Viewing data from:

TIVICAY PD

NDA

DOLUTEGRAVIR SODIUM | N213983 | VIIV HEALTHCARE CO

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)TodayPED (+6 mo)

2027

2028

2029

2030

Today

8129385

Apr. 5, 2028

9242986

Jun. 8, 2030

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. Lupin Limited et al 1:2021cv01561 1 patentANDA 216470dolutegravir	D. Del.	2021-11-02	Terminated 2023-03-14	—

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 Tivicay Pd (2023)

Total Spending

$36K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$7.70

Spending Trend

$22K(2021)→$25K(2022)→$36K(2023)

YoY Change:+6.6%

5yr CAGR:+7.0%

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

API Supply Chain27 active DMFs

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

APITORIA PHARMA PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 287212014

MATRIX PHARMACORP PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 300112015

CIPLA LTDDOLUTEGRAVIR SODIUM

DMF 300552016

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDDOLUTEGRAVIR SODIUM

DMF 303652016

HETERO LABS LTDDOLUTEGRAVIR SODIUM

DMF 305442016

LEK PHARMACEUTICALS DDDOLUTEGRAVIR SODIUM

DMF 309332016

LAURUS LABS LTDDOLUTEGRAVIR SODIUM

DMF 309352016

CIPLA LTDDOLUTEGRAVIR SODIUM (FORM C)

DMF 311072017

MATRIX PHARMACORP PRIVATE LTDDOLUTEGRAVIR SODIUM (PROCESS-II)

DMF 312092016

MICRO LABS LTDDOLUTEGRAVIR SODIUM

DMF 312222017

MSN LIFE SCIENCES PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 312432016

MACLEODS PHARMACEUTICALS LTDDOLUTEGRAVIR SODIUM

DMF 313012017

LUPIN MANUFACTURING SOLUTIONS LTDDOLUTEGRAVIR SODIUM (PROCESS A)

DMF 314722017

LUPIN MANUFACTURING SOLUTIONS LTDDOLUTEGRAVIR SODIUM ( PROCESS B)

DMF 314732017

LAURUS LABS LTDDOLUTEGRAVIR SODIUM (PROCESS-2)

DMF 318552017

HETERO LABS LTDDOLUTEGRAVIR SODIUM (PROCESS-II)

DMF 329552018

EMCURE PHARMACEUTICALS LTDDOLUTEGRAVIR SODIUM

DMF 331402018

LAURUS LABS LTDDOLUTEGRAVIR SODIUM (PROCESS-3)

DMF 337682019

CHROMO LABORATORIES INDIA PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 339922021

CIPLA LTDDOLUTEGRAVIR SODIUM PROCESS A

DMF 341152019

ARENE LIFE SCIENCES PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 344712020

STYRAX PHARMA PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 367432022

MSN LIFE SCIENCES PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 369992022

VIYASH LIFE SCIENCES PRIVATE LTDDOLUTEGRAVIR SODIUM

DMF 373042022

LAURUS LABS LTDDOLUTEGRAVIR SODIUM (HXA)

DMF 396782024

CHONGQING CARELIFE PHARMACEUTICAL CO LTDDOLUTEGRAVIR SODIUM

DMF 404472024

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDDOLUTEGRAVIR SODIUM

DMF 425542025

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 29, 2025	SUPPL -6	View Letter (PDF)
Apr 19, 2024	SUPPL -4	View Letter (PDF)
Oct 11, 2022	SUPPL -3	View Letter (PDF)
Jul 13, 2021	SUPPL -2	View Letter (PDF)
Mar 24, 2021	SUPPL -1	View Letter (PDF)
Jun 16, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 5MG BASE

RLD

2 patents0 exclusivities▴

TABLET, FOR SUSPENSION;ORAL | Approved: Jun 12, 2020

Patents (2)

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	—	—