10 drugs in the U.S. with patents due in 2020

Truvada Truvada, a compound drug made up of nuclear retrovirus inhibitors (entourtabin and fumarate novovir dipresteride), was first approved for treatment of HIV infection in 2004 and expanded to HIV-1 infection in adults as a result of preventive transmission in 2012.
has made headlines in recent years, and this year it faces a major test- and upcoming generic competition and a public dispute between Gilead and the U.S. government over Truvada's patents for preventive purposes.
, Gilead challenged four U.S. government patents for pre-exposure prophylaculative drugs for HIV, but recently lost the fight at the U.S. Patent and Trademark Office.
same time, the U.S. Department of Health sued Gilead for patent infringement, saying it tried to grant Gilead its patent, but the company refused.
, the fight will now take place in federal court.
generics, according to Gilead's recent 10-K filing with the Securities and Exchange Commission, the company has signed an agreement with Teva to allow the latter to launch generics for Truvada and Atripla on September 30, while generics for Mylan and Arabindi have also been approved, according to the FDA's website.
Domestically, Truvada (domestic trade name: Shufatai) was approved by the State Drug Administration in August 2020 to provide pre-exposure prevention (PrEP) in combination with safe sexual behaviour measures to reduce the risk of HIV-1 in adults and adolescents (weighing at least 35 kg or more) through high-risk sex.
December 26, 2020, Gilead announced Shufatai as the first and only approved pre-exposure drug for HIV in China.
Afinitor Evimos is an oral rapamycin (mTOR) that is suitable for the treatment of patients with advanced renal cell carcinoma after failure with schoinib or solafinib.
first marketed in Sweden in 2003 and was approved by the FDA for listing in the United States in 2009.
2019, Evimex's global sales reached $2,024 million, making it Novart's heavyweight drug.
, on December 10, 2019, Endo's Par Pharmaceutical announced the launch of the drug in 2.5 mg, 5 mg and 7.5 mg doses in the United States.
sales of these dosage-specific products reached $412 million in 2019 compared with the same period last year, according to Endo, the company's website, citing IQVIA data.
addition to Par Pharmaceutical, Teva's generics were approved by the FDA in December.
According to Novarma's annual report, the company said it had "resolved patent litigation with certain generic companies" and said "additional generic competition in the U.S. market could begin in mid-2020", without elaxising.
, in August 2013, Evimex (Chinese Commodity Name: Feinite) was approved by the China Drug Administration to enter the Chinese market and was included in the National Health Insurance Directory in 2017.
currently Jichuan Pharmaceuticals, Jiangsu Haussen, Haizheng Pharmaceuticals and other 8 domestic enterprises to obtain clinical approval of the generic drug.
can be part of the nicotine receptor exciter, which binds to nicotine receptors to play a smoking cessation mechanism.
, which was approved by the FDA in 2006, has global sales of $1,107 million in 2019, and its price has grown significantly as Chantix patent protection expires.
2018, GoodRx reported that Chantix prices had doubled in the past five years.
the Chantix patent expires in November 2020, and the drug's main patent expires in November, but other patents will continue until 2022.
generics, Endo's Par Pharmaceuticals bought a generic version of Valeniclan from Actavis and filed a lawsuit in court against Pfizer's Chantix 2022 patent, though Par did not challenge the patent, which expires in November 2020.
a Pfizer spokesman said the company was not sure if or when a generic chiantix would appear on the market.
in China, Mr. Niklan was approved to enter China in July 2008 with a product named Changpei.
At present, there are no relevant generic drugs approved for listing in China, but Insight data show that Jiangsu Jiayi Pharmaceuticals in March 2019 took the lead in submitting a new category 4 of salicy acid valeniclan tablets for listing applications, and was included in the priority review, in addition, in May 2020, Howson Pharmaceuticals' liquorite acid valeniclan tablets listing applications are to be included in the priority review.
NuvaRing NuvaRing is a long-acting birth control product and the first vaginal contraceptive ring approved by the FDA in recent years, a combination of hormones that works by inhibiting gondenoid hormones and is currently facing competition from Ambler's generic product, Elu Ryng.
December 2019, the FDA approved Amneal's Elu Ryng (based on acetylene/acetylene estradiol vaginal ring), the first generic drug to be generic for NuvaRing.
addition, amneal's chief executive said in a statement that he plans to launch more than a dozen complex imitations over the next 18-24 months, in addition to Elu Ryng's approval.
Forteo, a heavyweight drug for osteoporosis treatment, was first marketed in the U.S. in 2002 and is currently the only FDA-approved drug that promotes bone formation.
according to Lilly's annual report, Fortescue's U.S. sales in 2019 were $645 million, down from $758 million in 2018 and $965 million in 2017.
and Radius Health are rolling out new osteoporosis drugs, while Lilly partners Alvogen and Pfenex are also preparing to launch biosimilars.
