Healthcare & Lifesciences Insights

First Generic Drug Approvals 2023

US Market contributing more than 40% of the global pharma market, indicates the financial and R&D muscle power of the pharma companies entering into it.

Correct Predictive analysis of epidemiological data, first mover advantage competition, volume, pricing and strong distribution channels are the key strategic levers.

These things are planned well in advance of the Patent getting expired. The need for diligent consulting firm can not be just ignored trusting every inhouse opinion, since they are based on their own kpi and not on the future success or failure of the product.

Below is the list of first generic approved by US FDA

9. ANDA Number : 214836

Generic Name : Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)

ANDA Applicant : L. Perrigo Company

Brand Name : Advil Dual Action with Acetaminophen (Acetaminophen and Ibuprofen) Tablets (OTC)

ANDA Approval Date : 2/28/2023

ANDA Indication : Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis

8. ANDA Number : 217219

Generic Name : Tiopronin Delayed-Release Tablets, 100 mg and 300 mg

ANDA Applicant : Par Pharmaceutical, Inc.

Brand Name : Thiola (Tiopronin) EC Tablets

ANDA Approval Date : 2/24/2023

ANDA Indication+ : For the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone

7. ANDA Number : 215408

Generic Name : Doxepin Hydrochloride Cream, 5%

ANDA Applicant : Teva Pharmaceuticals Development, Inc.

Brand Name : Zonalon (Doxepin Hydrochloride) Cream

ANDA Approval Date : 2/17/2023

ANDA Indication+ : For the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus

6. ANDA Number : 216167

Generic Name : Topiramate Extended-Release Capsules, 200 mg

ANDA Applicant : Zydus Pharmaceuticals (USA) Inc.

Brand Name : Trokendi XR (Topiramate) Extended-Release Capsules

ANDA Approval Date : 2/9/2023

ANDA Indication+ : Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older; preventive treatment of migraine in patients 12 years of age and older

5. ANDA Number : 213947

Generic Name : Tirofiban Hydrochloride Injection, 5 mg/100 mL (50 mcg/mL), Single-Dose Containers

ANDA Applicant : Nexus Pharmaceuticals, Inc.

Brand Name : Aggrastat (Tirofiban Hydrochloride) Injection

ANDA Approval Date : 2/7/2023

ANDA Indication+ : To reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome

4. ANDA Number : 213073

Generic Name : Cysteine Hydrochloride Injection USP, 725 mg/10 mL (72.5 mg/mL)

ANDA Applicant : Nivagen Pharmaceuticals, Inc.

Brand Name : Cysteine Hydrochloride Injection

ANDA Approval Date : 1/26/2023

ANDA Indication+ : For use as an additive to amino acids solutions to meet nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN

3. ANDA Number : 211452

Generic Name : Morphine Sulfate Injection USP, 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, 15 mg/mL

ANDA Applicant : Hikma Pharmaceuticals International Limited

Brand Name : Morphine Sulfate Injection

ANDA Approval Date : 1/12/2023

ANDA Indication+ : For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

2. ANDA Number : 216496

Generic Name : Phenylephrine Hydrochloride Ophthalmic Solution USP, 10 %

ANDA Applicant : Mankind Pharma Limited

Brand Name : Phenylephrine Hydrochloride Ophthalmic Solution

ANDA Approval Date : 1/11/2023

ANDA Indication+ : For the purpose of dilating the pupils

1. ANDA Number : 215908

Generic Name : Nitisinone Capsules, 2 mg, 5 mg, 10 mg, and 20 mg

ANDA Applicant : Torrent Pharma Inc.

Brand Name : Orfadin (Nitisinone) Capsules

ANDA Approval Date : 1/9/2023

ANDA Indication+ : For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine

https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals