- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
December 2, 2024Robins Kaplan LLP Announces 2025 Partners
-
November 20, 2024Eighth Circuit Affirms U.S. Merchants Victory in Trade Dress Infringement Case
-
November 15, 2024Lauren Coppola Named an Emerging Leader by Profiles in Diversity Journal
-
December 11, 20242024 Year in Review: eDiscovery and Artificial Intelligence
-
December 12, 2024Strategies for Licensing AI: A Litigation Perspective
-
December 2024A Landmark Victory for Disabled Homeless Veterans: Q&A with the Trial Team
-
November 8, 2024Trademark tensions on the track: Court upholds First Amendment protections in Haas v. Steiner
-
November 8, 2024Destination Skiing And The DOJ's Mountain Merger Challenge
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Read our attorneys' take on the latest news and trends in the legal and business industries.
Generic Launches
Winter 2017
Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
---|---|---|---|---|---|
Kapvay | Concordia Pharmaceuticals | Clonidine HCl ER Tablets | Ajanta | used to treat attention deficit hyperactivity disorder (ADHD) | 11/21/2017 |
Tamiflu | Hoffman La-Roche | Oseltamivir Phosphate | Alvogen | used to treat the flu (Influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days. Tamiflu can also reduce the chance of getting the flu in people 1 year and older | 11/2/2017 |
Clolar | Genzyme | Clofarabine Injection | Amneal | used to treat pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens | 11/28/2017 |
Kenalog-40 | Apothecon | Triamcinolone Acetonide Injectable Suspension | Amneal | used to treat inflammation (swelling), allergic reactions, certain types of arthritis, gout, skin diseases, and many other medical problems | 12/19/2017 |
Renvela | Genzyme | Sevelamer Carbonate Tablets | Amneal | used to control serum phosphorus in adults with chronic kidney disease (CKD) on dialysis | 12/19/2017 |
Prometrium | Virtus Pharms | Progesterone Capsules | Amneal | used to prevent endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea | 12/19/2017 |
Bumex | Validus Pharms | Bumetanide Tablets | Amneal | used to treat edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome | 12/19/2017 |
Vytorin | Merck Sharp & Dohme | Ezetimibe / Simvastatin Tablets | Amneal | used to treat high cholesterol and triglyceride (fats) levels in the blood | 12/19/2017 |
Kapvay | Concordia Pharms | Clonidine HCl ER Tablets | Amneal | used to treat attention deficit hyperactivity disorder (ADHD) | 12/19/2017 |
Busulfex | Otsuka | Myleran Injecion | Mylan | used in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia | 12/4/2017 |
Zetia | Merck Sharp & Dohme | Ezetimibe Tablets | Aurobindo | used as adjunctive therapy for the reduction of elevated total cholesterol | 10/11/2017 |
Effient | Eli Lilly | Prasugrel Tablets | Aurobindo | used to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) | 10/30/2017 |
Seroquel XR | AstraZeneca | Quetiapine Fumarate ER Tablets | Aurobindo | used to treat schizophrenia, manic or mixed episodes associated with bipolar I disorder and as an adjunct therapy to antidepressants for the treatment of major depressive disorder (MDD) | 12/1/2017 |
Megace ES | Endo | Megestrol Acetate Oral Suspension | Breckenridge | used to treat anorexia (loss of appetite), cachexia (severe malnutrition), or an unexplained, significant weight loss in people with a diagnosis of AIDS | 12/4/2017 |
Renvela | Genzyme | Sevelamer Carbonate Tablets | InvaGen Pharmaceuticals | used to control serum phosphorus in adults with chronic kidney disease (CKD) on dialysis | 10/27/2017 |
Pulmicort Respules | AstraZeneca | Budesonide Inhalation Suspension | Cipla | used for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age | 11/17/2017 |
Dacogen | Otsuka | Decitabine Injection | Cipla | used to treat patients with myelodysplastic syndromes (MDS). | 11/20/2017 |
Clolar | Genzyme | Clofarabine Injection | Dr. Reddy's Labs | used to treat patients ages 1 year to 21 years with relapsed or refractory acute lymphoblastic leukemia after at least two prior treatment regimens | 11/14/2017 |
