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VEMLIDY

NDA

TENOFOVIR ALAFENAMIDE FUMARATE | N208464 | GILEAD SCIENCES INC

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

2032

2033

Today

8754065

Feb. 15, 2033

9296769

Feb. 15, 2033

NPP

Mar. 27, 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

3 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
GILEAD SCIENCES, INC. v. SABA ILAC SANAYI VE TICARET A.S. 2:2026cv03282 2 patentsANDA 220362tenofovir alafenamide	D.N.J.	2026-03-27	Active	—
Gilead Sciences, Inc. v. Macleods Pharmaceuticals Ltd. 1:2026cv00094 2 patentsANDA 220967tenofovir alafenamide	D. Del.	2026-01-28	Active	—
Gilead Sciences, Inc. v. Apotex, Inc. et al 1:2020cv00189 4 patentsANDA 213867, 214053, 214095, 214226, 213926, 214227, 214030, 213989, 214072, 213845, 214173, 214059, 214058, 214216, 214179, 211850tenofovir alafenamide	D. Del.	2020-02-07	Terminated 2022-09-12	—

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 Vemlidy (2023)

Total Spending

$187.9M

Total Claims

119,837

Beneficiaries

13,612

Avg Cost/Unit

$48.73

Spending Trend

$96.6M(2019)→$127.2M(2020)→$137.3M(2021)→$158.4M(2022)→$187.9M(2023)

YoY Change:+7.3%

5yr CAGR:+6.6%

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

API Supply Chain18 active DMFs

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

MATRIX PHARMACORP PRIVATE LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 300132015

CIPLA LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 309912016

LUPIN MANUFACTURING SOLUTIONS LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 315162017

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 317002017

EMCURE PHARMACEUTICALS LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 323122017

MACLEODS PHARMACEUTICALS LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 324932018

LAURUS LABS LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 335412019

LUPIN LTDTENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-B)

DMF 335472019

CIPLA LTDTENOFOVIR ALAFENAMIDE FUMARATE (C)

DMF 336032019

HEC PHARM CO LTDTENOFOVIR ALAFENAMIDE FUMARATE NON-STERILE BULK DRUG SUBSTANCE

DMF 338052019

SHILPA PHARMA LIFESCIENCES LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 338502019

MACLEODS PHARMACEUTICALS LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 339412019

AURISCO PHARMACEUTICAL CO LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 348482020

CDYMAX (INDIA) PHARMA PRIVATE LTDTENOFOVIR ALAFENAMIDE FUMARATE [DRUG SUBSTANCE (NON-STERILE)].

DMF 349062020

APITORIA PHARMA PRIVATE LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 351262020

LAURUS LABS LTDTENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-2)

DMF 364432021

REYOUNG CORPORATIONTENOFOVIR ALAFENAMIDE FUMARATE

DMF 371272022

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDTENOFOVIR ALAFENAMIDE FUMARATE

DMF 425562025

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Mar 28, 2024	SUPPL -16	View Letter (PDF)
Mar 28, 2024	SUPPL -17	View Letter (PDF)
Feb 21, 2023	SUPPL -15	View Letter (PDF)
Oct 18, 2022	SUPPL -14	View Letter (PDF)
Sep 17, 2021	SUPPL -13	View Letter (PDF)
Mar 5, 2021	SUPPL -12	View Letter (PDF)
Aug 19, 2020	SUPPL -11	View Letter (PDF)
Aug 19, 2020	SUPPL -10	View Letter (PDF)
Feb 5, 2020	SUPPL -8	View Letter (PDF)
Feb 13, 2019	SUPPL -7	View Letter (PDF)
Jul 6, 2018	SUPPL -4	View Letter (PDF)
Apr 12, 2017	SUPPL -1	View Letter (PDF)
Nov 15, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 25MG BASE

RLDAB

2 patents1 exclusivity▴

TABLET;ORAL | Approved: Nov 10, 2016

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8754065	Aug 15, 2032PED: Feb 15, 2033	PED	Yes	Yes		—
9296769	Aug 15, 2032PED: Feb 15, 2033	PED	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
NPP	Mar 27, 2027	< 1 year

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

New: New record