Ubrogepant - Generic Drug Details

What are the generic sources for ubrogepant and what is the scope of freedom to operate?

Ubrogepant is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ubrogepant has one hundred and three patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for ubrogepant

International Patents:	103
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	13
Patent Applications:	121
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ubrogepant
What excipients (inactive ingredients) are in ubrogepant?	ubrogepant excipients list
DailyMed Link:	ubrogepant at DailyMed

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

Constraining patent/regulatory exclusivity:

10,117,836

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 ubrogepant

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

Sponsor	Phase
AbbVie	Phase 1
Chicago Headache Center & Research Institute	Phase 4
AbbVie	Phase 4

See all ubrogepant clinical trials

Pharmacology for ubrogepant

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

Anatomical Therapeutic Chemical (ATC) Classes for ubrogepant

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for UBROGEPANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UBRELVY	Tablets	ubrogepant	50 mg and 100 mg	211765	4	2023-12-26

US Patents and Regulatory Information for ubrogepant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	8,912,210		Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	12,070,450
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	10,117,836		Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	9,499,545		Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	9,833,448
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	9,499,545		Y	Y
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-002	Dec 23, 2019		RX	Yes	Yes	8,754,096		Y	Y

International Patents for ubrogepant

Country	Patent Number	Title	Estimated Expiration
Australia	2021409718
Denmark	2821407
Canada	3206184
Taiwan	201305165	Piperidinone carboxamide azaindane CGRP receptor antagonists
Serbia	53610	ANTAGONISTI PIPERIDINON KARBOKSAMID AZAINDAN CGRP RECEPTORA (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS)
Slovenia	2821407
Japan	6666490

Supplementary Protection Certificates for ubrogepant

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	122023000058	Germany		PRODUCT NAME: ATOGEPANT ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	PA2023532	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	301248	Netherlands		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1750 20230814
2638042	LUC00321	Luxembourg		PRODUCT NAME: ATOGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	34/2023	Austria		PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814
2638042	C02638042/01	Switzerland		PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024

Ubrogepant Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ubrogepant

Introduction to Ubrogepant

Ubrogepant, marketed under the brand name Ubrelvy, is a novel oral calcitonin gene-related peptide (CGRP) receptor antagonist developed for the acute treatment of migraine. It has been approved by the FDA and is part of a new wave of migraine treatments that are revolutionizing the management of this debilitating condition.

Market Growth and Projections

The migraine market, which includes ubrogepant, is expected to experience significant growth. By 2033, the market across seven major markets (7MM) is projected to reach $16.4 billion, growing at a compound annual growth rate (CAGR) of 6.0% from $9.2 billion in 2023[1].

Key Drivers of Market Growth

The growth in the migraine market is primarily driven by the increased prescription of CGRP antagonists, including both monoclonal antibodies for migraine prevention and oral gepants like ubrogepant for both acute and preventive treatment. These newer drugs offer superior efficacy compared to traditional treatments such as triptans, antidepressants, anticonvulsants, and beta blockers[1].

Ubrogepant's Market Position

Ubrogepant is well-positioned in this growing market. According to GlobalData, AbbVie’s Ubrelvy (ubrogepant) is expected to be the top-selling drug in the migraine market by 2033, with projected sales of $1.07 billion. This is partly due to its later patent expiry date compared to other CGRP antagonists[1].

Clinical Efficacy and Safety

Ubrogepant has demonstrated strong clinical efficacy in treating acute migraines. Clinical trials have shown that ubrogepant achieves significant pain freedom and absence of most bothersome migraine symptoms at two hours post-dose. The drug has been tested in various doses, with the 50 mg and 100 mg doses showing similar efficacy and safety profiles[3][4].

Safety Profile

The safety profile of ubrogepant is favorable, with no major serious toxicities identified in clinical trials. Common adverse events include viral infections, nausea, somnolence, confusion, dizziness, dry mouth, and abdominal pain. Despite initial concerns over liver safety signals, these have been addressed, and the drug is considered safe for use[3][4].

