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DOVATO

NDA

DOLUTEGRAVIR SODIUM; LAMIVUDINE | N211994 | VIIV HEALTHCARE CO

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

Today

8129385

Apr. 5, 2028

9242986

Jun. 8, 2030

11234985

Jan. 24, 2031

NPP

Apr. 5, 2027

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ViiV Healthcare Company et al v. Cipla Limited et al 1:2019cv02085 1 patentANDA 213579dolutegravir sodium; lamivudine	D. Del.	2019-11-04	Terminated 2022-04-04	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Dovato (2023)

Total Spending

$433.4M

Total Claims

141,374

Beneficiaries

15,932

Avg Cost/Unit

$98.89

Spending Trend

$17.6M(2019)→$93.2M(2020)→$187.8M(2021)→$309.3M(2022)→$433.4M(2023)

YoY Change:+5.6%

5yr CAGR:+6.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Oct 29, 2025	SUPPL -23	View Letter (PDF)
Apr 8, 2024	SUPPL -19	View Letter (PDF)
Apr 8, 2024	SUPPL -18	View Letter (PDF)
Nov 13, 2023	SUPPL -20	View Letter (PDF)
Jan 26, 2023	SUPPL -14	View Letter (PDF)
Oct 11, 2022	SUPPL -15	View Letter (PDF)
Jan 21, 2022	SUPPL -12	View Letter (PDF)
Jan 21, 2022	SUPPL -13	View Letter (PDF)
Mar 24, 2021	SUPPL -11	View Letter (PDF)
Mar 2, 2021	SUPPL -10	View Letter (PDF)
Aug 7, 2020	SUPPL -6	View Letter (PDF)
Aug 7, 2020	SUPPL -7	View Letter (PDF)
Mar 25, 2020	SUPPL -4	View Letter (PDF)
Oct 25, 2019	SUPPL -5	View Letter (PDF)
Apr 10, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE;300MG

RLD

3 patents1 exclusivity▴

TABLET;ORAL | Approved: Apr 8, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8129385	Oct 5, 2027PED: Apr 5, 2028	PED	Yes	Yes	—	—
9242986	Dec 8, 2029PED: Jun 8, 2030	PED	Yes	Yes	—	—
11234985	Jan 24, 2031	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
NPP	Apr 5, 2027	< 1 year