Pharsight

Top 10 Blockbuster Drug Patents Expiring in 2023

1. ABILIFY MAINTENA KIT

Revenue: $15.5 Billion

Long-acting injectable antipsychotics are gaining popularity for treating schizophrenia, offering more consistent medication delivery. A leading drug in this category is Abilify Maintena from Otsuka Pharmaceutical, which generated impressive sales of around $15.5 billion in 2022. Abilify Maintena consists of aripiprazole in an extended release injectable suspension, dosed monthly for maintenance treatment of schizophrenia in adults. By providing steady levels of the drug, Abilify Maintena avoids daily pills and improves adherence. Since its approval in 2013, Abilify Maintena has become a prime choice for patients and doctors managing schizophrenia. Despite requiring in-office injections, the efficacy and convenience has driven strong revenue growth for Otsuka. With long-acting injectables gaining traction, Abilify Maintena is poised to continue dominating this growing antipsychotic market.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8759351 OTSUKA PHARM CO LTD Methods for administering aripiprazole
Aug, 2023

(10 months ago)

US8338428 OTSUKA PHARM CO LTD Methods for administering aripiprazole
Aug, 2023

(10 months ago)

2. OZEMPIC

Revenue: $3.6 Billion

The incretin mimetic class of diabetes medications continues to see substantial growth, driven by new GLP-1 receptor agonists like Ozempic from Novo Nordisk. Ozempic (semaglutide) is an injectable GLP-1 analogue used for improving glycemic control in type 2 diabetes patients. By mimicking the effects of the hormone GLP-1, Ozempic stimulates insulin release and suppresses glucagon secretion in a glucose-dependent manner. Since its approval in 2017, Ozempic has rapidly become a blockbuster diabetes drug for Novo Nordisk, generating annual sales of around $3.6 billion. However, it does require daily or weekly injection and has side effects like nausea. Still, with the growing diabetes population and strong efficacy, Ozempic is poised for continued commercial success for Novo Nordisk.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8579869 NOVO Needle mounting system and a method for mounting a needle assembly
Jun, 2023

(11 months ago)

3. OXYCONTIN

Revenue: $3 Billion

OxyContin (oxycodone controlled-release) is a powerful prescription opioid painkiller manufactured and marketed by Purdue Pharma. First approved in 1995, OxyContin generated over $3 billion in annual sales at its peak, making it the top-selling opioid painkiller in the U.S. However, OxyContin has also been at the center of the prescription opioid addiction epidemic, with Purdue Pharma paying out billions in legal settlements over allegations of deceptive marketing practices. While still available today for severe pain when alternative treatments are inadequate, OxyContin prescriptions have declined sharply in recent years as restrictions have tightened and public awareness of opioid addiction risks has grown. The story of OxyContin provides a cautionary tale about the pharmaceutical industry's pursuit of blockbuster profits and the tragic human consequences that can result.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9675610 PURDUE PHARMA LP Abuse-proofed dosage form
Jun, 2023

(a year ago)

US10369109 PURDUE PHARMA LP Abuse-proofed dosage form
Jun, 2023

(a year ago)

US10130591 PURDUE PHARMA LP Abuse-proofed dosage form
Nov, 2023

(6 months ago)

US8309060 PURDUE PHARMA LP Abuse-proofed dosage form
Nov, 2023

(6 months ago)

US10675278 PURDUE PHARMA LP Crush resistant delayed-release dosage forms
Nov, 2023

(6 months ago)

4. SYMBICORT

Revenue: $2.5 Billion

Respiratory diseases like asthma and COPD represent a significant market for pharmaceutical companies. A leading drug in this category is Symbicort from AstraZeneca, which generated sales of around $2.5 billion last year. Symbicort contains two active ingredients - budesonide, an inhaled corticosteroid, and formoterol, a long-acting beta2-agonist bronchodilator. By combining both ingredients, Symbicort provides effective anti-inflammatory and bronchodilator effects in a single inhaler for patients with asthma or COPD. Since its approval in 2006, Symbicort has become one of AstraZeneca's most successful respiratory drugs. Its ability to improve symptoms and reduce exacerbations has made it a go-to maintenance therapy for many patients. While cheap generic versions are now available, Symbicort remains a billion-dollar blockbuster franchise for AstraZeneca.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10166247 ASTRAZENECA Composition for inhalation
Jan, 2023

