Axinn’s FDA Practice Group provides counseling, FDA representation and litigation services relating to the development, approval, exclusivity and marketing of new and generic drug products, biologics, medical devices, human tissue products, veterinary products and tobacco products. By coupling knowledge of the complex and shifting FDA regulatory landscape with the firm’s scientific capability and patent litigation, antitrust and licensing expertise, the firm offers a comprehensive team to enable companies to develop product life cycle development strategies, to bring regulated products to market and to defend market positions such as exclusivity periods in the most efficient, competitive and profitable manner.
Representative experience includes:
- Counseling relating to biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA), including the requirements for the demonstration of biosimilarity and the patent resolution provisions
- Obtained the first district court order requiring FDA to approve a drug product
- Successful challenge in the Fourth Circuit of FDA’s decision to grant 180-day exclusivity to another ANDA applicant for a generic version of the blockbuster drug Celebrex®
- Successful argument to FDA that another ANDA holder had forfeited its exclusivity for a generic version of Valcyte® and successful defense of that decision in district court
- Successfully upheld final approval of ANDA in a case involving antibiotic marketing exclusivity for Vancocin®
- Successful intervention to defend FDA decision that approval of an ANDA was not blocked by orphan drug exclusivity relating to the multi-billion dollar drug Abilify®
- Innovative challenge in district and appellate court to FDA’s grant of NCE exclusivity to lisdexamfetamine, which contributed to the creation of the CDER Exclusivity Board
- Citizen petitions, including those regarding bioequivalence and abuse-deterrent products
- Negotiation and preparation of waiver requests for shared REMS programs
- Axinn Successfully Advocates for Preservation of 180-Day Marketing Exclusivity for Carvedilol ER
- Axinn Promotes Stacie Ropka, Suchira Ghosh and Jeny Maier
- Axinn Defeats TRO, Enabling Immediate Launch of Generic Versions of AstraZeneca’s Blockbuster Crestor
- U.S. District Court Grants Summary Judgment for Axinn’s Client Zydus in FDA Case
- Axinn Protects Client Endo Pharmaceuticals Inc.’s Approval for Generic Valcyte®
- Chad Landmon Named to Law360's Intellectual Property "Rising Star" List
- Chad Landmon Named to Law360's Life Sciences "Rising Star" List
- Axinn Obtains Favorable Decision in FDA Suit
- Axinn Obtains Summary Judgment Victory Against FDA
- Axinn Partner Chad Landmon Honored as Hartford Business Journal “40 Under 40” Winner
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Articles & Newsletters
- RMAT Designations: Lessons Learned on the “Clinical Evidence” Requirement
- Axinn FDA Update
- Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Second Edition
- FDA Focus: What Axinn's Practice Chair Is Watching
- What Hospitals Need To Know Before Forming A Drug Co.
- FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users
- US FDA Postpones Celltrion's Remicade Biosimilar Review Meeting
- Scientific Speech Highlighted In SCOTUS Petition To Overturn CEO Conviction
- Attorneys React to High Court's Gene Patent Ruling
- Dissecting The Rules Of Generic Drug User Fee Amendments
- 2012 Court Decisions Impact the Life Science Industry
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Speaking Engagements & Seminars
- Barclays Credit Symposium
- FDLI Webinar: Opioid Legislation – The Path Forward for FDA and DEA
- FDA News: "Expediting the Generic Drug Approval Process: FDA's New Initiatives on Drug Competition"
- FDLI: "FDA: Past, Present, and Future"
- ACI: "Follow-On Products: ANDAs and Biosimilars"
- FDLI Annual Conference: "Biosimilars: New Developments and Updates"
- ACI FDA Bootcamp: "Navigating the Approval Process for Drugs and Biologics"
- NYSBA Panel: "From Farm to Table – The Future of GMO Plants and Animals"
- Chad Landmon Discusses Quicker FDA Medical Device Approval
- Here and Now: Biosimilars for the treatment of IBD
- Legal and IP Strategies to Strengthen Biosimilar Medicine Developers
- Overview of Biological Products Law and Regulation
- Biosimilars at the Bar: Legal Issues
- FDLI Webinar: Key Regulatory Issues in Biosimilars
- Key Regulatory Issues in Biosimilars
- ACI 29th FDA Boot Camp
- Chad Landmon Spoke on FDA's Citizen Petition Process
- Chad Landmon Spoke at ACI's 24th FDA Boot Camp
- HCT/P: FDA’s Newest Regulatory Battleground
- Demonstrating Biosimilarity: Guidance from the FDA
- International Congress on Paragraph IV Litigation
- FDLI's Introduction to Drug Law and Regulation
- 2013 FDLI Annual Conference
- Bioequivalence - What Patent Lawyers Need to Know
- Chad Landmon Speaks on "How to Align the FDA Approval Process with Paragraph IV Strategy"
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