Suchira's practice focuses on regulatory and patent issues unique to the pharmaceutical industry. She provides counseling and litigation services relating to FDA and patent matters. Suchira has litigated disputes involving various marketing exclusivities arising under FDA authorities. She provides counseling services related to FDA matters, such as citizen petitions, REMS, abuse-deterrent drugs, biosimilars, user fee statutes, 505(b)(2) applications, marketing exclusivity, Orange Book issues, labeling, bioequivalence, patent notice letters, and approvals of drugs, biological products, HCT/Ps, medical devices and tobacco products.
While in law school, Suchira interned in the FDA's Office of Policy, where she worked on issues of drug counterfeiting, pedigrees and track-and-trace. Prior to law school, she worked in the pharmaceutical industry as a process engineer with Schering-Plough Research Institute's Sterile Pharmaceutical Product Development group where she was responsible for developing and optimizing manufacturing processes for new drugs, including injectables, inhalers and lyophilized products from laboratory to commercial scale and technology transfer.
- American Bar Association
- Drug Information Association
- Food and Drug Law Institute
- New York Intellectual Property Law Association
- Member, Cosmetics Law Committee, Food, Drug and Cosmetic Law Section, New York Bar Association
- Otsuka Pharmaceutical Co., Ltd. et al. v. Burwell, No: 15-00852GJH (D. Md.): Successfully intervened on behalf of our client, Zydus Pharmaceuticals, on the side of FDA to oppose Otsuka's motion for a TRO seeking to prohibit FDA from granting approvals for generic versions of Abilify based on an interpretation of the BPCA statutory provisions governing label carve outs.
- Mylan Pharms., Inc., Watson Labs., Inc. and Lupin Pharms., Inc. v. FDA, Nos. 14-1522, 14-1529, 14-1593 (Fourth Circuit): Successfully reversed a district court decision and FDA's underlying administrative decision thereby allowing our client, Watson Laboratories (now Actavis) to share in a period of 180-day marketing exclusivity for a generic version of Celebrex.
- ViroPharma Inc. v. Hamburg, No. 12-cv-584 (D.D.C.): Obtained a favorable decision for our client, Alvogen, Inc. at the preliminary injunction and summary judgment stages after intervening in an action against FDA by a competitor over generic versions of the antibiotic Vancocin.
- Roche Palo Alto LLC. v. Endo Pharmaceuticals Inc., No. 10-cv-00261-GMS (D. Del.): Patent infringement dispute involving valganciclovir hydrochloride (Valcyte).
- Actavis Elizabeth LLC v. FDA, No. 09-362-RMC (D.D.C.), No. 10-5066 (D.C. Circuit): Challenged FDA's new chemical entity exclusivity decision with respect to lisdexamfetamine dimesylate capsules (Vyvanse).
- Axinn Successfully Advocates for Preservation of 180-Day Marketing Exclusivity for Carvedilol ER
- Suchira Ghosh Named Law360 Rising Star
- 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 Successful in Protecting FDA Approval of Generic Versions of Otsuka’s Abilify
- Axinn Obtains Fourth Circuit Victory in Generic Celebrex® Case
- Axinn Successful in Protecting Client Alvogen's Entry to Drug Market
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- RMAT Designations: Lessons Learned on the “Clinical Evidence” Requirement, Pharmaceutical Executive, November 2, 2018
- Axinn FDA Update, Axinn Client Update, October 9, 2018
- Expert Q&A on Key Updates in BPCIA Litigation, Practical Law Intellectual Property & Technology Journal, August 2018
- J&J's Motion to Dismiss Pfizer's Biosimilar Antitrust Suit Might Shake Up Viability of Exclusionary Contracts if Unsuccessful; Granted Motion Could Stifle Innovation, Experts Say, BioPharm Insight, March 27, 2018
- J&J, Pfizer Biosimilar Payer Policy Case Could Survive Motion to Dismiss but Proving Anticompetitiveness Remains Challenging, Experts Say, BioPharm Insight, March 23, 2018
- Biosimilar Uptake Still Plagued By Interchangeability Hurdles, BioPharm Insight, February 28, 2018
- What Hospitals Need To Know Before Forming A Drug Co., Law360, February 13, 2018
- FDA Updates 1990s-Era Guide on Better Drug Applications, Bloomberg Law Pharmaceutical Law & Industry Report, December 15, 2017
- FDA Device Approval Stirs Calls for Telehealth, Bloomberg Law, November 22, 2017
- FDA Approves First Digital Pill: Otsuka/Proteus' Abilify MyCite, SCRIP Intelligence, November 14, 2017
- Grading Gottlieb: How Attys View FDA Chief's First 6 Months, Law360, November 9, 2017
- FDA Says 'No' to Baricitinib for Rheumatoid Arthritis, MedPage Today, April 17, 2017
- Who You Calling 'Slow'? FDA May Bristle at Trump's Latest Dig, STAT, March 1, 2017
- US FDA Gives Directions On Navigating Generic 180-Day Exclusivity Maze, The Pink Sheet, January 26, 2017
- FDA Clarifies How It Handles 180-Day Exclusivity, PharmTech, January 18, 2017
- Global Expedited Review, PharmaVoice, January 2017
- Leahy Looks to Amend 'Cures' Bill as Senate Prepares for Passage, Regulatory Focus, December 6, 2016
- 5 Takeaways From FDA Overture on Generic-Drug Approvals, Law 360, January 27, 2014
- FDA Announces Major Generic Drug Labeling Changes In the Wake of Preemption Decisions Involving Generic Drug Product Liability, Corporate Compliance Insights, November 21, 2013
- In Focus: Drug Sponsor and Contractor Relations, November 4, 2013
- Dissecting The Rules Of Generic Drug User Fee Amendments, Law360, May 9, 2013
- Federal Preemption and Labeling: Where Product Liability Collides with FDA, FDLI Update, July 1, 2010
- Note, The R.F.I.D. Act of 2006 and E-Pedigree: Tackling the Problem of Counterfeit Drugs in the United States Wholesale Industry, 13 Mich. Telecomm. Tech. L. Rev. 577 (2007).
- FDA News: "Expediting the Generic Drug Approval Process: FDA's New Initiatives on Drug Competition"
- ACI: "Follow-On Products: ANDAs and Biosimilars"
- ACI FDA Bootcamp: "Navigating the Approval Process for Drugs and Biologics"
- NYSBA Panel: "From Farm to Table – The Future of GMO Plants and Animals"
- Here and Now: Biosimilars for the treatment of IBD
- Overview of Biological Products Law and Regulation
- ACI 29th FDA Boot Camp
- FDLI: Biologics and Biosimilars
- ANDAs and 505(b)(2) Applications – Patent and Exclusivity Issues
- Suchira Ghosh Moderated Panel at NYSBA Annual Meeting
- ANDAs/505b2s & Patent and Exclusivity Issues
- FDLI: Introduction to Drug Law and Regulations, Biologics and Biosimilars
- The Abbreviated NDA (ANDA), 505(b)(2) Applications and Patent and Exclusivity Issues
- The Abbreviated NDA (ANDA), 505(b)(2) Applications, and, Patent and Exclusivity Issues
- FDLI's Introduction to Drug Law and Regulation
- JD – University of Michigan Law School (2007)
- BS – Columbia University (2000)
- New York
- US District Court Eastern District of New York
- US District Court Southern District of New York
- US Patent and Trademark Office