October 2019, Pfenex announced that the FDA had approved a new drug application for PF708 to treat osteoporosis in patients at high risk of certain fractures, and that the company was seeking FDA approval to treat the drug as a treatment equivalent to Forteo, and expressed the hope that the FDA would approve the decision as soon as possible.
addition, gedeon Richter launched a Forteo biosimilar in Europe in August 2019.
it is also worth mentioning that in April 2018, Tyling Pharmaceuticals entered into a development license agreement with Pfenex, which granted PF708 exclusive rights in commercial operations in Chinese mainland, Hong Kong, Singapore, Malaysia, and Thailand.
Atripla Atripla (Efaveren/Entoxebin/Tinofovir) is Gilead's other anti-HIV drug, which was approved in 2006 as the first single-drug cocktail therapy.
Atripla continued to grow at a high rate in the years that followed, and in 2010 it overtook Truvada as Gilead's best-selling drug of the year, selling $2.927 billion, but sales declined as new anti-AIDS drugs and related generics were introduced.
first half of 2020, Atripla's sales were $176 million.
Atripla entered the generic competition in the fall of 2020 under a patent agreement with Teva, but unlike Truvada, Tevada has not yet received Atripla's generic approval.
addition, generic drugs currently allegedly approved include Aurobindo and Cipla.
In China, Gilead has four anti-AIDS drugs on the market, namely, Aykauen propylene tablets (JetFluen), Entourtabin propofol tynofovir tablets (Daco wave), entretabinofovir tablets (Shufatai), Bickenpropino tablets (Bitovy), providing a comprehensive program from post-exposure prevention (PEP) to single-dose (STR) treatment, of which JetEcon was included in the health insurance list in 2019.
Ciprodex Ciprodex (Ciprodex/Desermisson) mixed suspension ear drops are the only safe and effective local drugs approved by the FDA for the treatment of ear infections.
Ciprodex, which was originally one of Ercon's flagship products, was also included in Novartic's portfolio when Novarma completed its acquisition of Ercon in 2011.
Ciprodex's 2019 sales figure in the U.S. was about $470 million, according to IQVIA, but Novart did not report specific sales, and a Novarma representative said the company did not report sales for "mature and smaller brands."
But the launch of Ciprodex generics is no shortage of competitors, and according to Endo's investor statement for the fourth quarter of 2019, the company has been preparing for the launch of Ciprodex generics, but no Ciprodex generics have yet been approved, according to FDA data.
Kuvan was first approved in 2007 for reducing blood phenylalanine levels in patients with phenylalanine uremia.
2015, BioMarin bought Kuvan's global interest from Merck for an upfront fee of $379 million, contributing $463 million in sales in 2019, or 30 percent of BioMarin's full-year sales.
from 2014 to 2016, two generic drug companies filed Kuvan's generic drug applications with the FDA, but BioMarin filed a patent infringement lawsuit and reached a settlement between 2015 and 2017.
also, according to the FDA, Endo's Par Pharmaceutical generics have been approved and Dr Reddy's generics have received provisional approval numbers.
(Risperdal Consta) Weston (Lippertone tablet) as a classic anti-schizophrenic drug, developed by Jansen (Johnson and Johnson subsidiary) and approved by the FDA in 1993 for sale, the second generation of anti-schizophrenic drug First-in-class.
, Johnson and Johnson have listed oral fluids, shraptony tablets, injections and so on.
Weston has been at the fore in the patent dispute, with the remaining patent expiring on November 25, 2020, and while no generic drug has yet been formally approved by the FDA, Johnson and Johnson and its partner, Alkermes, have sued at least one drug company to prevent the product from going on the market before Vesto's patent expires.
alkermes said in a recent filing with the SEC that the two companies had filed patent lawsuits against Greenlee Pharmaceuticals last year, but that the dispute had now been settled.
developed its own version of the injection, Lipe ketone re-release microbes, and did not seek approval through the FDA's generic approach.
In December 2019, Greenlee Pharmaceuticals announced that its self-developed innovative drug, LY03004, had been included in the priority review process by the Drug Review Center (CDE) of the State Drug Administration of China, and that it was expected to accelerate its listing in China.
NDA review of the drug in the U.S. is at an advanced stage, and its production sites have passed fda-approved pre-market inspections.
Proair HFA was successfully approved in 2004 by Teva's original Proair HFA (Salbonide Sulphate).
In April 2020, the FDA approved the first ProAir-HFA inhalation aerosol generic drug, developed by Teva's partner Perrigo, to treat or prevent bronchial spasms in patients with reversible obstructive airway disease aged 4 years and older, and to prevent tracheal spasms caused by exercise in patients 4 years of age and older.
fact, as early as 2014, Teva signed a patent agreement with Perrigo and Catalent that allowed the two companies to sell Proair HFA generics in limited quantities from December 2016 to June 2018, with unlimited sales after June 2018.
that Perrigo and Catalent's efforts proved more challenging than expected.
after numerous setbacks, Proair finally got approval for generics in February 2020, and the company is now rolling out a limited supply of generics and stepping up production.
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