Viewing data from:

INVOKAMET XR

NDA

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE | N205879 | JANSSEN PHARMACEUTICALS INC

4 strengths3 unique patents2 unique exclusivities

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (2)TodayPED (+6 mo)Exclusivity

2027

2028

2029

Today

7943582

Aug. 26, 2029

7943788

Jan. 14, 2028

8513202

Jun. 3, 2028

NPP

Jun. 18, 2028

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
MITSUBISHI TANABE PHARMA CORPORATION et al v. AUROBINDO PHARMA USA, INC. 1:2020cv03102 2 patentsANDA 213900canagliflozin and metformin hydrochloride	D.N.J.	2020-03-20	Terminated 2020-07-17	—
MITSUBISHI TANABE PHARMA CORPORATION et al v. MSN LABORATORIES PRIVATE LTD. et al 3:2019cv18958 1 patentANDA 210462, 213403canagliflozin	D.N.J.	2019-10-14	Terminated 2020-02-26	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

11 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants NCT02846506	Phase 1	Completed	Janssen Research & Development, LLC	44	2016-08 → 2016-10
A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers NCT01508182	Phase 1	Completed	Janssen Research & Development, LLC	64	2012-01 → 2012-03
A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes NCT04288778	Phase 4	Completed	Johnson & Johnson Private Limited	276	2020-11-25 → 2022-07-26
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants NCT02865668	Phase 1	Completed	Janssen Research & Development, LLC	44	2016-08 → 2016-10
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers NCT01508195	Phase 1	Completed	Janssen Research & Development, LLC	64	2012-01 → 2012-03
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants NCT02851095	Phase 1	Completed	Janssen Research & Development, LLC	44	2016-08 → 2016-11
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers NCT01463774	Phase 1	Completed	Janssen Research & Development, LLC	74	2011-09 → 2011-12
A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers NCT01273571	Phase 1	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	18	2010-12 → 2011-02
Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants NCT02221180	Phase 1	Completed	Janssen Research & Development, LLC	2	2014-08 → 2014-11
Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants NCT02220218	Phase 1	Completed	Janssen Research & Development, LLC	2	2014-08 → 2014-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$9.68

per ea

Lowest NADAC/Unit

$9.52

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50458094001INVOKAMET XR 50-500 MG TABLET	$9.68	EA	Brand	—	2025-12-17
50458094101INVOKAMET XR 50-1,000 MG TAB	$9.66	EA	Brand	—	2026-06-17
50458094201INVOKAMET XR 150-500 MG TABLET	$9.56	EA	Brand	—	2026-06-17
50458094301INVOKAMET XR 150-1,000 MG TAB	$9.52	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 | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$447.39

Highest Price

$598.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50458-0942-01INVOKAMET XR TABS 150/500MG	$598.55	FSS	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0942-01INVOKAMET XR TABS 150/500MG	$448.02	Big4	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0940-01INVOKAMET XR TABS 50/500MG	$598.55	FSS	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0940-01INVOKAMET XR TABS 50/500MG	$448.00	Big4	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0941-01INVOKAMET XR TABS 50/1000MG	$598.55	FSS	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0941-01INVOKAMET XR TABS 50/1000MG	$447.54	Big4	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0943-01INVOKAMET XR TABS 150/1000MG	$598.55	FSS	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029
50458-0943-01INVOKAMET XR TABS 150/1000MG	$447.39	Big4	Johnson & Johnson Health Care Systems, Inc. obo Janssen Pharmaceuticals,Inc	09/28/2029

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

Medicare Part D Spending

CMS annual spending data for Invokamet XR (2024)

Total Spending

$10.2M

Total Claims

10,648

Beneficiaries

2,419

Avg Cost/Unit

$9.29

Spending Trend

$17.6M(2019)→$22.1M(2020)→$16.5M(2021)→$16.2M(2022)→$13.1M(2023)→$10.2M(2024)

YoY Change:-9.3%

5yr CAGR:+1.8%

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2024	SUPPL -23	View Letter (PDF)
Aug 26, 2024	SUPPL -22	View Letter (PDF)
Jan 23, 2024	SUPPL -20	View Letter (PDF)
Jul 7, 2023	SUPPL -19	View Letter (PDF)
Oct 14, 2022	SUPPL -18	View Letter (PDF)
Aug 19, 2020	SUPPL -17	View Letter (PDF)
Jan 28, 2020	SUPPL -11	View Letter (PDF)
Jan 27, 2020	SUPPL -14	View Letter (PDF)
Oct 31, 2018	SUPPL -7	View Letter (PDF)
Oct 30, 2018	SUPPL -9	View Letter (PDF)
Jan 3, 2018	SUPPL -2	View Letter (PDF)
Aug 21, 2017	SUPPL -6	View Letter (PDF)
Jul 28, 2017	SUPPL -5	View Letter (PDF)
Sep 29, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 50MG;500MG

RLD

3 patents2 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 20, 2016

Patents (3) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7943582	Feb 26, 2029PED: Aug 26, 2029	PED	Yes	Yes		—
7943788	Jul 14, 2027PED: Jan 14, 2028	PED	Yes	Yes	—	—
8513202	Dec 3, 2027PED: Jun 3, 2028	PED	Yes	Yes		—

Exclusivities (2)

Code	Date	Status
NPP	Dec 18, 2027	Active
PED	Jun 18, 2028	Active

#002 — 50MG;1GM

RLD

3 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 20, 2016

#003 — 150MG;500MG

RLD

3 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 20, 2016

#004 — 150MG;1GM

RLD

3 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 20, 2016