(1 year, 4 months ago)

US8575137 ASTRAZENECA Composition for inhalation
Jan, 2023

(1 year, 4 months ago)

US8143239 ASTRAZENECA Composition for inhalation
Jan, 2023

(1 year, 4 months ago)

US7759328 ASTRAZENECA Composition for inhalation
Jan, 2023

(1 year, 4 months ago)

US11311558 ASTRAZENECA Composition for inhalation
Jan, 2023

(1 year, 4 months ago)

US11311558

(Pediatric)

ASTRAZENECA Composition for inhalation
Jul, 2023

(10 months ago)

US7759328

(Pediatric)

ASTRAZENECA Composition for inhalation
Jul, 2023

(10 months ago)

US8143239

(Pediatric)

ASTRAZENECA Composition for inhalation
Jul, 2023

(10 months ago)

US8575137

(Pediatric)

ASTRAZENECA Composition for inhalation
Jul, 2023

(10 months ago)

US10166247

(Pediatric)

ASTRAZENECA Composition for inhalation
Jul, 2023

(10 months ago)

5. ENTRESTO

Revenue: $2.5 Billion

Heart failure is a major health concern, with few recent blockbuster drugs emerging. One exception is Entresto from Novartis, which generated impressive sales of around $2.5 billion in 2022. Entresto (sacubitril/valsartan) is an oral combination drug used for reducing the risk of cardiovascular death and hospitalization in patients with chronic heart failure. By enhancing the protective neurohormonal systems while suppressing the harmful effects, Entresto helps improve outcomes. Since its FDA approval in 2015, Entresto has become a blockbuster heart failure drug for Novartis. Its ability to significantly reduce heart failure hospitalizations compared to older drugs like ACE inhibitors has driven its commercial success. With an aging population and rising prevalence of heart failure, Entresto is positioned to continue generating robust revenue growth for Novartis.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8796331 NOVARTIS PHARMS CORP Methods of treatment and pharmaceutical composition
Jan, 2023

(1 year, 5 months ago)

US8404744 NOVARTIS PHARMS CORP Methods of treatment and pharmaceutical composition
Jan, 2023

(1 year, 5 months ago)

US8796331

(Pediatric)

NOVARTIS PHARMS CORP Methods of treatment and pharmaceutical composition
Jul, 2023

(11 months ago)

US8404744

(Pediatric)

NOVARTIS PHARMS CORP Methods of treatment and pharmaceutical composition
Jul, 2023

(11 months ago)

US7468390 NOVARTIS PHARMS CORP Methods of treatment and pharmaceutical composition
Nov, 2023

(6 months ago)

6. PRADAXA

Revenue: $1.8 Billion

The oral anticoagulant market has seen substantial growth in recent years, driven by new options like Pradaxa from Boehringer Ingelheim. Pradaxa (dabigatran etexilate) is a direct thrombin inhibitor approved for reducing stroke risk in patients with atrial fibrillation and treating venous thromboembolism. As an alternative to warfarin, Pradaxa provides more convenient anticoagulation without regular blood monitoring. Despite some bleeding risks, Pradaxa has been widely adopted since its approval in 2010, generating impressive sales of around $1.8 billion for Boehringer Ingelheim in 2022. However, lower-cost generics have started eroding Pradaxa's market share. Still, its efficacy and brand recognition makes Pradaxa an important player in the competitive anticoagulant space, although future revenue growth is uncertain due to generic competition.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9925174 BOEHRINGER INGELHEIM Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof
Jun, 2023

(1 year, 2 days ago)

US9925174

(Pediatric)

BOEHRINGER INGELHEIM Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof
Dec, 2023

(6 months ago)

7. JENTADUETO

Revenue: $1.7 Billion

The Type 2 diabetes market continues to grow globally, with combination therapies gaining significant use. One such combination is Jentadueto from Boehringer Ingelheim and Eli Lilly, which generated sales of around $1.7 billion in 2022. Jentadueto contains linagliptin and metformin hydrochloride, combining a DPP-4 inhibitor with metformin in a single pill. By tackling Type 2 diabetes through complementary mechanisms, Jentadueto provides improved glycemic control compared to the individual components alone. Since its approval in 2012, Jentadueto has become an important option for doctors and patients looking to intensify diabetes management beyond metformin. However, the recent introduction of a generic version of Jentadueto is expected to substantially impact revenue going forward. Still, the convenience and efficacy of the combination gives Jentadueto an edge in the competitive diabetes market.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8119648 BOEHRINGER INGELHEIM 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Aug, 2023

