Your Shopping Cart
By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Close
Hello. Sign In
Your Account

Log In to ComplianceOnline
Welcome back! Please log in below to continue.
0
Cart
Toll Free:
+1-888-717-2436
+1-888-717-2436
Industries
- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
Webinars
By Industries
Seminars
The Drug Development Process from Concept to Market
Analytical Instrument Qualification and System Validation
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
Biocompatibility Testing: What You Need to Know
Navigating the Medical Device Post-Market Maze and Challenges ...
Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions
The Veterinary Drug Approval Process and FDA Regulatory Oversight
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Standards
Aerospace
Agriculture and Farm Machinery
Automotive, Aircraft & Marine technology
Banking, Corp. finance & Sox
Biotech & Pharmaceutical Standards
Chemical technology
Civil engineering and construction
Computer Hardware
Electrical Engineering
Electronic Equipment
ANSI
Audit Net
BIN
BPA
Business Basics
Complianceonline
IT Governance
LabCompliance
Quality-Control-Plan
RCGLOBAL
SHOQ Quality Assurance Manuals
SEPT
Home
› Best Practices
FDA Approves Ranbaxy’s Lipitor Generic – How Does the Agency Approve Generic Drugs?
- By: Staff Editor
- Date: December 12, 2011
On the day that Pfizer’s patent for its cholesterol drug, Lipitor, expired, the FDA granted approval to Ranbaxy to begin selling its generic or copycat version of the same drug, named Atorvastatin. Besides Ranbaxy, Watson Pharmaceuticals Inc. is also selling a generic version of the drug under agreement with Pfizer.
As Ranbaxy was the first to challenge Lipitor with a generic drug, the company will be allowed by the FDA to sell its drug for six months (till May 2012) before other generic drugs come onto the market. This exclusive six month period is in accordance with the 1984 Hatch-Waxman Act.
But how does the FDA give approval to generic drugs? And what happens once a pharma company’s patent for its drug expires?
FDA approval for generic drugs
The process for approval of generic drugs by the FDA includes the following steps:
- Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product.
- When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.
- The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.
- Generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug).
- Scientists can demonstrate bioequivalence by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.
- When an ANDA is approved, the FDA adds the drug to its Approved Drug Products list, also known as the Orange Book, and annotates the list to show equivalence between the reference listed drug and the approved generic.
What can pharma companies do once drug patents expire?
The FDA states that drug patents expire 20 years from the date of filing of the patent.
Lipitor was Pfizer’s biggest selling drug – bringing in total annual sales of $7.6 billion in the US until September, 2011. The company, now having lost its patent for the drug, has made deals with pharmacy benefit managers (PBMs) and health insurers to prevent patients buying Ranbaxy’s generic version of the drug until the end of May 2012, when other firms will start selling their copycat versions of Lipitor. Bloomberg.com quoted Watson Pharmaceutical CEO Paul Bisaro as saying that “Such deals may help Pfizer retain as much as 40 percent of the Lipitor market during the six-month period in which Ranbaxy and Watson will be the only providers of generic versions.”
Get a better understanding of pharmaceutical regulatory requirements by attending any of the following ComplianceOnline webinars:
|
||
Compliance Trainings

Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime

How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime

Compliance Standards
Best Sellers
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
By: Miles HutchinsonAdd to CartPrice: $249
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
San Francisco, CA | Aug 6-7, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 18-19, 2020
-
Los Angeles, CA | Aug 20-21, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 25-26, 2020
-
Virtual Seminar | Jun 10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | Jul 6-7, 2020
-
San Francisco, CA | Oct 22-23, 2020
-
Virtual Seminar | Jul 9-10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | June 3-4, 2020
-
Miami, FL | Jul 29-31, 2020
-
Virtual Seminar | Jun 17, 2020
-
Provider: ANSIAdd to CartPrice: $142
- Add to Cart
- Add to Cart
- Add to Cart
-
Provider: ANSIAdd to CartPrice: $120
-
Provider: ANSIAdd to CartPrice: $250
-
Provider: SEPTAdd to CartPrice: $299
- Add to Cart
-
Provider: Quality-Control-PlanAdd to CartPrice: $37
- Add to Cart
-
Provider: At-PQCAdd to CartPrice: $397
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
You Recently Viewed