Financial Performance

AbbVie, the company behind ubrogepant, has reported significant financial growth driven by its neuroscience portfolio, which includes Ubrelvy. In 2023, global net revenues from the neuroscience portfolio increased by 22.6%, with Ubrelvy net revenues specifically increasing by 18.9% to $234 million[2].

Revenue Projections and Growth

AbbVie has reaffirmed its expectations for a high single-digit compound annual revenue growth rate through 2029. The company has also raised its peak sales outlook for Ubrelvy and another migraine treatment, Qulipta, to more than $3 billion combined. This indicates strong confidence in the financial trajectory of ubrogepant and other related treatments[2].

Competitive Landscape

The migraine market is becoming increasingly competitive with the introduction of other CGRP antagonists. However, ubrogepant's unique position as an oral treatment and its strong clinical data make it an attractive option for patients and healthcare providers. It competes with other oral gepants like Biohaven's rimegepant and injectable CGRP inhibitors such as Amgen and Novartis' Aimovig (erenumab)[4].

Patient Needs and Prescribing Factors

A significant portion of migraine patients are non-responsive or intolerant to traditional treatments like triptans. Ubrogepant addresses this gap by offering effective pain relief and a favorable safety profile, making it a preferred choice for many patients. According to David Dodick, a professor of neurology at the Mayo Clinic, headache relief is the biggest prescribing factor, and ubrogepant's efficacy in this area is a major advantage[4].

Reimbursement and Patent Considerations

While the growth of CGRP antagonists is promising, it is also limited by reimbursement restrictions and patent expiries. The high annual costs of therapy for these drugs compared to generic alternatives may restrict their adoption. However, ubrogepant's later patent expiry date relative to other CGRP antagonists gives it a longer market exclusivity period, which is beneficial for its financial trajectory[1].

Conclusion

Ubrogepant is poised to play a significant role in the growing migraine market. With its strong clinical efficacy, favorable safety profile, and strategic market position, it is expected to be a top-selling drug in the migraine market by 2033. AbbVie's financial projections and the increasing demand for effective migraine treatments further solidify ubrogepant's promising financial trajectory.

Key Takeaways

• The migraine market is expected to reach $16.4 billion by 2033, driven by CGRP antagonists.
• Ubrogepant is projected to be the top-selling drug in the migraine market by 2033.
• The drug has demonstrated strong clinical efficacy and a favorable safety profile.
• AbbVie's neuroscience portfolio, including Ubrelvy, has shown significant financial growth.
• Ubrogepant competes in a crowded market but stands out due to its oral formulation and strong clinical data.
• Reimbursement restrictions and patent expiries are key factors influencing the market growth.

FAQs

Q: What is ubrogepant used for? A: Ubrogepant is used for the acute treatment of migraine.

Q: How effective is ubrogepant in treating migraines? A: Ubrogepant has shown significant efficacy in achieving pain freedom and absence of most bothersome migraine symptoms at two hours post-dose.

Q: What are the common adverse events associated with ubrogepant? A: Common adverse events include viral infections, nausea, somnolence, confusion, dizziness, dry mouth, and abdominal pain.

Q: How does ubrogepant compare to other migraine treatments? A: Ubrogepant offers superior efficacy compared to traditional treatments like triptans and has a favorable safety profile compared to some other CGRP antagonists.

Q: What are the financial projections for ubrogepant? A: Ubrogepant is expected to achieve sales of $1.07 billion by 2033 and is part of AbbVie’s neuroscience portfolio, which is projected to grow significantly.

Sources

1. Clinical Trials Arena: "Migraine market expected to reach $16.4bn across 7MM by 2033"[1]
2. AbbVie Investors: "AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results"[2]
3. FDA Access Data: "211765Orig1s000 CLINICAL REVIEW(S)"[3]
4. BioPharma Dive: "Allergan defends ubrogepant's marketability"[4]