(10 months ago)

US8178541 BOEHRINGER INGELHEIM 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Aug, 2023

(10 months ago)

8. XELJANZ

Revenue: $1.6 Billion

Xeljanz, developed by Pfizer, is a blockbuster drug for the treatment of rheumatoid arthritis that generated revenue of around $1.6 billion in 2022. Xeljanz (tofacitinib) is an oral small-molecule Janus kinase (JAK) inhibitor that was approved in 2012 for moderate to severe rheumatoid arthritis in adults. As a targeted immunosuppressant, Xeljanz can reduce joint inflammation and damage in rheumatoid arthritis. Since its launch, Xeljanz has become an important treatment option for rheumatologists and patients looking for an alternative to biologic DMARDs. However, Xeljanz does carry risks like serious infections, malignancies, and thrombosis. Despite these safety concerns, Xeljanz continues to be a successful blockbuster franchise for Pfizer thanks to its oral administration and efficacy for rheumatoid arthritis symptoms. But it faces biosimilar competition on the horizon.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6965027 PF PRISM CV Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate
Mar, 2023

(1 year, 2 months ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6965027 PF PRISM CV Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate
Mar, 2023

(1 year, 2 months ago)

9. XELJANZ XR

Revenue: $1.6 Billion

In addition to the original immediate-release Xeljanz, Pfizer also markets Xeljanz XR, an extended-release formulation of tofacitinib. Approved in 2015, Xeljanz XR generates comparable annual sales to Xeljanz IR, around $1.6 billion. As an oral Janus kinase (JAK) inhibitor, Xeljanz XR provides sustained exposure over 24 hours with once daily dosing. This makes it more convenient than twice daily Xeljanz IR for patients with moderate to severe rheumatoid arthritis. Like the original, Xeljanz XR can reduce inflammation and halt progression of joint damage associated with rheumatoid arthritis. However, it carries similar safety risks of serious infections and other side effects. While facing impending biosimilar threats, the Xeljanz franchise remains an important blockbuster for Pfizer thanks to the efficacy and oral administration of Xeljanz XR and Xeljanz.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6956027 PFIZER N-terminally chemically modified protein compositions and methods
Mar, 2023

(1 year, 2 months ago)

US6965027 PFIZER Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate
Mar, 2023

(1 year, 2 months ago)

10. OTEZLA

Revenue: $1.6 Billion

Otezla, marketed by Amgen, is a blockbuster oral medication used for treating psoriasis and psoriatic arthritis. In 2022, Otezla generated impressive sales of around $1.6 billion. Otezla (apremilast) is a phosphodiesterase 4 (PDE4) inhibitor that was approved in 2014 for plaque psoriasis and active psoriatic arthritis. As an oral alternative to injectable biologics, Otezla offers a convenient option for reducing skin and joint inflammation associated with psoriasis. While not as potent as biologics for severe disease, Otezla provides clinically meaningful improvements in symptoms for many patients. Despite some gastrointestinal side effects, Otezla has become an important first-line systemic therapy for moderate plaque psoriasis. Its continued success has established Otezla as a blockbuster psoriasis drug for Amgen.

Drug Patent Number Company Drug Patent Title Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7893101 AMGEN INC Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
Dec, 2023

(6 months ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8455536 AMGEN INC Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
Mar, 2023

(1 year, 2 months ago)

US8802717 AMGEN INC Methods of treating arthritic conditions using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
Mar, 2023

(1 year, 2 months ago)

US7208516 AMGEN INC Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione
Mar, 2023

(1 year, 2 months ago)

US7659302 AMGEN INC Methods of using (+)-2-[1-(3-ethoxy-4 methoxyphenyl)-2-methylsulfonylethyl]-4 acetylaminoisoindoline 1,3-dione
Mar, 2023

(1 year, 2 months ago)

US9018243 AMGEN INC Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
Mar, 2023

(1 year, 2 months ago)

US6962940 AMGEN INC (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof
Mar, 2023

(1 year, 2 months ago)

US9724330 AMGEN INC Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione
Mar, 2023

(1 year, 2 months ago)

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