirements. Its commercial visibility is lower than during the Allergan growth period.

Can patients without a gallbladder take Viberzi?

No. The FDA labeling contraindicates Viberzi in patients without a gallbladder because of the risk of serious pancreatitis and sphincter of Oddi complications.

Is Viberzi more exposed to generic competition than Xifaxan?

Viberzi has the structural profile of a conventional small-molecule generic candidate. Xifaxan also faces generic risk, but its broader commercial platform and patent disputes have produced a different competitive and litigation profile.

Does Viberzi have pediatric exclusivity?

Viberzi was approved for adults with IBS-D. Its principal commercial exclusivity has been based on new chemical entity and patent protection rather than a major pediatric-exclusivity strategy.

What would most likely reduce Viberzi’s remaining value?

A therapeutically equivalent generic tablet, a successful Paragraph IV challenge, a major payer shift toward lower-cost alternatives, or further safety-related prescribing restrictions would reduce the product's remaining value.

References

1. U.S. Food and Drug Administration. (2015). FDA approves Viberzi to treat irritable bowel syndrome with diarrhea. https://www.fda.gov
2. Allergan plc. (2019). Annual report for the year ended December 31, 2019.
3. U.S. Food and Drug Administration. (2017). FDA warns about increased risk of serious pancreatitis with Viberzi in patients without a gallbladder. https://www.fda.gov
4. U.S. Food and Drug Administration. (2019). FDA warns about increased risk of serious pancreatitis with Viberzi. https://www.fda.gov
5. U.S. Drug Enforcement Administration. (2016). Schedules of controlled substances: Placement of eluxadoline into schedule IV. Federal Register.
6. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov
7. AbbVie Inc. (2019). AbbVie completes acquisition of Allergan. https://news.abbvie.com