Alkeran | Apotex | Melphalan HCl for Injection | Dr. Reddy's Labs | used for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate | 12/26/2017 |
Emend | Merck Sharp & Dohme | Aprepitant Capsules | Glenmark | used in adults for the prevention of postoperative nausea and vomiting | 10/16/2017 |
Ancobon | Valeant | Flucytosine Capsules | West-Ward Pharms | used to treat serious infections caused by susceptible strains of candida and/or cryptococcus | 11/3/2017 |
Renvela | Genzyme | Sevelamer Carbonate Tablets | Impax Labs | used to control serum phosphorus in adults with chronic kidney disease (CKD) on dialysis | 10/23/2017 |
Norco | Allergan | Hydrocodone Bitartrate / Acetaminophen Tablets | Lupin | used for relief of moderate or moderately severe pain | 10/10/2017 |
Acticlate | Aqua Pharmaceuticals | Doxycycline Hyclate Tablets | Lupin | used to treat infections caused by various microorganisms and as an adjunctive therapy in severe acne | 11/2/2017 |
Clozaril | Novartis | Clozapine Tablets | Mayne Pharma | used as an antipsychotic | 11/9/2017 |
Cancidas | Merck | Caspofungin Acetate for Injection | Mylan | used for empirical therapy for presumed fungal infections in febrile, neutropenic patients; treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections; treatment of esophageal candidiasis; and treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies | 10/2/2017 |
Copaxone | Teva | Glatiramer Acetate Injection | Mylan | used for the treatment of people with relapsing forms of Multiple Sclerosis (MS) | 10/4/2017 |
Avelox | Bayer | Moxifloxacin HCl in 0.8% Sodium Chloride Injection | Mylan | used to treat infections in adults caused by designated susceptible bacteria in community acquired pneumonia, skin and skin structure infections, complicated intra-abdominal infections, plague, acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis | 10/5/2017 |
Clolar | Genzyme | Clofarabine Injection | Mylan | used to treat pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens | 11/9/2017 |
Estrace | Allergan | Estradiol Vaginal Cream | Mylan | used to treat vulvar and vaginal atrophy | 12/29/2017 |
Exalgo ER | Mallinckrodt | Hydromorphone HCl ER Tablets | Perrigo | used for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time | 11/27/2017 |
Mycolog II | Mylan | Nystatin / Triamcinolone Acetonide Cream | Perrigo | used to treat cutaneous candidiasis | 11/27/2017 |
Zoloft | Pfizer | Sertraline Oral Solution | Rising Pharmaceuticals | used to treat the following: major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder | 10/24/2017 |
Diamox | Teva | Acetazolamide | Strides |
used to prevent and reduce the symptoms of altitude
sickness. Acetazolamide is also used with other medications to treat a certain type of
eye problem (open-angle glaucoma)
|
11/22/2017 |
Viagra | Pfizer | Sildenafil Citrate | Teva | used to treat erectile dysfunction (ED) | 12/11/2017 |
Viread | Gilead Sciences | Tenofovir Disoproxil Fumarate | Teva | used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older, and for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older | 12/15/2017 |
Reyataz | Bristol-Myers Squibb | Atazanavir | Teva | used in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg | 12/27/2017 |
GENERICally Speaking Winter 2017
Related Professionals
Miles A. Finn, Ph.D.
Counsel
Related Publications
September 18, 2024
Astellas Pharma, Inc. v. Sandoz Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 9, 2024
Purdue Pharma L.P v. Accord Healthcare Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 4, 2024
Exeltis USA, Inc. v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
August 28, 2024
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.
GENERICally Speaking Hatch Waxman Bulletin
August 13, 2024
Allergan USA, Inc. v. MSN Labs. Private Ltd.
GENERICally Speaking Hatch Waxman Bulletin
Related News
October 14, 2022
September 9, 2022
Back to Top
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.