- 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
- 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 Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
June 23, 2022Robins Kaplan’s Antitrust Class Action Practice Recognized as Leader In The Field For Fourth Consecutive Year
-
June 17, 2022Robins Kaplan Secures Complete Dismissal of $160 Million Copyright and Software License Dispute
-
June 13, 2022Robins Kaplan Wins Judgment Vacating Two Confessions of Judgment Totaling Nearly $20 Million
-
July 18, 202240th Annual Public Justice Gala & Awards Presentation
-
July 25, 2022Tee It Up for the Troops
-
September 22, 202220th Annual Golf Tournament
-
June 21, 2022Briefly: How To Oppose An Extension If You Really Need To
-
June 7, 2022Damned if You Do,
Damned if You Don’t -
June 7, 2022Take-Home COVID: The New Frontier?
-
June 24, 2022Biggest US Banks Sail Through Latest Round of Fed Stress Testing
-
June 23, 2022Powell Admits Recession Possible, Sees Tricky Path to Soft Landing
-
June 22, 2022Meta Reaches Settlement With Feds Over Allegedly Discriminatory Housing Ads
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
Abbreviated New Drug Applications and 505(b)(2) Applications
First Quarter
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Adderall XR | Takeda | amphetamine | Camber / Hetero | Used to treat attention deficit hyperactivity disorder (ADHD) | 1/4/2022 |
| Cuvposa | Merz | glycopyrrolate | Endo | Used to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy) | 1/4/2022 |
| Protopic | LEO | tacrolimus | Mayne | Used to treat atopic dermatitis |
1/12/2022 |
| Vasostrict | Endo | vasopressin | Eagle | Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines | 1/17/2022 |
| Colcrys | Takeda | colchicine | Camber / Hetero | Used to treat and for prophylaxis of gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or older | 1/19/2022 |
| Combigan | AbbVie | brimodine / timolol | Apotex | Used to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension | 1/19/2022 |
| Purified Cortrophin gel | ANI | repository corticotropin | ANI | Used to treat certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome | 1/24/2022 |
| Nitropress | Hospira | sodium nitroprusside | Xiromed | Used to treat the symptoms of acute heart failure, hypertensive crisis and controlled hypotension during surgery | 1/24/2022 |
| Focalin XR | Novartis | dexmethylphenidate | Camber / Hetero | Used to treat attention deficit hyperactivity disorder (ADHD) | 1/26/2022 |
| Alphagan P | AbbVie | brimonidine | Apotex | Used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
1/31/2022 |
| Pemfexy | Eli Lilly | pemetrexed | Eagle | Used in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non- squamous, non-small cell lung cancer (NSCLC) | 2/1/2022 |
| Vasostrict | Endo/Par | vasopressin | American Regent | Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines | 2/3/2022 |
| Vasopressin RTU | Endo | vasopressin | Par | Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines | 2/7/2022 |
| Restasis | AbbVie | cyclosporine | Apotex | Used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca | 2/7/2022 |
| Cubicin | Merck | daptomycin | Apotex | Used to treat complicated skin and skin structure infections (cSSSI). It is also used to treat infections in the bloodstream (bacteremia), including right-sided infective endocarditis | 2/7/2022 |
| Vasostrict | Endo | vasopressin | Dr. Reddy's Labs | Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines | 2/9/2022 |
| Emend | Merck | fosaprepitant | Camber / Hetero | Used to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin; delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) | 2/9/2022 |
| AmBisome | Astellas | amphotericin B liposome | Sun | Used for empirical therapy for presumed fungal infection in febrile, neutropenic patients; treatment of cryptococcal meningitis in HIV-infected patients; treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections; and treatment of visceral leishmaniasis | 2/15/2022 |
| Digoxin | Almirall | lanoxin | Aurobindo | Used to treat mild to moderate heart failure in adults; increases myocardial contractility in pediatric patients with heart failure; and for the control of ventricular response rate in adult patients with chronic atrial fibrillation | 2/21/2022 |
| Compazine | Glaxo | prochlorperazine edisylate | Cosette | Used to control severe nausea and vomiting. Prochlorperazine edisylate is also used for the treatment of schizophrenia | 2/22/2022 |
| Epaned O.S. | Azurity | enalapril | Camber / Hetero | Used for the treatment of hypertension, to lower blood pressure in adults and children older than one month | 2/25/2022 |
| Naftin | Sebela | naftifine | Xiromed | Used for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum | 2/25/2022 |
| Renagel | Genzyme | sevelamer | Lupin | Used for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis | 3/1/2022 |
| Apokyn | Supernus | apomorphine | TruPharma | Used to treat loss of control of body movements in people with advanced Parkinson's disease | 3/1/2022 |
| Myfortic | Novartis | mycophenolate | TWi | Used for the prophylaxis of organ rejection in adult patients receiving a kidney transplant | 3/1/2022 |
| Revlimid | Celgene | lenalidomide | Natco / Teva | Used in adults for the treatment of multiple myeloma in combination with the medicine dexamethasone, certain myelodysplastic syndromes, and mantle cell lymphoma following specific prior treatment |
3/7/2022 |
| Rezipres | Eton | ephedrine | Eton / XGEN Pharms | Used to treat clinically important hypotension occurring in the setting of anesthesia | 3/14/2022 |
| Tobradex | Novartis | dexamethasone / tobramycin | Padagis | Used for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists | 3/21/2022 |
| Advair Diskus | Glaxo | fluticasone / salmeterol | Teva | Used for the twice-daily treatment of asthma in patients aged 4 years and older; of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema | 3/23/2022 |
| Zipsor | Assertio | diclofenac | Teva | Used to relieve mild to moderate acute pain in adult and pediatric patients 12 years of age and older |
3/24/2022 |
GENERICally Speaking Hatch Waxman Bulletin
Related Professionals
GENERICally Speaking Hatch Waxman Bulletin
READ MORE Related Publications
First Quarter
ANDA Litigation Settlements
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
New ANDA Cases
GENERICally Speaking Hatch Waxman Bulletin
First Quarter
ANDA Approvals
GENERICally Speaking Hatch Waxman Bulletin
March 22, 2022
Genentech, Inc. v. Sandoz, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Fed. Cir. 2022
GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
Related News
August 2, 2021
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.