To state the obvious: Drugs are increasingly complex and so are their patent lives.
It’s not uncommon for a drug to have a dozen or more patents covering everything from the active ingredient to the delivery mechanism, to whether the biologic is a fully humanized or not. If the respective IP is submitted at different times, the patents may expire years apart.
Adding to the confusion is the fickle nature of the patent cliff. Exclusivity timelines wax and wane with competitor lawsuits or incentives such as pediatric exclusivity, which delay the generic onslaught by a full six months.
So, with all those caveats in mind, here’s a round-up of prescription drugs set to expire in 2018 — based on current information.
The list began with the National Pharmaceutical Services (NPS) calendar of medications coming off-patent by 2022. This was cross-referenced with the FDA’s ‘Orange Book,’ which provides up-to-date information on the status of brand-name and generic drugs; Drugs.com’s generic availability database; and the Therapeutic Research Center’s ‘Anticipated Availability of First-Time Generics’ list. For biologic drugs, The Center for Biosimilars and a range of news sources were factored in — due to the absence of Orange Book data.
- Acanya, (benzoyl peroxide/clindamycin) – July 1, 2018
- Adcirca (tadalafil) – May 21, 2018
- Ampyra (dalfampridine) – July 30, 2018
- Apidra (insulin glulisine) – June 2018
- Cialis (tadalafil) – September 27, 2018
- Fentora (fentanyl) – March 26, 2019
- Finacea (azelaic acid) – November 18, 2018
- Follistim (follitropin beta) – January 14, 2018
- Fortesta (testosterone) – November 9, 2018
- Levitra/Staxyn (vardenafil) – October 31, 2018
- Lexiva (fosamprenavir) – June 2018.
- Lotronex (alosetron) – October 5, 2018
- Lyrica (pregabalin) – December 30, 2018
- Makena (hydroxyprogesterone) – February 3, 2018
- Promacta (eltrombopag) – October 30, 2018
- Rapaflo (Silodosin) – December 1, 2018
- Remodulin (treprostinil) – June 26, 2018
- Sensipar tablet (cinacalcet) – March 8, 2018
- Spiriva (tiotropium) – July 30, 2018
- Symbicort (budesonide/formoterol) – September 9, 2018
- Tekamlo (aliskiren) – July 21, 2018
- Tekturna HCT (aliskiren/hctz) – July 21, 2018
- Tikosyn (dofetilide) – October 9, 2018
- Treximet (naproxen/sumatriptan) – February 14, 2018
- Tyvaso (treprostinil) – November 13, 2018
- Vesicare (solifenacin) – October 19, 2018
Five drugs: Namzaric (memantine/donepezil), Pradaxa (dabigatran), Revlimid (lenalidomide), Astepro (azelastine), and Xolair (omalizumab), were also listed on the NPS document, but current information shows their expiration date is either before or after 2018.
How much money is on the line?
According to the EvaluatePharma World Preview 2017, Outlook to 2022 report, $194 billion in brand-name sales are at risk during the 2017-2022 period and an estimated $31 billion could be lost due to patent expirations in 2018 alone.
No further details about the brands or the manufacturers were given, so it’s difficult to know if Evaluate’s calculations are based on a comparable list. Of the 26 drugs identified in this article, there are several big franchises at risk.
Pfizer’s Lyrica (pregabalin) for fibromyalgia and neuropathic pain will expire in December 2018. Since 2007, the drug has achieved blockbuster U.S. sales in excess of $1 billion per year. By 2016, that figure had climbed to $5 billion, helped along by its status as a non-opioid painkiller.
Pfizer successfully defended its patent exclusivity for pregabalin in a 2014 court case, maintaining its 2018 deadline. The company had one more trick up its sleeve: In October 2017, the company announced it had won FDA approval for an extended-release version of the drug (albeit for limited indications), a common tactic that could help soften the blow of any pending generics.
Respiratory products appear to be on the cusp of significant upheaval. The field’s biggest earner, GSK’s Advair (fluticasone propionate), lost its exclusivity in 2016. Another top seller, Xolair (omalizumab), expired in 2017. Looking ahead to 2018, two other substantial franchises are on the line.
Boehringer Ingelheim’s Spiriva, a COPD staple, will lose patent protection over its active ingredients in mid-2018, courtesy of a six-month pediatric exclusivity boost. It banked just under $1.9 billion in U.S. sales in 2016. AstraZeneca’s Symbicort (budesonide/formoterol) expires several months later, putting its $1.4 billion in U.S. sales at risk. On the bright side for the companies, inhalers are not an easy field for generic manufacturers to come after, given they are both drugs and devices.
Eli Lilly is still clinging on to patent exclusivity for Cialis (tadalafil), its second-highest grossing drug, which pulled in $1.5 billion in U.S. sales in 2016. While most of its IP has now expired, one last patent covering unit dose remains. Following a recent court settlement, Lilly announced that it will likely keep competition at arms-length until September 2018 or later.
Bayer Healthcare’s Levitra/Staxyn (vardenafil), a lesser-known competitor of Viagra and Cialis, also has patents that start expiring in 2018. While vardenafil has never had a large piece of the erectile dysfunction market, it will still be impacted by the generics waiting in the wings. After all, the market is forecast to be worth $3.2 billion per year by 2022.
On an administrative front, generics manufacturers have entered a favorable period. Streamlining the approval process for generics has been a priority for new FDA Commissioner Scott Gottlieb, who Tweeted about the agency’s 2017 success in late December:
This year #FDA approved a record number of generic drugs. For the 11 months from Jan-Nov FDA gave 771 full and 168 tentative generic approvals. Plus, the Dec total is still to come. That compares to the second highest record, in 2016, with a 12-month total of 630 full approvals
— Scott Gottlieb, M.D. (@SGottliebFDA) December 25, 2017
The ultimate test will be whether total spending on prescription medicines begins to track down.
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