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QULIPTA

NDA

ATOGEPANT | N215206 | ABBVIE INC

3 strengths9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents, 2 exclusivities by expiration date

Active (9)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

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2044

Today

Sep. 28, 2035

Nov. 10, 2031

Mar. 13, 2033

Jan. 30, 2035

Jul. 29, 2041

Feb. 27, 2043

Jun. 6, 2039

Sep. 27, 2042

Sep. 27, 2042

I-909

Apr. 17, 2026

NCE

Sep. 28, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

6 cases on OB patents (6 active) from PACER

Case	Court	Filed	Status	Judge
ABBVIE INC. et al v. MICRO LABS LIMITED et al 3:2026cv00518 8 patentsANDA 220772atogepant	D.N.J.	2026-01-15	Active	—
ABBVIE INC. et al v. HETERO USA INC. et al 3:2026cv00114 4 patentsANDA 220986atogepant	D.N.J.	2026-01-07	Active	—
ABBVIE INC. et al v. MSN PHARMACEUTICALS INC. et al 3:2026cv00115 8 patentsANDA 221083atogepant	D.N.J.	2026-01-07	Active	—
ABBVIE INC. et al v. MACLEODS PHARMACEUTICAL LTD. et al 3:2025cv19038 4 patentsANDA 220982atogepant	D.N.J.	2025-12-29	Active	—
ABBVIE INC. et al v. DR. REDDY'S LABORATORIES, LTD. et al 3:2025cv19039 8 patentsANDA 221029atogepant	D.N.J.	2025-12-29	Active	—
ABBVIE INC. et al v. APOTEX INC. 3:2025cv18972 8 patentsANDA 220979atogepant	D.N.J.	2025-12-23	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine NCT03700320	Phase 3	Completed	Allergan	744	2018-10-08 → 2020-05-21
Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention NCT02848326	Phase 2/3	Completed	Allergan	834	2016-09-06 → 2018-04-23
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine NCT03777059	Phase 3	Completed	Allergan	910	2018-12-14 → 2020-06-19
Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine NCT03939312	Phase 3	Completed	Allergan	685	2019-05-06 → 2021-03-31
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine NCT03855137	Phase 3	Completed	Allergan	778	2019-03-11 → 2022-01-20

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$38.47

per ea

Lowest NADAC/Unit

$38.36

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00074709430QULIPTA 60 MG TABLET	$38.47	EA	Brand	—	2026-06-17
00074709630QULIPTA 30 MG TABLET	$38.41	EA	Brand	—	2026-06-17
00074709530QULIPTA 10 MG TABLET	$38.36	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$726.37

Highest Price

$726.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-7094-30QULIPTA 60MG TAB	$726.37	FSS	Abbvie US LLC	07/31/2030
00074-7094-30QULIPTA 60MG TAB	$726.37	Big4	Abbvie US LLC	07/31/2030
00074-7095-30QULIPTA 10MG TAB	$726.37	FSS	Abbvie US LLC	07/31/2030
00074-7095-30QULIPTA 10MG TAB	$726.37	Big4	Abbvie US LLC	07/31/2030
00074-7096-30QULIPTA 30MG TAB	$726.37	FSS	Abbvie US LLC	07/31/2030
00074-7096-30QULIPTA 30MG TAB	$726.37	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Qulipta (2024)

Total Spending

$260.3M

Total Claims

209,816

Beneficiaries

45,046

Avg Cost/Unit

$35.98

Spending Trend

$1.3M(2021)→$51.3M(2022)→$137.9M(2023)→$260.3M(2024)

YoY Change:-2.3%

5yr CAGR:+1.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MACLEODS PHARMACEUTICALS LTDATOGEPANT

DMF 409362025

MSN LIFE SCIENCES PRIVATE LTDATOGEPANT

DMF 412652025

MICRO LABS LTDATOGEPANT

DMF 418572025

HONOUR LAB LTDATOGEPANT MONOHYDRATE

DMF 422582025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 2, 2025	SUPPL -13	View Letter (PDF)
Jun 12, 2025	SUPPL -10	View Letter (PDF)
Jun 12, 2025	SUPPL -12	View Letter (PDF)
Mar 25, 2025	SUPPL -11	View Letter (PDF)
Sep 29, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG

RLD

9 patents2 exclusivities▴

TABLET;ORAL | Approved: Sep 28, 2021

Patents (9) · 7 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8754096	Sep 28, 2035	—	Yes	Yes		—
9499545	Nov 10, 2031	—	Yes	Yes		—
9850246	Mar 13, 2033	—	Yes	—	—	—
10117836	Jan 30, 2035	—	—	Yes	—	—
12090148	Jul 29, 2041	—	—	—		—
12350259	Feb 27, 2043	—	—	—		—
12383545	Jun 6, 2039	—	—	—		—
12465598	Sep 27, 2042	—	—	—		—
12622897	Sep 27, 2042	—	—	—		—

Exclusivities (2)

Code	Date	Status
I-909	Apr 17, 2026	Expired
NCE	Sep 28, 2026	< 1 year

#002 — 30MG

RLD

7 patents2 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2021

#003 — 60MG

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Sep 28, 2021