FDA — authorised 17 December 1996
- Application: NDA020702
- Marketing authorisation holder: UPJOHN
- Local brand name: LIPITOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lipitor in United States
FDA authorised Lipitor on 17 December 1996
Marketing authorisations
FDA — authorised 30 November 2011
- Application: ANDA076477
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 2012
- Application: ANDA090548
- Marketing authorisation holder: APOTEX INC
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 2012
- Application: ANDA091226
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 2012
- Application: ANDA202357
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 July 2012
- Application: ANDA091650
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 April 2013
- Application: ANDA091624
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 May 2013
- Application: NDA200153
- Marketing authorisation holder: ORGANON
- Local brand name: LIPTRUZET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2016
- Application: ANDA205519
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2017
- Application: ANDA204846
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 March 2017
- Application: ANDA205300
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
Teva Pharms USA received marketing authorisation from the FDA for Lipitor on 11 March 2025. This authorisation was granted through a standard expedited pathway. Lipitor is a medication used for its approved indication, which is listed in the labelling.
FDA — authorised 26 April 2017
- Application: ANDA206084
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LYPQOZET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2018
- Application: ANDA207687
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 2018
- Application: ANDA209912
- Marketing authorisation holder: GRAVITI PHARMS
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2018
- Application: ANDA206536
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2018
- Application: ANDA209288
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 November 2019
- Application: ANDA205945
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2020
- Application: ANDA208478
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 September 2021
- Application: ANDA214969
- Marketing authorisation holder: APOTEX
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 2022
- Application: ANDA216848
- Marketing authorisation holder: LEPU PHARM
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2022
- Application: ANDA216436
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 February 2023
- Application: NDA213260
- Marketing authorisation holder: CMP DEV LLC
- Local brand name: ATORVALIQ
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 September 2023
- Application: ANDA214344
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2023
- Application: ANDA212103
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2023
- Application: ANDA217634
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2024
- Application: ANDA217081
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2024
- Application: ANDA214513
- Marketing authorisation holder: LAURUS
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 2024
- Application: ANDA211886
- Marketing authorisation holder: SHANDONG XINHUA
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2024
- Application: ANDA217118
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2024
- Application: ANDA208480
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 2025
- Application: ANDA220276
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: ATORVASTATIN CALCIUM
- Indication: TABLET — ORAL
- Status: approved
Pricing & reimbursement
- annual_list: USD 70.00 per year
Lipitor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Lipitor approved in United States?
Yes. FDA authorised it on 17 December 1996; FDA authorised it on 30 November 2011; FDA authorised it on 29 May 2012.
Who is the marketing authorisation holder for Lipitor in United States?
UPJOHN holds the US marketing authorisation.
What does Lipitor cost in United States?
annual_list: USD 70.00 per year. Final patient cost depends on reimbursement and any patient access scheme.