Hatch-Waxman Litigation


Our patent litigation practice under the Hatch‑Waxman Act, involving both Abbreviated New Drug Applications (“ANDAs”) and “paper” NDAs, is varied and complex. Lerner David can help in planning for Hatch‑Waxman challenges, so our clients are ready to deal with such challenges by providing prosecution advice, opinions, notice letters, and integrated litigation strategies employing both district court and Patent and Trademark Office proceedings.

In ANDA cases, our team members include skilled courtroom advocates and crafty IP strategists, and we bring to bear our backgrounds and advanced degrees in chemical engineering, chemistry, organic chemistry, biochemistry, biology, biotechnology, materials science, genetics, and bacteriology, among others.  With nearly 70 lawyers and many other professionals devoted to IP law, we have the bench strength to handle any complex Hatch-Waxman matter.

We have been involved in the blockbuster cases of the past three decades representing some of the world's most recognized pharmaceutical companies before the courts and the PTAB involving drugs from A to Z:

Generic Product  Branded Product
Alogliptin Nesina®, Kasano®, Oseni ®
Apixaban Eliquis®
Calcium acetate Phoslo®
Canagliflozin/Metformin Invokamet®
Carbamazepine Carbatrol®
Cefaclor Ceclor®
Cefadroxil Duricef®
Dipyridamole/ Aggrenox®
acetylsalicylic acid
Doxycycline Oracea®
Doxycycline hyclate Periostat®
Dronedarone Multaq®
Dutasteride Avodart®
Esomeprazole Nexium®
Felodipine Plendil®
Fluocinonide cream Vanos®
Gabapentin Neurontin®
Ketorolac tromethamine Sprix®
Lansoprazole Prevacid®/Prevacid®Solutab
Lenalidomide Revlimid®
Lidocaine patch Lidoderm®
Linagliptin Tradjenta®/Jentadueto®
Loratadine Claritin®
Metformin Fortamet®
Mirtazipine Remeron®
Ondansetron Zofran®
Oxycarbazapine Trileptal®
Oxycodone OxyContin®
Paclitaxel Taxol®
Palonosetron Aloxi®
Paroxetine Paxil®
Prasugrel Effient®
Propofol Dipravan®
Quetiapine Seroquel XR®
Ranitidine Zantac®
Risperidone Risperdal Consta®
Rivastigmine Exelon®
Sertraline Zoloft®
Sodium oxabate Xyrem®
Terazosin Hytrin®
Terfenadine Seldane®
Testosterone gel AndroGel®
Venlafaxine Effexor XR®
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