First-time generic approvals for 2009

[chantell.reagan]

Listed below, please note the first-time generics approved in 2009 and currently available on the market:

Antiinfectives

Minocycline 45mg, 90mg, 135mg extended release tablets (AB rated generic* for Solodyn) by Impax and Barr (generic launches have not been announced yet)

Stavudine capsules (AB rated generic* for Zerit) by various manufacturers

Valacyclovir tablets (AB rated generic for Valcyte) by Ranbaxy
(Source: News article 11/09)

Antineoplastics

Bicalutamide 50mg tablet (AB rated generic* for Casodex) by various manufacturers

Related link: Estimating generic availability for Flomax, Casodex, Arimidex and Thalomid

Melphalan 50mg/vial (AP rated generic* for Alkeran) by Synerx

Cardiovascular

Clonidine TDS (AB rated generic* for Catapres TTS patch) by Par Pharmaceuticals/Aveva

•Link to Par press release 8/09

Perindopril 2, 4, 8mg tablets (AB rated generic* for Aceon) by various manufacturers (sources: Aurobindo press release 11/09; News article 11/09)

CNS

Alprazolam orally disintegrating tablets (AB rated generic* for Niravam) by Kali Labs

Buprenorphine sublingual tablet (AB rated generic* for Subutex) by Roxane

Carbamazepine extended-release tablets 100, 200, 400mg (AB rated generic* for Tegretol XR) by Taro

Clonidine 1mg/10ml injection (AP rated generic* for Duraclon) by Pharmaforce
(it is unclear if this product will be launched immediately or whether there is any current litigation)

Divalproex sodium 250mg, 500mg extended release tablets (AB rated generic* for Depakote ER) by various manufacturers

Divalproex sodium capsule, delayed release pellets (AB rated generic* for Depakote sprinkle capsules) by Dr. Reddys Labs

Fentanyl troche/lozenge (AB rated generic* for Actiq) by various manufacturers

•There is no current ongoing litigation.
•Barr settled with Cephalon in 2006 and launched an authorized generic in 9/2006. The authorized generic is still available through Teva and it's unclear when they will launch ANDA-based generic.
•Mallinckrodt announced that they received generic approval (10/09), with plans to launch their generic in early 2010; launched in 3/10

Galantamine oral solution (AA rated generic* for Razadyne) by Roxane

Indomethacin 75mg extended-release capsules (AB rated generic* for Indocin SR) by Avanthi Inc; previously approved versions had been discontinued

Levetiracetam oral solution (AA rated generic* for Keppra) by various manufacturers

Lorazepam 2mg/ml oral concentrate (AB rated generic* for Intensol) by Paddock Labs

Oxcarbazepine oral suspension (AB rated generic* for Trileptal) by Ranbaxy

Risperidone 0.25mg, 0.5mg, 2mg, 3mg, 4mg orally disintegrating tablets (AB rated generic* for Risperdal M-Tab) by various manufacturers

Sumatriptan Succinate tablets (AB rated generic* for Imitrex tablets) by Teva (25, 50, and 100 mg) and Ranbaxy (100 mg tablets only)

o FDA approval letters (Teva letter, Ranbaxy letter)- grant 180-day exclusivity
o Teva press release - announces the launch

Sumatriptan Succinate injections (AB rated generic* for Imitrex injections) by multiple manufacturers

Temazepam 7.5mg capsule (AB rated generic* for Restoril) by URL/Mutual

Topiramate 25, 50, 100, 200mg tablets (AB rated generic* for Topamax) by various manufacturers

o see related discussion - Estimating generic availability for Radazyne ER, Aricept and Topamax

Topiramate 15, 25mg capsules (AB rated generic* for Topamax Sprinkles) by Teva

Tramadol 100, 200mg extended-release tablets (AB rated generic* for Ultram ER) by Par
-Note:Par Pharmaceuticals was awarded a 180-day exclusivity, and began shipping upon approval this week (source: Par press release 11/09)

Endocrine/diabetes

Liothyronine 5mcg tablet (AB rated generic* for Cytomel) by Coastal Pharma

Nateglinide 60, 120mg tablets (AB rated generic* for Starlix) by various manufacturers (Par, Dr. Reddy's and Teva)
(source: Par press release 9/09)

Triamcinolone acetone injectable suspension 40mg/ml (AB rated generic* for Kenalog-40) by Sandoz

Gastrointestinal agents

Chenodiol tablets (generic* for Chenix) by Nexgen

Lansoprazole 15, 30mg delayed-release capsules (AB rated generic* for Prevacid) by Teva
(sources: RTT News 11/10/09; RTT News update 11/10/09)

Nizatidine soluton (AA rated generic* for Axid solution) by Amneal

Ursodiol 250mg, 500mg tablets (AB rated generic* for Urso 250 and Urso Forte) by Teva

Immunologic agents

Mycophenolate 250mg capsules, 500mg tablets (AB rated generic* for Cellcept) by various manufacturers

Tacrolimus capsules (AB rated generic* for Prograf) by Sandoz

Obstetrics and Gynecology

Ethinyl estradiol and norethindrone (AB rated generic* for Femhrt) by Barr/Teva
-Note:Teva Pharmaceuticals can begin marketing generic 6 months before patent expiry (sources: Warner Chicott annual report 2/09; Barr press release)

Levonorgestrel 0.75mg tablet (AB rated generic* for Plan B) by Watson

Ophthalmologic agents

Apraclonidine 0.5% solution/drops (AT rated generic* for Iopidine) by Akorn

Azelastine 0.5% solution/drops (AT rated generic* for Optivar) by Apotex
(sources: News article; Apotex products)

Ketorolac tromethamine ophthalmic solution 0.4%, 0.5% (AT rated generic* for Acular) by various manufacturers
(sources: Akorn press release 11/09; Caraco press release 11/09)

Respiratory agents:

Budesonide 0.25 mg/2 mL inhalation suspension (AN rated generic for Pulmicort Respules)
(source: Teva products)

Related link:Estimating generic availability for Pulmicort and Rhinocort

Topicals

Benzoyl peroxide 5%/clindamycin 1% gel (AB rated generic* for Benzaclin) by Dow Pharm Sciences

Ciclopirox 1% shampoo (AT rated generic* for Loprox) by Paddock

Malathion 0.5% lotion (AT rated generic* for Ovide) by Synerx Pharma

* The key to the FDA’s Therapeutic Equivalence Evaluation Codes is available at: Orange Book Annual Preface

Sources:
U.S. Food and Drug Administration. Drugs@FDA. Available at: First Time Generics and Drugs@FDA

[Chip Robison]

Diana,

Thank you very much for the generic first-time approvals for 2009 report.

Nicely done !!

Happy New Year !!


Chip Robison