13 companies list darunavir as a human prescription drug in the openFDA NDC Directory, led by Janssen Pharmaceuticals, Inc., Camber Pharmaceuticals, Inc., Lupin Limited, Zydus Lifesciences Limited, CIPLA PHARMACEUTICALS LIMITED. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.

Is there a generic PREZISTA?

12 companies list darunavir under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies darunavir active ingredient?

4 companies list darunavir as a bulk ingredient, including Hetero Labs Limited, CIPLA PHARMACEUTICALS LIMITED, Honour Lab Limited, LAURUS LABS LIMITED.

Drug

Who makes darunavir?

13 companies list darunavir as a human prescription drug, including under the names PREZISTA. Forms: suspension; tablet; tablet, film coated. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing darunavir

Company	Forms	Application	NDCs	Registered sites
Janssen Pharmaceuticals, Inc.	suspension; tablet, film coated	NDANDA021976, NDA202895	5	0
Camber Pharmaceuticals, Inc.United States	tablet, film coated	ANDAANDA202083, ANDA216168	4	1
Lupin LimitedIndia	tablet, film coated	ANDAANDA202073	2	14
Zydus Lifesciences LimitedIndia	tablet, film coated	ANDAANDA214085	2	12
CIPLA PHARMACEUTICALS LIMITEDIndia	tablet	ANDAANDA206288	2	7
Aurobindo Pharma LimitedIndia	tablet, film coated	ANDAANDA210677	2	6
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States	tablet	ANDAANDA206288	2	5
Bryant Ranch PrepackUnited States	tablet; tablet, film coated	ANDAANDA206288, ANDA215389	2	1
Amneal Pharmaceuticals NY LLC	tablet, film coated	ANDAANDA212493	2	0
Dr. Reddys Laboratories Limited	tablet, film coated	ANDAANDA211578	2	0
Novadoz Pharmaceuticals LLC	tablet, film coated	ANDAANDA215389	2	0
Viona Pharmaceuticals Inc.	tablet, film coated	ANDAANDA214085	2	0
NuCare Pharmaceuticals,Inc.United States	tablet, film coated	ANDAANDA210677	1	1

Bulk ingredient listings

Hetero Labs LimitedIndia · 2 NDC
CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
Honour Lab LimitedIndia · 1 NDC
LAURUS LABS LIMITEDIndia · 1 NDC

Orange Book patents

2 unexpired patents list darunavir as the active ingredient, expiring between Dec 2026 and Jun 2027. Application holder: JANSSEN PRODUCTS LP.

Enquiry

Common questions

Who makes darunavir?: 13 companies list darunavir as a human prescription drug in the openFDA NDC Directory, led by Janssen Pharmaceuticals, Inc., Camber Pharmaceuticals, Inc., Lupin Limited, Zydus Lifesciences Limited, CIPLA PHARMACEUTICALS LIMITED. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic PREZISTA?: 12 companies list darunavir under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies darunavir active ingredient?: 4 companies list darunavir as a bulk ingredient, including Hetero Labs Limited, CIPLA PHARMACEUTICALS LIMITED, Honour Lab Limited, LAURUS LABS LIMITED.